ACT
Of 6 September, 2001
Pharmaceutical Law
(uniform text)
Chapter 1
General provisions
Article 1. 1. The Act defines:
1) principles and procedure of marketing authorization of medicinal products, considering in particular
the requirements relating to quality, efficacy and safety of their administration;
1a) conditions of conducting clinical trials of medicinal products;
2) conditions of manufacturing of medicinal products;
3) requirements concerning advertising of medicinal products;
4) conditions of marketing in medicinal products;
5) requirements concerning pharmacies, pharmaceutical warehouses and non-pharmaceutical marketing
facilities;
6) tasks of the Pharmaceutical Inspection and the rights of its competent authorities.
2. The provisions of this Act shall be also applied to medicinal products being intoxicants and
psychotropic substances and precursors in the meaning of the provisions on counteracting drug addiction,
in the scope not regulated by these provisions.
Article 2. For the purpose of this Act the following shall apply:
1) biological activity of medicinal product - refers to strength of the effect of its active substance or
substances, which may be expressed in international or biological units;
2) clinical trial - means any trial carried out with the participation of human subjects for the purpose of
stating or confirming clinical, pharmacological, including pharmacodynamic effects of action of one or
more tested medicinal products, or in order to identify undesirable effects of one or more tested
medicinal products, or to monitor the absorption, distribution, metabolism and excretion of one or
more tested medicinal products, with respect to their safety and efficacy;
2a) researcher – is any physician or stomatologist, if a clinical trial concerns stomatology, or veterinarian
– in the event of veterinary clinical trial, having the right to exercise a profession on the territory of the
Republic of Poland and who posses relevant professional authorizations, scientific knowledge and
experience in contact with patients, necessary to conduct a given clinical trial or veterinary clinical
trial, responsible for carrying out of such trials in a given centre; in the event, in which a clinical trial or
veterinary clinical trial is carried out by a team, a researcher appointed by sponsor, by assent of a
manager of health care facility, in which such clinical trial is conducted, plays the role of the team
manager responsible for carrying out of such trial in a given centre;
2b) veterinary clinical trial – means any trial, purpose of which is to confirm the assumed efficacy or
safety of tested veterinary medicinal product, carried out with the participation of one or more target
animal species;
2c) tested medicinal product – is a substance or a mixture of substances, which were formed into a
pharmaceutical form of an active substance or placebo, which is tested or used as a reference
product in a clinical trial, including also the products already authorized to the market, however used
or prepared in a different way comparing to the form authorized to the market, or used for indication
not covered by such authorization, or used for the purpose of obtaining additional information
concerning the forms already authorized to the market;
2d) tested veterinary medicinal product – is a substance or a mixture of substances, which were formed
into a pharmaceutical or a biological form and which are used in clinical veterinary trials;
3) undesirable effect of tested medicinal product or of tested veterinary medicinal product – is any
unfavourable and unintentional effect of these medicinal products, occurring after administration of
any dose of these products;
3a) undesirable effect of medicinal product – is any unfavourable and unintentional effect of a medicinal
product, occurring during administration of doses recommended in humans for prophylactic,
diagnostic, therapeutic purposes, or for modification of physiological functions;
3b) undesirable effect of veterinary medicinal product – is any unfavourable and unintentional effect of a
veterinary medicinal product
a) occurring during administration of doses recommended in animals for prophylactic, diagnostic
and therapeutic purposes, or for modification of physiological functions
b) Occurring in humans after the exposure on veterinary medicinal product;
3c) severe undesirable event after administration of tested medicinal product or tested veterinary
medicinal product – is such event, which regardless of administered dose of a tested medicinal
product or a tested veterinary medicinal product, results in patient’s death, life threat, necessity of
hospitalization or its prolongation, permanent or considerable health injury, inborn defect or foetus
injury;
3d) severe undesirable effect of medicinal product – is such effect, which regardless of administered
dosage of a medicinal product, results in patient’s death, life threat, necessity of hospitalization or its
prolongation, permanent or considerable health injury or any other effect of a medicinal product,
which a physician, according to his/her best knowledge, shall consider severe, or is an illness, inborn
defect or foetus injury;
4) Good Distribution Practice - is the practice, which ensures safe receiving, transport, storage and
dispensation of medicinal products;
5) (repealed);
6) Good Clinical Practice - is the group of requirements recognized by international community
concerning ethics and quality of scientific research, in the course of carrying out clinical trials,
guaranteeing protection of law, safety and welfare of participants of such trials as well as credibility of
the results;
6a) Good Clinical Veterinary Practice - is the group of requirements recognized by international
community concerning ethics and quality of clinical veterinary trials, carried out to ensure animals
welfare and safety of the personnel participating in the clinical veterinary trial as well as
environmental protection and health of consumer of food of animal origin;
7) Good Manufacturing Practice - is the practice ensuring that the medicinal products are manufactured
and controlled adequately to their intended use and in compliance with the requirements included in
their specifications and documents constituting a basis to issue a permit for marketing authorization of
medicinal product;
7a) import of medicinal products – is any activity, consisting in import of finished medicinal product from
the other countries than the Member States of the European Union or the Member States of the
European Free Trade Association (EFTA) – parties to the Agreement on the European Economic
Area, including in particular their storage, quality control in the course of batch release and
distribution;
7b) parallel import – is any activity, consisting in import of a medicinal product from the Member States of
the European Union or from the Member States of the European Free Trade Association (EFTA) –
parties to the Agreement on the European Economic Area, meeting all of the following conditions:
a) the imported medicinal product has the same active substance (active substances), at least: the
same indications concerning the 3rd level of the ATC/ATCvet code (code of anatomical –
therapeutic and chemical classification), the same strength, the same administration route and the
same form as the medicinal product authorized to market on the territory of the Republic of Poland
or similar form, which shall not result in any therapeutic differences in relation to the medicinal
product authorized to market on the territory of the Republic of Poland,
b) the imported medicinal product and the medicinal product authorized to market on the territory of
the Republic of Poland are in the country, from which the product is imported and on the territory
of the Republic of Poland, respectively, the reference medicinal products or analogues of the
reference medicinal products simultaneously;
8) therapeutic mineral - is unprocessed mineral forming a deposit in earth’s crust, applicable for
therapeutic purposes; in particular it concerns curative water and medicinal peat;
9) initial batch control - is the control of each batch of the manufactured medicinal product, carried out
before placing the product on the market;
10) pharmaceutical medicine - is the medicine prepared in a pharmacy according to the pharmacopeial
recipe and intended to dispensation in this pharmacy;
11) finished medicine - is a medicinal product placed on the market under a specified name and in a
specified packaging;
12) prescription medicine - is a medicinal product prepared in a pharmacy on the basis of the medical
prescription, and in the event of a veterinary medicinal product – on the basis of prescription issued
by the veterinarian;
12a) strength of medicinal product – is the content of active substances, expressed quantitatively per unit
of dose, unit of capacity or per unit of weight, depending on its pharmaceutical form;
13) Maximum Residue Limit – is the limit defined in Article 1(1) b) of the Council Regulation (EEC) No,
2377/90 of 26 June 1990, laying down a Community procedure for the establishment of maximum
residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ EC L 224 of
18.08.1990, page 1, as amended; OJ EU Polish special edition, chapter 3, vol. 10, page 111),
hereinafter referred to as the “Regulation No. 2377/90";
13a) initial material – is any substance used to manufacture a medicinal product, excluding packaging
materials;
14) name of medicinal product - is the name given to a medicinal product, which may be either a proper
name, providing no possibility of being mistaken with a common name, or a common or scientific
name provided with a trademark or a name of the responsible entity;
15) common name - is the international name recommended by the World Health Organization, or if such
name does not exist, the popular common name of the medicinal product;
16) undesirable event - is any undesirable event of medical nature having undesirable effects on a patient
or a participant of a clinical trial, to whom a medicinal product or a tested medicinal product, or a
tested veterinary medicinal product has been administered, even if there was no causality with the
usage of this product;
17) unexpected undesirable effect - is any negative effect of a medicinal product, nature or level of
intensity of which is incompliant with data included in appropriate information on the medicinal
product – the most often for medicinal products in clinical trials - data often included in researcher's
brochure, and for medicinal products authorized to market – in the Specification of Medicinal Product;
17a) severe unexpected undesirable effect of medicinal product- is any undesirable effect of a medicinal
product, nature or level of intensity of which is incompliant with data included in appropriate
information on the medicinal product:
a) for medicinal products in clinical trials – most often included in researcher's brochure,
b) for medicinal products authorized to the market – in the Specification of Medicinal Product or in
the Specification of Veterinary Medicinal Product
which, regardless of an administered dose of the medicinal product, results in patient’s death, life
threat, necessity of hospitalization or its prolongation, permanent or considerable health injury or
any other effect of the medicinal product, which the physician, according to his/her best
knowledge, shall consider as severe, or is an illness, inborn detect or foetus injury;
18) (repealed);
19) period of grace - is the period that must lapse from the last administration of a veterinary medicinal
product to the moment of animal slaughtering, and in the case of milk, eggs or honey, to the first
moment of launching of manufacturing of these products for consumption in order to ensure that
animal tissues and products do not contain residues in quantity exceeding Maximum Residue Limits;
20) primary packaging of the medicinal product - is the packaging having direct contact with a medicinal
product;
21) secondary packaging of medicinal product - is the packaging into which the primary packaging is
placed;
22) labelling of medicinal product - is information on the primary or secondary packaging of a medicinal
product;
22a) reference state – is any Member State of the European Union or Member State of European Free
Trade Association (EFTA) – parties to the Agreement on the European Economic Area, which:
a) prepares draft assessment report within the decentralized procedure;
b) issued a permit constituting a basis to launch the procedure of mutual recognition;
23) (repealed);
24) responsible entity - is an entrepreneur, in the meaning of the Act of 2 July, 2004 on freedom of
business activity (Journal of Laws No. 173, item 1807) or entity running a business activity in any
Member State of the European Union or in any Member State of the European Free Trade
Association (EFTA) – parties of Agreement on the European Economic Area, who applies for or has
received the marketing authorization for a medicinal product;
25) residues of veterinary medicinal products - are any residues of medicinal products, referred to in
Article 1(1) a) of the Regulation No. 2377/90;
26) marketing authorization - is a decision given by the authorized authority, confirming that a given
medicinal product may be marketed on the territory of the Republic of Poland;
27) medicated pre-mix - is any veterinary medicinal product, which in result of technological process has
been prepared in a form allowing for mixing with feed in order to produce medicinal feed;
27a) medicinal product intended for special feeding purposes – is any medicinal product intended for
feeding treatment, which has been properly processed and produced and has precisely specified
composition, administered to humans at the order and under the control of a physician;
28) (repealed);
29) homoeopathic medicinal product - is any medicinal product prepared from homeopathic primary
substances or their mixtures, in accordance with a homoeopathic production procedure described in
the European Pharmacopoeia or, in case of lack of such description, in the Pharmacopoeias officially
recognized by the Member States of the European Union or in the Member States of the European
Free Trade Association (EFTA) – parties to the Agreement on the European Economic Area;
30) immunological product - is any medicinal product, constituting serum, vaccine, toxin or allergen, used
to:
a) induce active immunity (vaccines),
b) transfer of passive immunity (sera),
c) diagnose the immunity status (in particular tuberculin),
d) identification or induction of specific acquired change in immunological response for sensitizing
factor (allergens);
31) hematogenic product – is any medicinal product manufactured in industrial manner from blood or its
components, in particular albumin, coagulating factors and immunoglobulin;
32) medicinal product - is any substance or a mixture of substances, which is presented as having the
properties of preventing or treating human or animal diseases or administered to humans or animals
in order to provide medical diagnosis or to restore, improve or modify physiological functions of an
organism by means of pharmacologic, immunological or metabolic actions;
33) (repealed);
33a) medicinal product of plant origin - is any medicinal product composed of one or more plant
substances or one or more plant preparations or one or more plant substance as active components
combined with one or more plant preparation, provided that:
a) plant substance – are all, mainly whole plants, plants divided or cut into parts, pieces of plants,
algae, fungi, unprocessed lichens, usually dried or fresh; some secretions, which have not been
subject to a specific process, may also be recognized as plant substances; plant substances are
defined in details by the used part of a plant and its botanical name,
b) plant preparation - is any preparation received by processing plant substances by means of:
extraction, distillation, squeezing, separation, cleaning, thickening and fermentation; preparations
are in particular crumbled or powdered plant substances, liqueurs, tinctures, oils and squeezed
juices;
34) veterinary medicinal product - is any medicinal product administered to animals exclusively;
35) radiopharmaceutical product - is any medicinal product, excluding a veterinary medicinal product,
containing one or more radioactive isotopes intended for medical purposes;
35a) representative of the responsible entity – is any legal or physical person, appointed by the
responsible entity to perform its duties and rights on the territory of the Republic of Poland;
35b) reference medicinal product – is any medicinal product authorized to market on the basis of complete
dossier;
35c) risk of medicinal product use – is any threat to health of a patient or public health related to quality,
safety or efficacy of a medicinal product and any threat posed by an undesirable impact on the
environment, and in the event of veterinary medicinal products – any threat to health of animals or
humans, related to quality, safety or efficacy of a veterinary medicinal product and any threat posed
by an undesirable impact on the environment;
36) (repealed);
37) batch - is any quantity of medicinal product or pharmaceutical raw material, or packaging material,
which has been manufactured in a process consisting of one or more operations in such a way that it
may be considered as homogenous;
37a) sponsor – is any physical or legal person or an organizational unit, having no legal personality,
responsible for launching, carrying out and financing of a clinical trial, having a seat on the territory of
one of the Member States of the European Union or Member States of the European Free Trade
Association (EFTA) – parties to the Agreement on the European Economic Area. If a sponsor has no
seat on the territory of one of the states of the European Economic Area, it may act only and
exclusively by proxy of its legal representative having a seat on this territory;
37b) risk – benefit balance – is the assessment of positive therapeutic results of a medicinal product in
relation to the risk connected with usage of the medicinal product, excluding threat posed by
undesirable impact on the environment, and in the event of a veterinary medicinal product - the
assessment of positive therapeutic results of a veterinary medicinal product in relation to the risk
connected with usage of the veterinary medicinal product;
38) substance - is any matter which may be of:
a) human origin, in particular human blood and human blood elements and components,
b) animal origin, in particular microorganisms, whole animal organisms, parts of organs, animal
secretions, toxins, extracts, animal hematogenic elements and components,
c) vegetable origin, in particular microorganisms, whole plant organisms, parts of plants, plant
secretions and extracts,
d) chemical origin, in particular chemical elements or chemical compounds occurring naturally in
the environment or obtained by means of chemical transformations or synthesis;;
39) (repealed);
40) pharmaceutical raw material - is any substance or mixture of substances used for preparation or
manufacturing of medicinal products;
40a) participant of clinical trial – is a person, who, after being informed of the essence, significance,
effects and risk of a clinical trial, expressed its informed consent for participation in a trial; the
document confirming such informed consent is kept together with dossier of such clinical trial;
41) leaflet - is any information intended for a user, approved in the process of marketing authorization,
prepared as a separate written document and attached to the medicinal product;
42) manufacturing of medicinal products - is any activity leading to development of a medicinal product,
including purchase and reception of materials used in manufacturing process by a manufacturer,
production, authorization to the subsequent production stages, including packaging, re-packaging as
well as storing and distribution of own medicinal products, together with control activities related to
the abovementioned activities;
42a) manufacturing of active substances used as initial materials intended for manufacturing of medicinal
products – is any activity leading to development of active substances, including import of active
substances used as initial materials intended for manufacturing of medicinal products from the
countries other than the Member States of the European Union or the Member States of the
European Free Trade Association (EFTA) – parties to the Agreement on the European Economic
Area, distribution, packaging, re-packaging and re-labelling;
43) manufacturer - is an entrepreneur, in the meaning of the Act of 2 July, 2004 – on freedom of business
activity, who, on basis of authorization issued by an authorized authority, performs at least one of the
activities mentioned in item 42;
44) batch release - is a confirmation provided by a qualified person that a given batch of a medicinal
product or tested medicinal product has been manufactured and controlled pursuant to the legal
regulations and the requirements on marketing authorization or the conditions for launching of a
clinical trial.
Chapter 2
Marketing authorization of medicinal products
Article 3. 1. Subject to the provisions of Paragraph 4 and Article 4, the medicinal products, which
received marketing authorization, hereinafter referred to as the “authorization” shall be authorized to the
market.
2. Also the medicinal products, which have received the authorization issued by the Council of the
European Union or the European Commission, shall be authorized to the market.
3. Minister of Health shall be the authority entitled to issue the authorizations.
4. The following products shall be authorized to the market without the need to receive the authorization,
referred to in Paragraph 1:
1) prescription medicines;
2) pharmaceutical medicines;
3) radiopharmaceutical products being prepared at the time of their application in the authorized health
service units, from the generators, kits, radionuclides and precursors authorized to the market, in
accordance with the manufacturer’s instructions, as well as radionuclides in the form of closed
radiation sources;
4) blood and plasma in its full composition, or blood cells of human or animal origin, excluding plasma
processed in the course of an industrial process;
5)
pharmaceutical raw materials, not intended for preparation of prescription and pharmaceutical
medicines
6) immunological veterinary medicinal products produced from pathogens or antigens originating from
animals bred in a given holding and intended for treatment of animals present in this holding.
Article 3a. The provisions of this Act shall be applied to the product meeting simultaneously the
criteria of a medicinal product and criteria of the other type of product, in particular diet supplements or
cosmetics, specified by separate provisions.
Article 4. 1. Medicinal products imported from other countries shall be authorized to the market
without the need to receive the authorization, if their application is indispensible to save patient’s life or
health, provided that the given medicinal product is authorized to the market in the exporting country and
has valid marketing authorization, subject to the provisions of Paragraph 3 and 4.
2. The basis to import a medicinal product, referred to in Paragraph 1, shall be a request of a hospital
or a physician practicing outside the hospital, confirmed by a consultant specializing in the relevant field of
medicine.
3. The following medicinal products shall not be authorized to the market, referred to in Paragraph 1:
1) medicinal products, in relation to which the minister competent for health issued a decision on refusal
of issuing of an authorization, refusal of prolongation of validity period of the authorization, withdrawal
of the authorization and
2) medicinal products containing the same active substance or the same active substances, the same
dose and form as the medicinal products, which have received the authorization, subject to the
provisions of Paragraph 3a.
3a. The provision of Paragraph 2(2) shall be not applied to the medicinal products, referred to in
Paragraph 1, price of which is competitive to the price of a medicinal product having an authorization,
referred to in Article 3(1) or (2), provided that the request confirmed by the consultant specializing in a
given field of medicine has been issued by a health insurance physician and the minister competent for
health shall express, by means of a decision, its consent for their import.
4. Medicinal products, specified by the provisions of Paragraph 1, which, considering the safety of
their usage and import volume, should be authorized to market pursuant to Article 3(1), shall be not
authorized to the market.
5. Pharmacies, warehouses and hospitals marketing the medicinal products, referred to in Paragraph
1 shall keep the register of these products.
6. On the basis of the registers kept, a pharmaceutical warehouse shall provide the minister
competent for health, not later than by the tenth day after the end of each quarter, with a list of imported
medicinal products.
7. The minister competent for health shall specify, by means of a regulation:
1) (repealed);
2) detailed method and procedure of import of medicinal products, referred to in Paragraph 1, taking in
particular into consideration:
a) template of a request,
b)
methods of confirmation by the minister competent for health of the circumstances, referred to in
Paragraph 3,
c) methods of confirmation by the President of the National Health Fund of circumstances, referred
to in Article 36 (4) of the Act of 27 August, 2004 on healthcare benefits financed from public funds
(Journal of Laws No. 210, item 2135, as amended 1)),
d) methods of keeping the registers of imported medicinal products by warehouses, pharmacies and
hospitals and
e)
the scope of information provided by a pharmaceutical warehouse to the minister competent for
health.
8. The minister competent for health, and in case of veterinary medicinal products on request of the
minister competent for agriculture, may, in case of natural disaster or any other threat to humans’ life or
health or threat to animals’ life or health, authorize to the market, for a definite period of time, medicinal
products, which do not have the authorization.
9. The minister competent for health, and in case of veterinary medicinal products on request of the
minister competent for agriculture, may, in case of natural disaster or any other threat to humans’ or
animals’ life or health, issue a decision on import, pursuant to the conditions specified in Paragraph 2, 3, 5
and 6, of a medicinal product, which, simultaneously:
1) has the authorization, referred to in Article 3(1) or (2),
2) is authorized to the market in the country, from which it is imported,
3) is unavailable on the territory of the Republic of Poland
- provided that there is no medicinal product available on the territory of the Republic of Poland, which
consists of the same active substance or active substances, of the same strength and form, as the
imported medicinal product.
Article 4a. Medicinal products, which are a subject of parallel import and received the authorization
for parallel import, shall be also authorized to the market.
Article 4b. The minister competent for health may issue a decision on labelling of packaging in
foreign language for a specified number of orphan medicines specified in the Regulation (EC) No.
141/2000 of the European Parliament and of the Council of 16 December, 1999 on orphan medicinal
products (OJ EC L 18 of 22.01.2000, page 1; OJ EU Polish special edition, chapter 15, volume 5, page
21).
Article 5. The following shall require no authorization:
1) medicinal products used exclusively in scientific research, carried out by scientific units, in the
meaning of the Act of 12 January, 1991 on State Committee for Scientific Research (Journal of Laws
of 2001 No. 33 item 389, as well as of 2003 No. 39, item 335), which conduct their activity of medical
nature
2) medicinal products used by manufacturers;
3) tested medicinal products, used for clinical trials exclusively or for veterinary clinical trials, listed in the
Central Register of Clinical Trials and
4) semi-products produced for usage in further manufacturing process conducted by the manufacturer.
Article 6. (repealed).
Article 7. 1. Applications on issuing of the authorization, change of data constituting the basis for issuing
of the authorization, change the validity period of the authorization, shall be submitted by the responsible
entity to the minister competent for health through the agency of the President of the Office for
Registration of Medicinal Products, Medical Devices and Biocides, hereinafter referred to as the ‘President
of the Office’.
2. Issuing of the authorization, change of data constituting the basis for issuing of the authorization,
change the validity period of the authorization, refusal of prolongation, and shortening of the validity period
as well as withdrawal of authorization is made by the decision of the minister competent for health.
3. The authorization shall be issued for a period of five years.
4. The authorization may be issued for a veterinary medicinal product applied to target animal
species, tissues of which or obtained products are intended for human consumption, only in the event, in
which the pharmacological substances contained in this product are listed in Annex I, II or III to the
Regulation No. 2377/90.
5. (repealed).
6. (repealed).
7. (repealed).
Article 7a. 1. For a veterinary medicinal product containing pharmacologically active substances not
listed in Annex I, II or III to the Regulation No. 2377/90, the authorization shall be issued, if the product
does not contain pharmacologically active substances listed in Annex IV to the Regulation No. 2377/90
and is intended for usage in registered Equidae animals, which are not subject to slaughter and intended
for human consumption and for which an ID card (passport) has been issued.
2. For the veterinary medicinal product, referred to in Paragraph 1, the authorization shall be not
issued, if an authorization for the other veterinary medicinal product intended for treatment of a given
disease unit has been issued earlier.
Article 7b. 1. The authorization shall not be issued for any veterinary medicinal product applied to
target animal species, tissues of which or obtained products are intended for human consumption,
containing pharmacologically active substances not listed in Annex I, II or III to the Regulation No.
2377/90, if no application on determination of the Maximal Residue Limit containing complete information
and an enclosed dossier pursuant to the Regulation No. 2377/90 was submitted.
2. Application on issuing of the authorization shall be submitted not earlier than in 6 months after
submitting of an application on determination of the Maximal Residue Limit.
Article 8. 1. Marketing authorization shall be issued by the minister competent for health on the basis
of a report, prepared by the President of the Office.
1a. Before preparation of the report, the President of the Office:
1) shall verify the application, described in Article 10, together with the attached dossier;
2) may request from the responsible entity to complete or provide explanations concerning dossier,
referred to in Article 10, as well as present risk management system for application of medicinal
product;
3) in case of any objections concerning control methods, referred to Article 10 (2), Clause 2, and in the
event of veterinary medicinal products – concerning testing methods, referred to in Article 10(2b),
Clause 6a), which may be explained by experimental method only, order to test a medicinal product,
initial materials and intermediate products or any other components of a medicinal product being the
subject of the application prior to ordering tests of the medicinal product, initial materials and
intermediate products or any other components of the medicinal product, the President of the Office
shall inform the responsible entity in writing on any doubts and justifies the need of conducting of
such tests;
4) may consult the Commission for Medicinal Products, acting under separate provisions;
5) prepares the assessment report containing a scientific opinion on a medicinal product.
1b. The assessment report shall be updated, when any new information important for quality, safety
or efficacy of the given medicinal product occurs.
1c. After issuing of the authorization, the assessment report shall be made available, pursuant to the
provisions on access to public information.
1d. The responsible entity, submitting an application, referred to in Article 7(1), may apply to the
President of the Office to not to reveal information contained in the assessment report, which is the
company’s secret in the meaning of Article 11(4) of the Act of 16 April, 1993 on combating unfair
competition (Journal of Laws of 2003, No. 153, item 1503 as amended 2)), and in particular information on
supply sources.
2. The Commission shall be obliged to issue an opinion together with justification thereof within the period
of up to 30 days from the day of receiving an application; lack of the opinion from the Commission shall be
regarded as a positive opinion.
3. The decision of issuing of marketing authorization for a veterinary medicinal product, excluding
immunological products administered to animals, tissues of which or the obtained products are intended
for human consumption, shall be made only when at least interim Maximum Residue Limits accepted on
the territory of the Member States of the European Union or the Member States of the European Free
Trade Association (EFTA) – parties to the agreement on the European Economic Area have been
specified, or it was decided that for the active substances involved such limits are not required.
4. Data and documents attached to applications, reports and other documents collected in the course
of the proceeding on marketing authorization, prolongation of authorization or change thereof, should be
kept by the Office for Registration of Medicinal Products, Medical Devices and Biocides, hereinafter
referred to as the ‘Registration Office’ for the period of 10 years after termination of the marketing
authorization.
5. Date of issuing of the decision on change of data covered by the authorization and on change of
dossier constituting a basis of issuing of an authorization as well as date of issuing of the decision on the
basis of a separate application on issuing of marketing authorization of medicinal product, including in
additional strength, form, administration route, packaging size, concerning the other animal species, under
a different name or with other Specification of Medicinal Product or Specification of Veterinary Medicinal
Product, for the same entity, who obtained the first marketing authorization of a medicinal product or any
other entity, shall be not considered as a date of the first marketing authorization of the medicinal product
in the meaning of Article 15(1), Clause 2, and in relation to a veterinary medicinal product – in the
meaning of Article 15a(1) and (2), subject to the provisions of Article 15a (5), (8) and (9).
Article 8a. 1. The minister competent for health may, in the cases justified by public health
protection, issue marketing authorization of a medicinal product having no such authorization on the
territory of the Republic of Poland, provided that the this product has been authorized to the market in any
other Member State of the European Union or in any Member State of the European Free Trade
Association (EFTA) – a party to the Agreement of the European Economic Area, pursuant to the
requirements specified in Directive 2001/83/EC of the European Parliament and of the Council of 6
November, 2001 on the Community code relating to medicinal products for human use (OJ EC L 311 of
28.11.2001, page 67, as amended; OJ EU Polish special edition, chapter 13, volume 27, page 69),
hereinafter referred to as the “Directive 2001/83/EC".
2. The provisions of the Act are applied to the authorizations issued under Paragraph 1 respectively.
3. Prior to issuing of the authorization, referred to in Paragraph 1, the minister competent for health:
1) informs the responsible entity in the state, referred to in Paragraph 1, on an intention to issue
marketing authorization on the territory of the Republic of Poland;
2) submits to the competent authorities of the state, referred to in Paragraph 1, to deliver an updated
assessment report on this medicinal product and copy of marketing authorization of this product.
4. In the event of issuing, withdrawal or termination of the authorization, referred to in Paragraph 1,
the minister competent for health informs the European Commission about such fact, indicating in
particular the name of the medicinal product and name and address of the responsible entity.
5. In the event, in which any Member State of the European Union or Member State of the European
Free Trade Association (EFTA) – a party to the Agreement of the European Economic Area, applies under
Article 126a of Directive 2001/83/EC to the minister competent for health, through the medium of the
President of the Office, to deliver an assessment report and a copy of marketing authorization of a
medicinal product authorized to market on the territory of the Republic of Poland, dossier of which is
compliant with the requirements of the Act, the President of the Office provides such updated assessment
report and the copy of authorization within the period of 120 days.
Article 9. 1. Launching of the proceedings in the issues, referred to in Articles 7, 18a and 19 shall
take place at the moment of submitting of the application.
2. The minister competent for health shall specify, by means of a regulation, template of an
application on issuing of marketing authorization of a medicinal product, taking in particular type of
medicinal products and scope of required dossier into consideration.
Article 10. 1. Application on marketing authorization of medicinal product, subject to the provisions of
Articles 15 and 16, should consist in particular the following:
1) name and address of the responsible entity, manufacturer or importer, by whom bath release takes
place, place of manufacturing, including the site, in which batches are controlled or the place of
conducting import activity, in which its batches are controlled, as well as numbers of manufacturing
authorizations or permits to import a medicinal product;
2) name of the medicinal product;
3) detailed qualitative and quantitative data of the active substances and other substances, relating to
the medicinal product as well as their common names, and when such names do not exist – chemical
names;
4) pharmaceutical form, strength and the administration route as well as the expiration date of the
medicinal product and data on environmental protection related to utilization of the medicinal product,
if it is necessary and results from the properties of the product.
2. The following shall be attached to application, referred to in Paragraph 1:
1) description of manufacturing of the medicinal product;
2) description of control methods employed in the manufacturing process;
3) information on special requirements on storage of the medicinal product, dispensation to patients and
utilization of the product after its expiration date together with assessment of environmental threat
related to the medicinal product and description of methods aiming at risk reduction;
4) results, summaries and reports of the following trials:
a) pharmaceutical: physicochemical, biological or microbiological;
b) non-clinical: pharmacological and toxicological,
c) clinical
- together with general summary of quality, non-clinical review and summary of non-clinical data as
well as clinical review and summary;
5) description of undesirable effects monitoring system, which shall be implemented by the responsible
entity;
6) description of the medicinal product risk management system, which shall be implemented by the
responsible entity, if required pursuant to the guidelines of the European Community;
7) in the event of clinical trials carried out outside the territory of the EU Member States or the Member
States of the European Free Trade Association (EFTA) – a party to the Agreement of the European
Economic Area, a statement that these trials meet the ethical conditions defined in the provisions of
Chapter 2a;
8) statement of the responsible entity confirming that such entity has at its disposal services of the
person engaged in permanent surveillance over monitoring of safe use of the medicinal product being
the subject of the application, and that such entity has at its disposal a system ensuring an
opportunity of immediate reporting of any suspicion of undesirable effect on the territory of the EU
Member States or the Member States of the European Free Trade Association (EFTA) – parties to
the Agreement of the European Economic Area or any other states;
9) statements signed by the experts preparing general quality summary, non-clinical review and nonclinical data summary as well as clinical review and summary, referred to Clause 4, on having
indispensable technical or professional skills, described in the attached curriculum vitae;
10) in the event, referred to in Article 16(1), a justification prepared by an expert concerning use of
scientific literature pursuant to the requirements specified in Annex and to the Directive 2001/83/EC;
11) Specification of Medicinal Product;
12) template of primary and secondary packaging, presented in a descriptive and graphic form, as well as
a leaflet together with report from readability test;
13) copies of any authorizations, copies of Specifications of Medicinal Product approved by competent
authorities of the EU Member States or the Member States of the European Free Trade Association
(EFTA) – parties to the Agreement of the European Economic Area and copies of leaflets, if
applicable;
14) list of the EU Member States or the Member States of the European Free Trade Association (EFTA) –
parties to the Agreement of the European Economic Area, in which the application for authorization is
under examination and detailed information concerning refusal of authorization in any other state, if
applicable;
15) copy of manufacturing authorization of medicinal product issued in the country of product’s
manufacturing.
2a. Application on marketing authorization of a veterinary medicinal product, subject to the provisions
of Articles 15a and 16a, should cover any information documenting quality, safety and efficacy of a given
veterinary medicinal product, in particular:
1) name and address of the responsible entity, manufacturer or importer, by whom bath release of the
veterinary medicinal product takes place, place of manufacturing, including the site, in which batches
are controlled or the place of conducting import activity, in which its batches are controlled, as well as
numbers of manufacturing authorizations or permits to import a veterinary medicinal product;
2) name of the veterinary medicinal product;
3) detailed qualitative and quantitative data of the active substances and other substances, relating to
the veterinary medicinal product as well as their common names, and when such names do not exist
– chemical names;
4) pharmaceutical form, strength and the administration route as well as target animal species,
expiration date of the veterinary medicinal product, storage conditions and data on Maximum
Residual Limits.
2b. The application, referred to in Paragraph 2a, shall be accompanied by the following:
1) description of manufacturing of the veterinary medicinal product;
2) information on therapeutic indications, contraindications and undesirable effects of the veterinary
medicinal products;
3) information on dose for specific animal species, for which such veterinary medicinal product is
intended and conditions of administration and use;
4) determination of utilization methods for the veterinary medicinal product and waste from such
veterinary medicinal product as well as defining of potential risk related to application of the veterinary
medicinal product for the environment, humans, animals and plants;
5) determining of the period of grace for veterinary medicinal products applied to target animal species,
tissues of which or obtained products are intended for human consumption, together with description
of trials’ methods;
6) results, summaries and reports of the following trials:
a) pharmaceutical: physicochemical, biological or microbiological;
b) safety and residues,
c) preclinical and clinical,
d) ecotoxicity: determination of potential risk related to use of veterinary medicinal product for the
environment
- accompanied by the experts’ reports;
7) statements signed by the experts preparing the reports, referred to Clause 6, on having indispensable
technical or professional skills, described in the attached curriculum vitae;
8) in the event, referred to in Article 16a(1), a justification prepared by an expert concerning use of
scientific literature pursuant to the requirements specified in Annex and to the Directive 2001/82/EC
of the European Parliament and of the Council of 6 November 2001 on the Community code relating
to veterinary medicinal products (OJ EC L 311 of 28.11.2001, page 1, as amended; OJ EU Polish
special edition, chapter 13, volume 27, page 3), hereinafter referred to as the “Directive 2001/82/EC";
9) description of the safe use of the veterinary medicinal products monitoring system;
10) description of the medicinal product risk management system, which shall be implemented by the
responsible entity, if necessary;
11) statement of the responsible entity confirming that such entity has at its disposal services of the
person engaged in permanent surveillance over monitoring of safe use of the veterinary medicinal
product being the subject of the application, and that such entity has at its disposal a system ensuring
an opportunity of immediate reporting of any suspicion of undesirable effect on the territory of the EU
Member States or the Member States of the European Free Trade Association (EFTA) – parties to
the Agreement of the European Economic Area or any other states;
12) Specification of Veterinary Medicinal Product;
13) template of primary and secondary packaging, presented in a descriptive and graphic form, as well as
a leaflet;
14) copies of any authorizations, copies of Specifications of Veterinary Medicinal Product approved by
competent authorities of the EU Member States or the Member States of the European Free Trade
Association (EFTA) – parties to the Agreement of the European Economic Area and copies of
leaflets, if applicable;
15) list of the EU Member States or the Member States of the European Free Trade Association (EFTA) –
parties to the Agreement of the European Economic Area, in which the application for authorization is
under examination, copies of the proposed Specifications of Veterinary Medicinal Product and copies
of the proposed leaflets, if applicable;
16) detailed information on refusal to authorize in any other state, if applicable;
17) copy of manufacturing authorization of veterinary medicinal product issued in the country of
manufacturing;
18) in the event of the veterinary medicinal products, referred to in Article 7b, a document confirming that
the responsible entity submitted an application to specify the Maximal Residue Limit pursuant to the
Regulation No. 2377/90.
3. When submitting an application, referred to in Paragraph 1 and 2a, the responsible entity presents
the guidelines of the European Commission, European Medicines Evaluation Agency (EMEA) or the
World Health Organization, constituting a basis of the prepared documentation.
4. Data and documents, referred to in Paragraphs 2 and 2b, may be presented in English language,
excluding documents, referred to in Paragraph 1(11) and (12) and Paragraph 2b(12) and (13), which shall
be presented in Polish language.
4a. In the event of change of data, referred to in Paragraph 2(13) and (14) and Paragraph 2b(14) and
(15), the applicant presents the minister competent for health, by medium of the President of the Office,
information on changes made and documents considering such changes.
5. In the event of justified doubt resulting from the submitted dossier on quality of medicinal product,
the minister competent for health may request to present a report from the inspection carried out in a
place of manufacturing of the medicinal product (on-site) produced abroad in order to confirm conformity
of manufacturing conditions with the authorization, referred to in Paragraph 2(15) and Paragraph 2b(17).
6. Inspection shall be conducted by the Inspectors for Manufacturing of the Main Pharmaceutical
Inspectorate or Inspectors for Manufacturing of the competent authorities in the EU Member States, or the
Member States of the European Free Trade Association (EFTA) – parties of an agreement on European
Economic Area, or states mutually recognizing the inspection for manufacturing, at the request and
expense of the responsible entity or at the request and expense of the manufacturer if it is different from
the responsible entity..
6a. The costs of inspection, referred to in Paragraph 5, include costs of travelling, stay and working
time of an inspector.
7. The minister competent for health shall define, by means of a regulation, detailed method of
presenting of the dossier, referred to in Paragraph 1 and 2, taking the provisions of Article 15, 16, 20, 20a,
21 and 23a(3) and (4) and Article 31(2), Clause 3, as well as the laws and guidelines of the European
Community on registration procedure for medicinal products.
8. The minister competent for health shall define, by means of a regulation, detailed method of
presenting of the dossier, referred to in Paragraph 1 and 2, taking the provisions of Article 15a, 16a, 20,
20a, 21 and 23a(3) and (4) and Article 31(2), Clause 3, as well as the laws and guidelines of the
European Community on registration procedure for veterinary medicinal products.
9. The minister competent for health shall define, by means of a regulation, test method for
readability of a leaflet for the purposes of report from this test, taking the guidelines of the European
Community into consideration.
Article 11. 1. The Specification of Medicinal Product, referred to in Article 10(2), Clause 11, shall
include as follows:
1) name of the medicinal product; together with determination of strength and pharmaceutical form of
such medicinal product;
2) qualitative and quantitative composition concerning the active substances and such auxiliary
substances, in the event of which such information is crucial for the proper administration of the
medicinal product, provided that common name or chemical name is used;
3) pharmaceutical form;
4) clinical data including:
a) therapeutic indications,
b) dosage and method of administration to adults and children in the event of use of the medicinal
product in children,
c) contraindications,
d) special warnings and precautions related to the administration and in the event of immunological
medicinal products – special precaution measures taken by the persons having contact with such
products and special precaution measures in the course of administration to the patients, together
with precaution measures to be taken by the patient,
e) interactions with other medicines and other forms of interaction,
f) administration during pregnancy and breastfeeding,
g) influence on the capability to drive mechanical vehicles and on the capability to operate machines
in motion,
i) overdosing, including its symptoms, actions taken during first help and antidotes;
5) pharmacological properties including:
a) pharmacodynamic properties,
b) pharmacokinetic properties,
c) non-clinical data on safety;
6) pharmaceutical data including:
a) list of auxiliary components,
b) main pharmaceutical incompatibilities,
c) expiry date and, if necessary, validity after re-constitution of the medicinal product or after the first
opening of its primary packaging,
e) type of packaging and composition of packaging materials,
f) special precaution measures when utilizing the medicinal product or waste from such medicinal
product, if applicable;
7) name and address of the responsible entity;
8) number of marketing authorization;
9) date of issuing and number of the first marketing authorization of prolongation of the authorization
validity;
10) date of the last updating of the Specification of Medicinal Product content;
11) in the event of radiopharmaceutical products also:
a) information on dosimetry of internal radiation,
b) guidelines on direct preparation and control of the product’s quality, and , if necessary, maximal
storage period, in which eluate or ready-to-use radiopharmaceutical product maintain their
properties pursuant to the specification.
2. Specification of Veterinary Medicinal Product, referred to in Article 10(2b), Clause 12, included as
follows:
1) name of the veterinary medicinal product; together with determination of strength and pharmaceutical
form of such veterinary medicinal product;
2) qualitative and quantitative composition concerning the active substances and such auxiliary
substances, in the event of which such information is crucial for the proper administration of the
veterinary medicinal product, provided that common name or chemical name is used;
3) pharmaceutical form;
4) clinical data including:
a) target animal species
b) therapeutic indications for particular target animal species
c) contraindications,
d) special warnings on application in target animal species,
e) special precaution measures in usage, including special precaution measures for the persons
administering the veterinary medicinal product,
f) undesirable effects (frequency and level of intensity),
g) administration during pregnancy, breastfeeding and egg yield,
h) interactions with other medicinal products or veterinary medicinal products or any other types of
interactions,
i) dosage and administration routes for particular target animal species,
j) overdosing, including its symptoms, actions taken during first help and antidotes,
k) period of grace;
5) pharmacological properties:
a) pharmacodynamic properties,
b) pharmacokinetic properties,
6) pharmaceutical data including:
a) list of auxiliary components,
b) main pharmaceutical incompatibilities,
c) expiry date and, if necessary, validity after re-constitution of the veterinary medicinal product or
after the first opening of its primary packaging,
e) type of packaging and composition of packaging materials,
f) special precaution measures when utilizing the non-used veterinary medicinal product or waste
from such veterinary medicinal product, if applicable;
7) name and address of the responsible entity;
8) number of marketing authorization;
9) date of issuing and number of the first marketing authorization of prolongation of the authorization
validity;
10) date of the last updating of the Specification of Veterinary Medicinal Product content.
3. To the moment of expiry of patent rights on the territory of the Republic of Poland for therapeutic
indications or pharmaceutical forms, the responsible entity, which submits an application on marketing
authorization of equivalent of the reference medicinal product or veterinary medicinal product, shall be not
obliged to present in the Specification of Medicinal Product or of Veterinary Medicinal Product of this
product of a part of Specification of Medicinal Product of the reference medicinal product or of a part of
Specification of Veterinary Medicinal product of the reference veterinary medicinal product, related to
therapeutic indications or a form, which will be covered by patent protection on the territory of the Republic
of Poland on the day of placing of the equivalent of the reference medicinal product or of the reference
veterinary medicinal product on the market.
4. In the event, referred to in Paragraph 3, the responsible entity submits a statement confirming that
data not provided in the Specification of Medicinal Product or Specification of Veterinary Medicinal
Product related to therapeutic indications or pharmaceutical forms are covered by patent protection.
5. Data provided in Specification of Medicinal Product and Specification of Veterinary Medicinal
Product is public.
Article 12. In relation to radiopharmaceutical products, apart from the requirements specified in
Article 10 and 11, the application should, in its part relating to radiopharmaceutical generators, include
also the following information and data:
1) general description of the system together with a detailed description of the system's elements, which
may influence the composition or quality of generated radionuclide preparations;
2) qualitative and quantitative data on the eluate or the sublimate;
3) detailed information on the internal dosimetry of radiation;
4) detailed indications on direct preparation and quality control of the preparation, as well as, if
applicable, the maximum storage period, in which the eluate or the ready-to-use radiopharmaceutical
product maintains its properties pursuant to the specification.
Article 13. 1. In relation to medicinal products of human or animal blood origin, in each document,
covered by the application, referred to in Article 10, the international name, and in case of its lack - the
common name of the active substances should be provided at least once. In other parts of the documents
the name may be given in an abbreviated form.
2. Quantitative data of medicinal product of human or animal blood origin should be expressed in
mass units or international units or biological activity units, depending on unit applicable for a given
product.
3. The application, referred to in Article 10, relating to medicinal products of human or animal blood
origin, should indicate the methods used to eliminate viruses and other pathogenic elements, which might
be transmitted by the medicinal products of human or animal blood origin.
Article 14. (repealed).
Article 15. 1. Independently from the protection resulting from the provisions of the Act of 30 June,
2000, on the industrial property law (Journal of Laws of 2003, No. 119, item 1117, as amended 3)) the
responsible entity shall be not obliged to present the results of non-clinical or clinical trials, if it proves that:
1) the medicinal product is an equivalent of a reference medicinal product, which was authorized to the
market on the territory of the Republic of Poland or any other EU Member States, or the Member
States of the European Free Trade Association (EFTA) – a party of an agreement on European
Economic Area and the entity responsible having the marketing authorization for the reference
medicinal product to the market agreed for making use of the results of non-clinical and clinical
analyses, included in the dossier of the reference medicinal product, in evaluation of application for
marketing authorization of this equivalent, or
2) the medicinal product is equivalent of a reference medicinal product, which was or is authorized to the
market on the territory of the Republic of Poland, or in any other Member State of the European
Union or one the Member States of European Free Trade Association (EFTA) – a party to the
Agreement on European Economic Area, and from the date of the first marketing authorization of the
reference medicinal product in any of these countries, to the date of submission of the application for
marketing authorization on the territory of the Republic of Poland a period of 6 years has passed,
unless patent protection of the reference medicinal product on the territory of the Republic of Poland
has expired earlier;
2. If the reference medicinal product is not or was not authorized to the market on the territory of the
Republic of Poland, the applicant shall indicate in its application the Member State of the European Union
or one the Member States of the European Free Trade Association (EFTA) – a party to the Agreement on
European Economic Area, in which the reference medicinal product is or was authorized to the market. In
such event, the President of the Office shall request the competent authority of this country to confirm that
the reference medicinal product is or was authorized to the market in this country and to provide
information on, at least, the product's composition.
3. The President of the Office, on request of any Member State of the European Union or one the
Member States of the European Free Trade Association (EFTA) – a party to the Agreement on European
Economic Area, confirms, within the period of 30 days, that the reference medicinal product is or was
authorized to the market on the territory of the Republic of Poland and provides information on, at least,
the product's composition.
4. If a medicinal product fails to meet the requirements for the equivalent of the reference medicinal
products or posses other indications, other administration route, other strength or pharmaceutical form
comparing to the reference medicinal product, differs in relation to the active substances or bioequivalence in the course of bio-accessibility tests may not be proved, the responsible entity shall be
obliged to present the results of the appropriate non-clinical or clinical trials.
5. Shall any biological medicinal product, similar to the reference medicinal product, fail to meet the
requirements for the equivalent of the reference medicinal product, in particular due to differences in initial
materials or manufacturing processes of these products, the responsible entity shall be obliged to present
the results of the appropriate non-clinical or clinical trials in the scope of the requirements, which were not
met, pursuant to Annex and of the Directive 2001/83/EC.
6. An equivalent of the reference medicinal product is a medicinal product of the same quantitative
and qualitative composition of active substances, the same pharmaceutical form comparing to the
medicinal product, and bio-equivalence with the reference medicinal product of which was proved by
means of relevant bio-accessibility tests.
7. Salts, esters, ethers, isomers, isomers mixtures, complexes or derivatives of an active substance
authorized to the market shall be considered the same active substance, if they are not significantly
different from the active substances in the scope of its properties in relation to safety or efficacy. In such
events the responsible entity attaches dossier confirming safety or efficacy or salts, esters, ethers,
isomers, isomers mixtures, complexes or derivatives of the active substance authorized to the market.
8. Various oral pharmaceutical forms of immediate release shall be considered the same
pharmaceutical form.
9. Bio-accessibility tests shall be not required, if the responsible entity proves that the equivalent of
the reference medicinal product meets the criteria specified in the guidelines of the European Community.
Article 15a. 1. 1. Independently from the protection resulting from the provisions of the Act of 30
June, 2000 - the industrial property law, the responsible entity shall be not obliged to present the results of
safety and residues tests and pre-clinical and clinical trials, if it submits an application on marketing
authorization of an equivalent of a reference veterinary medicinal product, which was or is authorized to
the market on the territory of the Republic of Poland, or in any other Member State of the European Union
or one the Member States of European Free Trade Association (EFTA) – a party to the Agreement on
European Economic Area, and from the day of issuing of the first marketing authorization of the reference
veterinary medicinal product in any of these states, to the day of submitting an application on marketing
authorization on the territory of the Republic of Poland, a period of at least 8 years has passed (data
exclusivity).
2. Independently from the granted marketing authorization, an equivalent of the reference veterinary
medicinal product may be placed on the market by the responsible entity not later than after 10 years of
the day of issuing of the first marketing authorization of the reference veterinary medicinal product in any
Member State of the European Union or in any Member State of the European Free Trade Association
(EFTA) – a party to the Agreement on the European Economic Area (market exclusivity).
3. If the reference veterinary medicinal product is not or was not authorized to the market on the
territory of the Republic of Poland, the applicant shall indicate in its application the Member State of the
European Union or one the Member States of the European Free Trade Association (EFTA) – a party to
the Agreement on European Economic Area, in which the reference veterinary medicinal product is or was
authorized to the market. In such event, the President of the Office shall request the competent authority
of this country to confirm that the reference veterinary medicinal product is or was authorized to the
market in this country and to provide information on, at least, the full qualitative and quantitative
composition of the product, and, if necessary, safety and efficacy dossier, enabling issuing of the decision
on marketing authorization of the reference veterinary medicinal product.
4. The President of the Office, on request of any Member State of the European Union or one the
Member States of the European Free Trade Association (EFTA) – a party to the Agreement on European
Economic Area, confirms, within the period of 30 days, that the reference veterinary medicinal product is
or was authorized to the market on the territory of the Republic of Poland and provides information on, at
least, the full product's composition and, if necessary, relevant dossier. In such event data exclusivity
period or market exclusivity period in force in the Member State of the European Union or the Member
State of the European Free Trade Association (EFTA) – a party to the Agreement on European Economic
Area applies.
5. The period, referred to in Paragraph 2, shall be prolonged for the period not exceeding 3 years in
the event of veterinary medicinal product intended for fish, bees or any other animal species specified
pursuant to the procedure, referred to in Article 5 of the Council Decision of 28 June 1999 laying down the
procedures for the exercise of implementing powers conferred on the Commission (OJ EC L 184 of
17.07.1999, page 23; OJ EU Polish special edition, chapter 1, volume 3, page 124).
6. If a veterinary medicinal product posses other indications, other administration route, other
strength or pharmaceutical form comparing to the reference veterinary medicinal product, differs in
relation to the active substances or bio-equivalence in the course of bio-accessibility tests may not be
proved, the responsible entity shall be obliged to present the results of the appropriate safety and residues
tests and non-clinical or clinical trials.
7. Shall any biological veterinary medicinal product, similar to the reference veterinary medicinal
product, fail to meet the requirements for the equivalent of the reference veterinary medicinal product, in
particular due to differences in initial materials or manufacturing processes of these products, the
responsible entity shall be obliged to present the results of the appropriate non-clinical or clinical trials in
the scope of the requirements, which were not met, pursuant to Annex and of the Directive 2001/82/EC.
8. For veterinary medicinal products intended for target animal species, tissues of which or obtained
products are intended for human consumption and containing a new active substance not authorized in
the EU Member States or in the Member States of the European Free Trade Association (EFTA) – parties
to the Agreement on European Economic Area to the day of 30 April 2004, the period, referred to in
Paragraph 2, shall be prolonged by one year in the event of extension of the authorization to the other
target animal species, tissues of which or obtained products are intended for human consumption within 5
years from the day of issuing of the first authorization. In the event of granting an authorization for four or
more target animal species, tissues of which or obtained products are intended for human consumption,
the period, referred to in Paragraph 2, may be prolonged up to 13 years.
9. The period, referred to in Paragraph 2, shall be prolonged from one year to three years,
respectively, for a veterinary medicinal product intended for target animal species, tissues of which or
obtained products are intended for human consumption, if the responsible entity submitted earlier an
application on determination of Maximum Residua Limits for target animal species covered by the
authorization.
10. An equivalent of the reference veterinary medicinal product is a medicinal product of the same
quantitative and qualitative composition of active substances, the same pharmaceutical form comparing to
the reference veterinary medicinal product, and bio-equivalence with the reference veterinary medicinal
product of which was proved by means of relevant bio-accessibility tests.
11. Salts, esters, ethers, isomers, isomers mixtures, complexes or derivatives of an active substance
authorized to the market shall be considered the same active substance, if they are not significantly
different from the active substances in the scope of its properties in relation to safety or efficacy. In such
events the responsible entity attaches dossier confirming safety or efficacy or salts, esters, ethers,
isomers, isomers mixtures, complexes or derivatives of the active substance authorized to the market.
12. Various oral pharmaceutical forms of immediate release shall be considered the same
pharmaceutical form.
13. Bio-accessibility tests shall be not required, if the responsible entity proves that the equivalent of
the reference veterinary medicinal product meets the criteria specified in the guidelines of the European
Community.
Article 16. 1. Independently from the protection resulting from the provisions of the Act of 30 June,
2000 - the industrial property law, the responsible entity shall be not obliged to present the results of
safety and residues tests and pre-clinical and clinical trials, if an active substance or substances of a
medicinal product have an established medical use on the territory of the Member State of the European
Union or one the Member States of the European Free Trade Association (EFTA) – a party to the
Agreement on European Economic Area, for the period of at least 10 years, from the moment of the first
regular and documented usage of this substance in a medicinal product and recognized efficacy and
acceptable safety level. In such event, results of non-clinical or clinical tests are replaced or supplemented
by publications in scientific literature.
2. Established medical use, referred to in Paragraph 1, means the established medical use on the
territory the Member State of the European Union or one the Member States of the European Free Trade
Association (EFTA) – a party to the Agreement on European Economic Area prior to entering of this state
into the agreement on the European Economic Area.
3. In the event of complex medicinal product, containing a mixture of known active substances
present in medicinal products authorized to market, not used in the given composition for medical
purposes to this moment, the responsible entity shall present the results of new non-clinical or clinical
trials in relation to the complex medicinal product. In such event the responsible entity shall be not obliged
to present the results of such tests in relation to each active substance separately.
4. In the of homeopathic medicinal products with therapeutic indications, containing a mixture of
medicinal homeopathic substances, not used in the given composition for medical purposes to this
moment or not described in scientific literature, the responsible entity shall be obliged to present the
results of appropriate non-clinical and clinical trials with respect to the complex homeopathic medicinal
product and with respect to each component separately.
5. The responsible entity shall be not obliged to present dossier, referred to in Article 10(2), Clause 1
– 4, if it obtained a consent of the other responsible entity to use dossier, referred to in Article 10 (2),
Clause 1 – 4, of the medicinal product of the same quantitative and qualitative composition with respect to
active substances and the same pharmaceutical form, authorized earlier to the market on the territory of
the Republic of Poland, for evaluation of the application purposes.
Article 16a. 1. Independently from the protection resulting from the provisions of the Act of 30 June,
2000 - the industrial property law, the responsible entity shall be not obliged to present the results of
safety and residues tests and pre-clinical and clinical trials, if it proves that an active substances of a
veterinary medicinal product is of an established efficacy and acceptable safety level and is used in the
Member States of the European Union or in the Member States of the European Free Trade Association
(EFTA) – parties to the Agreement on European Economic Area for at least 10 years. In this case the
responsible entity shall present relevant data from scientific literature. Reports published by the EMEA
after evaluation of applications on determination of Maximum Residues Limits may be included to
scientific literature as data, in particular in safety-related dossier.
2. If the responsible entity submits an application on marketing authorization of a veterinary medicinal
product specified in Paragraph 1 for target animal species, tissues of which or obtained products are
intended for human consumption, and an application for the same veterinary medicinal product, however
for the other target animal species, tissues of which or obtained products are intended for human
consumption, containing new results of residues tests, pursuant to the Regulation No. 2377/90 and new
results of clinical trials, it may not use these results of tests in order to assess the veterinary medicinal
product, for which an application was submitted pursuant to the provisions of Article 15a, for the period of
3 years from the day of issuing of authorization for these other target animal species, tissues of which or
obtained products are intended for human consumption.
3. The responsible entity shall be not obliged to present dossier, referred to in Article 10(2), Clause 6,
if it obtained a consent of the other responsible entity to use dossier, referred to in Article 10 (2), Clause 6,
of the medicinal product of the same quantitative and qualitative composition with respect to active
substances and the same pharmaceutical form, authorized earlier to the market on the territory of the
Republic of Poland, for evaluation of the application purposes.
4. In the event of a veterinary medicinal product, containing active substances present in veterinary
medicinal products authorized to market, not used in the given composition for medical purposes to this
moment, the responsible entity shall present the results of relevant safety and residues tests as well as of
non-clinical or clinical trials in relation to the veterinary medicinal product. In such event the responsible
entity shall be not obliged to present the results of such tests in relation to each active substance
separately.
5. In the event of immunological veterinary medicinal products the responsible entity shall be not
obliged to present the results of tests carried out in different conditions than laboratory conditions, if such
tests may not be conducted.
Article 17. 1. Tests referred to in Article 10 (2), Clause 3 b), conducted in order to assess the safety
of a medicinal product, or the tests, referred to in Article 10 (2b), Clause 6 b), conducted to assess the
safety of a veterinary medicinal product, shall be carried out pursuant to the principles of Good Laboratory
Practice in the meaning of the Act of 11 January, 2001 on chemical substances and preparations (Journal
of Laws No. 11, item 84, as amended 4)).
1a. Tests of medicinal products, referred to in Article 10 (2), Clause 3 c) shall be conducted in
accordance with the requirements of Good Clinical Practice, whereas the tests of veterinary medicinal
products, referred to in Article 10(2b), Clause 6 c), shall be made pursuant to the requirements of the
Good Clinical Veterinary Practice.
2. The requirements on documenting the tests results, referred to in Article 10(2), Clause 4, of
medicinal products, including radiopharmaceutical products, plant medicinal products other than these,
referred to in Article 20a, homeopathic medicinal products other than these, referred to in Article 21(1),
shall be defined in Annex and to the Directive 2001/83/EC.
2a. In the event of veterinary medicinal product, including homeopathic medicinal products intended
for animals exclusively, other than these, referred to in Article 21(4), the requirements on documenting the
tests’ results, referred to in Article 10(2b), Clause 6, shall be defined by Annex and to the Directive
2001/82/EC.
3. The minister competent for health shall define, by means of a regulation, the requirements on
documenting the tests’ results of medicinal products intended for special feeding purposes, antiseptics,
taking in particular the nature of the specific products and a necessity to present an expert’s report into
consideration.
Article 18. 1. The proceedings on marketing authorization of a medicinal product should be
concluded no later than within 210 days, subject to the deadlines defined in Article 18a and 19.
1a. After submission of application, the Minister of Health, within the period of 30 days, shall conduct
a formal examination of the application. The formal examination consists of checking whether the
application includes all elements and all additional documents had been submitted, provided by the
provisions of this chapter. In case of stating formal deficiencies, the Minister of Health shall request the
applicant to complete them.
1b. In the event of requesting the applicant to complete the deficiencies, the time period, referred to
in Paragraph 1, shall be counted from the date of their completion.
2. The course of the time period, referred to in Paragraph 1 shall be counted from the date of
submission of application on marketing authorization of a medicinal product, including complete
information, together with the required dossier attached.
3. The proceedings on marketing authorization of a medicinal product, referred to in Article 4a, should
be concluded no later than within 45 days from the date of submission of application on issuing of the
authorization for parallel import, including complete information together with the required dossier
attached.
4. The course of the time period, referred to in Paragraph 1 shall be suspended in cases of a
necessity to complete the documents or provide explanations.
5. The minister competent for health shall issue the decision on suspension of the course of time
period in the event referred to in Paragraph 4.
Article 18a. 1. In the event of simultaneous submission to the minister competent for health by
medium of the President of the Office and in the other the Member State of the European Union or in the
Member State of the European Free Trade Association (EFTA) – a party to the Agreement on European
Economic Area of an application on marketing authorization of the same medicinal product, which has no
authorization in any Member State of the European Union or in the Member State of the European Free
Trade Association (EFTA) – a party to the Agreement on European Economic Area, the minister
competent for health shall launch a procedure to issue a marketing authorization of the medicinal product,
hereinafter referred to as the “decentralized procedure”.
2. In the event, in which in the application, referred to in Paragraph 1, the responsible entity shall
indicate the Republic of Poland as a reference state, the President of the Office, within the period of 120
days from the day of receiving of a complete application, shall prepare draft assessment report and
provides it to the competent authorities of the interested Member States of the European Union or the
Member States of the European Free Trade Association (EFTA) –parties to the Agreement on European
Economic Area as well as to the responsible entity, together with the following attached drafts:
Specification of Medicinal Product or Specification of Veterinary Medicinal Product, labelling of packaging
and leaflet.
3. Within the period of 90 days from the day of delivery of the draft assessment report, pursuant to
Paragraph 2, the President of the Office shall inform the responsible entity on:
1) approval by the states participating in the decentralized procedure of the draft assessment report,
draft Specification of Medicinal Product or Specification of Veterinary Medicinal Product, draft
labelling of packaging and leaflet or
2) refusal to approve by the states participating in the decentralized procedure of the draft assessment
report, draft Specification of Medicinal Product or Specification of Veterinary Medicinal Product, draft
labelling of packaging and leaflet and launching of the explanatory procedure, referred to in
Paragraph 6.
4. The minister competent for health shall issue an authorization pursuant to the assessment report,
Specification of Medicinal Product or Specification of Veterinary Medicinal Product, labelling of packaging
and leaflet approved in the mode of the decentralized procedure, within the period of 30 days from the day
of their approval.
5. The minister competent for health, on request of the President of the Office, within the period of 90
days from the day of receiving of the assessment report together with Specification of Medicinal Product
or Specification of Veterinary Medicinal Product, labelling of packaging and leaflet, prepared by the
competent authority of the reference state, shall accept this report and inform the competent authority of
the reference state on this fact. The provisions of Paragraph 4 shall be applied respectively.
6. If in the course of the decentralized procedure arise any justified doubts that issuing of marketing
authorization may pose a threat to public health and in case of a veterinary medicinal product – threat to
humans or animals health or environment in the meaning of the guidelines of the European Community,
the President of the Office shall launch an explanatory procedure and provide reasonable justification to
the competent authorities of the reference state, interested Member States of the European Free Trade
Association (EFTA) – parties to the Agreement on European Economic Area and to the applicant.
7. The application, referred to in Paragraph 1, shall be submitted by the responsible entity or the
responsible entity being the subsidiary or dominant entity in the meaning of the Act of 29 July, 2005 ct on
public offerings and conditions governing the introduction of financial instruments to organized marketing
and on public companies (Journal of Laws No. 184, item 1539, of 2006, No. 157, item 1119 and of 2007,
No. 235, item 1734) to the responsible entity or being its licensor or licensee or an entity, aim of which is
to cooperate with the responsible entity in placing on the market of a medicinal product, excluding the
entity, referred to in Article 16(5) and Article 16a(3).
8. The medicinal product, referred to in Paragraph 1, shall be considered the same medicinal product
as the product of the identical qualitative and quantitative composition with respect to active substances,
identical pharmaceutical form and compliant labelling of packaging, leaflet and Specification of Medicinal
Product or Specification of Veterinary Medicinal Product in the following areas: indications, dosage,
administration router, contraindications, warnings and precaution measures, provided that possible
differences have no impact on safety or efficacy of use of the medicinal product.
Article 19. 1. Shall the minister competent for health, by medium of the President of the Office,
submit an application on marketing authorization of a medicinal product, having the authorization issued
by a competent authority of any Member State of the European Union or in the Member State of the
European Free Trade Association (EFTA) – a party to the Agreement on European Economic Area, the
minister competent for health launches proceedings on issuing of marketing authorization of a medicinal
product, hereinafter referred to as the „mutual recognition procedure”.
2. In the event, in which marketing authorization of a medicinal product was issued on the territory of
the Republic of Poland, the responsible entity may submit to the minister competent for health, by medium
of the President of the Office, an application to prepared an assessment report for the medicinal product
or to update the existing report. The President of the Office shall prepare or update the assessment report
within the period of 90 days from the day of receiving of the application and provides the assessment
report, Specification of Medicinal Product or Specification of Veterinary Medicinal Product, labelling of
packaging and leaflet to the competent authorities of the interested Member States of the European Union
or Member States of the European Free Trade Association (EFTA) – parties to the Agreement on
European Economic Area and to the applicant.
3. The minister competent for health, within the period of 90 days from the day of receiving of the
application and provides the assessment report, Specification of Medicinal Product or Specification of
Veterinary Medicinal Product, labelling of packaging and leaflet prepared by the competent authority of the
reference state, shall accept such report and inform the competent authority of the reference state on this
fact. The provisions of Article 18a(4) shall be applied respectively.
4. If in the course of the mutual recognition procedure arise any justified doubts that marketing
authorization may pose a threat to public health, and in case of a veterinary medicinal product – threat to
humans or animals health or environment in the meaning of the guidelines of the European Community
the President of the Office shall launch an explanatory procedure and provide reasonable justification to
the competent authorities of the reference state, interested Member States of the European Union or
Member States of the European Free Trade Association (EFTA) – parties to the Agreement on European
Economic Area and to the applicant.
5. The application, referred to in Paragraph 1, shall be submitted by the responsible entity or the
responsible entity being the subsidiary or dominant entity in the meaning of the Act of 29 July, 2005 ct on
public offerings and conditions governing the introduction of financial instruments to organized marketing
and on public companies to the responsible entity or being its licensor or licensee or an entity, aim of
which is to cooperate with the responsible entity in introduction to the market of a medicinal product,
excluding the entity, referred to in Article 16(5) and Article 16a(3).
6. . The medicinal product, referred to in Paragraph 1, may concern a medicinal product, which with
respect to the product having an authorization issued by the competent authority of the Member State of
the European Union or the Member State of the European Free Trade Association (EFTA) – a party to the
Agreement on European Economic Area, has the identical qualitative and quantitative composition with
respect to active substances, identical pharmaceutical form and compliant labelling of packaging, leaflet
and Specification of Medicinal Product or Specification of Veterinary Medicinal Product in the following
areas: indications, dosage, administration router, contraindications, warnings and precaution measures,
provided that possible differences have no impact on safety or efficacy of use of the medicinal product.
Article 19a. Mutual recognition and decentralized procedures shall be not applied in the event of:
1) submitting an application on change of data covered by the authorization and change to dossier in
case of changes requiring submitting of the application, referred to in Article 10, if the authorization
was not issued in compliance with the provisions of Article 18a or 19 or dossier, including
Specification of Medicinal Product or Specification of Veterinary Medicinal Product, labelling of
packaging and leaflet of this product was not uniformed under Article 31(1);
2) homeopathic medicinal products other than these, referred to in Article 21 (1) and (4);
3) traditional plant medicinal products, for which no Community Monograph, referred to in Article 16h(3)
of the Directive 2001/83/EC, hereinafter referred to as the „Community Monograph”, has been
prepared, and traditional plant medicinal products not composed of plant substances, preparations or
their mixtures, present at the Community list of traditional plant medicinal products, referred to in
Article 16f(1) of the Directive 2001/83/EC;
4) medicinal products, dossier of which has been not completed and made compliant with the
requirements of the Act, referred to in Annex XII to the Treaty made between the Kingdom of
Belgium, the Kingdom of Denmark, the Federal Republic of Germany, the Hellenic Republic, the
Kingdom of Spain, the French Republic, Ireland, the Italian Republic, the Grand Duchy of
Luxembourg, the Kingdom of the Netherlands, the Republic of Austria, the Portuguese Republic, the
Republic of Finland, the Kingdom of Sweden, the United Kingdom of Great Britain and Northern
Ireland (Member States of the European Union) on the accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the
Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the
Slovak Republic to the European Union, signed in Athens on 16 April 2003 (Journal of Laws of 2004,
No. 90, item 864), in the event, in which the responsible entity shall indicate the Republic of Poland
as the reference state.
Article 19b. 1. The applications, referred to in Article 18a and 19, contain data, referred to in Article
10 (1) and (2) and in case of veterinary medicinal products – in Article 10(2a) and (2b), and declaration of
conformity of the submitted dossier with dossier being a subject of the assessment report.
2. Applications and documents, referred to in Paragraph 1, may be presented in Polish or English
language version, excluding Specification of Medicinal Product or Specification of Veterinary Medicinal
Product, labelling of primary and secondary packaging and leaflet, which are presented in Polish and
English language version.
Article 19c. If, after submitting of an application on marketing authorization of a medicinal product,
the President of the Office shall be informed that the application on marketing authorization of a medicinal
product being the subject of this application is examined in any other Member State of the European
Union or Member State of the European Free Trade Association (EFTA) – a party to the Agreement on
European Economic Area, or that a competent authority of any other Member State of the European
Union or Member State of the European Free Trade Association (EFTA) – a party to the Agreement on
European Economic Area, issued a marketing authorization of this product, the President shall inform the
responsible entity on a necessity to apply the procedure defined in Article 18a or 19 respectively and
discontinues the proceedings.
Article 19d. In the event of launching of the explanatory procedure, referred to in Article 18a(6) or
Article 19(4) and failure to reach an agreement between the Member States within the period of 60 days,
the minister competent for health may, on request of the responsible entity, issue an authorization prior to
termination of the explanatory procedure, provided that the assessment report, Specification of Medicinal
Product or Specification of Veterinary Medicinal Product, labelling of packaging and leaflet has been
earlier accepted.
Article 19e. The minister competent for health shall define, by means of a regulation, scope and
mode of proceeding in the course of explanatory procedure, referred to in Article 18a(6) and Article 19(4),
taking legal provisions and guidelines of the European Community in the area of marketing authorization
of medicinal products into consideration.
Article 20. 1. The application on marketing authorization of:
unprocessed pharmaceutical raw material used for medicinal purposes, ,
vegetable raw material in a crumbled form,
therapeutic mineral,
medicinal product, manufactured with the use of industrial methods, pursuant to the provisions
included in the Polish Pharmacopoeia,
5) pharmaceutical raw material, designated for manufacturing prescription and pharmaceutical
1)
2)
3)
4)
medicines, ,
6) veterinary medicinal product, administered to decorative pets, especially to aquarium fish, decorative
birds, pigeons, terrarium animals and small rodents, ferrets and rabbits kept as pets,
- should contain in particular information defined in Paragraph 2.
2. The application, referred to in Paragraph 1, should contain:
1) name of the medicinal product and name of an active substance together with specification of its
pharmaceutical form and dose administration route, if applicable;
2) size of packaging;
3) name and the permanent address of the responsible entity submitting the application and data related
to the manufacturer or manufacturers, in the event, in which the responsible entity is not the
manufacturer of the medicinal product;
4) list of documents attached to the application.
3. The minister competent for health, and in relation to veterinary medicinal products, in cooperation
with the minister competent for agriculture, shall specify, by means of a regulation, a detailed list of data
and documents covered by the application, referred to in Paragraph 2, of products and raw materials
specified in Paragraph 1(1 - 5), as well as a list of medicinal products manufactured using industrial
methods, pursuant to the provisions included in the Polish Pharmacopoeia, unprocessed pharmaceutical
raw materials used for therapeutic purposes and plant raw materials in a crumbled form, which may be
authorized to the market pursuant to Paragraph 1(1 - 5) and Paragraph 2.
4. The minister competent for health, and in relation to veterinary medicinal products, in cooperation
with the minister competent for agriculture, shall specify, by means of a regulation, a detailed list of data
and documents covered by the application, referred to in Paragraph 2, of products specified in Paragraph
1(6), taking composition of these products and protection against using of these product in different animal
species.
Article 20a. 1. Traditional plant medicinal products shall be the plant medicinal products meeting
together the following conditions:
1) have indications specific for a traditional plant medicinal product exclusively, due to their composition
and intention, may be used without a physician control for therapeutic, diagnostic or therapy
monitoring purposes and meet the criteria of a medicinal product dispensed without a physician’s
prescription;
2) are intended to use in a specified strength and dosage method exclusively;
3) are intended to oral or external use or inhalation exclusively;
4) were used in traditional manner in the period, referred to in Paragraph 5(6);
5) have sufficient data on their traditional use, in particular safety of use, according to the method,
referred to in Clause 2, and their sufficient pharmacological effect and efficacy have been stated on
the basis of their long-term usage and experience in therapeutics.
2. Traditional plant medicinal products shall be subject to simplified marketing authorization
procedure.
3. The provision of Paragraph shall be not applied in the event, in which a traditional plant medicinal
product may be authorized to the market under Article 10 or Article 21.
4. Traditional plant medicinal product may contain an additive of mineral compounds and vitamins of
confirmed safety of use in a given composition, provided that their effect in of subordinate nature
comparing to the other active plant components in relation to the specific indications.
5. An application on marketing authorization of traditional plant medicinal products contains in
particular:
1) name and address of the responsible entity;
2) name of the medicinal product;
3) detailed quantitative and qualitative data concerning the medicinal product and all its components as
well as their common names, if present;
4) pharmaceutical form, strength and administration route as well as the expiration date of the medicinal
product and data on environmental protection related to use and utilization of the medicinal product, if
it is necessary and results from the nature of the product;
5) indications, contraindications and undesirable effects;
6) data from literature, including scientific literature, or experts’ opinions stating that the plant medicinal
product or equivalent product was used for therapeutic purposes for the period of at least 30 years
preceding the date of submitting of the application, including at least 15 years in the Member State of
the European Union or Member State of the European Free Trade Association (EFTA) – a party to
the Agreement on European Economic Area;
7) results of pharmaceutical tests specified in Article 10(4), Clause 4 a).
6. In case of mixtures of plant substances or plant preparations or a traditional plant medicinal
products, data, referred to in Paragraph 5(6), should refer to the mixture, and in the event, in which
particular plant substances or plant preparations are not known sufficiently, data should also refer to these
components.
7. The following shall be attached to the application:
1) Specification of Medicinal Product, excluding data, referred to in Article 11(1), Clause 4;
2) copies of documents confirming marketing authorizations in the Member States of the European
Union or Member States of the European Free Trade Association (EFTA) – parties to the Agreement
on European Economic Area, or in any other states or detailed information on refusal of issuing of an
authorization in any other state, if applicable;
3) review of literature, including scientific literature, concerning safety, together with expert’s report and,
on request of the President of the office, data to assess safety of a medicinal product.
8. The President of the Office may request from the Committee for Plant Medicinal Product of the
EMEA to issue an opinion on recognition of the submitted dossier as relevant to state the traditional use of
a traditional plant medicinal product or equivalent product, attaching dossier of the traditional plant
medicinal product to the application on issuing the opinion.
9. An equivalent product is a traditional plant medicinal product containing the same plant substances
or plant preparations, independently from the auxiliary substances and having the same or similar
intended use, equivalent strength and dose and the same or similar administration route as the traditional
plant medicinal product being the subject of the application, referred to in Paragraph 5.
Article 20b. 1. In the event of submitting a motion, referred to in Article 20a(5), the responsible entity
shall be not obliged to present a marketing authorization of a traditional plant medicinal product in the
period, referred to in Article 20a(5), Clause 6. Requirement of 30 years of use of the traditional plant
medicinal product shall be met also in the event, in which a number of components of the traditional plant
medicinal product or their content have been reduced within this period.
2. In the event of submitting a motion on marketing authorization of a traditional plant medicinal
product used in the Member States of the European Union or Member States of the European Free Trade
Association (EFTA) – parties to the Agreement on European Economic Area, for a period not exceeding
15 years, the President of the Office provides the Committee for Plant Medicinal Product of the EMEA with
dossier of this product in order to state by the Committee, if the other conditions necessary to recognize a
traditional use of the traditional plant medicinal product were met. When examining the application on
marketing authorization of a traditional plant medicinal product, the President of the Office shall consider
the Community Monograph.
3. In the event, in which for the traditional plant medicinal product, being the subject of the
application, referred to in Article 20a(5), the Community Monograph was prepared, or components of this
product are listed on the Community list of substances of traditional plant medicinal products, referred to
in Article 16f(1) of the Directive 2001/83/EC, the provisions of Article 18a and 19 shall apply.
4. In the event of submitting of the application, referred to in Article 20a(5), the President of the Office
takes marketing authorizations of a given traditional plant medicinal product, issued in the other Member
States of the European Free Trade Association (EFTA) – parties to the Agreement on European
Economic Area, into consideration.
Article 21. 1. Homeopathic medicinal products, which:
1) are administered orally or externally,
2) do not have usage indications in labelling and leaflet,
3) are of relevant dilution level, ensuring safety of use; i.e. do not contain more than 1/10.000 part of the
parent solution or not more than 1/100 of the lowest dose of active substance contained in the
medicinal product dispensed by prescription,
- are subject to simplified marketing authorization procedure.
2. The application on marketing authorization of the products, referred to in paragraph 1, should
include in particular:
1) name and address of the responsible entity, manufacturer or importer, by whom bath release of the
medicinal product takes place, place of manufacturing, including the site, in which batches are
controlled or the place of conducting import activity, in which its batches are controlled, as well as
numbers of manufacturing authorizations or permits to import a medicinal product;
2) name and permanent address of the manufacturer of parent solution, from which the homeopathic
medicinal product is to be manufactured;
3) scientific or pharmacopoeian name of the product, compliant with the name of the raw material listed
in the European Pharmacopoeia or in other appropriate pharmacopoeias recognized by the Member
States of the European Union and in case of absence of such names, common name together with
specification of administration route, pharmaceutical form and dilution level;
4) composition of the product, taking the auxiliary components into consideration;
5) storage and transport conditions;
6) size and type of packaging as well as the content of a homeopathic medicinal product in primary
packaging.
3. The application, referred to in Paragraph 2, should be accompanied by the following:
1) description of the method of obtaining and control of the parent solution and confirmation based on
literature, including scientific literature, of its homeopathic nature;
2) description of manufacturing process, including the description of dilution and dynamization methods;
3) description of control methods for each pharmaceutical form, including stability and microbiological
purity tests;
3a) results, summaries and reports from qualitative, biological and pharmacological tests, including the
expert's report;
4) original or certified copy of manufacturing authorization of a homeopathic medicinal product;
5) copies of authorizations issued in the other countries;
6) commitment of the responsible entity to provide a sample of the parent solution, from which the
product is to be manufactured for analytic control purposes, as well as a sample of the finished
product;
7) draft label or a leaflet;
8) data concerning primary packaging, together with the specification of quality requirements as well as
the templates of primary and secondary packaging, size of packaging and the content of the
homeopathic medicinal product in primary packaging;
9) expiry date of homeopathic medicinal product;
10) data and warnings concerning:
a) conditions of storage and transportation,
b) administration route.
4. Homeopathic veterinary medicinal products shall be also subject to the simplified marketing
authorization procedure, in the event, in which:
1) their labelling has no indications for application,
2) are of relevant dilution level, ensuring safety of use; i.e. do not contain more than 1/10.000 part of the
parent solution or not more than 1/100 of the lowest dose of active substance contained in the
medicinal product dispensed by prescription of a physician,
3) their administration router was described in the European Pharmacopoeia or in the other
pharmacopoeias officially recognized by the Member States of the European Free Trade Association
(EFTA) – parties to the Agreement on European Economic Area
- excluding immunological homeopathic veterinary medicinal products.
5. Application on marketing authorization of the products, referred to in Paragraph 4, should contain
in particular:
1) name and address of the responsible entity or manufacturer, if the manufacturer is not the
responsible entity, place of manufacturing and number of manufacturing authorization;
2) name and permanent address of the manufacturer of parent solution, from which the homeopathic
medicinal product is to be manufactured;
3) scientific or pharmacopoeian name of the product, compliant with the name of the raw material listed
in the European Pharmacopoeia or in other appropriate pharmacopoeias recognized by the Member
States of the European Union and in case of absence of such names, common name of the
homeopathic medicinal product together with specification of administration route, pharmaceutical
form and dilution level;
4) composition of the product, taking the auxiliary components into consideration;
5) storage and transport conditions;
6) size and type of packaging as well as the content of the product in primary packaging.
6. The application, referred to in Paragraph 5, shall be accompanied by the following:
1) description of the method of obtaining and control of the initial substances and confirmation based on
literature, including scientific literature, of its homeopathic nature;
2) description of manufacturing of the homeopathic veterinary medicinal product, including description of
dilution and dynamization methods;
3) description of control methods for each pharmaceutical form, including stability and microbiological
purity tests;
4) original or certified copy of manufacturing authorization of a product;
5) copies of authorizations issued in the other countries;
6) commitment of the responsible entity to provide a sample of the parent solution, from which the
product is to be manufactured for analytic control purposes, as well as a sample of the finished
product;
7) draft label or a leaflet;
8) data concerning primary packaging, together with the specification of quality requirements as well as
the templates of primary and secondary packaging, size of packaging and the content of the in
primary packaging;
9) expiry date of homeopathic medicinal product;
10) data and warnings concerning:
a) conditions of storage and transportation,
b) application method
c) period of grace with complete justification.
7. The homeopathic medicinal products, referred to in Paragraphs 1 and 4, shall not require any proof of
their therapeutic efficacy.
7a. Application on marketing authorization, referred to in Paragraph 2 and 5, may cover a list of
homeopathic medicinal products originating from the same homeopathic initial substance or substances.
8. The minister competent for health shall specify, by means of a regulation, detailed method of
presenting the documentation, referred to in Paragraphs 2, 3, 5 and 6, taking in particular the nature of the
presented documentation into consideration.
9. The minister competent for health shall specify, by means of a regulation, templates of
applications, referred to in Paragraphs 2 and 5, and other types of documents than mentioned in
Paragraphs 3 and 6, taking data included in Paragraphs 2 and 5 into consideration.
Article 21a. 1. Application for issuing of an authorization for parallel import or the application on
change to the authorization shall be submitted to the minister competent for health through the agency of
the President of the Office.
2. Issuing of an authorization for parallel import, refusal of issuing of the authorization, change to the
authorization, as well as withdrawal of the authorization shall be made by means of a decision of the
minister competent for health, based on the President's of the Office report.
3. Authorizations for parallel import shall be issued for a period of 5 years.
3a. Authorization for parallel import shall empire after a period of one year from the day of expiration
of the marketing authorization on the territory of the Republic of Poland, whereas in the event of expiry of
marketing authorization of a medicinal product in the Member State of the European Union or Member
State of the European Free Trade Association (EFTA) – a party to the Agreement on European Economic
Area, from which the medicinal product is imported in parallel manner, shall expire on the day of expiration
of this authorization.
3b. Withdrawal of marketing authorization on the territory of the Republic of Poland or in any Member
State of the European Union or Member State of the European Free Trade Association (EFTA) – a party
to the Agreement on European Economic Area, from which the medicinal product is imported in parallel
manner, due to the reasons related to threat to life or health of humans or animals, in particular these,
referred to in Article 33(1), Clause 1, 2, 4 and 7, results in withdrawal of authorization for parallel import.
4. The provisions of Article 23(1-2), Article 29(1-2a), Article 33 and Article 37 shall be applied to
authorizations for parallel import and withdrawal of these authorizations, respectively.
5. In the event, in which the minister competent for health is not able to, on the basis of the
possessed dossier, decide, whether the differences between the medicinal product from parallel import
and the medicinal product having a marketing authorization on the territory of the Republic of Poland, may
be recognized as significant from the point of view of safety or efficacy of these products, it shall request
from the competent authorities of the Member State of the European Union or Member State of the
European Free Trade Association (EFTA) – a party to the Agreement on European Economic Area, from
which the parallel product is imported, to provide additional dossier, other than defined in Paragraph 7 and
8.
6. In the event, in which the minister competent for health decides that the differences between the
medicinal product from parallel import and the medicinal product having a marketing authorization on the
territory of the Republic of Poland, are significant from the point of view of safety or efficacy of these
products, and may pose a threat to life and health of humans or animals, it shall refuse to issue an
authorization for parallel import of this product or implement changes to the authorization for parallel
import.
7. Application for authorization for parallel import shall include:
1) basic data included in the authorization issued by the Member State of the European Union or
Member State of the European Free Trade Association (EFTA) – a party to the Agreement on
European Economic Area, from which the medicinal product is imported;
2) data of the parallel importer.
8. The following shall be attached to the application for authorization for parallel import:
1) template of packaging labelling and leaflet;
2) copy of manufacturing authorization issued by the authorized authority of the Member State of the
European Union or Member State of the European Free Trade Association (EFTA) – a party to the
Agreement on European Economic Area, including the area of re-packaging;
3) confirmation of settling of a charge for submission of the application.
8a. After obtaining of the authorization for parallel import, the entity authorized to such parallel import
shall inform, on at least 30 days prior to the scheduled day of placing on the market, of an expected date
of placing of a medicinal product on the market on the territory of the Republic of Poland:
1) Main Pharmaceutical Inspector;
2) President of the Office;
3) the responsible entity having a marketing authorization on the territory of the Republic of Poland.
9. The entity authorized to parallel import may place the product imported in parallel manner on the
market under the name:
1) used on the territory of the Republic of Poland or
2) used in any Member State of the European Union or Member State of the European Free Trade
Association (EFTA) – a party to the Agreement on European Economic Area, from which the
medicinal product is imported or
3) commonly used or scientific name provided with a trademark or name of the entity authorized to
parallel import.
9a. The entity authorized to parallel import shall immediately inform the minister competent for health
on expiration of marketing authorization of a medicinal product in any Member State of the European
Union or Member State of the European Free Trade Association (EFTA) – a party to the Agreement on
European Economic Area, from which the medicinal product is imported in parallel manner.
10. The minister competent for health, in cooperation with the minister competent for agriculture, shall
specify, by means of a regulation, template of application on issuing of an authorization for parallel import
and detailed list of data and documents covered by the application of change to the authorization,
considering data and documents, referred to in Paragraph 7 and 8, taking the type of a medicinal product
and scope of data covered by the authorization for parallel import into consideration.
Article 22. 1. In the course of the proceedings of issuing of a marketing authorization, a product shall
be, pursuant to Article 8(1a), Clause 3, subject to quality tests, at the expense of a responsible entity.
2. (repealed).
3. The minister competent for health, shall specify, by means of a regulation:
1) research units handling tests of medicinal products and veterinary medicinal products, taking the
scope of tests, which should be made to assess the quality of a medicinal product, qualifications of
the personnel employed in a given unit and experience in the area of medicinal product analyses into
consideration;
2) list of charges collected for conducting quality tests, referred to in paragraph 1, taking in particular the
scope of performed tests, expenditures for tests conducting, as well as the type of the examined
product into consideration.
Article 23. 1. The authorization shall specify:
1) the responsible entity;
2) the name and address of the manufacturer, at which a batch of medicinal product shall be released,
place of manufacturing or place of import activity, in which batch control shall take place;
3) the name and the common name of medicinal product, if such exist, its form, administration route,
strength, dose of the active substance, full qualitative composition as well as size and type of packaging;
4) category of medicinal product's availability;;
4a) application category with respect to veterinary medicinal products;
5) expiry date of a medicinal product;
6) validity date of the authorization;
7) period of grace with respect to veterinary medicinal products;
8) species of animals, to which a given medicinal product may be administered;
9) requirements concerning storage and transport;
10) code compliant with the EAN UCC system;
11) number of authorization and date of its issuing;
12) entity authorized to parallel import;
13) date authorizing to place on the market of an equivalent of the reference veterinary medicinal product
in the event, referred to in Article 15a(2);
14) conditions resulting from dossier assessment, referred to in Article 23b, if applicable.
1a. Data covered by authorization are public.
2. Issuing of an authorization shall be equivalent to approval of the Specification of Medicinal
Product, leaflet and packaging of medicinal product, including its labelling, quality requirements and
methods of quality tests of medicinal product as well as quality requirements related its packaging.
3. The minister competent for health shall specify, by means of a regulation, criteria of classification
of a medicinal product to particular availability categories, taking in particular the nature of particular
availability categories and safety of use of a medicinal product into consideration.
3a. The minister competent for health in cooperation with the minister competent for agriculture shall
specify, by means of a regulation, criteria of classification of a veterinary medicinal product to particular
availability categories, taking in particular the nature of particular availability categories and safety of use
of a veterinary medicinal product into consideration.
4. The authorization may cover the list of homeopathic medicinal products without indications in the
area of administration, meeting the requirements referred to in Article 21(1) and (4).
Article 23a. 1. Medicinal products authorized to the market shall be provided with one of the
following availability categories:
1) dispensed without a physicians’ prescription - OTC;
2) dispensed with a physicians’ prescription - Rp;
3) dispensed with a physicians’ prescription to restricted use - Rpz;
4) dispensed with a physicians’ prescription, containing doping or psychotropic substances, defined by
separate provisions - Rpw;
5) used in closed therapeutics exclusively - Lz.
2. The provisions of Paragraph 1(2) and (2) shall be applied to veterinary medicinal products,
respectively.
3. In the event, in which the responsible entity submits an application to change the availability
category of a medicinal product, referring to the results of significant non-clinical or clinical tests
conducted earlier for a medicinal product by the other responsible entity and on the basis of which
availability category has been changed, the President of the Office shall not consider the results of such
tests within the period of one year from the date of issuing a decision on change to availability category.
4. In the event, in which the application, referred to in Paragraph 3, is submitted prior to the lapse of
one year from the day of issuing a decision on change to availability category, the minister competent for
health shall suspends the proceedings to the moment of a lapse of one year from the day of issuing of this
decision.
Article 23b. 1. In exceptional circumstances, considering safety of use of a medicinal product, the
minister competent for health may issue a marketing authorization, subject to meeting by the responsible
entity of specified conditions, pursuant to Annex and to the Directive 2001/83/EC, and in the event of a
veterinary medicinal product – pursuant to Annex and do the Directive 2001/82/EC, in particular
concerning safety of usage of a medicinal product, reporting of undesirable effects related to this product
and taking certain actions, together with providing a deadline to meet these conditions.
2. The authorization, referred to in Paragraph 1, is subject to verification conducted every 12 months,
starting from the day of its issuing.
Article 24. 1. The responsible entity, which obtained an authorization, shall be obliged to:
1) indicate a person, whose responsibilities shall include supervision over monitoring the safety of use of
the medicinal product;
2) keep a register of any undesirable effects reported;
3) present to the President of the Office:
a) reports concerning individual cases of undesirable effects of medicinal product reported by a
physician, stomatologist, veterinarian, pharmacist or medical representative, provided that the
reports on severe undesirable effects shall be reported immediately, however not later than within
15 days from the moment of obtaining information on these effects,
b) periodic reports concerning the safety of medicinal products, compliant with data kept in the
register of reported undesirable effects:
– every six months from the day of obtaining by a given medicinal product of a first marketing
authorization ever to the day of placing of the product on the market,
– every six months in the course of the first 2 years from the day of placing of the product on the
market,
– every 12 months in the course of the subsequent 2 years from the third year after placing the
product on the market, and then every 3 years,
– in justified cases, on any request of the President of the Office;
4) presents reports from tests on safety, conducted after obtaining of marketing authorization;
5) presents the studies on risk – benefit balance.
2. The President of the Office, on request of the responsible entity, may specify other deadlines to
present periodical reports than these mentioned in Paragraph 3 b); these reports should be presented at
least once in 3 years.
3. The responsible entity shall be also obliged to:
1) report on a necessity to make immediate changes to the Specification of Medicinal Product or the
Specification of Veterinary Medicinal Product;
2) inform immediately on any changes related to the medicinal product authorized to the market,
approved in any other Member State of the European Union or Member States of the European Free
Trade Association (EFTA) – parties to the Agreement on European Economic Area, which may
influence risk – benefit balance;
3) notify the President of the Office on the first date of placing of a medicinal product on the market;
4) notify the President of the Office on temporary or permanent suspension of marketing in medicinal
product, not later than within 60 days from the day of cessation of placing of the medicinal product on
the market;
5) present, on request of the President of the Office, data on volume of sale of a medicinal product;
6) implement permanent scientific and technical progress related to production and control methods of
manufacturing products, pursuant to recognized scientific methods;
7) supply medicinal products exclusively to:
a) entities authorized to wholesale marketing ,
b) health care facilities to hospital pharmacies,
c) research and development units, scientific centre of the Polish Academy of Science as well as
basic organizational units of the public universities in order to conduct scientific research,
d) within export conducted by such responsible entity or ordered to the other entity outside the
territory of the Republic of Poland.
3a. The responsible entity, which obtained an authorization, may not publish alarming information
related to safety of pharmacotherapy with respect to its medicinal products without earlier or simultaneous
providing of such information to the President of the Office.
3b. In the event of obtaining by the President of the Office of information on new significant threats
concerning safety of use of a medicinal product, the President of the Office shall oblige the responsible
entity to make changes to dossier of the medicinal product, defining a deadline to submit an application on
making changes.
3c. The responsible entity as well as the entrepreneurs engaged in wholesale marketing in medicinal
products shall be obliged to ensure, in order to satisfy the patients’ needs, relevant and permanent
meeting of demand of the entities authorized to retail marketing in medicinal products and the
entrepreneurs engaged in wholesale marketing in medicinal products.
4. The minister competent for health and with regard to veterinary medicinal products - in cooperation
with the minister competent for agriculture, shall specify, by means of a regulation, the way and mode of
monitoring the safety of medicinal products, taking in particular into consideration:
1) development and maintenance of the system guaranteeing, that all information related to suspicions
of any undesirable effects of medicinal products shall be provided to the responsible entity as well as
to the medical representatives and collected in a way to provide easy access to them in one place;
2) preparation of reports, referred to in Paragraph 1(3);
3) ensuring that any request of the President of the Office to provide additional information
indispensable to assess benefits and threats related to use of a given medicinal product shall result in
fast and completed response together with information on volume of sale of a given medicinal
product;
4) obligations of physicians and pharmacists in the scope of reporting of undesirable effects, as well as
mode and way of reporting and the notification template;;
5) detailed scope and mode as well as the way of notification of undesirable effects of a medicinal
product by the responsible entity, taking in particular the type of submitted effect into consideration.
Article 24a. 1. Control of monitoring system for safety of use of medicinal products shall be
conducted by the President of the office, who may in particular:
1) control the responsible entities in the scope of monitoring system for safety of use of medicinal
products;
2) request to provide dossier related to ensuring operation of the monitoring system for safety of use of
medicinal products;
3) request explanations on ensuring operation of the monitoring system for safety of use of medicinal
products.
2. The minister competent for health shall define, by means of a regulation, way of conducting and
scope of control of the monitoring system for safety of use of medicinal products, taking the reliability of
data collecting, analyses and transfer to the system into consideration.
Article 25. 1. Basic quality requirements, as well as methods of examination of the medicinal
products and of their packaging as well as of the pharmaceutical raw materials shall be specified by the
European Pharmacopoeia or its translation into the Polish language included in the Polish
Pharmacopoeia.
2. If the European Pharmacopoeia does not contain a monograph, the requirements, referred to in
Paragraph 1, shall be defined by the Polish Pharmacopoeia or relevant Pharmacopoeias recognized in
the Member States of the European Union or Member States of the European Free Trade Association
(EFTA) – parties to the Agreement on European Economic Area.
Article 26. 1. The packaging, its labelling as well as the content of the information leaflet of a
medicinal product should be compliant with data included in dossier, pursuant to Article 23(2).
1a. Name of a medicinal product shall be placed on the secondary packaging in Braille system.
1b. The provision of Paragraph 1a shall be not applied to medicinal products of an availability
category, referred to in Article 23a(1), Clause 5 and to veterinary medicinal products.
1c. The responsible entity shall ensure accessibility of the content of leaflet on patient’s request by
the medium of patients’ organization, in a form appropriate for blind or poorly seeing persons.
1d. The minister competent for health may release the responsible entity from its obligation to place
specific information on packaging and agree to implement leaflet in the language other than Polish, if the
product is intended to be administered by a veterinarian exclusively. The President of the Office shall
inform the Chief Veterinary Officer on its decision.
1e. The minister competent for health may, by means of a regulation, define categories of medicinal
products, at the secondary packaging of which the name of a medicinal product in Braille system shall be
not placed, taking the safety of use of the medicinal product, administration route or packaging size into
consideration.
2. The minister competent for health shall define, by means of a regulation, the requirements on
labelling of packaging of a medicinal product and the content of leaflet as well as scope of accessibility of
such leaflet in a form appropriate for blind and poorly seeing persons, taking in particular specific
conditions on proper usage of medicinal products, including radiopharmaceutical, homeopathic and
traditional plant medicinal products into consideration.
3. The minister competent for health in cooperation with the minister competent for agriculture shall
define, by means of a regulation, the requirements of on labelling of packaging of a veterinary medicinal
product and the content of leaflet, taking in particular specific conditions on proper usage of veterinary
medicinal products.
Article 27. 1. Medicinal products may also contain preservatives, sweeteners, colorants,
antioxidants, and in reference to veterinary medicinal products - also the marker substances, providing the
provisions of Paragraph 2.
2. The minister competent for health and with respect to the veterinary medicinal product in
cooperation with the minister competent for agriculture, shall specify, by means of a regulation, the list of
substances referred to in paragraph 1, that may be the components of the medicinal products, basic
quality requirements for these substances and method of their description in dossier attached to the
application for marketing authorization of the medicinal product, taking in particular the safety of medicinal
products and procedures with the Member States. of the European Union into consideration.
Article 28. 1. A medicinal product authorized to the market shall be entered into the Register of
Medicinal Products Authorized to the Market on the territory of the Republic of Poland, hereinafter referred
to as the “Register”.
2. The Register, referred to in Paragraph 1, shall be kept by the President of the Office.
3. The minister competent for health shall specify, by means of a regulation, the way and mode of
keeping the Register, taking in particular the mode of proceedings in making the entries, changes and
deletes in the Register as well as the mode of providing access to it into consideration.
Article 29. 1. The validity period of an authorization may be extended or shortened on request of a
responsible entity.
2. The validity period of the authorization may be prolonged for an undefined period of time on the
basis of the application submitted by the responsible entity at least 6 months prior to the expiry of validity
period. The application should include unified dossier in the area of quality, safety and efficacy in relation
to any and all changes implemented within the validity period of the authorization, excluding changes,
referred to in Article 31(2), Clause 3, as well as data from the monitoring defined by the provisions issued
under Article 24(4) together with their assessment.
2a. When examining an application on prolongation of the validity period of the authorization for a
given medicinal product, the minister competent for health may, in justified cases, taking data on safety of
use of the medicinal product into consideration, issue an individual decision on prolongation of the validity
period of the authorization for subsequent 5 years.
3. Issuing of the decision on prolongation of the authorization’s validity shall result in issuing of an
updated text of authorization, covering the changes made within the period of its validity.
3a. Applications on prolongation of validity period of the marketing authorization, issued within the
mutual recognition procedure, should be submitted in all the states, which had previously authorized that
product to the market under this procedure. The provisions of Article 18a and 19 shall apply respectively.
4. The minister competent for health shall define, by means of a regulation, template of application,
referred to in Paragraph 1, taking data covered by the application and safety monitoring data into
consideration.
5. The medicinal product, which was refused to prolong the validity period of the authorization, may
be produced and placed on the market for a period of 6 months from the day of issuing of final decision,
and remain in marketing up to the expiry date of a medicinal product, unless the decision refusing to
prolong the validity period of the authorization was subject to the order of immediate enforceability.
6. The medicinal product, authorization of which expired due to failure to submit by the responsible
entity of an application on prolongation of the validity period of the authorization, may remain in marketing
up to the expiry date of the medicinal product.
7. In the event of failure to examine the application, referred to in Paragraph 1, submitted within the
time limits, referred to in Paragraph 2, the medicinal product, after the expiry of the validity date of the
authorization, may be produced and placed on the market to the moment of its deciding.
Article 30. 1. The minister competent for health may issue a decision on refusal of issuing of the
authorization, if:
1) application and attached dossier fail to meet the requirements specified in the Act;
2) results of performed tests prove that application of the medicinal product is characterized by risk
incommensurate with the expected therapeutic effect, in the scope of indications, contraindications
and the recommended dose specified in the application;
3) results of tests prove that the medicinal product does not confirm its declared therapeutic efficacy, or
if this efficacy is insufficient;
4) results of tests prove that the qualitative or quantitative composition or other quality properties of the
medicinal product are not compatible with the declared ones;
5) the period of grace provided by the responsible entity is not sufficiently long to ensure that the food
products obtained from treated animals do not contain any products, which could pose a threat to
human health, or this period is not sufficiently verified.
2. Moreover, the minister competent for health, subject to the provisions of Paragraph 3, shall issue a
refusal of marketing authorization of immunological medicinal product administered to animals exclusively,
if:
1) administration of products to animals would be in conflict with the execution of the national
programme of diagnosis, control or elimination of infectious diseases, or if it prevented monitoring of
infections occurrence;
2) the disease, against which the product is to immunize, is not present on the territory of the Republic
of Poland.
3. The Provision of Paragraph 2 shall not apply to inactivated immunological veterinary medicinal
products, manufactured from pathogens and antigens obtained from animal or animals in a holding and
used for treatment of this animal or these animals in a given holding in the same place.
4. The minister competent for health shall issue a decision on refusal to prolong the validity period of
the authorization, due to the reasons specified in Paragraph 1 or 2.
5. If the minister competent for health decides, in the course of the procedure for marketing
authorization, carried out under Article 19(1), that the medicinal products, due to the reasons mentioned in
Paragraph 1, is not to be authorized to the market, it shall submit to the authorities of the European Union
to launch an appropriate procedure.
6. In the event of issuing of a decision on refusal to issue a marketing authorization of a traditional
plant medicinal product, the minister competent for health shall notify the European Commission about
this fact, providing the reasons of such refusal.
Article 31. 1. Changes to data covered by an authorization as well as changes to dossier being the
basis for issuing of the authorization, shall be made by the minister competent for health on request of the
responsible entity.
1a. The minister competent for health may specify, in a decision on change to data covered by an
authorization and change to dossier being a basis for issuing of the authorization proposed by the
responsible entity, the date of entering of the changes into force, unless this decision concerns safety of
use of the medicinal product or is issued on the basis of the decision of the European Commission notified
in the Republic of Poland. The deadline specified by the decision of the minister competent for health may
not exceed 6 months from the day of its issuing.
1b. In the event of change to data covered by the authorization or change to dossier being a basis for
issuing of the authorization within the mutual recognition procedure or decentralized procedure, the
responsible entity shall submit the applications in every Member States of the European Union or Member
States of the European Free Trade Association (EFTA) – parties to the Agreement on European
Economic Area, in which the medicinal product was authorized to the market. The provisions of Article
18a(6) and Article 19(4) shall be applied respectively.
2. The minister competent for health, and in relation to veterinary medicinal products in cooperation
with the minister competent for agriculture, shall specify, by means of a regulation:
1) template of an application for introduction of changes into authorization and dossier related to placing
of a medicinal product on the market;
2) type and scope of the introduced changes as well as scope of the required documents and research
justifying introduction of such change;
3) types of changes requiring submission of an application, referred to in Article 10, taking in particular
data covered by the changes, methods of their documenting as well as scope of research justifying
introduction of such change into consideration;
4) way and mode of introducing changes, referred to in Paragraph 1.
Article 32. 1. In the event of a change of the responsible entity the minister competent for health
shall issue a new authorization on the basis of an application of a person taking over the rights and
responsibilities of the previous responsible entity. Decision issued in favour of the new responsible entity
shall enter into force not later than within 6 months after its issuing. The new authorization shall be issued
not later than within 30 days from submitting of the application and shall keep the previous number and
code compatible with the EAN UCC system.
2. The new responsible entity should attach to the application, referred to in Paragraph 1, an
agreement on cession of rights and responsibilities as well as a statement that the remaining elements of
the authorization and dossier, being the basis for issuing thereof, have not changed.
Article 33. 1. The minister competent for health shall withdraw the authorization in the event of:
1) stating of an unexpected and severe undesirable effect of a medicinal product, threatening human life
or health and in relation to veterinary medicinal products – threatening life or health of an animal;
2) lack of declared therapeutic efficacy or confirmation of risk-related application incommensurate with a
therapeutic effect;
3) stating that the medicinal product is placed on the market incompliant with the conditions of
authorization or the provisions of the Act;
3a) failure to settle on time of a charge, referred to in Article 36(2);
4) stating that the recommended period of grace is insufficiently long to ensure that the food products
originating from treated animals do not contain any residuals, which could pose a risk to consumer’s
health;
5) failure to submit to the President of the Office of novel information covered by the dossier, referred to
in Article 10, that may influence limitation of use of a medicinal product;
6) deleting from the Community list of traditional medicinal products, referred to in Article 16f(1) of the
Directive 2001/83/EC, unless the responsible entity completes dossier, referred to in Article 20a(5),
Clause 6 and Paragraph 7(2) and (3), within the period of 3 months from the date of deleting from
such list, and the minister competent for health issues a positive decision on the application, referred
to in Article 20a(5);
7) failure to meet the conditions, referred to in Article 23b;
8) removal of pharmacologically active substance from Annexes I, II or III to the Regulation 2377/90;
9) in the event of lapse of the deadline, referred to in Article 24(3b).
2. In the event of withdrawal of the authorization, the competent authority removes the medicinal
products from the Register.
3. The minister competent for health shall notify the European Council or Commission on withdrawal
of authorization.
4. In the event, referred to in Paragraph 1(6), the provisions of Article 31 shall apply.
5. The minister competent for health informs the Main Pharmaceutical Inspector, and in case of
veterinary medicinal products also the Chief Veterinary Officer, on the decision, referred to in Paragraph
1.
Article 33a. 1. The authorization shall expire in the event, in which:
1) the responsible entity fails to place the medicinal product on the market within the period of 3 years
from the moment of obtaining of the authorization;
2) medicinal product has been not placed on the market for the period of 3 subsequent years.
2. Referring to the public health protection and in case of a veterinary medicinal product – referring to
protection of humans or animals health or environmental protection and in the event of exceptional
circumstances, in particular in the event of issuing by the court of a temporary order, prohibiting placing of
a medicinal product on the market, the minister competent for health may, on request of the responsible
entity, by means of a decision, state that the authorization, referred to in Paragraph 1, shall not expire.
Article 34. The Register as well as the documents submitted in the course of the proceedings for
marketing authorization, shall be made available to all persons having a legal interest, subject to the
provisions concerning protection of classified information and protection of industrial property.
Article 35. In cases not regulated by the Act, relating to marketing authorization of medicinal
products and clinical trials, the provisions of the Code of Administrative Proceedings shall be applied.
Article 36. 1. The responsible entity shall be obliged to pay a charge connected with marketing
authorization of a medicinal product, for submission of the application on:
1) issuing of the authorization, referred to in Article 7, 18a, 19, 20, 20a, 21, 21a and 32;
2) prolongation of validity period of the authorization, referred to in Article 7, 18a, 19, 20, 20a, 21 and
21a;
4) other changes resulting from administrative actions related to the issued authorization, referred to in
Article 7, 18a, 19, 20, 21 and 21a;
5) preparation of the assessment report, referred to in Article 18a(2) and Article 19(2);
6) updating of the assessment report, referred to in Article 19(2);
7) preparation of documents constituting a basis to launch an explanatory procedure;
8) (…) referred to in Article 33a(2).
2. The responsible entity, which obtained prolongation of validity period of the authorization for an
undefined period of time, referred to in Article 29(2), settles a payment within the validity period of such
authorization for each year of its validity.
3. In the event of application covering a list of homeopathic medicinal products, referred to in Article
21(1) and (4), a single payment is made.
4. The payments, referred to in Paragraph 1 and 2, shall be the revenue of the State Budget.
Article 36a. The minister competent for health and with respect to veterinary medicinal products in
cooperation with the minister competent for agriculture shall define, by means of a regulation, detailed
method of determining charges, referred to in Article 36(1) and (2) and method of their settling, taking the
amount of such charge in the Member States of the European Union of similar gross domestic product per
capita and cost of labour related to execution of a given action and level of costs borne by the Office for
Registration.
Article 37. 1. Obtaining of the authorization and designation by the responsible entity of the
representative of the responsible authority shall not exclude the responsible authority from penal or civil
liability resulting from use of a medicinal product, including the responsibility under the provisions on
responsibility for the product.
2. Designation of the representative of the responsible authority shall be made by a written
agreement provided with a date, defining the scope of rights and responsibilities of such representative of
the responsible authority.
3. The agreement, referred to in Paragraph 2, and its further changes, shall be notified by the
responsible entity to the President of the Office and Main Pharmaceutical Inspector.
4. The responsible entity, manufacturer, entity authorized to wholesale or retail marketing, physician
or any other persons authorized to prescribe and dispense a medicinal product on the basis of separate
provisions shall not borne civil or disciplinary responsibility for the effects of application of the medicinal
products in other way, than provided in therapeutic indications covered by the authorization or for the
effects of application of the medicinal product having no authorization, if such application is related with
marketing authorization of the medicinal product for a period of time defined by the minister competent for
health under Article 4(8).
Chapter 2a
Clinical trials of medicinal products
Article 37a. 1. Clinical trials shall be conducted according to the principles specified in Articles 37b37ag, whereas the veterinary clinical trials according to Articles 37ah-37ak.
2. Clinical trial of a medicinal product is a medical experiment with use of the medicinal product,
carried out on human subjects, in the meaning of the provisions of the Act of 5 December 1996 on
physician and stomatologist profession (Journal of Laws of 2002 No. 21, item 204, No. 76, item 691, No.
152, item 1266 and No. 153, item 1271 and of 2003 No. 90, item 845), hereinafter referred to as the “‘Act
on physician profession’.
Article 37b. 1. Clinical trials, including tests concerning biological availability and equivalence shall
be planned and carried out and reports from clinical trials shall be presented pursuant to the principles of
Good Clinical Practice.
2. Clinical trials shall be carried out considering that the patient’s welfare is superior to scientific or
public interest, in particular if:
1) the predictable risks and inconveniences were compared with the expected benefits for individual
participants of a clinical trial, including present and future patients, and the Bioethics Commission,
referred to in Article 29 of the Act on physician profession as well as the minister competent for health
acknowledged that the expected therapeutic benefits and benefits for public health shall justify
admission of risk introduction, provided that a clinical trial may be carried out only if conformity with
protocol is monitored in permanent manner;
2) participant of a clinical trial, and in the event, in which this person is unable to express its informed
consent – its statutory representative, in the course of an interview made before the clinical trial with a
researcher or any member of its team, have acquainted with the objectives, risks and inconveniences
related to the clinical trial as well as with the conditions of carrying out of the clinical trial and they
have been also informed of their right to withdraw from the clinical trial at any moment;
3) right of a participant of a clinical trial to guarantee its physical and mental integrity, privacy, and
protection of its personal data shall be observed;
4) participant of a clinical trial, and in the event, in which such person is unable to express its informed
consent – its statutory representative, after being informed of the essence, significance, results and
risks of a clinical trial, expressed its informed consent for participation in the trial; a document
confirming the expression of informed consent shall be kept with dossier from such clinical trial;
5) relevant proceedings have been assumed to assure that a withdrawal of a participant from the clinical
trial shall not result in any harm to such person;
6) sponsor and researcher have entered into an agreement on obligatory civil responsibility insurance
for damages resulting from carrying-out of a clinical trial.
3. The minister competent for financial institutions, in cooperation with the minister competent for
health shall, after consulting the Polish Chamber of Insurance, specify, by means of a regulation, detailed
scope of obligatory insurance, referred to in Paragraph 2(6), deadline to establish an insurance obligation
as well as the minimal guaranteed amount, taking in particular the specifics of a clinical trial into
consideration.
Article 37c. Conducting a clinical trial shall not exempt a sponsor and a researcher from criminal or
civil responsibility resulting from the carried-out clinical trial.
Article 37d. 1. A participant of a clinical trial may, at any moment, withdraw from the clinical trial
without any harm.
2. The entity indicated in the requirements of Good Clinical Practice shall inform a participant of a
clinical trial about the possibility to obtain additional information concerning its rights.
Article 37e. In clinical trials, excluding clinical trials conducted on adult and healthy participants of a
clinical trial, it is prohibited to introduce any financial incentives or benefits, excluding compensation for
the incurred costs.
Article 37f. 1. Expression of informed consent shall be understood as a declaration of will expressed
in writing, provided with the date and signature, which shall be submitted by a participant able to submit
such declaration of its own free will, and in the event of a participant unable to submit such declaration –
by its statutory representative; the declaration shall also contain a note, that it was submitted after
receiving relevant information on the essence, significance, results and risks connected with a clinical trial.
2. In the event, in which such informed consent, referred to in Paragraph 1, may not be submitted in
writing, the consent expressed verbally in the presence of at least two witnesses shall be equally
recognized. Consent submitted in such way shall be recorded in dossier of a clinical trial.
Article 37g. The minister competent for health shall specify, by means of a regulation, detailed
requirements of Good Clinical Practice, taking in particular the way of planning, carrying out, monitoring,
documenting and reporting of clinical trial results, pursuant to the provisions in the area of Good Clinical
Practice in force in the European Union.
Article 37h. 1. A clinical trial with the participation of the minors may be carried out, provided that the
following conditions are met:
1) informed consent of a statutory representative and of the minor has been obtained, under the
principles specified in Article 25 of the Act on physician profession;
2) researcher or a person indicated by the researcher, having an experience in contacts with the minors,
provided the minor with comprehensible information on the clinical trial as well as related risks and
benefits;
3) researcher shall guarantee, that it will respect at any moment a request of a minor, able to express its
opinions and assess the abovementioned information, concerning its refusal to participate in a clinical
trial, or its withdrawal from such test the test,
4) a group of patients shall potentially gain direct benefits from a clinical trial and the conduction of such
clinical trial shall be indispensable to confirm data obtained from clinical trials, participants of which
were the patients able to express their informed consent, or from clinical trials carried out with the use
of other scientific methods;
5) a clinical trial shall concern directly a disease occurring in a given minor, or carrying out of such trial is
possible only with the participation of the minors;
6) a clinical trial was scheduled in a way to minimize pain, fear and any other predictable risks
connected with the disease and patient’s age.
2. The minister competent for health shall specify, by means of a regulation, the method of
conducting clinical trials with the participation of the minors, taking in particular the legitimacy of
participation of the minors in clinical trial, ways to minimize risks related to such clinical trials, order of
execution of clinical trials considering the age of patients, classification of clinical trials according to the
type and nature of disease, schedule of execution of clinical trials with the participation of the minors,
considering the advancement level of clinical trials referring to the tested medicinal product, the type of
conducted tests, the type of clinical dossier required before launching of clinical trials with the participation
of the minors, following the provisions of the European Union in the area of principles for conducting
clinical trials with the participation of children into consideration.
Article 37i. 1. In the event of a clinical trial with participation of:
1) fully incapacitated person –an informed consent for participation of such person in clinical trials shall
be expressed by its statutory representative, and of such person is able to knowingly express its
opinion on taking part in a clinical trial, it is also necessary to obtain consent of this person in writing;
2) person having full legal capacity, being not able to express its opinion on its participation in a clinical
trial – an informed consent for participation of such person in a clinical trial shall be given by the
custodial court, competent for the location of a clinical trial.
2. The persons mentioned in Paragraph 1(2), may not be subject to clinical trials, if such persons,
having their full legal capacity, refused knowingly to participate in such clinical trials.
3. The clinical trial with the participation of the persons, referred to in Paragraph 1, may be conducted
if the following conditions are additionally met:
1) this person was provided with comprehensive information concerning the clinical trial, including the
related risks and benefits;
2) researcher shall guarantee, that it will respect at any moment a request of a minor, able to express its
opinions and assess the abovementioned information, concerning its refusal to participate in a clinical
trial, or its withdrawal from such test;
3) clinical trial is necessary to confirm data obtained in the course of clinical trials, participants of which
were patients able to express their informed consent and concerned directly a disease occurring in a
given person, posing a threat to its life or causing disability;
4) a clinical trial was scheduled in a way to minimize pain, fear and any other predictable risks
connected with the disease and patient’s age;
5) there are reasons to suppose that administration of a tested medicinal product shall associate with
benefits to a patient and shall not be connected with any risks.
Article 37j. The sponsor and the researcher shall be responsible for the damages caused in
connection with the execution of a clinical trial.
Article 37k. 1. Sponsor shall supply free of charge the tested medicinal products and equipment
used for their administration to the participants of a clinical trial.
2. The tested medicinal products, referred to in paragraph 1, must meet the principles of Good
Manufacturing Practice in the scope of manufacturing.
3. Import from abroad of the tested medicinal products and equipment indispensable to conduct
clinical trials, requires obtaining of a certificate of the President of the Office, confirming, that the clinical
trial was listed in the Central Register of Clinical Trials and that the given product or equipment is imported
for the purposes of such trial.
4. The provision of Paragraph 3 shall be not applied to import of the tested medicinal product and the
equipment indispensable to conduct the clinical tests from any Member State of the European Union or in
any Member State of the European Free Trade Association (EFTA) – a party to the Agreement on the
European Economic Area.
Article 37l. 1. A clinical trial may be launched, if the Bioethics Commission issued a positive opinion
on carrying-out of the trial and the minister competent for health Minister of Health issued the
authorization for carrying-out of the clinical trial.
2. A clinical trial may be also launched, if the minister competent for health did not request for
information, referred to in Article 37n(2) within the period, specified in Article 37p(1).
3. The provisions of Paragraph 2 shall not concern clinical trials of the tested medicinal products
intended for gene or cell therapy, or clinical trials of the tested medicinal products containing genetically
modified organisms.
4. Issuing of the authorization, referred to in paragraph 1, and refusal to issue the authorization shall
be made by means of an administrative decision.
5. The President of the Office shall register a clinical trial in the Central Register of Clinical Trials; the
registration shall also cover the information on refusal to issue the authorization for conducting the clinical
trial.
Article 37m. 1. Application on launching of a clinical trial shall be submitted by a researcher or
sponsor to the minister competent for health by the agency of the President of the Office.
2. The following should be particularly attached to the application, referred to in Paragraph 1:
1) data concerning the tested medicinal product;
2) protocol of a clinical trial, being the document describing the purposes, schedule, methodology,
statistical issues and organization of a clinical trial;
3) information for patients and the informed consent form;
4) documents confirming conclusion of the insurance agreement, referred to in Article 37b (2), Clause 6;
5) clinical observations chart;
6) data concerning the researchers and units participating in a clinical trial;
7) confirmation of payment of a charge for the submission of an application;
8) description of scientific and professional activity of a researcher signed and provided with the date;
9) agreements on clinical trials made between parties participating in a clinical trial.
3. For submitting of the application, referred to in Paragraph 1, a charge is collected.
Article 37n. 1. If the submitted dossier, referred to in Article 37m, requires to be completed, the
minister competent for health shall specify a deadline of such completion by the sponsor or researcher,
together with an instruction that lack of such completion shall result in no examination of the application.
2. In the course of the procedures related to issuing of an authorization for carrying-out of a clinical
trial, the minister competent for health may, once, request from a sponsor or researcher to provide
supplementary information necessary for issuing of the authorization. The deadline for delivery of the
supplementary information shall not exceed 90 days.
Article 37o. The minister competent for health shall issue a decision on refusal to issue an
authorization for carrying-out of clinical tests, in the event, in which:
1) application or dossier fails to meet the requirements defined by the Act;
2) assumptions of a clinical trial pose a threat to public order or are incompliant with the principles of
social co-existence;
3) assumptions of a clinical trial fail to meet the requirements of Good Clinical Practice.
Article 37p. 1. Issuing of an authorization for carrying-out of a clinical trial or refusal to issue such
authorization shall be made by the minister competent for health within a period not exceeding 60 days.
2. The deadline, referred to in Paragraph 1, shall be counted from the date of submission of the
dossier, specified in Article 37m.
3. The deadline, referred to in Paragraph 1, may be prolonged by the period not exceeding 30 days,
and in the event of consulting an expert, by the subsequent 90 days in relation to clinical trials concerning
the tested medicinal products intended for gene or cell therapy, or concerning the tested medicinal
products containing genetically modified organisms.
4. The deadline, referred to in Paragraph 1, shall be suspended to the moment of receiving
information, referred to in Article 37n(2), provided that such period shall not exceed 90 days.
5. The provisions of Paragraphs 1 - 4 shall not apply to clinical trials concerning xenogenic therapy.
Article 37r. 1. The Bioethics Commission shall provide an opinion on a clinical trial upon a request of
a sponsor or researcher, submitted together with the dossier constituting the basis for its issuing.
2. Providing the opinion referred to in Paragraph 1, the Bioethics Commission shall assess in particular:
1) legitimacy, feasibility and schedule of a clinical trial;
2) analysis of the assumed benefits and risks;
3) correctness of clinical trial protocol;
4) correctness of the researcher and team members’ selection;
5) quality of researcher’s brochure;
6) quality of a centre;
7) level and completion of written information to be handled to the participants of a clinical trial;
8) correctness of procedures applied to obtain an informed consent as well as justification for carrying-out
of a clinical trial with participation of the persons unable to express such informed consent, taking the
special restrictions mentioned in Articles 37h and 37i into consideration;
9) Amounts of indemnities or compensations provided for in the event of possible body injury or death
caused by the participation in a clinical trial;
10) Amounts of remunerations or compensations for the personnel conducting the clinical trial and the
participants of the clinical trials, as well as the agreements on the clinical trial, made between a sponsor
and a centre;
11) principles for recruitment of the participants of a clinical trial;
12) the agreement, referred to in Article 37b(2), Clause 6.
Article 37s. 1. Shall the clinical trials be carried out by different researchers on the basis of a single
protocol and in many research centres located on the territory of the Republic of Poland or the other
countries (multi-centre clinical trials), the sponsor shall choose a coordinator of the clinical trial from
among all the researchers carrying out the clinical trial on the territory of the Republic of Poland.
2. In the event of clinical trials referred to in Paragraph 1, conducted on the territory of the Republic of
Poland, a sponsor or coordinator of the clinical trial shall submit an application to the Bioethics
Commission competent for the seat of coordinator of the clinical trial.
3. Opinion issued by the Commission, referred to in Paragraph 2, shall be binding for all the centres
on behalf of which the sponsor or coordinator submitted the application for issuing of the opinion.
4. The Bioethics Commission, referred to in Paragraph 2, shall inform all the Bioethics Commissions
competent for the location a conducted clinical trial on the territory of the Republic of Poland, on the
scheduled participation of a given centre in the clinical trial. These Commissions, within the period of 14
days, may lodge their objections related to the participation of a researcher or a centre in a given clinical
trial; failure to lodge the objections within the abovementioned period, shall mean the approval of the
participation of the researcher and the centre in the given clinical trial.
Article 37t. 1. The Bioethics Commission, within the period not longer than 60 days, shall present its
opinion to a sponsor or to a researcher and to the minister competent for health by the agency of the
President of the Office.
2. The provisions of Article 37n and Article 37p shall be applied respectively.
3. If in the composition of the Bioethics Commission issuing an opinion on a clinical trial:
1) with the participation of a minor – there is no paediatrician present, the Bioethics Commission shall
seek an opinion of such paediatrician;
2) with the participation of the persons unable to express their informed consent – there is no
specialist physician in a field of medicine, which concerns such conducted clinical trial, the Bioethics
Commission shall seek an opinion of such specialist.
Article 37u. Sponsor or researcher shall have the right to appeal against a negative opinion of the
Bioethics Commission to the Appeal Bioethics Commission, referred to in Article 29 in the Act on
physician profession.
Article 37w. The minister competent for health shall specify, by means of a regulation:
1) template of application to the Bioethics Commission on issuing of the opinion on the clinical trial,
referred to in Article 37r(1), and to the minister competent for health on launching of the clinical trial,
referred to in Article 37m(1),
2) dossier, referred to in Article 37r(1),
2a) dossier, referred to in Article 37m(2),
2b) template of application to the Bioethics Commission and to the minister competent for health on
expressing an approval in the area of changes, , referred to in Article 37x(1),
2c) template of application to the Bioethics Commission and to the minister competent for health on
termination of the clinical trial, referred to in Article 37ab
- taking in particular the guidelines of the EMEA and the necessity to submit applications and notifications
in Polish and English language versions and in the event of applications and notifications to the minister
competent for health also in electronic form into consideration;
3) amounts of charges, referred to in Article 37m(3) and the payment method – taking in particular the
phase of clinical trial, amount of labour connected with a given activity and the costs incurred by the
Registration Office as well as the amounts of charges in the European Union Member States with
similar Gross Domestic Product per capita into consideration.
Article 37x. 1. Making significant changes, having impact on safety of the participants of a clinical
trial, in the protocol of such clinical trial or dossier on a given medicinal product constituting a basis of
issuing of an authorization for carrying-out of a trial, shall require obtaining of the opinion in this issue from
the Bioethics Commission, which provided its opinion on this trial, and a consent of the minister competent
for health.
2. The assent referred to in Paragraph 1 shall be issued within the period not exceeding 35 days from
the date of submission of the application.
3. The changes, referred to in Paragraph 1, may be also introduced, if the minister competent for
health failed to submit its objectives concerning the admissibility of their introduction within the period
specified in Paragraph 2.
Article 37y. 1. In the case of any event, which could have impact on safety of the participants of a
clinical trial, a sponsor or researcher shall withdraw from carrying-out of the clinical trial pursuant to the
protocol of clinical trial in force. In such case a sponsor and researcher shall be obliged to take relevant
measures to ensure safety of the participants of the clinical trial.
2. The sponsor shall inform the President of the Office and the Bioethics Commission, which provided
the opinion on the clinical trial, on the emerged situation and the taken security measures.
Article 37z. 1. Obligations of a researcher, carrying out a clinical trial in a given centre, shall include
in particular:
1) ensuring medical care to the participants of a clinical trial;
2) monitoring the conformity of a carrying-out clinical trial with the principles of Good Clinical Practice;
3) reporting to sponsor on any severe undesirable events related to the tested medicinal product,
excluding the events specified by the protocol or researcher’s brochure as not requiring an immediate
report.
2. The researcher shall be obliged to draw up a written report, including a description of any severe
undesirable event, in which the participants of a clinical trials are identified by a code numbers, together
with reporting of events referred to in Paragraph 1(3).
3. Reporting to sponsor on any other severe undesirable event than referred to in Paragraph 1(3),
and on any incorrect result of laboratory tests, shall be made under the proceedings specified in a clinical
trial protocol.
4. In case of reporting a participant’s death, a researcher, on request of a sponsor or the Bioethics
Commission, shall present all available information not mentioned in the report, referred to in paragraph 2.
5. A sponsor shall keep the dossier referred to in Paragraphs 2-4, pursuant to the principles of Good
Clinical Practice and shall make it available on request of the Member States of the European Union or
the Member States of European Free Trade Association (EFTA) – parties to the Agreement on European
Economic Area, on the territory of which the given clinical trial is carried out, subject to the provisions of
Article 37aa.
Article 37aa. 1. In the event of any suspicion, that an undesirable event, referred to in Article 37z(1)
Clause 3, constitutes an unexpected severe undesirable effect of a medicinal product, resulting in death or
posing a threat to life of a participant of a clinical trial, a sponsor shall immediately, not later than within 7
days from the date of receiving of the information, provide this information to the competent authorities of
the Member States of the European Union or the Member States of European Free Trade Association
(EFTA) – parties to the Agreement on European Economic Area European, on the territory of which the
given clinical trial is carried out and to the Bioethics Commission, which provided the opinion on the
clinical trial and provide it in electronic form to the European database on undesirable effects.
2. Additional information, including a description of the unexpected severe undesirable effect of a
medicinal product, shall be delivered by the sponsor to the Bioethics Commission, which provided the
opinion on the clinical trial, within the period of 8 days from the date of delivery of the information referred
to in Paragraph 1 and delivered in electronic form to the European database on undesirable effects.
3. In the event of any suspicion, that the undesirable event is an unexpected severe undesirable
effect of a medicinal product, other than specified in Paragraph 1, sponsor shall immediately, not later
than within 15 days from the date of receiving of the information, deliver the information to the competent
authorities of the Member States of the European Union or the Member States of European Free Trade
Association (EFTA) – parties to the Agreement on European Economic Area European, on the territory of
which the given clinical trial is carried out, and to the Bioethics Commission, which provided the opinion on
the clinical trial and provide it in electronic form to the European database on undesirable effects.
4. Independently from information delivered in a manner specified in Paragraphs 1-3, a sponsor shall
inform all the researchers carrying out the given clinical trial on the territory of the Republic of Poland, on
the suspicion of an unexpected severe undesirable effect.
5. In each year of carrying-out of a clinical trial, a sponsor shall submit a list containing all suspicions
on occurrence of severe undesirable effects in the given year and annual report on the patients’ safety to
the competent authorities of the Member States of the European Union or the Member States of European
Free Trade Association (EFTA) – parties to the Agreement on European Economic Area, on the territory
of which the given clinical trial is carried out, and to the Bioethics Commission, which provided the opinion
on the clinical trial.
6. The President of the Office shall collect information concerning unexpected severe undesirable
effects of a medicinal product, which occurred in connection with carrying-out of clinical trials on the
territory of the Republic of Poland.
7. The minister competent for health shall specify, by means of a regulation, the mode of reporting on
unexpected severe undesirable effects of a medicinal product, data covered by dossier, referred to in
Article 37z (5), as well as the templates of application forms for unexpected severe undesirable effect,
taking in particular the way of collecting, verification and presenting information on unexpected severe
undesirable effect of a medicinal product and an unexpected event into consideration.
Article 37ab. 1. A sponsor shall inform the Bioethics Commission, which provided the opinion on the
clinical trial as well as the minister competent for health by the agency of the President of the Office on
termination of a clinical trial conducted on the territory of the Republic of Poland within a period of 90 days
from the date of termination of such clinical trial.
2. In the event of termination of a clinical trial prior to the declared deadline, a sponsor shall inform
the Bioethics Commission, which provided the opinion on the clinical trial as well as the minister
competent for health by the agency of the President of the Office, within a period of 15 days from the date
of termination of clinical trial and shall give reasons for the earlier termination of the clinical trial.
Article 37ac. 1. In the event of a justified suspicion, that the conditions specified in an authorization
for carrying-out of a clinical trial failed to be met or the obtained information question the safety or
scientific legitimacy of the conducted clinical trial, the minister competent for health may:
1)issue a decision to suspend a clinical trial
2) withdraw the authorization for conduction of a clinical trial,
3) indicate the actions which have to be taken in order to continue the trial.
2. If there is no direct threat to safety of the participants of a clinical trial, the minister competent for
health shall, prior to issuing of the decision referred to in Paragraph 1, request from the sponsor and
researcher to take a position on this issue within the period of 7 days.
3. The minister competent for health shall inform the sponsor, states participating in a clinical trial, the
Bioethics Commission, which provided the opinion on the clinical trial, the European Medicines Evaluation
Agency and the European Commission on issuing of the decision referred to in Paragraph 1.
Article 37ad. 1. The President of the Office shall enter information concerning clinical trial into the
European database on clinical trials.
2. Information, referred to in Paragraph 1, shall cover in particular:
1) required data from the application on launching of a clinical trial,
2) any changes made to the submitted dossier,
3) date of receiving of the opinion of the Bioethics Commission,
4) statement on termination of the clinical trial,
5) information concerning controls of the clinical trial conducted pursuant to the principles of Good
Clinical Practice.
3. Upon a justified request of the Member States of the European Union or the Member States of
European Free Trade Association (EFTA) – parties to the Agreement on European Economic Area, the
European Medicines Evaluation Agency or the European Commission, the President of the Office shall
deliver additional information concerning the given clinical trial, other than information available in the
European database.
Article 37ae. 1. Control of clinical trials in the scope of conformity of the trials with the principles of
Good Clinical Practice shall be conducted by the Inspection of Clinical Trials.
2. The control, referred to in Paragraph 1, shall be conducted by a person authorized by the
President of the Office, hereinafter referred to as the ‘trial controller’.
3. Trial controller may in particular:
1) control units carrying out clinical trials, seat of a sponsor, an organization carrying out the
commissioned clinical trials, or other sites recognized as significant for the execution of clinical trials;
2) request presentation of dossier related to the conducted clinical trial;
3) demand explanations concerning a conducted clinical trial and the presented dossier.
4. The President of the Office shall inform the European Medicines Evaluation Agency on the results
of control and provides the report from the conducted control to the European Medicines Evaluation
Agency, other Member States of the European Union or the Member States of European Free Trade
Association (EFTA) – parties to the Agreement on European Economic Area and the Bioethics
Commission, which provided the opinion on the clinical trial, on their justified request.
5. Inspection of Clinical Trials may also conduct the control on request of the European Commission.
6. Results from controls of clinical trials conducted on the territory of other Member State of the
European Union, shall be recognized by the President of the Office.
7. The minister competent for health shall specify, by means of a regulation, the mode and scope of
controls of clinical trials, considering in particular the nature of the trials carried out, following the principles
of Good Clinical Practice.
Article 37af. The minister competent for health shall cooperate with the European Commission, the
European Medicines Evaluation Agency as well as with the competent authorities of the Member States of
the European Union or the Member States of European Free Trade Association (EFTA) – parties to the
Agreement on European Economic Area, in the scope of conducting controls of the clinical trials; the
minister competent for health, on request of the President of the Office, may apply to the European
Commission to carry out a control in a country outside the territory of the Member States of the European
Union or the Member States of European Free Trade Association (EFTA) – parties to the Agreement on
European Economic Area.
Article 37ag. The provisions on medical experiment, referred to in Chapter IV of the Act on physician
profession, shall be applied to the clinical trials of medicinal products in the scope not regulated by the
provisions of this chapter.
Article 37ah. 1. Sponsor or researcher shall submit an application to issue an authorization for
conducting a veterinary clinical trial to the minister competent for health by the agency of the President of
the Office.
2. The provisions of Paragraph 1 shall be also applied to the veterinary clinical trials on residues of a
tested veterinary medicinal products in tissues and to the other veterinary clinical trials on animals, tissues
or products of which are intended for consumption.
3. For submission of the application, referred to in Paragraph 1, charges are collected.
4. A veterinary clinical trial may be launched or carried out after receiving of an authorization from the
minister competent for health, if the minister states, that the proposed clinical trial is compliant with the
principles of Veterinary Good Clinical Practice. The minister competent for health shall grant an
authorization or refuse to do so by means of a decision.
5. The President of the Office shall register a veterinary clinical trials, which obtained an authorization
or not from the minister competent for health in the Central Register of Clinical Trials.
6. Import of tested veterinary medicinal products and of equipment necessary to conduct veterinary
clinical trials shall require obtaining of a certificate of the President of the Office, confirming, that the
veterinary clinical trial was registered in the Central Register of Clinical Trials and that the given product or
equipment is imported for the purposes of this trial.
Article 37ai. 1. The Inspection of Clinical Trials shall conduct the controls of veterinary clinical trials in the
scope of conformity of such trials with the principles of Veterinary Good Clinical Practice.
2. Trial controller, authorized by the President of the Office, may in particular:
1) control the centres carrying out the veterinary clinical trials, seat of a sponsor, organizations carrying
out the commissioned veterinary clinical trials or other sites significant for execution of a veterinary
clinical trial;
2) request presentation of dossier related to the conducted veterinary clinical trial;
3) demand explanations concerning a conducted veterinary clinical trial and the presented dossier.
3. In the event, in which the clinical trial of a tested veterinary medicinal product shall pose a threat to
health or life of animals being subject to the veterinary clinical trial or if its execution is inconsistent with
the protocol of the veterinary clinical trial, or has a negligible scientific value, the minister competent for
health, on request of the President of the Office, by means of a decision, shall order suspension or
interruption of the veterinary clinical trial; the President of the Office shall submit an application after
carrying out of control of veterinary clinical trials.
Article 37aj. The minister competent for health in cooperation with the minister competent for
agriculture, shall specify, by means of a regulation:
1) template of the application, referred to in Article 37ah(1);
2) manner and scope of conducting a control of the veterinary clinical trials in the area of conformity of
these trials with the principles of Veterinary Good Clinical Practice, taking the nature of a tested
veterinary medicinal product as well as its intension and the range of the conducted veterinary clinical
trials into consideration;
3) way and mode of keeping the Central Register of Clinical Trials in the scope of a tested veterinary
medicinal products, taking in particular data covered by this register into consideration;
4) amounts of charges, referred to in Article 37ah(3), and the way of their settling, taking in particular
amount of work connected with a given activity into consideration;
5) detailed requirements of the Veterinary Good Clinical Practice, taking in particular the method of
scheduling, conducting, monitoring, documenting and reporting the results from veterinary clinical
trials as well as the responsibilities of the entities participating in or applying for carrying out of clinical
trials into consideration.
Article 37ak. To the issues not regulated by the Act on conducting the veterinary clinical trials, the
provisions of the Act of 2 August, 1997 on animals protection (Journal of Laws of 2003 No. 106, item
1002, as amended 6)) shall be applied.
Article 37al. The provisions of this chapter shall be not applied to not-intervention studies, in which:
1) medicinal products are applied in a way specified in the marketing authorization;
2) assignation of a patient to a group, subject to specific medical treatment, is not based on the trial
protocol, but depends on the current practice, and the decision on administration of a medicine is
explicitly separated from the decision on including a patient into the trial;
3) patients are not subject to any additional diagnostic procedures or monitoring, and epidemiological
methods are used to analyze the collected data.
Chapter 2b
General provisions on business activities covered by the authorizations
Article 37am. Before making a decision on issuing of an authorization, a competent authority issuing
such authorization, hereinafter referred to as the ‘authorizing authority':
1) may request from an applicant to complete, within a specified period, the missing dossier confirming,
that it meets the conditions specified by law, required to conduct a specific business activity of the
conditions specified in the regulations of Law, required for execution of a given economic activity;
2) may verify data provided in the application for issuing of an authorization, in order to state that the
entrepreneur meets the conditions of execution of an economic activity covered by the authorization.
Article 37an. 1. An entrepreneur intending to launch a business activity in the area subject of
authorization, may apply for a promise of authorization, hereinafter referred to as the ‘promise’. Within
such promise it is possible to make issuing of an authorization conditional on meeting the requirements of
conducting a business activity covered by the authorization.
2. In the proceedings for issuing of a promise the provisions on granting the authorization, specified
by the provisions of the Act, shall apply.
3. Validity date defined in the promise may not be shorter than 6 months.
4. Within the validity period of the promise it is not possible to refuse issuing of an authorization to
conduct a business activity defined in a promise, unless:
1) data included in the application for issuing of the promise were changed, or
2) an application failed to meet all of the conditions listed in the promise, or
3) an applicant fails to meet the conditions for conducting of a business activity covered by the
authorization, or
4) it is justified by a threat to the national defence or safety or to any other important public interests.
Article 37ao. 1. The authorization shall be issued for an undefined period of time.
2. The authorization may be issued for a defined period of time on request of an entrepreneur.
Article 37ap. 1. The competent authority shall withdraw the authorization, if:
1) legally valid judgment has been issued prohibiting the entrepreneur to conduct a business activity,
covered by the authorization;;
2) entrepreneur failed to meet the conditions specified by the provisions of law, required to execute the
business activity specified in the authorization;
3) entrepreneur did not modify, within a period specified by the authorizing authority, the actual or legal
state incompliant with legal provisions regulating business activity covered by the authorization.
2. The authorizing authority may withdraw the authorization in cases specified by the provisions of
the Act.
Article 37ar. An entrepreneur shall be obliged to report any changes of data specified in the
authorization to the authorizing authority.
Article 37as. An entrepreneur, whose authorization has been withdrawn from the reasons referred to
in Article 37ap(1), may apply again for issuing of an authorization in the same scope not earlier than after
3 years from the day of issuing of the decision of the authorization withdrawal.
Article 37at. 1. The authorizing authority shall be entitled to control the business activity, for which
the authorization was issued.
2. Control activities shall be conducted on the basis of the authorization issued by the authorizing
authority.
3. The persons, authorized by the authorizing authority to conduct the control, shall be authorized in
particular to:
1) the entry onto the area of a real estate, facility, premise or their part, in which the business activity
covered by the authorization is executed or should be executed;
2) demand oral or written explanations, presentation of documents or other information carriers and to
provide access to data related to the subject of control.
4. The authorizing authority may request from an entrepreneur to remove any infringements stated in
the course of a control, in a defined period of time.
5. The authorizing authority may authorize to conduct the controls, referred to in Paragraph 1, the
other competent administrative authority, specialized in controls of a given type of activity. The provisions
of Paragraphs 2 - 4 shall be applied respectively.
Chapter 3
Manufacturing and import of medicinal product
Article 38. 1. Launching of business activity in the scope of manufacturing of a medicinal product
shall require, subject to the provisions of Paragraph 4, obtaining of the manufacturing authorization.
1a. Launching of business activity in the scope of manufacturing of a medicinal product shall require,
subject to the provisions of Paragraph 4, obtaining of the import permit.
2. The Main Pharmaceutical Inspector shall be the authority competent for issuing, refusing and
withdrawing as well as changing of the manufacturing authorization or the import permit.
3. (repealed).
3a. To the business activities conducted in the scope of import of medicinal products the provisions of
Article 40(2), Article 41, Article 42, Article 43(2) and (4), Article 46 and Articles 48-51 shall apply
respectively.
4. The Main Pharmaceutical Inspector shall issue an opinion on conformity of manufacturing
conditions with the requirements of the Good Manufacturing Practice, referred to in Article 39(4), of a
medicinal product manufactured abroad, if:
1) the responsible entity applies for issuing of the authorization, referred to in Article 10(1) and (2a), or
2) medicinal product is imported on the territory of the Republic of Poland for further processing.
- after stating on the basis of an inspection carried out by the inspectors for manufacturing of the Main
Pharmaceutical Inspectorate or the report from the inspection conducted within the last 3 years by the
Member State of the European Union or the Member State of European Free Trade Association (EFTA) –
a party to the Agreement on European Economic Area or a state having an agreement of mutual
recognition of inspection with any Member State of the European Union or the Member State of European
Free Trade Association (EFTA) – a party to the Agreement on European Economic Area, that the
requirements indispensable to obtain a medicinal product of a quality compliant with the declared one
were met and after providing of a certified copy of a manufacturing authorization issued by a competent
authority in the state, in which the product is manufactured.
5. In the event, referred to in Paragraph 4(1), the Main Pharmaceutical Inspector shall provide its
opinion to the minister competent for health.
6. Inspection, referred to in Paragraph 4, shall be carried out by the inspector for manufacturing of the
Main Pharmaceutical Inspectorate, at the expense of the responsible entity applying for providing of the
opinion, referred to Paragraph 4.
7. The provisions of Paragraphs 4 – 6 shall be not applied to the Member States of the European
Union or the Member States of European Free Trade Association (EFTA) –a party to the Agreement on
European Economic Area other than the Republic of Poland and the states of equivalent requirements of
Good Manufacturing Practice and equivalent inspections system comparing to the European Union.
8. (repealed).
9. The Main Pharmaceutical Inspector shall deliver copies of decisions, referred to in Paragraphs 1
and 1a, to the EMEA.
Article 39. 1. The applicant applying for manufacturing authorization should:
1) submit the application on issuing of an authorization, including the company of the applicant together
with Tax Identification Number (TIN) and determining type and name of the medicinal product, its
pharmaceutical form, place of manufacturing, range of manufacturing and places of control;
2) deliver detailed data on quality assurance, including conformity with the requirements of Good
Manufacturing Practice, referred to in Paragraph 4(1);
3) have appropriate premises and technical and control devices indispensible to produce, control and
store of medicinal products listed in the application;
4) employ a qualified person, responsible for ensuring, before placing on the market, that each batch of
the medicinal product has been manufactured and controlled pursuant to the provisions of the Act
and the requirements included in the specifications and documents constituting the basis for
marketing authorization of this product.
1a. The applicant applying for import permit should:
1) submit the application on issuing of a permit, including the company of the applicant together with Tax
Identification Number (TIN) and determining type and name of the medicinal product, its
pharmaceutical form, location of conducting a business activity in the scope of import, range of import
and places of control;
2) deliver detailed data on quality assurance, including conformity with the requirements of Good
Manufacturing Practice, referred to in Paragraph 4(1);
3) have appropriate premises and technical and control devices indispensible to import, control and
store the medicinal products listed in the application;
4) employ a qualified person, responsible for ensuring, before placing on the market, that each batch of
the medicinal product has been manufactured and controlled pursuant to the provisions of the Act
and the requirements included in the specifications and documents constituting the basis for
marketing authorization of this product.
2. Manufacturing authorization and import permit shall be issued for undefined period of time after
stating by the Pharmaceutical Inspection that the applicant applying for authorization meets the
requirements described in Paragraph 1 or in Paragraph 1a, respectively.
3. If application for an authorization relates to a greater number of medicinal products, names of
medicinal products included in the application any be listed in an attachment to the application.
4. The minister competent for health shall specify, by means of a regulation:
1) requirements of Good Manufacturing Practice, taking the relevant guidelines of the European
Community into consideration;
2) requirements to be met by the person, referred to in Paragraph 1(4) and in Paragraph 1a(4), taking in
particular education and professional experience into consideration and having in mind proper
performance of its duties;
3) template of application on manufacturing authorization of medicinal products and template of
application on permit for import of medicinal products, taking documents confirming data, referred to
in Paragraphs 1 and 1a, as well as types of documents attached to the application into account,
considering type of medicinal product and the range of manufacturing and import covered by the
authorization;
4) template of the application on change of the manufacturing authorization of the medicinal product and
template of the application for change of the permit for import of the medicinal products, taking data
related to changes into consideration.
Article 40. 1. The manufacturing authorization shall contain:
1) name and address of the manufacturer,
2) indication of places of manufacturing and control,
3) type and name of medicinal product,
4) detailed range of manufacturing stated in the authorization,
5) number of the authorization and date of its issuing.
1a. The import permit shall contain:
1) name and address of the importer,
2) indication of places of conducting a business activity in the scope of import,
3) type and name of medicinal product,
4) detailed range of import stated in the authorization,
5) number of the authorization and date of its issuing.
2. Shall the authorization relate to a greater number of medicinal products, names of the medicinal
products stated in the authorization may be specified in annex to the authorization.
3. The minister competent for health shall specify, by means of a regulation, template of
manufacturing authorization of a medicinal product and template of import permit of a medicinal product,
taking in particular data specified in Paragraphs 1 and 1a into consideration.
Article 41. 1. Issuing of a decision on issuing or refusal to issue a manufacturing authorization of a
medicinal product ,may not exceed 90 days from the day of submission of the application by the applicant.
2. The course of a deadline, referred to in Paragraph 1, shall be suspended, if the application needs
completion.
3. Issuing of a decision on changing the manufacturing authorization, shall be made within 30 days
from the day of submitting of the application; in justified cases this period may be prolonged, however not
longer than by subsequent 60 days; the provisions of Paragraph 2 shall be applied respectively.
4. A charge collected for issuing of manufacturing authorization and for issuing of import permit as
well as for changing the manufacturing authorization and for changing the import permit shall constitute
the revenue of the State Budget.
5. The minister competent for health shall specify, by means of a regulation, the amount and method
of collecting of the fee, referred to in Paragraph 4, considering in particular that the amount may not be
higher than sevenfold the lowest remuneration for work, specified on the basis of the provisions
concerning the lowest remuneration for work and the range of manufacturing and import.
Article 42. 1. Duties of the manufacturer shall be as follows:
1) manufacturing of medicinal products covered by the authorization only and exclusively, referred to in
Article 38(1), subject to the provisions of Article 50;
1a) sale of the manufactured medicinal products:
a) to an entrepreneur manufacturing the medicinal products or running wholesale marketing in
medicinal products,
b) to the institutions of closed therapeutics in the scope of medicinal products used in the course of
providing services of health care performed within the agreements made with the National Health
Fund;
2) notifying the Main Pharmaceutical Inspector in writing and at least 30 days prior to the planned
change in the manufacturing conditions, in particular immediate notifying on the necessary change of
the qualified person;
3) keeping the archive samples of the medicinal products in the conditions specified in the authorization
for a period longer by one year than the expiry date of the medicinal product, however not shorter
than for three years;
4) providing access to the facilities of the manufacturing plant, dossier and other data related to
manufacturing, for the purpose of carrying out of the inspection by the Inspectors for manufacturing of
the Main Pharmaceutical Inspectorate and enabling them to take samples of medicinal products for
quality tests purposes, including access to the archive;
5) enabling the qualified person, employed in the manufacturing plant, to take independent decisions in
the scope of its competences;
6) applying the requirements of the Good Manufacturing Practice to the medicinal products and using
only these active substances, which were manufactured pursuant to the requirements of Good
Manufacturing Practice related to active substances intended for manufacturing of the medicinal
products, as initial materials intended for manufacturing of the medicinal products;
7) applying the requirements of Good Manufacturing Practice in relation to auxiliary substances
specified in the provisions issued under Paragraph 3.
2. In the course of manufacturing of the medicinal product with the use of the human blood as the
initial product, the manufacturer shall be obliged to:
1) take all necessary measures in order to prevent transmission of infectious diseases;
2) comply with the arrangements agreed in the Polish Pharmacopoeia or pharmacopoeias recognized in
the Member States of the European Union;
3) observe the recommendations of the European Council and World Health Organization in the scope
of selection of blood donors;
4) use only blood originating from those persons, health condition of whose was specified pursuant to
the separate provisions.
3. The minister competent for health shall specify, by means of a regulation, a list of auxiliary
substances, in relation to which the requirements of Good Manufacturing Practice shall be applied, as well
as the scope of application of these requirements, taking the legal provision of the European Community
into consideration.
Article 43. 1. The Main Pharmaceutical Inspector shall withdraw, by means of a decision, a
manufacturing authorization, if the manufacturer fails to comply with the requirements, referred to in Article
39(1), Clauses 2 and 3, Article 42(1), Clause 1 and Paragraph 2, as well as in the authorization referred
to in Article 40(1).
2. Authorization may be withdrawn in the event of violation of the provisions of Articles 42(1), Clauses
2 - 6.
3. The Main Pharmaceutical Inspector, by means of a decision, shall withdraw the import permit, if
the importer fails to comply with the requirements specified in Article 39(1), Clause 2 and 3, Article 42(1),
Clause 1 and in the authorization referred to in Article 40(1a).
4. Main Pharmaceutical Inspector shall inform the minister competent for health on the withdrawal of
manufacturing authorization
Article 44. (repealed).
Article 45. (repealed).
Article 46. 1. Pharmaceutical inspector for manufacturing of the Main Pharmaceutical Inspectorate,
shall, independently of inspections, referred to in Paragraph 3, control at least once in three years,
whether the manufacturer meets the obligations resulting from the Act; the inspector shall inform the
manufacturer about the date of launching of the control at least 30 days prior to the scheduled term.
2. The conducted control shall be summarized with a report, on the basis of which an opinion on
meeting by the manufacturer of the requirements of Good Manufacturing Practice is issued; the report
shall be delivered to the manufacturer.
3. In the event of justified suspicion of manufacturer’s infringements, posing a threat to quality, safety
of use or efficacy of medicinal products manufactured by such manufacturer, the Main Pharmaceutical
Inspector shall order an immediate inspection of the manufacturing plant without prior warning.
4. In the event of justified suspicion of manufacturer’s infringements, posing a threat to quality or
safety of active substances, the Main Pharmaceutical Inspector shall order an immediate inspection by the
manufacturer of active substances or by the responsible entity.
5. The inspection, referred to in Paragraph 4, shall be ordered by the Main Pharmaceutical
Inspectorate also on request of the competent authority of the Member State of the European Union or the
Member State of European Free Trade Association (EFTA) – a party to the Agreement on European
Economic Area, EMEA or the European Commission.
6. The competent authority of the Member State of the European Union or the Member State of
European Free Trade Association (EFTA) – a party to the Agreement on European Economic Area, the
European Medicines Evaluation Agency or the European Commission may submit to the Main
Pharmaceutical Inspectorate an application to conduct an inspection of manufacturing conditions by the
manufacturer of medicinal products or manufacturer of active substances.
7. The Main Pharmaceutical Inspectorate may apply to the manufacturer of medicinal products or
manufacturer of active substances having a seat in a state other than the Member State of the European
Union or the Member State of European Free Trade Association (EFTA) – a party to the Agreement on
European Economic Area to conduct an inspection of manufacturing conditions on its site.
8. On the basis of findings of the inspection, referred to in Paragraph 1 and 3, in order to protect
humans and animals against the medicinal products not compliant with the laid down quality , safety of
use or efficacy requirements or in order to ensure that the medicinal products shall be manufactured
compliant to the Act, the Main Pharmaceutical Inspector may, by means of a decision:
1) order the manufacturer to remove the infringements stated in the report within a specified period of
time, including under a penalty of withdrawal of the authorization;
2) suspend manufacturing of the medicinal product in total or to the moment of removal of the stated
infringements.
Article 47. 1. The manufacturer, exporter or the authority authorized to issue a marketing
authorization in the importer’s country may apply to the Main Pharmaceutical Inspector for a certificate
stating that the manufacturer of the medicinal product holds the manufacturing authorization of the given
medicinal product.
2. The certificate, referred to in Paragraph 1, should comply with the applications adopted by the
World Health Organization.
3. 3. The following should be attached the application, referred to in Paragraph 1:
1) Specification of Medicinal Product, if the manufacturer is a responsible entity;
2) explanations concerning absence of marketing authorization, if the manufacturer has no such
authorization.
Article 47a. 1. Manufacturer may apply to the Main Pharmaceutical Inspector with the application to
conduct an inspection in order to issue a certificate of conformity of the manufacturing conditions with the
requirements of Good Manufacturing Practice.
2. Manufacturer of active substances may apply to the Main Pharmaceutical Inspector with the
application to conduct an inspection in order to issue a certificate of conformity of the manufacturing
conditions with the requirements of Good Manufacturing Practice.
3. Within 90 days from the moment of termination of the inspections, referred to in Paragraph 1 and 2
and in Article 46(1)(6), the Main Pharmaceutical Inspector shall issue the certificate, referred to in
Paragraph 1 in the event, in which the results of the inspection conducted by the inspector for
manufacturing of the Main Pharmaceutical Inspectorate confirm the conformity of the manufacturing
conditions with the requirements of Good Manufacturing Practice.
4. The Main Pharmaceutical Inspector shall transfer information on issuing or refusal to issue the
certificate, referred to in Paragraph 1, to the European database on manufacturing.
5. If in the result of the inspections, referred to in Paragraph 1 and 2 and in Article 46(1)(6), it is
stated that the manufacturer of medicinal product or manufacturer of active substances fails to meet the
requirements of Good Manufacturing Practice, the Main Pharmaceutical Inspector shall transfer such
information to the European database on manufacturing.
Article 47b. 1. The inspections, referred to in Article 46(6) and Article 47a(1)(2), shall be conducted
at the expense of manufacturer of medicinal products or manufacturer of active substances, applying for
issuing of the certificate.
2. Costs of conducting of the inspections, referred to in Article 46(6) and Article 47a(1)(2), shall cover
in particular travelling costs, stay costs and costs of activities taken by the inspector for manufacturing of
the Main Pharmaceutical Inspectorate.
3. The minister competent for health shall specify, by means of a regulation, the charge and method
of payment of the costs of conducting of the inspection, referred to in Article 10(5), Article 38(6) and Article
47a, following in particular of the amount of work connected with executing of a given activity, amount of
costs incurred by the Main Pharmaceutical Inspectorate, as well as the amount of such in the Member
States of the European Union of a similar Gross Domestic Product per capita.
Article 47c. 1. The President of the Office shall keep a register of manufacturers of active
substances used in production of veterinary medicinal products of anabolic, anti-infectious, anti-parasitic,
anti-inflammatory, hormonal or psychotropic properties.
2. The register covers:
1)
name and address of the seat and place of conducting a business activity on the territory
of the Republic of Poland, referred to in Article 2(42a), related to manufacturing of active substances of
anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties;
2) scope of conducted activity in relation to manufacturing of active substances;
3) trade name and common name of active substance in Latin and English language version, and in the
event of lack of common name – one of the following names: after European Pharmacopoeia, Polish
Pharmacopoeia, popular or scientific name.
3. The entrepreneur conducting a business activity in the scope of manufacturing of active
substances, referred to in Paragraph 1, shall be obliged to apply for entering into the register, making a
change to the register or removing from the register.
4. The President of the Office shall make a removal from the register on request of the entrepreneur
or in the event of obtaining of information on cessation of business activity of the entrepreneur in the
scope of manufacturing of active substances, referred to in Paragraph 1.
5. The President of the Office collects charges for entering into the register, change to the register
and removal from the register, made on request.
6. The entrepreneurs entered into the register shall be obliged to keep dossier, in particular invoices,
bills and agreements on marketing in active substances, referred to in Paragraph 1, for the period of 3
years.
7. The minister competent for health shall specify, by means of a regulation:
1) method of keeping the register,
2) mode of proceedings in the course of entering into the register, changes to the register and removals
from the register as well as mode to provide access to the register,
3) template of an application on entering into the register, change to the register and removal from the
register,
4) amount of charges, referred to in Paragraph 5 and method of their payment, taking the amount of
work related to execution of a given activity and amount of costs incurred by the Registration Office
into consideration
- taking in particular data specified in Paragraph 2 into consideration.
Article 48. 1. The qualified person shall be responsible for stating and certifying that:
1) in the event of medicinal products manufactured on the territory of the Republic of Poland - each
batch of the medicinal product has been manufactured and controlled pursuant to the legal provisions
of and to the requirements specified in the marketing authorization;
2) in the event of a medicinal product originating from import, independently from the fact that the
product was manufactured in the Member State of the European Union or in the Member State of
European Free Trade Association (EFTA) – a party to the Agreement on European Economic Area –
each batch of the medicinal product was subject to complex qualitative and quantitative analysis on
the territory of the Republic of Poland, at least in relation to all active substances, as well as to the
other tests, referred to in Article 10(2), Clause 2, indispensable to ensure quality of the medicinal
product pursuant to the requirements defined in the marketing authorization.
2. Batches of medicinal products that were subject to the control in the Member State of the
European Union or in the Member State of European Free Trade Association (EFTA) – a party to the
Agreement on European Economic Area, shall be excluded from the control, referred to in Paragraph 1(2),
if they are present on the market in one of the Member States of the European Union or in the Member
States of European Free Trade Association (EFTA) – parties to the Agreement on European Economic
Area European Union Member States and if a certificate of exclusion of such batch from control was
submitted and signed by the qualified person.
3. In the event of medicinal products imported from the other states, with which the European Union
made relevant agreements assuring that the manufacturer of the medicinal products complies at least
these requirements of Good Manufacturing Practice that are in force in the European Union, and that the
inspections referred to in Paragraph 1(2) were carried out in the exporting country, the qualified person
may withdraw from conducting of such inspections.
4. In all the cases, and in particular in which the batch of the medicinal product is released to the
market, the qualified person must certify that each manufactured batch is compliant with the requirements
defined in Paragraph 1.
5. The document referred to in Paragraph 4 must be kept for a period of one year longer comparing
to the expiry date of the medicinal product, however not shorter than five years, and must be accessible
for the Pharmaceutical Inspection on its each request.
Article 49. The qualified person employed in a manufacturing plant may be, on request of the Main
Pharmaceutical Inspector, suspended by the employer in duties specified in Article 48(1), if the
proceedings against such person related to dereliction of its duties were lodged.
Article 50. 1. The responsible entity or the manufacturer may enter into an agreement on
manufacturing of medicinal products with the other manufacturer meeting the requirements specified in
the Act, subject to the provisions of Paragraph 2, and shall inform the Main Pharmaceutical Inspector on
entering into such agreement.
2. The agreement on manufacturing of medicinal products should be made in writing on, unless being
null and void, and should specify the responsibilities of both parties the scope of quality assurance as well
as indicate the qualified person responsible for batch release.
3. (repealed).
4. The manufacturer receiving an order for manufacturing of medicinal products based on the
agreement on manufacturing of medicinal products shall be not allowed to commission manufacturing of
these products to other sub-contractors without the consent of the ordering party expressed in writing. The
provisions of Paragraph 1 shall be applied respectively.
Article 51. Obtaining of the manufacturing authorization shall not exempt the manufacturer from
penal or civil liability resulting from administration of medicinal products or veterinary medicinal products.
Article 51a. The provisions of this Chapter shall be also applied to the medicinal products intended
for export exclusively, intermediate products and the tested medicinal products.
Chapter 4
Advertising of medicinal products
Article 52. 1. Advertising a medicinal product shall mean any activity consisting of informing and
encouraging using the medicinal product, aiming to increase the number of prescriptions, supply, sale or
consumption of the medicinal products.
2. The activity, referred to in Paragraph 1 shall in particular cover:
1) advertisements of medicinal products addressed to the general public;
2) advertisements of medicinal products addressed to all persons authorized to issue the prescriptions
or to persons engaged in marketing in these products;
3) visits to the persons authorized to issue prescriptions and to persons engaged in marketing in
medicinal products paid by sales or medical representatives;
4) providing samples of medicinal products;
5) sponsoring of the promotional meetings organized for persons authorized to issue prescriptions or for
persons engaged in marketing in medicinal products;
6) sponsoring of scientific conferences, symposia and congresses for persons authorized to issue
prescriptions or for persons engaged in marketing in medicinal products.
3. The following shall not be regarded as advertisement of a medicinal product:
1) information compliant with marketing authorization, placed on the packaging and attached to the
packaging of a medicinal product;
2) correspondence accompanied by informational materials, of non-promotional nature, indispensable to
providing a response on questions relating to a specific medicinal product;
3) advertisements of informative nature relating in particular to change of packaging, warnings on
undesirable effects, provided that they do not include information relating to properties of medicinal
products;
4) marketing catalogues or price lists containing only a specific name, common name, dose, form and
price of a medicinal product and in the event of a medicinal product subject to refund - official retail
price, provided that they do not include content related to properties of medicinal products, including
therapeutic indications
5) information related to the health and diseases of humans and animals, provided that it is not related,
even indirectly, to the medicinal products;
6) making the Specification of Medicinal Product or Specification of Veterinary Medicinal Product
available.
4. (repealed).
Article 53. 1. Advertising of a medicinal product may not mislead, it should present a medicinal
product in neutral manner and inform on its reasonable use.
2. Advertising of a medicinal product may not consist in offering or promising any benefits in direct or
indirect manner for purchasing of the medicinal product or providing an evidence, that such purchase was
made.
3. Advertising of a medicinal product may not be addressed to children nor contain any element,
which is addressed to them.
4. Advertising of a medicinal product, being a reminder of a full advertising may, apart from its
specific and common name, included only a trademark without any references to therapeutic indications,
pharmaceutical form, dose, commercial slogans or other advertising contents.
Article 54. 1. Advertising of a medicinal product addressed to the persons authorized to issue
prescriptions or persons engaged in marketing in medicinal products should contain information compliant
with the Specification of Medicinal Product or Specification of Veterinary Medicinal Product and
information on granted availability category, and in the event of medicinal products entered into a list of
refunded medicines – also information on official retail price and maximal amount of additional payment
incurred by the patient.
2. Dossier provided to the persons, referred to in Paragraph 1, should contain reliable, up-to-date,
verifiable and complete information to enable the receiver making of its own assessment of therapeutic
value of a medicinal product and information of preparation date or last updating date. Citations, tables
and other figures taken from scientific literature should be presented in true manner and contain reference
to a source.
3. Advertising consisting in free supply of samples of medicinal products may be addressed
exclusively to the persons authorized to issue prescriptions, provided that:
1) a person authorized to issue prescriptions have applied in writing to a sales or medical representative
for a delivery of a sample of a medicinal product;
2) a person supplying a sample keeps their register of the supplied samples;
3) size of each delivered sample is smaller than the smallest single package of the medicinal product
authorized to the market on the territory of the Republic of Poland;
4) each delivered sample is labelled ‘free sample – not for sale’;
5) Specification of Medicinal Product or Specification of Veterinary Medicinal Product is attached to
each delivered sample;
6) number of samples of the same medicinal product supplied to the same person does not exceed five
packages per year.
4. The provisions of Paragraph 3 shall be applied also to the samples supplied to a physician and used
to treat patients in health care facilities, referred to in Article 2(1), Clause 1 of the Act of 30 August 1990
on health care facilities (Journal of Laws of 2007, No. 14, item 89, as amended 7)). These samples must
be registered by the hospital pharmacy, referred to in Article 87(1), Clause 2, health centre pharmacy,
referred to in Article 87(1), Clause 3 or hospital pharmacy division, referred to in Article 87(4).
5. Advertising consisting in free supply of samples of medicinal products may not apply to medicinal
products being intoxicants or psychotropic substances.
.
Article 55. 1. Advertising of a medicinal product addressed to the general public may not consists in:
1) presenting the medicinal products by scientists, persons fulfilling public functions or persons with
medical or pharmaceutical education, or the persons suggesting a possession of such education;
2) referring to recommendations of scientists, persons fulfilling public functions, persons with medical or
pharmaceutical education, or the persons suggesting a possession of such education.
2. Advertisements of a medicinal product addressed to the general public may also not include any
contents that:
1) suggest that:
a) it is possible to avoid physician’s advice or surgical operation, in particular by making a diagnosis
or recommending a treatment by way of correspondence,
b) even a healthy person taking a given medicine would improve its health condition,
c) failure to take of the given medicine may deteriorate health condition of a given person; this
reservation does not apply to vaccinations, referred to in Article 57(2),
d) medicinal products are groceries, cosmetic products or other consumer goods,
e) efficacy or safety of use of a medicinal product results from its natural origin;
2) assure that taking of a given medicine guarantees an appropriate effect, it is not accompanied by any
undesirable effects or that effect is better or the same as in case of another method of treatment or
treatment with the use of another medicinal product;
3) lead to false auto-diagnosis arising from the detailed descriptions of cases and symptoms of a disease
mentioned in the advertisement;
4) include inappropriate, alarming or misleading definitions of graphically presented pathologic changes,
injuries to human body or the influence of a medicinal product on human body or its parts;
5) justify the administration of a medicinal product with the fact of its marketing authorization.
Article 56. It shall be prohibited to advertise medicinal products:
1) not authorized to the market on the territory of the Republic of Poland;
2) containing information inconsistent with the Specification of Medicinal Product or Specification of
Veterinary Medicinal Product.
Article 57. 1. Advertising of the following medicinal products, addressed to the general public, shall
be prohibited:
1) dispensed exclusively on the basis of the prescription;
2) containing intoxicants and psychotropic substances;
3) entered into, pursuant to the separate provisions, the lists of the refunded medicines and
authorized for issuing without prescription, with the proper name identical with the name placed on these
lists.
1a. The provisions of Paragraph 1 shall be also applied to advertising of a medicinal product, name of
which is identical with the name of a medicinal product dispensed on the basis of the prescription
exclusively.
to protective vaccinations specified in separate regulations.
2. The provisions of Paragraph 1 shall not be applied to protective vaccinations specified in the
communication of the General Sanitary Inspector issued under Article 14(9) of the Act of 6 September,
2001 on infectious diseases and on infections (Journal of Laws No. 126, item 1384, as amended 8)).
Article 58. 1. It shall be prohibited to address advertisements of a medicinal product consisting in
providing, offering or promising material benefits, gifts and various facilitations, prizes and trips, as well as
consisting in organization and financing of meetings promoting the medicinal products, in the course of
which manifestation of the hospitality exceeds the main aim of such a meeting to the persons authorized
to issue medical prescriptions and to the persons engaged in marketing in medicinal products,.
2. It is prohibited to accept the benefits referred to in paragraph 1.
3. The provisions of Paragraphs 1 and 2 shall not refer to acceptance items of a value not exceeding
the amount of PLN 100, related to medical or pharmaceutical practice, provided with the symbol of
advertising a particular company or a medicinal product.
Article 59. The minister competent for health and in relation to veterinary medicinal product, in
cooperation to the minister competent for agriculture, shall specify, by means of a regulation:
1) conditions and forms of advertising the medicinal products addressed to general public, persons
authorized to issue prescriptions and to the persons engaged in marketing in medicinal products,
2) necessary data, which an advertisement should include;
3) ways of providing the advertisement,
4) dossier constituting the basis for introduction of the samples of medicinal products intended for
advertising purposes on the territory of the Republic of Poland,
- taking in particular an obligation of neutral presentation of a medicinal product and safety of its use into
consideration.
Article 60. 1. Advertising of a medicinal product may be conducted by the responsible entity
exclusively or at its commission.
2. The responsible entity shall appoint, in the scope of its activity, a person, whose responsibilities
shall include, among others, informing on the medicinal product placed by the responsible entity on the
market.
3. Obligations of the responsible entity shall include ensuring that:
1) an advertisement is compliant with the provisions in force;
2) drafts of advertisements have been stored for period of 2 years from the end of the calendar year,
in which the advertising was broadcasted;
3) decisions made by the authority referred to in Article 62(2) were executed immediately
4. The responsible entity shall employ as the medical and sales representatives the persons, who
have sufficient scientific knowledge to be able to deliver possibly complex and precise information on the
advertised medicinal product.
5. The provisions of Paragraph 1 – 4 shall be applied to the entity authorized to parallel import.
Article 61. 1. The responsible entity shall ensure that its medical representatives will collect and
provide such entity any information concerning medicinal products, and in particular concerning their
undesirable effects reported by visited persons.
2. The responsible entity shall ensure a system of trainings for its medical representatives.
3. In the course of executing the activity, referred to in Article 52(2), Clause 3, a medical or sales
representative shall be obliged to deliver or provide access to the Specification of Medicinal Product or
Specification of Veterinary Medicinal Product and in the event of medicinal products entered into a list of
refunded medicines – also information of official retail price and maximal amount of additional payment
incurred by the patient.
Art. 62. 1. Main Pharmaceutical Inspector, and in relation to the veterinary medicinal products the
Chief Veterinary Officer, shall hold the supervision over the observance of the provisions of the Act in the
scope of advertising.
2. The authorities referred to in Paragraph 1 may order, by means of a decision:
1) cessation of publishing or broadcasting the advertisements of a medicinal product, which are
contrary to the provisions in force;
2) publication of the issued decision in the places where the advertisement contrary to the legislation
in force has been published, as well as the publication of the correction of the misleading advertisement;
3) amendment of the stated infringements.
3. The decisions, referred to in Paragraph 2(1) (3) shall be subject to the order of immediate
enforceability.
Article 63. The responsible entity shall be obliged to the following, upon a request of the authorities
of the Pharmaceutical Inspection::
1) draft of each advertisement addressed to the general public together with information on the method
and date of its broadcasting;
2) information on each advertisement addressed to the persons authorized to issue prescriptions and to
the persons supplying the medicinal products.
Art. 64. The provisions of Articles 62 and 63 shall not infringe the Act of 16 April, 1993 on combating
unfair competition.
Chapter 5
Trading in medicinal products
Article 65. 1. marketing in medicinal products may be conducted only and exclusively under the
principles defined by the Act.
1a. marketing in medicinal products for the needs of the State’s reserves shall be not considered as
marketing.
2. Import from abroad of samples of a medicinal product by a responsible entity for advertising
purposes shall be not considered as marketing.
3. Medicinal products, referred to in Paragraph 4, may remain in marketing, provided that they were
subject to initial batch control, at the expense of the responsible entity.
4. The following shall be subject to the initial batch control:
1) immunological products intended for humans, being:
a) vaccines containing live microorganisms,
b) vaccines intended for the newborns or other risk groups,
c) vaccines administered within public vaccinations programmes,
d) new immunological medicinal products or immunological medicinal products manufactured using
new, modified or new for a given manufacturer types of technologies in the period indicated in the
marketing authorization;
2) immunological veterinary medicinal products;
3) hematogenic products;
4) raw materials used to prepare prescription or pharmaceutical medicines, prior to their distribution for
this purpose.
5. The initial batch control of medicinal products, referred to in Paragraph 4, shall be conducted in
research and development units and medicines quality control laboratories.
6. Main Pharmaceutical Inspector may request from the manufacturer of an immunological medicinal
product to present certificates of quality control of each batch, certified by the person, referred to in Article
39(1), Clause 4.
7. The research and development units authorized to conduct the batch control, shall exempt from
such initial batch control a given batch of the medicinal product, referred to in Paragraph 4(1 – 3),
provided that it was subject to such controls made by the competent authorities of any Member State of
the European Union or in the Member State of European Free Trade Association (EFTA) – a party to the
Agreement on European Economic Area and a document confirming execution of such tests was
provided.
8. (repealed).
9. Deadline to execute an initial batch control for the products, referred to in Paragraph 4(1 – 3), shall
be 60 days, and for the products referred to in Paragraph 4(4), shall be 30 days.
10. The minister competent for health and in relation to veterinary medicinal products in cooperation
with the minister competent for agriculture, shall specify, by means of a regulation:
1) conditions and mode of conducting the initial batch control – taking in particular the number of
samples taken for tests, indication of documents necessary for batch control notification and method
of delivery of samples for testing purposes into consideration;
2) research and development units as well as medicines quality control laboratories, in the scope of
analysis of medicinal products, referred to in Paragraph 4 (1 – 3), as well as in Paragraph 7 – taking
meeting by these entities of the requirements of Good Laboratory Practice in the meaning of the Act
of 11 January, 2001 on chemical substances and preparations into consideration;
2a) medicines quality control laboratories specializing in testing products, referred to Paragraph 4(4) –
taking in particular meeting by these entities of the requirements of Good Laboratory Practice in the
meaning of the Act of 11 January, 2001 on chemical substances and preparations into consideration;
3) template of a certificate issued by the units, referred to in Clause 2.
Article 66. The medicinal products may remain in marketing within the expiry date established for
them.
Article 67. 1. marketing as well as the administration of medicinal products that fail to meet the
specified quality requirements and of medicinal products with the exceeded expiry date shall be
prohibited.
2. Medicinal products, referred to in Paragraph 1, shall be utilized subject to the provisions of Article
122(1), Clause 2.
3. Utilization costs of the medicinal products, failing to meet the quality requirements, shall be
incurred by the entity indicated in the decision issued under Article 122, and in the event of medicinal
products after their expiry date – the entity, by which the reason for necessity of withdrawal of the
medicinal product from the market occurred.
Article 68. 1. Retail marketing in medicinal products shall be conducted by generally accessible
pharmacies, subject to the provisions of Paragraph 2, Article 70(1) and Article 71(1).
2. Retail marketing in veterinary medicinal products purchased in pharmaceutical warehouse of
veterinary medicinal products shall be conducted within the business activity of a clinic for animals.
2a. The entities responsible for marketing, referred to in Paragraph 2, is the manager of a clinic for
animals or a veterinarian appointed by this manager.
3. Mail sale of medicinal products dispensed without prescription by publicly accessible pharmacies
and pharmaceutical points of sale is permissible.
3a. The minister competent for health shall specify, by means of a regulation, conditions of mail sale
of medicinal products dispensed without prescription and way of delivery of these products to the
receivers, taking ensuring of their relevant quality into consideration.
4. Direct administration to a patient by a physician, a stomatologist, or any other person of medical
profession, of medicinal products, as well as medicinal products contained in anti-shock kits, need for
administration of which results from the type of provided health service, shall be not considered as retail
marketing.
4a. Direct administration to an animal, by a veterinarian, of veterinary medicinal products or
medicinal products, need for administration of which results from the type of the provided medical veterinary service, shall be not considered as retail marketing.
5. Import of medicinal products for own medicinal needs, in a quantity not exceeding 5 smallest
packages, shall not require authorization of the minister competent for health.
6. The provisions of Paragraph 5 shall not apply to intoxicants and psychotropic substances, import
of which is specified by the provisions of the Act of 29 July, 2005 on counteracting drug addiction (Journal
of Laws No. 179, item 1485, as amended 9)), and to veterinary medicinal product intended for animals,
tissues of which or products are intended for human consumption.
7. The minister competent for health shall specify, by means of a regulation:
1) the list of medicinal products, which may be temporary administered in connection with a provided
health service, taking the type of a provided service into consideration,
2) the list of medicinal products contained in the anti-shock kits, saving life.
Article 69. 1. 1. The veterinarian providing medical – veterinarian services within a clinic for animals
shall be obliged to:
1) keep the dossier of each transaction related to veterinary medicinal products dispensed by prescription
in a form of:
a) register of detailed marketing,
b) medical – veterinary register in a way specified by the Act of 11 March, 2004 on animals health
protection and combating animal infectious diseases (Journal of Laws No. 69, Item 625, as
amended 10));
2) conducting, at least once a year, of a control inventory of medicinal veterinary products on stock,
together with notification on any incompliance.
2. Veterinarian applies veterinary medicinal products to safe life or health of animals, and in particular
to limit suffering of animals.
3. In the event, in which tissues and products of animal origin are intended for human consumption,
owners of such animals or persons responsible for them shall be obliged to hold dossier of veterinary
medicinal products in a form of a register of purchase, possession and use of veterinary medicinal
products and treating of animals conducted pursuant to the provisions of the Act f 11 March, 2004 on
animals health protection and combating animal infectious diseases.
4. Dossier, referred to in Paragraph 1 and 3, shall be kept by a veterinarian, owner of animals and the
person responsible for animals for the period of 5 years from the day of its preparation.
5. The minister competent for agriculture shall specify, by means of a regulation, method of keeping
the register of detail marketing in veterinary medicinal products and its templates, taking the assurance of
harmonization of this dossier and protection of humans or animals’ health or environmental protection, as
well as the provisions of the European Community in force.
6. The minister competent for health shall, in cooperation with the minister competent for agriculture
specify, by means of a regulation, the mode of proceedings in the course of using of medicinal products
in situations, in which there is no relevant veterinary medicinal products authorized to the market for a
given animal species, taking in particular taking the need to ensure, that food originating from the treated
animals shall not contain residues harmful to consumer.
Article 70. 1. Apart from the pharmacies the retail marketing in medicinal products may be conducted
by pharmaceutical points of sale, subject to the provisions of Article 71(1) and (3), Clause 2.
2. The pharmaceutical point of sales, referred to in Paragraph 1, may be run by a physical or legal
person, as well as a commercial law company without legal status.
2a. Each pharmaceutical point of sale must be managed by an appointed person responsible for
running of such point of sale, being the manager of the point of sale.
2b. Manager of a pharmaceutical point of sale may be a pharmacist with a one-year experience or a
pharmaceutical technician with a three-year professional experience in generally accessible pharmacies.
3. Pharmaceutical points of sales established after the day of entry of the Act into force may be
situated only in rural areas, if there is no generally accessible pharmacy on the territory of a given village.
4. Running a pharmaceutical points of sale shall require authorization. The provisions of Article 99(2)
and (3), Article 100 (1 - 3), Articles 101-104, as well as Article 107 shall be applied respectively.
5. In the area of storing and keeping the dossier of the purchased and sold medicinal products, as
well as the way and mode of conducting a control of receiving the medicinal products and the conditions
and mode of providing information on marketing and stock level of particular medicinal products, the
provisions on pharmacies shall be apply respectively.
6. Charges shall be collected for granting an authorization to run a pharmaceutical point of sale and
for change to authorization to run a pharmaceutical point of sale, being the revenue of the State Budget.
7. The minister competent for health shall, by means of a regulation, specify the amount of fee,
referred to in Paragraph 6, taking in particular the type of conducted business activity into consideration,
provided that the amount of these charges should be not higher than twofold the lowest remuneration for
work, specified under the provisions on minimum remuneration for work.
Article 71. 1. Apart from the pharmacies and the pharmaceutical points of sale the retail marketing in
medicinal products dispensed without prescription, excluding veterinary medicinal products, may be
conducted by:
1) medical - herbal shops,
2) specialist shops of the medical supply,
3) generally accessible shops
- hereinafter referred to as the „non-pharmaceutical marketing facilities”.
1a. Apart from the health care facilities for animals, the entrepreneurs may conduct retail marketing in
veterinary medicinal products dispensed without prescription after notifying the Regional Veterinarian on 7
days prior to launching of business activity.
2. The shops referred to in Paragraph 1(1) may be run by a pharmacist, pharmaceutical technician,
as well as a graduate of a II degree course in the area of knowledge on herbal products or entrepreneurs
employing the abovementioned persons as the managers of these facilities.
3. The minister of health shall specify, by means of a regulation:
1) criteria of classification of medicinal products to the lists, referred to in Clause 2,
2) lists of medicinal products, authorized to the market in non-pharmaceutical marketing facilities and in
pharmaceutical points of sale,
3) qualifications of persons dispensing medicinal products in non-pharmaceutical marketing facilities,
4) requirements that shall be met by the premise and equipment of a pharmaceutical marketing facility
and pharmaceutical point of sale, referred to in Article 70
- considering the safety of use of medicinal products as well as the requirements related to storage and
distribution of medicinal products in these facilities.
4. The minister competent for agriculture shall specify, by means of a regulation::
1) criteria of classification of veterinary medicinal products to the lists, referred to in Clause 2,
2) lists of veterinary medicinal products, which may be subject to marketing by the entities, referred to in
Paragraph 1a,
3) conditions to be met by the entities, referred to in Paragraph 1a,
- considering assurance of safety of marketing in veterinary medicinal products as well as hygienic and
sanitary conditions and in particular ensuring due separation of these products from the other products
and ensuring proper storage conditions.
5. The lists, referred to in Paragraph 3(2) and in Paragraph 4(2), shall be updated every 12 months.
Article 72. 1. Wholesale marketing in medicinal products, subject to the provisions of Paragraph 8(2),
may be conducted by pharmaceutical warehouses, customs and consignment warehouses of medicinal
products exclusively.
2. The provisions concerning pharmaceutical warehouses shall be applied respectively to customs
and consignment warehouses of medicinal products.
3. Wholesale marketing shall mean any activity consisting in purchase, storage, supply or export of
medicinal products or veterinary medicinal product by a Member State of the European Union or in the
Member State of European Free Trade Association (EFTA) – a party to the Agreement on European
Economic Area or the authorization, referred to in Article 2(2), conducted with the manufacturers or
importers in the area of manufactured or imported by them medicinal products or with the entrepreneurs
engaged in warehouse marketing or with pharmacies or health care facilities for animals or with others
authorized entities, excluding direct supply to population.
3a. Placing of a medicinal product into the warehouse marketing on the territory of the Republic of
Poland shall require prior notification of:
1) the responsible entity on an intention to import a medicinal product;
2) the President of the Office.
4. Wholesale marketing in the meaning of Paragraph 3 is import of medicinal product onto the
territory of the Republic of Poland or import of medicinal products from the territory of the Member States
of the European Union or in the Member States of European Free Trade Association (EFTA) – parties to
the Agreement on European Economic Area.
5. Pharmaceutical warehouses can also conduct wholesale marketing in:
1) medical devices,
1a) medicinal products intended for export exclusively, having a marketing authorization other than
specified in Paragraph 3,
2) foodstuffs of special feeding purpose,
2a) diet supplements, in the meaning of the provisions on food and feeding safety,
3) cosmetic products, in the meaning of Article 2 of the Act of 30 March, 2001 on cosmetics (Journal of
Laws No. 42, item 473, as amended 11)), excluding cosmetics intended for perfuming or beauty
cosmetics,
4) hygienic products,
5) items for newborns and sick persons care,
6) foodstuffs containing pharmacopoeian natural components of plant origin in their composition,
7) disinfectants used in medicine
- meeting the requirements specified by separate provisions.
6. Pharmaceutical warehouses may conduct the wholesale marketing in technical supply products
necessary for operation of hospitals, pharmacies and the facilities, referred to in Articles 70 and 71.
7. Pharmaceutical warehouses of veterinary medicinal products may also conduct the wholesale
marketing in:
1) feed, feed additives and premixes;
2) hygienic products;
3) biocidal products;
4) devices used in veterinary medicine in the meaning of Article 2(2) of the Act of 20 April, 2004 on
devices used in veterinary medicine (Journal of Laws No. 93, item 893);
5) forms used in veterinary medicine;
6) devices used to identify pets in the meaning of Article 4(22) of the Act of 22 July, 2006 on feed
(Journal of Laws No. 144, item 1045)
8. The following shall be not considered as wholesale marketing:
1) (repealed);
2) reception and dispensing, including import and export of medicinal products and medical devices
intended for humanitarian aid, excluding intoxicants and psychotropic substances as well as products
containing precursors of the I-R group, if the recipient agrees to receive them – provided that the
products will meet the requirements specified by separate provisions.
9. The minister competent for health shall specify, by means of a regulation, requirements that should
be met by medicinal products intended for humanitarian aid as well as detailed procedures of receiving
and dispensation of medicinal products intended for humanitarian aid.
Article 73. (repealed).
Chapter 6
Pharmaceutical warehouses
Article 74. 1. Launching of business activity in the area of pharmaceutical warehouse shall require
an authorization of the Main Pharmaceutical Inspector.
2. Issuing of an authorization, refusal to issue an authorization, change and withdrawal of an
authorization shall be made by means of a decision of the Main Pharmaceutical Inspector, subject to the
provisions of Paragraphs 3 and 4.
3. Issuing of an authorization, refusal to issue an authorization, change and withdrawal of an
authorization on running a pharmaceutical warehouse of veterinary medicinal products shall be made by
means of a decision of the Chief Veterinary Officer. The provisions of Articles 75, 76, 77(1) and Article
78(1) shall be applied respectively.
4. The Chief Veterinary Officer shall inform the Main Pharmaceutical Inspector of issuing of a
decision on the issues referred to in Paragraph 3.
5. Running wholesale marketing in intoxicants, psychotropic substances and precursors of the I-R
group shall require an additional authorization defined by separate provisions.
6. Charges shall be collected for issuing of an authorization for running pharmaceutical warehouse
and pharmaceutical warehouse of veterinary medicinal products.
6a. Charges in the amount of half of the fee, referred to in Paragraph 6 shall be collected for change
to the authorization or its prolongation in the event of issuing of an authorization for a defined period of
time.
6b. The charges, referred to in Paragraph 6 and 6a, shall be the revenue of the State Budget.
7. The minister competent for health and with respect to veterinary medicinal products the minister
competent for agriculture shall specify, by means of a regulation, the fee, referred to in Paragraph 6,
taking in particular the type of the conducted business activity, provided that such amount may be not
higher than sevenfold of the lowest remuneration specified under the provisions on minimum
remuneration for work.
Article 75. 1. An application for issuing an authorization for running of a pharmaceutical warehouse,
hereinafter referred to as the ‘application’, should contain:
1) Ref. No. of an entrepreneur applying for authorization;
2) seat and address of an entrepreneur;
3) definition of types of medicinal products to be subjected to marketing in the event of assortment
limitation;
4) indication of the site and premises intended for running of a pharmaceutical warehouse;
5) indication of additional reloading chambers, referred to in Article 76, located outside the main site of
running the pharmaceutical warehouse, if such exist;
6) date of launching of the intended activity;
7) date of drawing up the application and the signature of the person submitting an application.
2. The following should be enclosed to the application:
1) abstract from the register pursuant to the separate provisions;
2) legal title to the premises of the warehouse or a reloading chamber;
3) technical scheme description of the premises of a warehouse, taking the provisions of Paragraph
1(5) into consideration, drawn up by a person authorized to do so;
4) certified copies of documents confirming professional authorizations of the qualified person
responsible for running the warehouse, as well as its statement, confirming that such person is willing
to perform such duties;
5) description of the proceedings enabling an effective withholding or withdrawal of a medicinal product
from the market and hospital pharmacies;
6) opinion of the Regional Pharmaceutical Inspector on the usability of premises intended for a
warehouse, and in the event of warehouse of veterinary medicinal products, the opinion of the
Regional Veterinary Officer;
7) opinion of the State Sanitary Inspectorate on the site, pursuant to the separate provisions.
3. In the event, in which the entrepreneur intends to run a warehouse in two or more locations, a
separate application must be submitted for each of these locations.
4. The application, referred to in Paragraph 1, must be submitted by the entrepreneur to the Main
Pharmaceutical Inspector, and in the case of pharmaceutical warehouse of veterinary medicinal products
– to the Chief Veterinary Officer.
Article 76. 1. Authorization for running of a pharmaceutical warehouse should contain:
1) name and seat of the entrepreneur;
2) name of the pharmaceutical warehouse, if such exists;
3) number of authorization;
4) location of running of a pharmaceutical warehouse;
5) indication of additional reloading chambers, if such exist;
6) validity period of the authorization, if the period is limited;
7) basic terms and conditions regulating operation of a pharmaceutical warehouse and duties imposed
on the entrepreneur in connection with running of the pharmaceutical warehouse;
8) description of types of medicinal products, to marketing in which the warehouse is authorized, in case
of assortment limitation.
2. Authorization for running a warehouse shall be issued for an undefined period, unless the applicant
applied for an authorization for a defined period of time.
3. The reloading chamber shall constitute a part of transportation system of a warehouse, and can be
located outside the place of running the warehouse. Medicinal products stored in the reloading chambers
should be equipped with transport documentation, including a note on the date of delivery to the chamber.
4. Premises of the reloading chamber must meet the technical requirements as specified the
requirements for premises of a pharmaceutical warehouse, which shall be stated, by means of a decision,
by the Regional Pharmaceutical Inspector competent for the territory on which the reloading chamber is
located.
5. Reloading chambers located outside the place of running the warehouse may serve the
entrepreneur, authorized to run a pharmaceutical warehouse, for temporary storage of medicinal products,
however not longer than 36 hours, in closed transportation packaging or the collective packaging of the
manufacturer in the conditions specified for given medicinal products exclusively.
6. (repealed).
Article 76a. 1. Launching of a reloading chamber shall require a change in the authorization for
running a pharmaceutical warehouse.
2. The application for changing the authorization, referred to in Paragraph 1, shall contain data listed
in Article 75(1), Clauses 1, 2, 5 and 7.
3. The following shall be enclosed to the application:
1) legal right to the premises of a reloading chamber;
2) technical scheme and description of the premises of reloading chamber, prepared by the person
authorized to do so;
3) decision, referred to in Article 76(4).
Article 77. 1. The entrepreneur launching an activity consisting in running a pharmaceutical
warehouse should:
1) administer objects that allow for appropriate wholesale marketing;
2) employ a qualified person – a manager of the warehouse - responsible for managing the
warehouse, meeting the requirements defined in Article 84;
3) meet the obligations defined in Article 78.
2. The provisions of Paragraph 1(2) shall be not applied, if a person launching the activity is a Master
of Pharmacy, personally serving as the manager, meeting the requirements defined in Article 84.
Article 78. 1. The responsibilities of an entrepreneur engaged in an activity related to running of a
pharmaceutical warehouse shall include:
1) purchase of medicinal products exclusively from entrepreneurs engaged in manufacturing or running
a wholesale marketing;
2) possessing exclusively the medicinal products received from the entities authorized to their supply;
3) delivery of medicinal products exclusively to the authorized entities;
4) observing the Good Distribution Practice principles;
5) ensuring permanent supply of the correct assortment;
6) providing the minister competent for health and in case of veterinary medicinal product the minister
competent for agriculture, quarterly reports on volume of marketing in medicinal products, together
with structure of this marketing;
7) keeping documents, referred to in Clause 6, for a period of 5 years, starting from the end of a given
calendar year.
2. The minister competent for health shall specify, by means of a regulation, a list of the entities
authorized to purchase of medicinal products in pharmaceutical warehouses, whereas the minister
competent for agriculture shall specify, by means of a regulation, a list of entities authorized to purchase
of veterinary medicinal products in pharmaceutical warehouses of veterinary medicinal products, taking in
particular taking the scope of activity carried out by individual entities into consideration.
3. The minister competent for health shall specify, by means of a regulation, the method and scope of
providing data, referred to in Paragraph 1(6), assuring keeping of marketing secrets, and taking in
particular taking the structure of marketing in medicinal products intended for open health care and health
care facilities as well as the method of product identification into consideration.
4. The minister competent for agriculture shall specify, by means of a regulation, the scope of,
referred to in Paragraph 1(6), and method of its providing, assuring keeping of marketing secrets, and
taking in particular taking the structure of marketing in veterinary medicinal products intended for health
care facilities for animals as well as the method of product identification into consideration.
Article 79. The minister competent for health, and in relation to pharmaceutical warehouses of
veterinary medicinal products in cooperation with the minister competent for agriculture, shall specify, by
means of a regulation, the procedures of Good Distribution Practice, considering in particular:
1) principles of storage of medicinal products according to the conditions specified in marketing
authorization;
2) maintenance of proper technical and sanitary condition of the premises;
3) principles and mode for the reception and dispensing of medicinal products;
4) conditions for transport and loading;
5) procedures for proper running a warehouse, including duties of an employee receiving and
dispensing goods, as well as the principles and mode of preparing a reception report;
6) the way of entrusting, to a substitute person, duties, referred to in Article 85, of the qualified person
responsible for running the warehouse.
Article 80. 1. Main Pharmaceutical Inspector shall refuse to issue an authorization for running the
pharmaceutical warehouse if:
1) applicant does not meet the requirements for running a warehouse, defined in Articles 77-79;
2) applicant had an authorization for running a pharmacy or a pharmaceutical warehouse, which was
withdrawn up to three years before submitting of an application;
3) applicant runs a pharmacy or submitted an application for authorization for running a pharmacy.
2. In the event of a warehouse of veterinary medicinal products, decisions referred to in Paragraph 1
shall be issued by the Chief Veterinary Officer.
Article 81. 1. Main Pharmaceutical Inspector, and in relation to pharmaceutical warehouses of
veterinary medicinal products the Chief Veterinary Officer, shall withdraw an authorization for running a
pharmaceutical warehouse, if the entrepreneur trades medicinal products not authorized to the market.
2. Main Pharmaceutical Inspector, and in relation to pharmaceutical warehouses of veterinary
medicinal products the Chief Veterinary Officer, may withdraw an authorization in particular if:
1) despite of a warning, the entrepreneur prevents or hinders the performance of official duties by the
Pharmaceutical Inspection;
2) entrepreneur stores medicinal products in violation of the conditions of marketing authorization;
3) entrepreneur has not launched the warehouse activity within 4 months from the date of receiving an
authorization, or manages an activity not covered by the authorization for a period of at least six
months.
3. The authorization for running a pharmaceutical warehouse shall expire in case of:
1) death of a person, to whom the authorization was granted;
2) removal of a company from a register kept pursuant to the separate provisions.
4. The withdrawal or statement of expiration takes place by means of a decision of a competent
authority, which issued the authorization for running a warehouse.
5. In the event of stating by the Main Pharmaceutical Inspector in relation to an entrepreneur having
an authorization for wholesale marketing issued by the competent authority of the other Member State of
the European Union or the Member State of European Free Trade Association (EFTA) – a party to the
Agreement on European Economic Area, that there are circumstances present, referred to in Paragraph 2
or 3, it shall inform the European Commission and a competent authority of the other Member State of the
European Union or the Member State of European Free Trade Association (EFTA) – a party to the
Agreement on European Economic Area on this fact and on taken decisions immediately.
Article 82. 1. The Main Pharmaceutical Inspector shall inform on withdrawal of authorization for
running a pharmaceutical warehouse:
1) competent customs authorities;
2) competent authorities of the Member States of the European Union or the Member States of
European Free Trade Association (EFTA) – parties to the Agreement on European Economic Area.
2. The Main Pharmaceutical Inspector shall inform on expiry of authorization for running a
pharmaceutical warehouse.
3. The Chief Veterinary Officer shall inform on withdrawal or expiry of authorization for running a
pharmaceutical warehouse of veterinary medicinal products.
Article 83. 1. Main Pharmaceutical Inspector, and in relation to a warehouse of veterinary medicinal
products, the Chief Veterinary Officer, shall keep a Register of Authorizations for Running a
Pharmaceutical Warehouse.
2. The Register, referred to in Paragraph 1, shall contain data mentioned in Article 76(1), Clause 1 –
6 and 8.
3. Issuing of an authorization, its change, withdrawal or expiry shall require entering of relevant
changes in the Register, referred to in Paragraph 1.
Article 84. 1. The qualified person, referred to in Article 77(1), Clause 2, may be a pharmacist with a
two-year professional experience in a pharmaceutical warehouse or in a pharmacy, subject to the
provisions of Paragraphs 2 - 4.
2. The qualified person in a warehouse of veterinary medicinal products may be also a veterinarian
having the right to perform the profession and having a two-year professional experience as veterinarian,
provided that this is its only position in the veterinarian profession, and also that it is not an owner or a coowner of a clinic for animals and does not conduct any medical - veterinary practice in the meaning of the
provisions of the Act of 16 April, 2004 on nature protection (Journal of Laws No. 92, item 880, as
amended 12)).
3. The qualified person responsible for running a pharmaceutical warehouse, managing marketing in
medical gases exclusively, may also be a graduate holding a general certificate of education and a proper
training in health and safety.
4. The same person may not simultaneously perform the duties of a qualified person responsible for
running a pharmaceutical warehouse and hold the position of a manager of a pharmacy.
5. The duties of a qualified person responsible for running a pharmaceutical warehouse may be
performed only in one pharmaceutical warehouse.
Article 85. The responsibilities of the qualified person responsible for running a pharmaceutical
warehouse include observing the principles of Good Distribution Practice, and in particular dispensing
medicinal products to authorized entities, and additionally:
1) providing information to the competent authorities of the Pharmaceutical Inspection, and in case of a
veterinary medicinal product also to the competent Regional Veterinary Officer on any suspicion or
statement, that a given medicinal product fails to meet the quality requirements defined for this
product;
2) suspending and withdrawing from the market and administration of the medicinal products, after
obtaining such decision from the competent authority;
3) (repealed);
4) proper course of training for the personnel in the area of duties entrusted to them.
Chapter 7
Pharmacies
Article 86. 1. A pharmacy is the public health care facility, in which the authorized persons provide in
particular pharmaceutical services referred to in Paragraph 2.
2. The name “pharmacy” shall be reserved exclusively to a site, in which the pharmaceutical services
are provided, covering:
1) dispensing medicinal products and medical devices specified by separate provisions;
2) preparation of prescription medicines, within a period not exceeding 48 hours from the moment of
submitting of the prescription by a patient, in the event of the a prescription for prescription medicines
containing intoxicants, or a prescription labelled - “to dispense immediately” - within 4 hours;
3) preparation of pharmaceutical medicines;
4) providing information on medicinal products and medical devices.
3. In relation to hospital pharmacies, pharmaceutical service includes also:
1) preparation of the medicines for extra-intestinal feeding,
2) preparation of the medicines for intestinal feeding,
3) preparation of medicines in daily doses, including cytostatic medicines
4) manufacturing of infusion liquids;
5) organization of supply of medicinal products and medical devices to a hospital;
6) preparation of solutions for hemo-dialysis and peritoneal dialysis;
7) participation in monitoring of undesirable effects of medicines;
8) participation in the clinical trials conducted in hospitals;
9) participation in pharmacotherapy rationalization;
10) co-participation in management of medicinal products and medical devices in hospitals.
4. In hospital pharmacies, apart from the provision of pharmaceutical services:
1) register of the samples for clinical trials, as well as of medicinal products and medical devices
obtained as donations shall be kept;
2) procedures for dispensing medicinal products or medical devices by a hospital pharmacy to hospital
wards and to the patient shall be established.
5. Generally accessible pharmacies may dispense, on the basis of a veterinarian’s prescription,
medicinal products or prescription medicines intended for humans, to be administered to animals.
6. (repealed).
7. (repealed).
8. Generally accessible pharmacies may, on separate stands, sell products specified in Article 72(5),
having the attests or authorizations required by law, provided that their storage and sale shall not obstruct
the basic activity of a pharmacy.
9. The minister competent for health may specify, by means of a regulation, other kinds of activity,
than specified in Paragraphs 2-4 and 8 related to health protection, allowed to be conducted in a
pharmacy.
Article 87. 1. The pharmacies shall be divided into:
1) generally accessible pharmacies;
2) hospital pharmacies supplying hospital wards or other, not mentioned by name, facilities intended for
persons, requiring a twenty-four-hour or daylong health services provided in these facilities or in an
organizational units being a part of such facility;
3) company’s pharmacies in the health care facilities established by the Minister of National Defence
and by the Minister of Justice supplying the offices, laboratories, sick-chambers and therapeutic
wards, as well as other facilities, not mentioned by name, intended for persons, requiring a twentyfour-hour or daylong health services provided in these facilities or in an organizational units being a
part of such facility.
2. Generally accessible pharmacies shall be intended for:
1) supplying population with medicinal products, pharmaceutical medicines, prescription medicines,
medical devices and other articles, referred to in Article 86(8),
2) conducting the activities specified in Article 86(1 – 2).
3. The Regional Pharmaceutical Inspector may exempt the units, referred to in Paragraph 1(2), from
the obligation of running a hospital pharmacy, taking into account:
1) the type of provided services;
2) number of beds and their usage.
4. The function of hospital pharmacy in the units, referred to in Paragraph 3, shall be fulfilled by a
hospital pharmacy ward, performing duties specified in Article 86(2), Clause 1 and 4, Paragraph 3(10) and
Paragraph 4.
Article 88. 1. Generally accessible pharmacies shall be run by an appointed pharmacist, referred to
in Article 2b(1), Clauses 1, 2 and 5 - 7 of the Act of 19 April, 1991 on Pharmacy Chambers (Journal of
Laws of 2003 No, 9, item 108, of 2004 No. 92, item 885 and of 2007, No. 176, item 1238), responsible for
managing the pharmacy, hereinafter referred to as the “manager of pharmacy”; such manager may act as
the manager of only one pharmacy.
2. The manager of the pharmacy may be a pharmacist, referred to in Paragraph 1, not older than 65
years, having at least 5 years of professional experience in a pharmacy, or 3 years of professional
experience in the event, in which such person specialized in the area of drugstore pharmaceutics.
2a. (repealed).
3. By consent of the Regional Pharmaceutical Inspector, issued on request of the interested person and
after consulting the regional pharmaceutical chamber, the period referred to in Paragraph 2 may be
extended up to 70 years, if the person managing a pharmacy is 65 or over.
4. The manager of the pharmacy shall appoint for the time of its absence due to sickness or leave, a
pharmacist, referred to in Paragraph 1, replacing such manager under the provisions specified in Article
95(4), Clause 5.
5. The manager of the pharmacy shall be responsible for:
1) organization of work in a pharmacy, consisting in, among others, receiving, dispensing, storing and
identifying medicinal products and medical devices, proper preparation of prescription medicines and
pharmaceutical medicines, as well as providing information on the medicines;
2) supervision over student placements and pharmaceutical technicians’ placements;
3) providing the President of the Office with information on undesirable effects of a medicinal product or
medical device;
4) providing the competent authorities of the Pharmaceutical Inspection with information on any
suspicion or stating, that a given medicinal product fails to meet the quality requirements defined for
this product;
5) purchase of medicinal products exclusively from the entities having an authorization for running a
pharmaceutical warehouse and their dispensing pursuant to Article 96;
6) keeping a register of persons employed in a pharmacy listed in Article 90;
7) providing the regional pharmacy chambers with necessary data for keeping the registers of
pharmacists, provided by the Act on Pharmacy Chambers;
8) suspending or withdrawing the medicinal products from the market and administration, after obtaining
of such decision from the competent authority.
6. The minister competent for health shall specify, by means of a regulation, template of keeping the
register of the persons, referred to in Paragraph 5, considering such data as:
1) name and surname of a Master of Pharmacy or a pharmaceutical technician;
2) date and place of birth of a Master of Pharmacy or a pharmaceutical technician;
3) number and date of a issue of the certificate of graduation of a Master of Pharmacy or a
pharmaceutical technician, as well as the name of the university or school issuing the certificate;
4) number and date of issuing of the certificate on a right to practice the Master of Pharmacy profession;
5) number and date of issuing of the certificate confirming completion of a one-year training by a Master
of Pharmacy;
6) number and date of issuing of the certificate confirming that a Master of Pharmacy holds a given
specialization degree;
7) date and signature of the manager of a pharmacy.
Article 89. 1. A pharmacist shall obtain the title of a specialist after completion of postgraduate
studies, confirming the possession of certain professional authorizations, hereinafter referred to as the
“specialization”, specified by the programme of specialization and passing of the state exam.
2. A person meeting jointly the following procedure may launch specialization proceedings, subject to
the provisions of Paragraph 3:
1) such person has the right to practice a pharmacist profession;
2) such person has a year of professional experience;
3) such person was qualified to complete a specialization within qualification proceedings.
3. A pharmacist shall pay charge for qualification proceedings, referred to in Paragraph 2()3, for
examination proceedings and for trainings within permanent training.
4. The amounts of fee, referred to in Paragraph 3, shall be established by the manager of a training
unit, specified in Article 89a(1).
5. The minister competent for health shall recognize the title of specialist obtained abroad as
equivalent with the title of specialist obtained in the Republic of Poland, provided that all the following
conditions are met:
1) pharmacist has the right to practice in pharmacist profession on the territory of the Republic of
Poland;
2) specialization programme in the scope of the required theoretical knowledge, as well as practical
skills, way of confirmation of the acquired knowledge and abilities, correspond in significant issues to the
programme of a given specialization in the Republic of Poland;
3) way and mode of taking an examination or other form of confirmation of the acquired knowledge
and abilities correspond to the conditions of examination taken by a pharmacist in the Republic of Poland.
6. A pharmacist failing to meet the requirements specified in Paragraph 5(2), may be obliged to
complete a supplementary training.
7. The minister competent for health shall specify, by means of a regulation:
1) list of pharmaceutical specializations, taking the demand for staff into particular consideration;
2) framework programmes of specializations and time necessary to complete them, taking in
particular the scope and form of acquisition of theoretical knowledge and the list of practical skills into
consideration;
3) way and mode of qualification proceedings, referred to in Paragraph 2(3), taking in particular the
template of an application for launching of the specialization and the criteria for evaluation of qualification
proceedings into consideration;
4) way of completing a specialization, taking in particular the mode of documenting its progress into
consideration;
5) way and mode of taking a state exam, referred to in Paragraph 1, taking in particular the
requirements related to written and oral exam into consideration;
6) procedure of recognition of the equivalence of a specialist title obtained abroad, taking in particular the
scope of training completed abroad as well as the mode and scope of completing the supplementary
training, referred to in Paragraph 6 into consideration;
7) template of the diploma issued after completing the exam, referred to in Paragraph 1;
8) the way of establishing charges, referred to in Paragraph 3, taking in particular the expenses connected
with qualification proceedings into consideration.
Article 89a. 1. Specializations within the postgraduate education shall be carried out by the
departments or other organizational units of the universities, having the faculties in pharmacy, hereinafter
referred to as the ‘training units’, after obtaining of accreditation from the minister competent for health.
2. The basis for granting an accreditation, as well as its obtaining by the training unit applying for
accreditation, shall be meeting by this unit of specific standards in specialization-related education of
pharmacists.
3. Accreditation shall be granted on application of a training unit applying for accreditation.
Accreditation certificate shall be a document confirming obtaining of accreditation.
4. Granting of accreditation and refusal of its granting as well as withdrawal of accreditation shall be
made by means of an administrative decision. To the issues not regulated by the Act, the provisions of the
Code of Administrative Procedure shall be applied.
5. Application, referred to in Paragraph 3, shall be submitted not later than in 4 months prior to the
scheduled date of starting the specialization studies by a training unit.
6. Application, referred to in Paragraph 3, shall contain:
1) Ref. No. of the training unit applying for accreditation;
2) statement on meeting the conditions necessary for complete execution of detailed specialization
programme, including information on the number and the qualifications of teaching staff, teaching base, as
well as organizational conditions specific for a given type of specialization.
7. Detailed programme of a specialization shall be enclosed to application.
8. The minister competent for health shall specify, by means of a regulation, the standards of
specialization-related education of pharmacists, taking in particular taking data concerning the number
and the qualifications of teaching staff, teaching base as well as organizational conditions of the training
into consideration.
Article 89b. 1. Accreditation shall be issued for the period of at least 3 years, however not exceeding
10 years.
2. The minister competent for health shall specify, by means of a regulation, the template of
accreditation certificate, taking in particular data covered by the certificate, including: name of a training
unit, its address and seat, as well as the type of specialization into consideration.
Article 89c. The minister competent for health may withdraw a certificate, if the training unit fails
execute the detailed programme of specialization, or fails to meet the standards of specialization training
of pharmacists, referred to in Article 89a(8).
Article 89d. 1. The minister competent for health shall hold the supervision over carrying out of
specialization training.
2. Within the supervision, referred to in Paragraph 1, the minister competent for health shall be
entitled to:
1) inspect the raining units;
2) require presentation of documentation and explanations concerning the specialization carried out;
3) give recommendations concerning removal of the stated infringements.
Article 89e. 1. A pharmacist (employed in a pharmacy or in a warehouse) shall be obliged to improve
its professional authorizations by participation in permanent trainings, to revise the gained knowledge and
to educate in permanent manner in the scope of new achievements in the pharmaceutical sciences.
2. The permanent trainings shall be conducted in the accredited training units, specified in Article
89a(1).
3. The minister competent for health after consulting the Polish Pharmaceutical Council and Polish
Pharmaceutical Association shall specify, by means of a regulation, a framework programme of
permanent trainings, taking in particular the scope and forms of gaining theoretical knowledge, way of
completing trainings considering the mode of documenting its course, standards of permanent education
as well as amount of charges for trainings into consideration.
Article 90. Only the pharmacists and pharmaceutical technicians may be employed to perform
professional activities in a pharmacy, within the framework of their professional authorizations.
Article 91. 1. A pharmaceutical technician with a full-time, 2-year professional experience in work in
a pharmacy, may conduct professional activities in a pharmacy, such as preparing, manufacturing and
dispensing medicinal products and medical devices, excluding medicinal products containing:
1) substances of particularly strong effect specified in the Official List of Medicinal Products
authorized to the market on the territory of the Republic of Poland,
2) intoxicants,
3) psychotropic substances of the I-P, and II-P groups
- specified in the separate provisions.
2. A pharmaceutical technician, referred to in Paragraph 1, may also conduct auxiliary activities,
when preparing and manufacturing medicinal products, referred to in Article 86(3), Clauses 1 - 4 and 6.
3. The minister competent for health shall specify, by way of decree, a programme of trainings in a
pharmacy, as well as the way and mode of its execution by a pharmaceutical technician, taking in
particular the scope of knowledge indispensable for conducting the activities, specified in Paragraphs 1
and 2, duties of the trainees’ tutor, scope of activities that may be conducted by the trainee itself, the form
and way of keeping a pharmaceutical training control book into consideration.
Article 92. A pharmacist, referred to in Article 88(1), should be present in a pharmacy within the
opening hours of pharmacy.
Article 93. 1. A pharmacy manager shall be appointed in a hospital pharmacy and in a company’s
pharmacy.
2. The provisions of Article 88(2 – 5) shall apply to pharmacy managers in hospital and company’s
pharmacies.
Article 94. 1. The opening hours of generally accessible pharmacies should be adjusted to the needs
of population and provide access to services also at night, on Sundays, during public holidays and on the
other free days.
2. The opening hours of generally accessible pharmacies on a given territory shall be established by
the management of the district after consultation with head of the commune (mayors, presidents of cities)
located on the territory of a district and pharmaceutical self-government.
3. The minister competent for health shall, after consulting the Polish Pharmaceutical Council specify
by means of a regulation:
1) maximum amount of additional charges imposed by the pharmacies for providing services at night,
taking the need for dispensing of a medicine into consideration;
2) a group of medicinal products, for dispensing of which at night the additional charge shall not be
imposed, taking the necessity of providing support to save life or health into consideration.
Article 94a. 1. Advertising of operation of pharmacies or pharmaceutical points of sale intended for
public information, which refers directly to the medicinal products or medical devices entered into the lists
of refunded medicines or medicinal products or medical devices of a name identical with the name of
medicinal products or medical devices entered into these lists is prohibited.
2. The Regional Pharmaceutical Inspector shall supervise over observance of the provisions of the
Act in the scope of advertising activity of the pharmacies and pharmaceutical points of sale.
3. Shall any infringement of the provision of Paragraph be stated, the Regional Pharmaceutical
Inspector orders, by means of a decision, cessation of such advertising.
4. The decision, referred to in Paragraph 3, shall have the order of immediate enforceability.
Article 95. 1. Generally accessible pharmacies shall be obliged to have the medicinal products and
medical devices in the quantity and assortment sufficient to satisfy the needs in the area of health care of
the local community, taking in particular the refunded medicines, price limit for which was established on
the basis of the separate provisions, subject to the provisions of Paragraph 2.
2. The Regional Pharmaceutical Inspector may, on request of a manager of a pharmacy, release the
pharmacy from dispensing intoxicants of the I-N group and psychotropic substances of the II-P group.
3. If the required medicinal product, including a prescription medicine, is not available in a generally
accessible pharmacy, the pharmacist, referred to in Article 88(1), should provide its purchase in this
pharmacy within the period of time agreed with the patient.
4. The minister competent for health shall specify, by means of a regulation, basic conditions for
running a pharmacy, taking in particular into consideration:
1) conditions of storage of medicinal products and medical devices;
2) conditions of preparation of prescription medicines and pharmaceutical medicines, including
preparation in aseptic conditions;
3) conditions of preparation of homeopathic medicinal products;
4) keeping the dossier, in particular of the purchased, sold, prepared, suspended and withdrawn from
the market medicinal products or medical devices;
5) detailed principles of entrusting duties of the pharmacy manager to a substitute manager and
notifying the Regional Pharmaceutical Inspector and Regional Pharmaceutical Chamber;
6) way and mode of conducting a control of reception by a pharmacy of medicinal products and medical
devices;
7) mode of releasing from dispensation of intoxicants of the I-N group and psychotropic substances of the
II-P group;
8) conditions and mode of providing information by a manager of a pharmacy, concerning marketing and
stock of particular medicinal products and medical devices.
Article 96. 1. Medicinal products and medical devices shall be dispensed in generally accessible
pharmacy by a pharmacist or by a pharmaceutical technician within its professional authorizations:
1) on the basis of a prescription;
2) without prescription;
3) on the basis of demand of authorized organizational units or physical persons entitled to it on the
basis of the separate provisions.
2. In case of a sudden threat to health or life the pharmacist, referred to in Article 88(1), may
dispense a medicinal product restricted to dispensing only on prescription without such prescription, in the
smallest available therapeutic package, excluding intoxicants, psychotropic substances and precursors of
the I-R group.
3. A pharmacist shall note down the fact of dispensing of a medicinal product, referred to in Article
88(2), on the prepared pharmaceutical prescription; the pharmaceutical prescription should contain the
name of the dispensed medicinal product, the dose, the reason for dispensing the medicinal product,
identity and address of the person, to whom the medicinal product was dispensed, date of dispensing,
seal and signature of the pharmacist, referred to in Article 88(1). The pharmaceutical prescription shall
replace the prescription payable in 100% and shall be subject to registration.
4. A pharmacist and a pharmaceutical technician may refuse to dispense a medicinal product, if its
dispensing may pose a threat to patient’s life or health.
5. Medicinal products and medical devices dispensed in a pharmacy shall not be subject to return,
subject to the provisions of Paragraph 6.
6. The provision of Paragraph 5 shall be not applied to a medicinal product or medical device
returned to a pharmacy due to quality defects or their inappropriate dispensing.
7. The minister competent for health and in relation to hospital and company’s pharmacies subject to
the Minister of National Defence and the Minister of Justice respectively, the Minister of National Defence
and the Minister of Justice shall specify, by means of a regulation, the medicinal products and medical
devices dispensing in a pharmacy, taking in particular into consideration:
1) responsibilities of the persons executing a prescription or demand, preparing prescription or
pharmaceutical medicines;
2) cases, in which it is possible to refuse to dispense a medicinal product or a medical device;
3) data that an order of purchase of medicinal products or medical devices should contain;
4) way and mode of keeping the register, referred to in Paragraph 3.
Article 97. 1. Generally accessible pharmacies may be a separate building or may be situated in the
facility of the other use, providing a full separation from the other premises of the facility and from the
other activities.
2. The premise of a generally accessible pharmacy shall include basic and auxiliary area. The service
premise constituting the basic area must be accessible for disabled persons.
3. The basic area of generally accessible pharmacies may not be smaller than 80 sq m. The area not
smaller than 60 sq m is permissible, in generally accessible pharmacies located in towns of population
lower than 1500 inhabitants and in rural areas.
4. In the event of preparation of a homeopathic medicinal product, the basic area of the pharmacy
should be appropriately increased, depending on the assortment of these products.
5. The minister competent for health, after consulting the Polish Pharmaceutical Council, shall
specify, by means of a regulation, a list of premises included into basic and auxiliary areas of a pharmacy,
taking in particular the size of individual premises and the assurance of execution of the pharmacy’s tasks
into consideration. .
Article 98. 1. The facility of a hospital pharmacy – the size, type, number of premises, taking the
provisions of Paragraphs 5 and 6 into consideration, should result from the type of activities performed by
the pharmacy, with consideration to the therapeutic profile, as well as the number of health services
provided in the facility, in which it was established.
2. Basic area of the hospital pharmacy should not be smaller than 80 sq m.
3. In the event of preparation of prescription medicines, for extra-intestinal or intestinal feeding,
preparation of individual therapeutic doses, as well as doses of cytostatic medicines, the basic area
should be increased, depending on the type of the provided services.
6. In the event of running a laboratory of infusive liquids, the basic area should be increased by the
area necessary for the establishment of the infusive liquids laboratory, as well as for a quality control
laboratory with the possibility of conducting the physical and chemical, microbiological and biological tests.
By consent of the Regional Pharmaceutical Inspector the biological tests may be performed in another
unit.
7. The minister competent for health shall specify, by means of a regulation, detailed requirements
that the facility of a pharmacy should meet, in particular specifying in particular their organization and
equipment.
8. The Minister of National Defence and the Minister of Justice in cooperation with the minister
competent for health shall specify, by means of regulations, determine, detailed requirements that should
be met by the premises of the company’s pharmacies, referred to in Article 87(1), Clause 3, specifying in
particular the organization and equipment.
Article 99. 1. A generally accessible pharmacy may operate on the basis of the obtained
authorization for running a pharmacy exclusively.
2. Issuing, refusal to issue, change, withdrawal or statement of expiry of an authorization for running
a pharmacy shall be the responsibility of the Regional Pharmaceutical Inspector.
3. The authorizations, referred to in Paragraph 1 shall not be issued, if the entity applying for
authorization:
1) runs or has applied for authorization for running a wholesale marketing in medicinal products, or
2) runs on the territory of a region more than 1% of generally accessible pharmacies, or if the entities
controlled by such applicant in a direct or indirect way, in particular the subsidiary entities in the meaning
of the provisions on competition and consumers protection, run altogether more than 1% of pharmacies
on the territory of the region;
3) is a member of a group of companies, in the meaning of the Act on competition and consumers
protection, members of which run more than 1% of generally accessible pharmacies on the territory of the
region.
4. The right to obtain an authorization for running a pharmacy shall be granted to physical persons,
legal persons, as well as commercial law companies without legal status.
4a. An entity running a pharmacy shall be obliged to employ a person responsible for the
management of the pharmacy, referred to in Article 88(2), ensuring proper management of the pharmacy.
4b. If the person applying for authorization for running a pharmacy is a physician or a stomatologist,
the authorization shall be issued, if the applicant provides a statement on not practicing the physician
profession.
5. (Repealed)
6. The provisions of Paragraph 4a shall be not applied to the pharmacists having the authorizations,
referred to in Article 88(2).
Article 100. 1. The entities, referred to in Article 99(4), applying for authorization for running a
generally accessible pharmacy, shall submit an application, including as follows:
1) Ref. No. of the entity, its seat and address, and in the event of a physical person - its name,
surname and address;
2) Tax Identification Number as well as Personal Identification Number or – in the event, in which this
number was not granted – passport No., No. of ID card or of any other document confirming the
identity, if the entity is a physical person;
3) indication of the address of the pharmacy;
4) name of the pharmacy, if applicable;
5) date of launching of the activity;
6) date of preparation of the application and signature of the person submitting the application.
2. The following should be enclosed to the application:
1) legal title to the premises of a generally accessible pharmacy;
2) abstract from the register pursuant to the separate provisions;
3) technical scheme and description of the premises intended for a pharmacy prepared by an
authorized person;
4) opinion issued by the Sanitary Inspection concerning the premises, pursuant to the separate
provisions;
5) name and surname of a pharmacist responsible for running the pharmacy, as well as the
documents confirming meeting of the requirements specified in Article 88(2);
6) statement enlisting all the entities controlled by the applicant in direct or indirect way, in particular
the subordinate entities, in the meaning of the Act on competition and consumers protection. The
applicant shall provide the Ref. No. of the entity, its seat and address, and in case of a physical person its
name, surname and address;
7) statement, enlisting all the entities - members of a group of companies, in the meaning of the Act
on competition and consumers protection, member of which is the applicant. The applicant shall provide
the Ref. No. of the entity, its seat and address, and in case of a physical person its name, surname and
address.
3. The application, referred to in Paragraph 1, shall be submitted by the person applying for an
authorization, to the Regional Pharmaceutical Inspector.
4. The minister competent for health shall specify, by means of a regulation, data required to be
included in a technical description of the premises, taking in particular taking the location and accessibility
of the premises, conditions of delivery of goods, data concerning the basic and auxiliary areas into
consideration.
Article 101. The Regional Pharmaceutical Inspector shall refuse to issue an authorization for running
a generally accessible pharmacy, if:
1) an applicant fails to meet the conditions specified in Article 88, Article 97, Article 99, Paragraphs 4,
4a and 4b and in Article 100, Paragraphs 2 and 4;
2) authorization for running a pharmacy or a pharmaceutical warehouse was withdrawn within the
period of three years preceding submission of an application;
3) an applicant runs a warehouse or submitted an application for authorization to run a warehouse;
4) an applicant fails to guarantee the proper management of a pharmacy.
Article 102. Authorization for running a pharmacy should include:
1) name and seat of the entity, to which the authorization has been issued, and in case of a physical
person, name, surname and the address;
2) commune, on the territory of which the pharmacy is going to be opened;
3) address, at which the pharmacy is being run;
4) name of the pharmacy, if such exists;
5) number of authorization for running the pharmacy;
6) validity date of authorization, if specified;
7) basic conditions of managing the pharmacy.
Article 103. 1. The Regional Pharmaceutical Inspector shall withdraw an authorization for running a
generally accessible pharmacy, if the pharmacy trades the medicinal products not authorized to the
market.
2. The Regional Pharmaceutical Inspector may withdraw an authorization, if:
1) the infringements indicated in the decision of the Regional Pharmaceutical Inspector, issued on the
basis of the Act, were not removed in the agreed date;
2) despite an earlier notice, performance of the official activities by the Pharmaceutical Inspection or
the National Health Fund, were made impossible or hindered;
3) the pharmacy fails to satisfy, in persistent manner, the needs of the community in the scope of
dispensing medicinal products;
4) the pharmacy has not been opened within 4 months from the day of receiving the authorization, or
the activity covered by the authorization has not been carried out for a period of at least 6 months;
4a) the pharmacy provides, excluding the Pharmaceutical Inspection and the National Health Fund, data
enabling identification of an individual patient, physician or services provider;
5) decision of the Regional Pharmaceutical Inspector, referred to in Article 94a(3), or the decision of the
Main Pharmaceutical Inspector, referred to in Article 62(2), was not executed.
Article 104. 1. The authorization for running the pharmacy shall expire in case of:
1) death of the person, to whom the authorization was issued, if the authorization was given to a
physical person;
2) resignation from carrying out the activity;
3) liquidation of the legal person, unless the separate provisions state otherwise.
1a. Authorization for running the pharmacy shall not expire in the event of death of a physical person,
if any of its successors meets the requirements, referred to in Article 99(3 – 4b) and Article 101 (2 – 4).
1b. The legal successor, referred to in Paragraph 1a, shall be obliged, running a pharmacy, to apply
to the Regional Pharmaceutical Inspector for making changes to the authorization in the scope of defining
an entity, to whom it was issued, within the period of 6 months from the day of death of the physical
person, referred to in Paragraph 1a.
2. Statement of withdrawal of an authorization shall me made by means of a decision of the authority,
which issued this decision.
3. (repealed)
4. (repealed).
Article 105. 1. A charge shall be collected for issuing of an authorization for running a pharmacy, in
the amount of fivefold of the lowest remuneration, specified under the provisions on minimum
remuneration for work.
2. Charge shall be collected for introducing changes to the authorization, or for its prolongation, in the
event of issuing of the authorization for a defined period of time, in the amount of half of the amount
referred to in Paragraph 1.
3. The charges, referred to in Paragraph 1 and 2, shall be the revenue of the State Budget.
Article 106. 1. A hospital pharmacy may be opened after obtaining the consent from the competent
Regional Pharmaceutical Inspector, subject to the meeting of the requirements specified in Article 98 and
employing a manager of the pharmacy, who meets the conditions specified in Article 88(2).
2. The consent, referred to in Paragraph 1 shall be granted on request of the director of a health care
facility, in which the pharmacy is going to be established.
3. Hospital pharmacy may provide the medicines to other health care facilities intended for persons
requiring a twenty-four-hour or daylong health care services in appropriate, stable premises, which do not
have their own pharmacies, on the basis of an agreement made between the authorized entities, provided
that it will have no negative impact on running of a basic activity of the pharmacy.
4. The manager of the hospital pharmacy shall be obliged to notify the Regional Pharmaceutical
Inspector immediately on entering into the agreement, referred to in paragraph 3, with the other health
care facility, as well as of an intention to liquidate the hospital pharmacy, giving the reasons for its
liquidation.
Article 107. 1. The Regional Pharmaceutical Inspector shall keep a register of authorizations for
running a generally accessible pharmacy, pharmaceutical points of sale, as well as a register of the issued
consents for running hospital and company’s pharmacies.
2. The register should contain:
1) with reference to generally accessible pharmacies and pharmaceutical points of sale - data
specified in Article 102(1 – 6) as well as the name and surname of the manager of the pharmacy;
2) with reference to hospital and company’s pharmacies:
a) health care facility,
b) address of the pharmacy,
c) range of the pharmacy’s activity as well as the name and surname of its manager.
3. Change, withdrawal or expiry of the authorization, as well as the change, withdrawal or expiry of
the consent shall require suitable changes to the Register.
Chapter 8
State Pharmaceutical Inspection
Article 108. 1. The State Pharmaceutical Inspection, hereinafter referred to as the ‘Pharmaceutical
Inspection’ holds supervision over:
1) conditions of manufacturing and import of medicinal products and the veterinary medicinal
products;
2) quality and marketing in medicinal products, excluding veterinary medicinal products;
3) trading in medical devices, excluding medicinal devices used in veterinary medicine;
- in order to secure public interest in the area of safety of health and life of humans in application of
medicinal products and medical devices, available in pharmaceutical warehouses, pharmacies,
hospital pharmacy wards, pharmaceutical points of sale and non-pharmaceutical marketing facilities.
2. (repealed)
3. (repealed).
4. The authorities of the Pharmaceutical Inspection shall make decisions concerning the following:
1) suspension or withdrawal from the market or application in health care facilities of the medicinal
products, in case of suspicion or stating that a given product is not authorized to the market in Poland;
2) suspension or withdrawal from the market or application in health care facilities of the medicinal
products, in case of suspicion or stating that a given product fails to meet the quality requirements
specified for it;
3) suspension or withdrawal from public pharmacies and pharmaceutical warehouses of goods, if their
marketing is prohibited;
4) granting, changing, withdrawing or refusing a authorization for:
a) running a pharmacy,
b) manufacturing of medicinal products,
c) wholesale marketing in medicinal products,
5) directing a medicinal product, authorized to the market on the territory of the Republic of Poland to
perform qualitative tests.
6) (repealed)
7) advertising of:
a) medicinal products,
b) activity of pharmacies and pharmaceutical points of sale
5. (repealed).
Article 108a. In the event, in which the results of the tests, conducted under Article 108(4), Clause 5,
Article 115(5a), Article 123(1), confirm that a medicinal products fails to meet the quality requirements,
specified for it, the costs of these tests and the taken sample shall be covered by the entity responsible for
occurrence of the stated incompliance in the scope of quality requirements of the medicinal product.
Article 109. Tasks of the Pharmaceutical Inspection shall cover in particular:
1) controlling of the conditions of manufacturing and import of medicinal products, pursuant to the
requirements of Good Manufacturing Practice, referred to in Article 39(4) and data specified
in Article 10(2), Clauses 1 – 3, 12, 13 and 15;
1a) controlling of the conditions of transport, reloading and storage of medicinal products and medical
devices;
2) holding the supervision over the quality of medicinal products and medical devices being the
subject of trade;
3) control over pharmacies and other units carrying out retail and wholesale marketing in medicinal
products and medical devices, referred to in Article 108(1);
4) controlling of the quality of prescription and pharmaceutical medicines prepared in pharmacies;
5) controlling of adequate labelling and advertising of medicinal products, as well as adequate
labelling of medical devices;
6) controlling of marketing in intoxicants, psychotropic substances and precursors of I-R group;
7) cooperation with the expert team of consultants for pharmaceutical issues;
8) giving opinion on usefulness of premises intended for a pharmacy or a warehouse, as well as for a nonpharmaceutical marketing facility;
9) cooperation with pharmaceutical self-governments and the other self-governments;
10) keeping a register of generally pubic and hospital pharmacies, as well as pharmaceutical points of
sale;
11) keeping the Register of Pharmaceutical Warehouses, as well as of Pharmaceutical Manufacturing
Plants;
12) giving opinions concerning pharmacies, in which probation may be completed.
Article 110. 1. Pharmaceutical Inspection shall be managed by the Main Pharmaceutical Inspector.
2. The supervision of the Main Pharmaceutical Inspector shall be performed by the minister
competent for health.
Article 111. 1. The Main Pharmaceutical Inspector shall be appointed by the Prime Minister, from
among the persons included into the state human resources, upon a request of the minister competent for
health. The Prime Minister shall dismiss the Main Pharmaceutical Inspector.
2. (repealed)
3. The Deputy Main Pharmaceutical Inspector shall be appointed by the minister competent for
health, from among the persons included into the state human resources, upon a request of the Main
Pharmaceutical Inspector.
Article 112. 1. Responsibilities of the Pharmaceutical Inspection, specified in the Act, shall be
performed by the following authorities:
1) Main Pharmaceutical Inspector, as the central authority of public administration, with the
assistance of the Main Pharmaceutical Inspectorate,
2) the Voivode, with the assistance of the Regional Pharmaceutical Inspector as the head of the
regional pharmaceutical inspection, constituting the integrated regional administration.
2. The Regional Pharmaceutical Inspector shall execute tasks and competences of the
Pharmaceutical Inspection, defined in this Act and in separate provisions.
3. In the issues related to carrying out tasks and competences of the Pharmaceutical Inspection, the
Regional Pharmaceutical Inspector is the authority f the first instance, whereas the appeal body is the
Main Pharmaceutical Inspector.
4. The organisation of the Main Pharmaceutical Inspectorate is specified by the statute laid down, by
means of a regulation, by the minister competent for health.
Article 113. 1. The Regional Pharmaceutical Inspector shall be appointed and dismissed by the
Voivode on request of the Main Pharmaceutical Inspector.
2. A candidate for the position of the Regional Pharmaceutical Inspector shall be selected by way of
competition, the principles and mode of which are to be specified, by means of a regulation, by the
minister competent for health, in cooperation with the minister competent for public administration, taking
in particular into cooperation:
1) composition of the competition jury,
2) requirements concerning the candidates,
3) procedures of conducting the competition,
3. Deputy Regional Pharmaceutical Inspector shall be appointed and dismissed by the Voivode on
request of the Regional Pharmaceutical Inspector.
4. The Main Pharmaceutical Inspector may, at any time, apply to the Voivode for dismissing the
Regional Pharmaceutical Inspector, if the interest of the service supports it, and in particular if the activity
of the inspector or any unit subordinate to it on the territory of a given inspectorate:
1) poses a threat of inadequate performance of Pharmaceutical Inspection‘s responsibilities,
2) infringes safety of the manufacturing of medicinal products or the quality of medicinal products and
medical devices,
3) infringes safety of marketing in medicinal products and medical devices,
- a dismissal requires a detailed justification in writing.
Article 114. 1. The responsibilities of the Pharmaceutical Inspection shall be performed by persons
meeting the conditions defined in Paragraphs 2 or 3.
2. The pharmaceutical inspector may be any person, meeting the requirements defined by separate
provisions relating to employees of the offices of the governmental administration authorities and:
1) is a pharmacist in the meaning of the provisions of Article 2b of the Act of 19 April 1991 on
pharmacists’ chambers;
2) has at least 5 years of professional experience compliant with its educational profile.
3. The pharmaceutical inspector for manufacturing of the Main Pharmaceutical Inspectorate, may be
any person, having a university degree in one of the following fields of science: Pharmacy, Medicine,
Veterinary Medicine, Biotechnology, Biology, Chemical Engineering, Chemistry, Microbiology,
Pharmaceutical Technology, as well as having at least five years of professional experience necessary for
ensure proper work in supervising over the medicinal products’ quality.
3a. The professional experience, referred to in Paragraph 3, includes work in the Pharmaceutical
Inspection in the scope of supervision over the manufacturing in research and development units, in
analytic and control laboratories and in enterprises possessing a relevant authorization for running the
laboratory works or for manufacturing connected with medicinal products or conducting scientific research
in this area.
4. (repealed).
5. (repealed) .
6. (repealed).
7. (repealed).
8. Pharmaceutical Inspectors, when performing the responsibilities of Pharmaceutical Inspection shall
follow the recommendations of the Main Pharmaceutical Inspector.
Article 115. The Main Pharmaceutical Inspector shall:
1) establish the directions of Pharmaceutical Inspection’s activity;
2) coordinate and control the execution of tasks by the Regional Pharmaceutical Inspectors;
3) may give instructions to regional pharmaceutical inspectors, concerning specific activities, in the
scope of their content-related operations, subject to the tasks connected with giving administrative
decisions, as an authority of the first instance, and may request from them to provide information in the
entire scope of Pharmaceutical Inspection’s activity;
4) fulfil the function of the authority of the second instance with regard to decisions of the Regional
Pharmaceutical Inspectors;
5) hold supervision over manufacturing conditions of medicinal products administered to humans and
animals;
5a) within the state quality tests of the medicinal products, hold supervision over the quality of the
medicinal products present on the market, excluding the veterinary medicinal products;
6) cooperate with the competent Pharmaceutical Inspections of the Member States of the European
Union or the Member States of the European Free Trade Association (EFTA) – parties to the Agreement
on European Economic Area, pursuant to the guidelines included in the collection of the procedures on
inspections and information exchange, referred to in Article 3(1) of the Commission Directive 2003/94/EC
of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of
medicinal products for human use and investigational medicinal products for human use (OJ EU L 262 of
14.10.2003, page 22; OJ EU Polish special edition, chapter 13, volume 32, page 424);
7) (repealed)
8) is the authority of the first instance in the issues specified by the Act;
9) issues the decisions, referred to in Article 108(4), Clauses 1-3, b) and c), Clause 5 and 7a.
Article 116. 1. The Regional Pharmaceutical Inspector shall manage the Regional Pharmaceutical
Inspectorate.
2. The Regional Pharmaceutical Inspectorate shall consist in, subject to the provisions of Paragraph
3, Medicine Quality Control Laboratories, carrying out the tasks defined in Article 65(8) and conducting
quality control tests of prescription and pharmaceutical medicines, as well as samples taken in the course
of such control.
3. The Main Pharmaceutical Inspector may, in justified cases, give its assent to withdraw from the
obligation of establishing a laboratory; in such cases the quality control tests of medicines shall be carried
out on the basis of an agreement made with the units specified in Article 22(2 – 3).
4. The units specified in Article 22(2 – 3) shall be also commissioned to carry out such laboratory
tests, performance of which is impossible in the Medicine Quality Control Laboratories due to the lack of
an appropriate equipment.
5. The Medicine Quality Control Laboratories may provide services in the scope of pharmaceutical
analysis; such services cannot disturb the execution of the statutory responsibilities the Pharmaceutical
Inspection.
6. (Repealed)
7. (Repealed)
8. (Repealed)
Article 117. 1. The inspectors of Main Pharmaceutical Inspectorate, holding the supervision over
conditions of manufacturing, may perform their duties in the area of several regions and may be seated in
the regional pharmaceutical inspectorates indicated by the Main Pharmaceutical Inspector.
2. In the events, referred to in Paragraph 1, the competent Regional Pharmaceutical Inspector shall
organise the workplace enabling the inspectors to execute their tasks, and shall cover the costs of their
maintenance connected with carrying out the administrative activities.
3. The Main Pharmaceutical Inspector shall ensure of carrying out of the inspection of manufacturing
and wholesale distribution according to uniform standard procedures of inspection.
4. The task, referred to in Paragraph 2, shall be financed from public funds reserved for this purpose
in the Voivode’s budget.
Article 118. 1. The supervision over manufacturing and marketing in medicinal products and medical
devices in the health care facilities established by the Minister of National Defence shall be executed by
organisational units subordinated to and indicated by this Minister, taking the principles of Good
Manufacturing Practice and Good Distribution Practice into consideration.
2. The supervision of marketing in veterinary medicinal products in the area of marketing and volume
of the administered veterinary medicinal products shall be hold by the Chief Veterinary Officer as well as
the Regional Veterinary Officers. The provisions of Article 119(3), Article 120 (1), Clause 2,m Article 120(2
– 3), Article 121(1 – 2), Article 121a(1), Article 122, Article 122a and Article 123(1) shall apply,
respectively.
2a. The Chief Veterinary Officer, within the state quality tests of the veterinary medicinal products
shall supervise the quality of the veterinary medicinal products present on the market.
3. The minister competent for health shall coordinate the execution of tasks by the authorities listed in
Paragraphs 1 and 2; in particular the minister may require information in that scope.
4. The minister competent for agriculture shall, by means of a regulation, in cooperation with the
minister competent for health, specify the way of executing supervision by the Regional Veterinary
Officers, and in particular:
1) way of conducting controls and types of controls;
2) way and mode of collecting samples for test purposes and conducting tests;
3) mode of conducting of the controls of received and dispensed medicinal products and the
conditions of their transport;
4) way and mode of keeping the control book, referred to in Article 123, way of making entries and
mode of notifying on removal of the stated infringements
- taking the legal provisions and guidelines of the European Community into consideration.
5. The Minister of National Defence shall, in cooperation with the minister competent for health,
designate, by means of a regulation, military authorities to supervise the manufacturing and marketing in
medicinal products and medical devices in the health care facilities established by the Minister of National
Defence and in the military units, taking in particular the tasks, competences and professional
requirements indispensable for holding the supervision into consideration.
6. The Minister of National Defence shall, in cooperation with the minister competent for health,
specify, by means of a regulation, forms of cooperation with the Pharmaceutical Inspection of the military
authorities supervising the manufacturing and marketing in medicinal products, excluding the veterinary
medicinal products, and medical devices in the health care facilities established by the Minister of National
Defence and the military units, considering:
1) way of mutual information sharing from the scope, referred to in Paragraph 1;
2) scope of cooperation;
3) conditions and way or organization, participation and conducting joint trainings.
Article 119. 1. The inspector for manufacturing of the Main Pharmaceutical Inspectorate, in
connection with execution of control, under Article 46(1), shall be entitled to:
1) access at any time, to any premises, in which manufacturing or control of medicinal products and
the activities connected with import of medicinal products or manufacturing of active substances are
carried out;
2) require written or oral explanations as well as presentation of documents;
3) take samples for test purposes.
2. The inspector for manufacturing of the Main Pharmaceutical Inspectorate, in connection with the
performance of control, under Article 46 (3 – 4), shall be entitled to:
1) access at any time, to any premises, in which manufacturing or control of medicinal products and
the activities connected with import of medicinal products or manufacturing of active substances are
carried out,
2) require written or oral explanations and presentation of documents,
3) take samples for test purposes.
3. The provisions of Paragraph 1 shall respectively apply to the pharmaceutical inspectors with
regard to inspection of pharmacies, pharmaceutical warehouses, as well as other non-pharmaceutical
marketing facilities in medicinal products and medical devices within the scope of their activity.
Article 119a. 1. The medicinal products, authorized to the market for the first time on the territory of
the Republic of Poland under the Act, shall be directed by the Pharmaceutical Inspection to quality tests
carried out by the units, referred to in Article 22(3), directly by the responsible entity, on the basis of
decision issued by the Main Pharmaceutical Inspector.
2. Quality control of medicinal products, specified in Paragraph 1, shall be carried out once, not later
than in the first year from the moment of placing of the medicinal product on the market. The responsible
entity informs the Main Pharmaceutical Inspector on placing the product on the market.
3. Costs of quality test, referred to in Paragraphs 1 and 2, including cost of a sample taken for the
test, shall be incurred by the responsible entity
Article 120. 1. In the event of stating any infringements of the requirements concerning:
1) conditions of manufacturing and import of medicinal products, the Main Pharmaceutical Inspector
shall order, by means of a decision, removal in the specified period of time, of the stated infringements
and may issue a decision on ban to place the medicinal product on the market or on withdrawal of the
medicinal products from the market.
2) storage and marketing in medicinal products and medical devices, the competent authority shall
order, by means of a decision, the removal of stated infringements in a defined period of time.
2. If the infringements, referred to in Paragraph 1, may pose a direct threat to human life or health,
the competent authority shall order, by means of a decision, a suspension of operation of the
manufacturing plant or its part, warehouse or its part, pharmacy or other facility engaged in marketing in
medicinal products and medical devices, or withdrawal of medicinal product or medical device from the
market.
3. The provisions of the Code of Administrative Proceedings, as well as the provisions of Executive
Proceedings in Administration are applied respectively for the purpose of the security proceedings.
Article 120a. Shall the infringements, referred to in Article 120(1), Clause 1, concern the
responsibilities of the manufacturer of a veterinary medicinal products, referred to in Article 42(1), Clause
6, the Main Pharmaceutical Inspector shall inform the Chief Veterinary Officer on this fact immediately.
Art. 121. 1. In case of a justified suspicion that a medicinal product fails to meet the quality
requirements defined for it, the Regional Pharmaceutical Inspector shall issue a decision on suspension of
marketing in the area of its competence of the specified batches of a medicinal product. The Regional
Pharmaceutical Inspector shall immediately notify the Main Pharmaceutical Inspector on this decision.
2. The decision about the suspension of marketing in the product on country-wide level shall be taken
by the Main Pharmaceutical Inspector.
3. In case of justified suspicion that a medical device fails to meet the quality requirements defined for
it, the Regional Pharmaceutical Inspector shall immediately notify the President of the Office and the Main
Pharmaceutical Inspector on this fact and on this that it secures the medical device from further marketing
and from the use determined for medicinal products.
4. Decisions referred to in Paragraphs 1 and 2 may be provided with a clause of immediate
enforceability.
5. The minister competent for health shall define, by means of a regulation, detailed principles and
mode of suspension and withdrawal of medicinal products and medical devices from the market, taking in
particular the procedure and scope of responsibilities of the Pharmaceutical Inspection authorities in
connection with their activities and the requirements of Good Manufacturing Practice.
Article 121a. 1. In the event of a justified suspicion, that application of a medicinal product results in
severe undesirable effects, changing the risk – benefit balance, the Main Pharmaceutical Inspector, on
request of the President of the Office, shall issue a decision on temporary ban of placing of this product on
the market, on suspension in marketing in this product or on withdrawal of this product from the market.
The Main Pharmaceutical Inspector shall inform the minister competent for health and the President of the
Office on this fact immediately. Depending on the existing circumstances, the Main Pharmaceutical
Inspector may order destruction of medicinal product at the expense of the responsible entity or the
entrepreneur engaged in marketing or permit its use or administration for the other purposes.
2. In the event of obtaining information on a medicinal product authorized to the market on
occurrence of threat to public health, the Main Pharmaceutical Inspector, on request of the minister
competent for health or the President of the Office, shall issue a decision on temporary ban of placing of
this product on the market, on suspension in marketing in this product or on withdrawal of this product
from the market. The Main Pharmaceutical Inspector shall inform the minister competent for health and
the President of the Office on this fact immediately. Depending on the existing circumstances, the Main
Pharmaceutical Inspector may order destruction of medicinal product at the expense of the responsible
entity or the entrepreneur engaged in marketing or permit its use or administration for the other purposes.
3. In the event of obtaining information on a veterinary medicinal product authorized to the market on
occurrence of threat to life or health of humans or animals or threat to the environment, the Chief
Veterinary Officer, on request of the minister competent for agriculture, the minister competent for health
or the President of the Office, shall issue a decision on temporary ban of placing of this product on the
market, on suspension in marketing in this product or on withdrawal of this product from the market. The
Chief Veterinary Officer shall inform the minister competent for agriculture, the minister competent for
health and the President of the Office on this decision immediately. Depending on the existing
circumstances the Chief Veterinary Officer may destruction of veterinary medicinal product at the expense
of the responsible entity or the entrepreneur engaged in marketing or permit its use or administration for
the other purposes.
4. If the decision, referred to in Paragraph 2 and 3, was issued in relation to the explanatory
proceedings under way, referred to in Article 18a(6) or Article 19(4), the President of the Office shall
inform the European Commission or competent authorities of the Member States of the European Union
or the Member States of the European Free Trade Association (EFTA) – parties to the Agreement on
European Economic Area on the issued decision not later than on the next working Day. This decision is
valid to the moment of completing the explanatory proceedings.
Article 122. 1. In the event of stating that a medicinal product fails to meet the established quality
requirements, the Main Pharmaceutical Inspector shall take the decision on a ban on placing on the
market or on the withdrawal of the product form the market, as well as, depending on circumstances, may:
1) order the destruction of this product at the expense of the responsible entity or a entrepreneur
managing its marketing,
2) allow for its use or administration for other purposes.
2. The entitlement, referred to in Paragraph 1, shall apply to the Regional Pharmaceutical Inspector,
if the medicinal product fails to meet the established quality requirements and is available only in its area
of competence.
3. If the products, referred to in Article 72(5), stored in pharmaceutical warehouses or in pharmacies
fail to meet the established quality requirements, the Regional Pharmaceutical Inspector shall make the
decision of suspension of those products from marketing, and shall notify about that fact the responsible
authority, on the basis of separate provisions referring to withdrawal of the given product from the market.
4. The entitlement, referred to in Paragraph 3, with regard to the products stored in a pharmaceutical
warehouse engaged in marketing in veterinary medicinal products shall be the right of the Regional
Veterinary Officers.
Article 122a. The Main Pharmaceutical Inspector shall, in the event referred to in Article 33(1), issue
a decision on withdrawal of the medicinal product from the market.
Article 123. 1. Temporary recommendations, comments or conclusions resulting from the performed
control visits have to be registered by the pharmaceutical inspector or the Inspector for manufacturing of
the Main Pharmaceutical Inspectorate into the control book, which is obligatorily kept by any subject
running the economic activity described in the Act, as well as by hospital, hospital pharmacy ward and
company’s pharmacies.
2. The minister competent for health shall specify, by means of a regulation, the control procedure,
taking in particular into consideration:
1) way of conducting controls and inspections as well as types of controls and inspections
2) method and mode of taking samples for tests and of carrying out the tests;
3) mode of control of received and dispensed medicinal products and medical devices, as well as
conditions of their transport;
4) standard and way of keeping the control books, principles of making entries and mode of notifying
on removal of the stated infringements
- taking legal provisions and the guidelines of the European Community into consideration.
Chapter 9
Penal provisions and final provision
Article 124. Whoever places on the market or stores, for the purpose of placing on the market, a
medicinal product without a marketing authorization, shall be subject to a fine, restriction of liberty or of
imprisonment for up to 2 years.
Article 124a. 1. Whoever places on the market or administers the veterinary medicinal products not
registered in the Register of Medicinal Products Authorized to the Market on the territory of the Republic of
Poland, shall be subject to a fine, restriction of liberty or of imprisonment for up to 2 years.
2. The person responsible for animals, allowing for administration of the veterinary medicinal
products not authorized to the market to animals, shall be subject to the same penalty.
Article125. Whoever launches a business activity in the area of manufacturing or import of a
medicinal product without the required authorization shall be liable to a fine, liberty restriction or
imprisonment for up to 2 years.
Article 126. Whoever places a medicinal product, expiry date of which has already expired, on the
market, shall be subject to a fine, liberty restriction or imprisonment for up to 2 years.
Article 126a. Whoever, without the required authorization or with a violation to the provisions of
Chapter 2a, conducts a clinical trial or veterinary clinical trial of a medicinal product, shall be subject to a
fine, restriction of liberty or imprisonment for up to 2 years.
Article 127. Whoever, without the required authorization launches an activity in the area of:
1) running a pharmaceutical warehouse, or
2) a generally accessible pharmacy, or
3) pharmaceutical point of sale,
shall be subject to a fine, liberty restriction or imprisonment for up to 2 years.
Art. 128. Whoever, violating the provisions of Article 58, provides or promises to persons authorized
to issue medical prescriptions, persons engaged in marketing in medicinal products, any material benefits
or receives such benefits within advertising of a medicinal product, shall be subject to a fine.
Article 129. 1. Whoever advertises medicinal products without the required authorization shall be
subject to a fine.
2. The same penalty shall be applied to the persons, who:
1) advertise the medicinal products not authorized to the market on the territory of the Republic of
Poland, or
2) advertise the medicinal products inconsistent with the Specification of Medicinal Product, or
Specification of Veterinary Medicinal Product
3) fails to keep the templates of advertisings, or
4) fails to keep the register of the received samples of medicinal products, or
5) fails to execute the decisions, in immediate manner, which order to:
a) withdraw from publishing or conducting advertising of medicinal products incompliant with the
provisions in force
b) publish the issued decision in the places, in which the advertising incompliant with the provisions in
force were published and publish a correction of a misleading advertising,
c) remove the stated infringements.
Article 129a. 1. Whoever publishes the advertising of the medicinal products:
1) dispensed on the basis of prescription exclusively, or
2) name of which is identical with the name of a medicinal product dispensed on the basis of
prescription exclusively, or
3) containing intoxicants or psychotropic substances, or
4) entered into the lists of the refunded medicines or medicinal products dispensed without prescription
of a name identical with the name of medicinal products entered into such lists,
- shall be subject to fine.
2. Whoever supplies the samples of the medicinal products to the unauthorized persons,
shall be subject to fine.
Article 129b. Whoever, running a generally public pharmacy or a pharmaceutical point of sale,
advertises its activity, which refers directly to medicinal products or medical devices entered into the lists
of the refunded medicines or the medicinal products or medical devices of a name identical with the name
of medicinal products or medical devices entered into such lists,
shall be subject to fine.
Article 130. Whoever ascribes the properties of a medicinal product to a product placed on the
market, regardless of the fact that the given product fails to meet the requirements determined by the Act,
shall be subject to a fine.
Article 131. 1. Whoever runs a pharmacy without the required authorization,
shall be subject to a fine.
2. The same penalty shall apply to the persons, who without professional authorizations, dispense
medicinal products in a pharmacy.
Article 132. Whoever prevents or hinders the execution of control within the scope of a
pharmaceutical inspection by a person authorized to perform such control,
shall be subject to a fine, or a punishment of imprisonment for up to 2 years, or both penalties jointly.
Article 132a. Whoever places on the market or administers in veterinary practice unprocessed
veterinary pharmaceutical raw materials
shall be subject to a fine or imprisonment for up to 3 years, or both these penalties jointly.
Article 132b. Whoever has no documents of purchase and administration to animals, tissues of
which and products obtained from which are intended for human consumption, of a veterinary medicinal
product of anabolic, anti-bacterial, anti-parasitic, anti-inflammatory, hormonal and psychotropic properties,
shall be subject to a fine or imprisonment for up to 2 years, or both these penalties jointly.
Article 132c. Whoever, engaged in retail marketing in veterinary medicinal products or medicinal
feeds, fails to keep marketing documentation related to the veterinary medicinal products or medicinal
feeds,
shall be subject to a fine or imprisonment for up to 2 years, or both penalties jointly.
Article 132d. Whoever:
1) fails to keep the register, referred to in Article 24(1), Clause 2, or
2) fails to deliver the reports, referred to in Article 24(1), Clause 3, to the President of the Office, or
3) violates the ban specified in Article 24(3a),
shall be subject to a fine or imprisonment for up to 2 years, or both penalties jointly.
Article 132e. Whoever, violating the provisions of Article 71(1a), runs detailed marketing in veterinary
medicinal products dispensed without the prescription without the notification of the Regional Veterinary
Officer of such fact,
shall be subject to a fine.
Art. 133. In the event of conviction for the crime specified in Article 124, Article 124a, Article 126,
Article 132a and Article 132b, the court shall decide the forfeiture of the subject of a crime, even if it is not
the property of an offender and may order its destruction.
Art. 134. The Act enters into force at the date and under the principles specified in the Act – The
provisions implementing the Pharmaceutical Law Act, the Act on medical devices and the Act on the
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
______
1)
Amendments to the mentioned Act were published in Journal of Laws of 2005 No. 94, Item 788, No.
132, Item 1110, No. 138, Item 1154, No. 157, Item 1314, No. 164, Item 1366, No. 169, Item 1411 and
No. 179, Item 1485, of 2006 No. 75, Item 519, No. 104, Item 708 and 711, No. 143, Item 1030, No.
170, Item 1217, No. 191, Item 1410, No. 227, Item 1658 and No. 249, Item 1824 and of 2007 No. 64,
Item 427 and 433, No. 82, Item 559, No. 115, Item 793, No. 133, Item 922, No. 166, Item 1172, No.
171, Item 1208, No. 176, Item 1243 and No. 180, Item 1280.
2)
Amendments to the uniform text of the mentioned Act were published in Journal of Laws of 2004 No.
96, Item 959, No. 162, Item 1693 and No. 172, Item 1804, of 2005 No. 10, Item 68 and of 2007 No.
171, Item 1206.
3)
Amendments to the uniform text of the mentioned Act were published in Journal of Laws of 2004 No.
33, Item 286, of 2005 No. 10, Item 68, No. 163, Item 1362 and No. 167, Item 1398, of 2006 No. 170,
Item 1217 and 1218 and No. 208, Item 1539 and of 2007 No. 99, Item 662 and No. 136, Item 958.
4)
Amendments to the mentioned Act were published in Journal of Laws of 2001 No. 100, Item 1085,
No. 123, Item 1350 and No. 125, Item 1367, of 2002 No. 135, Item 1145 and No. 142, Item 1187, 2
2003 No. 189, Item 1852, of 2004 No. 96, Item 959 and No. 121, Item 1263, of 2005 No. 179, Item
1485, of 2006 No. 171, Item 1225 and of 2007 No. 176, Item 1238.
5)
Amendments to the uniform text of the mentioned Act were published in Journal of Laws of 2006 No.
117, Item 790, No. 191, Item 1410 and No. 220, Item 1600 and of 2007 No. 123, Item 849, No. 166,
Item 1172 and No. 176, Item 1238.
6)
Amendments to the uniform text of the mentioned Act were published in Journal of Laws of 2004 No.
69, Item 625, No. 92, Item 880 and No. 96, Item 959, of 2005 No. 33, Item 289 and No. 175, Item
1462 and of 2006 No. 249, Item 1830.
7)
Amendments to the uniform text of the mentioned Act were published in Journal of Laws of 2007 No.
123, Item 849, No. 166, Item 1172, No. 176, Item 1240 and No. 181, Item 1290.
8)
Amendments to the mentioned Act were published in Journal of Laws of 2003 No. 45, Item 391 and
No. 199, Item 1938, of 2004 No. 96, Item 959, No. 173, Item 1808 and No. 210, Item 2135 and of
2006 No. 220, Item 1600.
9)
Amendments to the mentioned Act were published in Journal of Laws of 2006 No. 66, Item 469 and
No. 120, Item 826 and of 2007 No. 7, Item 48 and No. 82, Item 558.
10)
Amendments to the mentioned Act were published in Journal of Laws of 2005 No. 23, Item 188 and
11)
12)
No. 33, Item 289, of 2006 No. 17, Item 127, No. 144, Item 1045 and No. 249, Item 1830 and of 2007
No. 133, Item 920.
Amendments to the mentioned Act were published in Journal of Laws of 2003 No. 73, Item 659, No.
189, Item 1852 and No. 208, Item 2019 and of 2004 No. 213, Item 2158.
Amendments to the mentioned Act were published in Journal of Laws of 2005 No. 113, Item 954 and
No. 130, Item 1087 and of 2007 No. 75, Item 493, No. 176, Item 1238 and No. 181, Item 1286.