draft
Pharmaceuticals Act of the Kyrgyz Republic
Table of contents
Pharmaceuticals Act of the Kyrgyz Republic .................................................................................... 1
Table of contents ............................................................................................................................ 1
Chapter I. General provisions .......................................................................................................... 4
Article 1. Subject of regulation of this Act .................................................................................................................... 4
Article 2. Scope of this Act ............................................................................................................................................ 4
Article 3. Pharmaceutical legislation of the Kyrgyz Republic ........................................................................................ 4
Article 4. Main concepts used ....................................................................................................................................... 4
Article 5. Guiding principles of the National Pharmaceutical Policy........................................................................... 10
Chapter II. Government regulation of pharmaceutical market ....................................................... 10
Article 6. Government regulation of the pharmaceutical market .............................................................................. 10
Article 7. Powers of the Government of the Kyrgyz Republic in the field of pharmaceuticals .................................. 11
Article 8. Powers of the public health authorityof the Kyrgyz Republic ..................................................................... 12
Article 9. Licensing in the pharmaceutical market...................................................................................................... 13
Article 10. Circulation of the pharmaceuticals............................................................................................................ 13
Chapter III. Government system of control and supervision over quality, efficacy, and safety of
pharmaceuticals ........................................................................................................................... 14
Article 11. Registration, confirmation of registration (re-registration), and amendments in the pharmaceutical
dossiers ....................................................................................................................................................................... 14
Article 12. Pharmaceuticals subject to mandatory registration ................................................................................. 14
Article 13. Pharmaceuticals marketable in the Kyrgyz Republic without registration ............................................... 15
Article 14. National Register of Medicines of the Kyrgyz Republic ............................................................................. 15
Article 15. Certificate of the pharmaceutical registration .......................................................................................... 19
Article 16. Confirmation of pharmaceutical registration (re-registration) ................................................................. 19
Article 17. Termination of the pharmaceutical registration ....................................................................................... 19
Article 18. Cancellation of the pharmaceutical registration ....................................................................................... 20
1
draft
Article 19. Quality assessment of the pharmaceutical substance for inclusion in the National Register of Medicines
.................................................................................................................................................................................... 20
Article 20. Post-registration overseeing of the pharmaceutical market .................................................................... 21
Article 21. Storage and destruction of pharmaceuticals ............................................................................................ 21
Article 22. Dispute settlement in the field of pharmaceuticals .................................................................................. 22
Chapter IV. National Pharmacopeia of the Kyrgyz Republic ........................................................... 22
Article 23. Types of pharmacopeia monographs ........................................................................................................ 22
Article 24. Formulation of the National Pharmacopeia .............................................................................................. 22
Chapter V. Rights and responsibilities of citizens and pharmaceutical market entities ................... 22
Article 25. Rights of citizens ........................................................................................................................................ 22
Article 26. Responsibilities of citizens in the field of pharmaceuticals ....................................................................... 23
Article 28. Rights and obligations of pharmaceutical market entities ........................................................................ 24
Chapter VI. System of ensuring access to pharmaceuticals ............................................................ 25
Article 29. Ensuring access to pharmaceuticals .......................................................................................................... 25
Article 30. Order of provision of people of the Kyrgyz Republic with pharmaceuticals ............................................. 25
Article 31. Financing the pharmaceutical provision to people of the Kyrgyz Republic .............................................. 25
Article 32. Use of funds for pharmaceutical provision to people of the Kyrgyz Republic .......................................... 25
Chapter VII. Participation in the pharmaceutical activities ............................................................. 26
Article 33. Pharmaceutical activity ............................................................................................................................. 26
Article 34. Permission to pharmaceutical practice ..................................................................................................... 26
Chapter VIII. Development, preclinical and clinical trials (studies) of new medicines ..................... 26
Article 35. Development of new medicines ................................................................................................................ 26
Article 36. Preclinical trials (studies) of medicines ..................................................................................................... 27
Article 37. Clinical trials (studies) of medicines .......................................................................................................... 27
Article 38. Rights of persons involved in clinical trials (studies) of medicines............................................................ 28
Chapter IX. Production and manufacturing of pharmaceuticals ..................................................... 29
Article 39. Production of pharmaceuticals ................................................................................................................. 29
Article 40. Government overseeing the production and manufacturing of pharmaceuticals ................................... 29
Article 41. Labelling of pharmaceuticals ..................................................................................................................... 30
Article 42. Pharmaceutical manufacturing ................................................................................................................. 31
2
draft
Chapter X. Import and export of pharmaceuticals ......................................................................... 31
Article 43. Import of pharmaceuticals into the Kyrgyz Republic ................................................................................ 31
Article 44. Pharmaceuticals allowed for importation ................................................................................................. 31
Article 45. Pharmaceuticals prohibited for import ..................................................................................................... 32
Article 46. Entities entitled to import pharmaceuticals into the Kyrgyz Republic ...................................................... 32
Article 47. Import of pharmaceuticals into the Kyrgyz Republic for personal use and other non-commercial
purposes...................................................................................................................................................................... 33
Article 48. Export of pharmaceuticals ......................................................................................................................... 33
Article 49. Cooperation of the customs authorities and the public health authority of the Kyrgyz Republic............ 33
Chapter XI. Wholesale and retail sale of pharmaceuticals .............................................................. 33
Article 50. Wholesale of pharmaceuticals .................................................................................................................. 33
Article 51. Retail sales of pharmaceuticals ................................................................................................................. 34
Article 52. Pharmaceuticals prohibited for sale .......................................................................................................... 34
Article 53. Retail sale of prescription and over-the-counter medicines ..................................................................... 35
Chapter XII. Provision of pharmaceutical information ................................................................... 35
Article 54. Pharmaceutical information ...................................................................................................................... 35
Chapter XIII. Advertisement of pharmaceuticals. Specifics of pharmaceutical advertisement......... 37
Article 55. Pharmaceutical advertisement.................................................................................................................. 37
Chapter XIV. Concluding provisions ............................................................................................... 38
Article 56. Pharmaceuticals as humanitarian aid........................................................................................................ 38
Article 57. Liability for violation of the pharmaceutical legislation of the Kyrgyz Republic ....................................... 39
Article 58. International cooperation of the Kyrgyz Republic in pharmaceutical sector ............................................ 39
Article 59. Entry into force of this Act ......................................................................................................................... 39
3
draft
This Act provides a legal ground for pharmaceutical market entities, defines powers and liabilities of executive
authorities in the field of pharmaceuticals, and establishes uniform requirements to handling of pharmaceuticals in
the Kyrgyz Republic
Chapter I. General provisions
Article 1. Subject of regulation of this Act
This Act regulates the development, preclinical and clinical trials of pharmaceuticals, production, manufacture,
control of quality, efficacy, safety, sales of and other activities in the field of pharmaceuticals.
Article 2. Scope of this Act
This Act applies to relations in the field of pharmaceuticals for medical use in the Kyrgyz Republic.
This Act applies to circulation of narcotic and psychotropic medicines, with account to specifications established by
legislation of the Kyrgyz Republic on narcotics, psychotropic substances and precursors.
Article 3. Pharmaceutical legislation of the Kyrgyz Republic
The pharmaceutical legislation of the Kyrgyz Republic consists of this Act, other acts and other regulatory acts of the
Kyrgyz Republic.
If an international agreement, where the Kyrgyz Republic is party, establishes rules other than provided by this Act
then rules of the international treaty take precedence.
Article 4. Main concepts used
Pharmacy organizations are entities engaged in the retail distribution, manufacturing and sales of pharmaceuticals,
in accordance with requirements of the legislation.
Safety of medicines is a characteristic of the extent of risk of causing harm to health and negative effect of the
medicine on the human body.
Bioavailability is the relative amount of medicine that reaches the systemic circulation (extent of absorption) and
the speed with which this process takes place (rate of absorption).
4
draft
Biosimilar is a reproduced biological medicinal product that, in terms of quality, safety, and efficacy, is stated as
similar to the previously registered, reference innovative biological medicine, and that has similar international nonproprietary name.
Bioequivalence is a relatively similar bioavailability of the reproduced (generic) and reference medicines.
Reproduced (generic) medicine is a pharmaceutical product which has the same qualitative and quantitative
composition in active substances and the same pharmaceutical form as the reference medicinal product, and with
demonstrated satisfactory bioequivalence relative to the reference medicinal product.
Additives are substances of inorganic or organic origin used in the production and manufacturing of
pharmaceuticals, in order to obtain required physical and chemical properties attributed to a particular dosage form.
Secondary (outer) packaging is the packaging into which is placed the immediate packaging
Homeopathic medicine. Any medicinal product prepared from substances called homeopathic stocks in accordance
with a homeopathic manufacturing procedures and intended for use in a variety of formulations. Their efficacy is not
evidence-based; the safety and quality are controlled by the competent public health authority.
Registration of pharmaceuticals is a system of permitting the pharmaceuticals for medical use in the Kyrgyz
Republic, based on the expert assessment of the registration dossiers and the evaluation of studies of submitted
samples for quality, efficacy and safety for humans.
National register of medicines of the Kyrgyz Republic is the official document to account for pharmaceuticals,
pharmaceutical substances included in the medicinal products, and pharmaceutical substances that have passed
registration and quality assessment, registered and / or approved for medical use in the Kyrgyz Republic.
National pharmacopeia is a collection of principle quality standards used in the pharmacopeia analysis, production,
manufacture, and circulation of medicines. Until the National Pharmacopoeia of the Kyrgyz Republic is developed,
the Kyrgyz Republic will use the national pharmacopoeia of the USSR IX, X, XI editions, the International
Pharmacopoeia, the United States Pharmacopoeia (USP), the German Pharmacopoeia (DAB), the European
Pharmacopoeia (EP), the British Pharmacopoeia (BP), the Russian Federation National Pharmacopoeia, the National
Pharmacopoeia of the Republic of Kazakhstan, the French Homeopathic Pharmacopoeia, the German Homeopathic
Pharmacopoeia.
Preclinical studies (tests) of medicines are chemical, physical, biological, microbiological, pharmacological,
toxicological, and other preclinical studies (tests) carried out without participation of human subjects.
Active substances (active pharmaceutical ingredients) are pharmacologically active components of medicines.
5
draft
Manufacturing of pharmaceuticals is a kind of pharmaceutical activities related to manufacturing of medicines in
pharmacies by individual doctor prescriptions and official prescriptions; it employs purchase of pharmaceutical
substances, storage, quality control, design and sale of the manufactured medicines (formulations).
Instructions for medical use is a document intended for healthcare professionals, composed by the manufacturer,
approved by the public health authority of the Kyrgyz Republic, and containing instructions on proper use and
handling of pharmaceuticals.
Quality of the pharmaceutical is a set of properties that enable the pharmaceutical to meet requirements of
consumers in accordance with its intended purpose and to meet standards adopted by this Act.
Clinical trial (study) is any study on pharmaceutical products in human subjects in order to discover or verify the
clinical, pharmacological, and/or pharmacodynamic effects of one or several investigational products, and/or
identify any adverse reaction to one or several investigational products, and/or to study the absorption, distribution,
metabolism and excretion of one or several products with the object of ascertaining their efficacy and safety.
Counterfeit pharmaceutical is a medical product circulated illegally, with violation of the civil legislation.
Medicinal product. Any substance or combination of substances which may be used in or administered to human
beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological,
immunological or metabolic action, or to making a medical diagnosis
Medicinal preparations of biological origin is a preparation containing biological proteins (vaccines, hormones,
serum, cytokines, blood clotting factors, including low molecular weight heparins, immunological, insulin,
monoclonal antibodies, enzymes, colony stimulating factors, drugs based on tissue cells, drugs obtained via genetic
engineering and hybridoma technology) and biosimilars.
Medicinal herbs are fresh or dried whole herbs or their parts, used for production and manufacturing of medicines.
Medicines are substances or combinations thereof that contact the human or animal body, penetrate into organs
and tissues of the human or animal, are used for prevention, diagnosis (except for substances or combinations
thereof not in contact with the human or animal), treatment of diseases, rehabilitation, as well as for preservation,
preventing or interrupting the pregnancy, obtained from the blood, blood plasma, organs, tissues of human or
animal, plants, minerals or using biological techniques. The pharmaceutical substances represent medicines.
WHO prequalified medicines are pharmaceuticals with quality, efficacy, and safety confirmed via procedures of the
WHO program of pre-qualification of pharmaceuticals
Dosage form is a form of the pharmaceutical convenient for practical application.
6
draft
Package leaflet. A leaflet containing information for the user which accompanies the medicinal product. Composed
by the manufacturer and approved by the public health authority of the Kyrgyz Republic.
Labeling pharmaceuticals. Information on the immediate or outer packaging.
International non-proprietary name (INN) or generic name is a name assigned by the World Health Organization
(WHO) to a pharmaceutical substance or to an active pharmaceutical ingredient intended to use as a public property.
Narcotic medicines contain substances included in the list of narcotic drugs that is composed according to legislation
of the Kyrgyz Republic and is updated according to the Single Convention on Narcotic Drugs, 1961.
Substandard (substandard) medicines are medicines which are not suitable for use as a result of non-compliance
with standards adopted by this Act.
National Drug Formulary is an official document that represents a source of independent reliable information on
pharmaceuticals for medical use and facilitates the rational use of medicines.
Circulation of medicines is a generic term of activities that include the development, preclinical and clinical studies,
production, manufacture, storage, packaging, import into the Kyrgyz Republic, export from the Kyrgyz Republic,
transportation, government control and supervision, registration, standardization and quality control, sale, labeling,
advertising, use of drugs, destruction of dilapidated or expired drugs, and other actions.
Common pharmacopeia monograph is a set of standard indicators of quality and (or) quality control methods of
particular formulations, medicinal plants, description of biological, biochemical, microbiological, physical and
chemical, physical, chemical and other methods for analyzing the pharmaceuticals for medical application, as well as
technical requirements to chemicals, titrant, and indicators used for the analytical tests.
Wholesale distribution of medicines. All activities consisting of procuring, holding, supplying or exporting medicinal
products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers
or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled
to supply medicinal products to the public in the Member State concerned.
Original medicine is a pharmaceutical that contains the primary pharmaceutical substance or a new combination of
pharmaceutical substances, the efficacy and safety of which will be confirmed by outcomes of pre-clinical trials of
pharmaceuticals and clinical trials of medicines.
Orphan drug is a medicinal product developed to treat a rare disease.
List of essential medicines is the list of pharmaceuticals for medical use that cover priority healthcare needs in
prevention and treatment of diseases, including those prevailing in the Kyrgyz Republic. The Government of the
Kyrgyz Republic periodically approves the List.
Primary (immediate) packaging is the container or other form of packaging immediately in contact with the
medicinal product.
7
draft
Adverse drug reaction is a response to a medicinal product which is noxious and unintended and which occurs at
doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or
modification of physiological function.
Compliance assessment is a procedure that confirms compliance of medicines with standards (specifications)
provided by this Act.
Precursors are substances used in the production, manufacturing, processing of narcotic drugs and psychotropic
substances included in the List of narcotic drugs, psychotropic substances and their precursors.
Pharmaceutical manufacturing is a type of pharmaceutical activities that includes all operations that are essential
for serial production of medicines and are associated to receipt of materials and semi-finished products,
technological processes, storage, distribution of manufactured products, and related controls.
Psychotropic medicines contain substances included in the international or national lists of narcotic drugs,
psychotropic substances and precursors as narcotic drugs or psychotropic substances and updated in accordance
with the Single Convention on Psychotropic Substances of 1971.
Herbal medicines are finished medicinal products obtained by processing (extraction, distillation, extrusion,
separation, purification, concentration, fermentation, and others.) of the herbal raw materials.
Reference medicinal product is an original medicine or a well-studied generic medicine selected as the reference
drug (standard), in order to study the bioequivalence and / or bioavailability of a generic drug.
Retail sale of medicines is a set of pharmaceutical activities confined to the procurement, storage and
transportation of medicinal products to the final consumer.
Regulators-members of the International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Humans are the bodies which employ high standards of quality that meet standards of
relevant pharmaceutical practices recommended by the WHO and ICH: US Food and Drug Administration (FDA),
European Medicines Agency (EMA) (for centralized procedure), Swiss Agency for Therapeutic Products (Swissmedic),
Pharmaceutical and Medical Devices Agency of Japan (PMDA), the UK Medicines and Health Products Regulatory
Agency (MHRA), Australian administration of drugs (TGA).
Certificate of compliance is an official document issued by a public health authority of the Kyrgyz Republic certifying
that the products meet requirements of standards (specifications) provided by this Act.
Quality certificate is a document issued by the pharmaceutical manufacturer certifying that the products meet
requirements of standards (specifications).
Specification (Common pharmacopeia monograph, Pharmacopeia monograph, temporary pharmacopeia
monograph, Enterprise pharmacopeia monograph, regulatory document, analytical regulatory regulation, enterprise
8
draft
standards, technical conditions) is a quality standard that contains a list of indicators of quality and safety of the
pharmaceutical, as well as methods of controlling those indicators.
Shelf life of the pharmaceutical is the timeframe set for use of the medicine within which the safety, efficacy, and
quality are guaranteed, provided that conditions of transportation and storage are followed.
Pharmaceutical market entities are individual and legal entities, including foreigners who conduct pharmaceutical
activities in accordance with requirements of this Act.
Adulterated pharmaceutical is a ready pharmaceutical endowed intentionally with false labeling or packaging in
respect of its identity and / or source of origin.
Pharmacopoeia analysis is a set of official methods of studying (tests) of pharmaceutical substances, adjuvants, and
formulations as set out in the pharmacopoeia and used to confirm the authenticity of the studied (tested)
preparation, to test for absence or presence of threshold contents of impurities, and quantification of the active
ingredient or other ingredients that constitute the pharmaceutical.
Pharmacopeia monograph and the temporary pharmacopeia monograph is a quality standard approved by the
public health authority of the Kyrgyz Republic and containing a list of quality indicators and quality control methods
of the pharmaceutical for medical use.
Pharmaceutical activity comprises of the production, manufacture, and sale of medicines.
Pharmaceutical company is an individual or a legal entity engaged in pharmaceutical activities in accordance with
requirements of this Act.
Pharmaceutical substances are active substances, mixtures of active substances or mixtures of active substances
with adjuvants in certain ratios designed for production and manufacture of pharmaceuticals. Medicinal herbs and
derived extracts also represent pharmaceutical substances.
Pharmacovigilance is a system designed to identify, assess and understand possible negative effects of the medical
use of pharmaceuticals, to prevent their occurrence and to protect patients, is associated with research and
activities of the public health authorities.
Pharmaceutical inspection is a type of government control with the main purpose of checking the production of
pharmaceuticals (regardless of ownership), implementation of existing regulations of pharmaceutical quality,
efficacy, and safety. The inspection is conducted by the public health authority.
Efficacy of pharmaceuticals is a characteristic of the extent of the positive effect of the pharmaceutical on the
course and duration of the disease or its prevention, rehabilitation, as well as conservation, prevention or
interruption of pregnancy.
9
draft
Article 5. Guiding principles of the National Pharmaceutical Policy
The guiding principles of the National Pharmaceuticals Policy to protect public health are as follows:
- Ensuring well regulated access of people to pharmaceuticals, which represent a specific good due to risks to
individual’s health and life and due to the need of particular control over transportation, storage, production,
manufacture, sale and disposal of medicines;
- Ensuring access, safety, efficacy and quality of pharmaceuticals;
- Rational use of medicines;
- Establishment of essential legal and regulatory framework, in order to ensure sustainability of the pharmaceutical
activities;
- Formulation of national drug policy based on intersectoral approach;
- Develop and support the domestic production of essential medicines that are competitive in the markets;
- Ensuring good governance in the pharmaceutical market;
- Training of human resources for pharmaceutical sector;
- Provision of reliable information on properties and features of pharmaceuticals;
- Streamline ethical norms in the pharmaceutical market;
- Streamline the World Health Organization standards in the pharmaceutical market.
Chapter II. Government regulation of pharmaceutical market
Article 6. Government regulation of the pharmaceutical market
The pharmaceutical market will be regulated through the government overseeing the quality, safety and efficacy of
pharmaceuticals manufactured in or imported into the Kyrgyz Republic.
Government overseeing the quality, safety and efficacy of pharmaceuticals are established by this Act, legal and
regulatory acts of the Kyrgyz Republic and shall be effected as follows:
- assessment of quality, efficacy and safety of pharmaceuticals produced in and imported into the Kyrgyz Republic;
- registration, confirmation of registration (re-registration) of pharmaceuticals and amendments to the registration
dossier of pharmaceuticals;
- running the National register of pharmaceuticals;
10
draft
- approval of texts of instructions on medical use and texts of the package leaflets;
- approval of texts of the pharmacopoeia monographs;
- compilation and publication of the National Pharmacopoeia of the Kyrgyz Republic;
- overseeing the sales of prescription drugs;
- implementation of the post-registration overseeing the pharmaceutical market through the compliance
assessment, pharmaceutical inspection of the pharmaceutical market entities and of the pharmaceuticals;
- pharmacological vigilance;
- overseeing the placement of mandatory information on the official website;
- drafting and approval of rules of clinical trials;
- drafting and approval of production and manufacturing rules, and wholesale and retail sale rules;
- assessment of environmental and sanitary-epidemiological security of the pharmaceutical production;
- drafting and approval of good laboratory practice rules;
- monitor the manufacturers’ compliance to manufacturing rules;
- prohibition of sales of counterfeit, substandard and illegally imported pharmaceuticals into the Kyrgyz Republic;
- overseeing the pharmaceutical promotion;
- overseeing the production, manufacturing and marketing of pharmaceuticals.
Article 7. Powers of the Government of the Kyrgyz Republic in the field of pharmaceuticals
The Government of the Kyrgyz Republic will:
- Ensure implementation of consistent national policy to provide citizens of the Kyrgyz with good quality, effective
and safe pharmaceuticals;
- Formulate national programs to provide people of the Kyrgyz Republic with good quality, effective and safe
pharmaceuticals, to develop the pharmaceutical industry, and to enforce implementation;
- Approve the List of essential medicines;
- Determine effective pricing for pharmaceuticals out of the List of essential medicines;
- Establish procedures of social protection of citizens of the Kyrgyz Republic, the preferential provision of
pharmaceuticals to certain categories of citizens of the Kyrgyz Republic;
11
draft
- Ensure government overseeing the import into the Kyrgyz Republic and export from the Kyrgyz Republic of
pharmaceuticals.
Article 8. Powers of the public health authority of the Kyrgyz Republic
The government body of the Kyrgyz Republic authorized in public health will:
- Oversee the implementation of regulations that define procedures in the pharmaceutical market;
- Coordinate the research and development of new medicines and promote the application of advances of the
pharmaceutical science into the medical practice;
- Measure the consumption of medicines, following the established nomenclature;
- Monitor the prices and submits proposals on more effective price regulation to the Government of the Kyrgyz
Republic;
- Measure the consumption of narcotic and psychotropic medicines and oversee their use within healthcare facilities
and pharmaceutical organizations;
- Oversee the quality, efficacy, and safety of medicines produced and manufactured in and imported into the Kyrgyz
Republic;
- Run registration, confirmation of registration (re-registration) of pharmaceuticals, and amends the registration
dossiers;
- Coordinate agreements and permissions over the importation and exportation of pharmaceuticals;
- Define the List of essential medicines and submits for approval to the Government of the Kyrgyz Republic;
- Prepare the list of drugs that are allowed for importation and use without prior registration;
- Conduct compliance assessment of pharmaceuticals in the Kyrgyz Republic;
- Procurement of pharmaceuticals using funds of the national budget, grants, and credits;
- Issue licenses for production, manufacturing, wholesale, and retail sale of medicines, with maintained authority to
suspend the licenses in cases of violation of licensing requirements established by legislation of the Kyrgyz Republic;
- Define the order and conditions of specialized training of individuals with medical degree, in order to enable their
participation in sales of pharmaceuticals in remote villages;
12
draft
- Run a register of existing pharmaceutical business entities, with details published on the official website;
- Issue confirmation of the pharmaceuticals included in the list of medicines allowed for import and use in the Kyrgyz
Republic without registration;
- issue provisions, suspend production and sale of produced pharmaceuticals, and cancel the registration
certificate/s in cases as defined by this Act;
- Conduct the pharmacological vigilance;
- Suspend the use of medicines in cases of reported adverse effects, based on grounds established by the legislation
and based on procedures established by the Government of the Kyrgyz Republic.
The authorized government body of the Kyrgyz Republic in public health shall regularly place information on the
official website about as follows:
- Special list of drugs allowed for import and use in the Kyrgyz Republic without registration;
- Register of persons with medical education and permitted to provide sales of pharmaceuticals in remote
settlements;
- Number of active pharmaceutical entities;
- List of pharmaceuticals with permitted advertisement;
- Single register of pharmaceuticals received as humanitarian aid;
- Other registers as defined in this Act.
Article 9. Licensing in the pharmaceutical market
Licensing of activities in the pharmaceutical sector follow the legislation of the Kyrgyz Republic in the field of
licensing.
Article 10. Circulation of the pharmaceuticals
Pharmaceuticals can be imported, produced, sold and used in the Kyrgyz Republic, if they are included in the
National Register of Medicines of the Kyrgyz Republic following procedures determined by this Act, or on the basis of
temporary authorization of import and use in medical practice within the Kyrgyz Republic in exceptional cases,
according to procedures established by the Government of the Kyrgyz Republic.
13
draft
Chapter III. Government system of control and supervision over quality, efficacy, and
safety of pharmaceuticals
Article 11. Registration, confirmation of registration (re-registration), and amendments in the
pharmaceutical dossiers
The public health authority registers, confirms registration (re-registration) of pharmaceuticals and amends the
registration dossier of pharmaceuticals, within the timeframes specified by legislation of the Kyrgyz Republic.
The registration, confirmation of registration (re-registration) of pharmaceuticals, and amendments to registration
dossiers involve expert works. The fee for service cannot exceed the actual costs of the expert work during the
registration of pharmaceuticals.
The applicant holds all costs related to the expert work on registration of pharmaceuticals, confirmation of
registration (re-registration) and amendments to registration dossiers, in the amount established by the legislation
of the Kyrgyz Republic.
In cases medical care is needed in socially significant and rare diseases, the fast-track procedures of registration are
allowed in relation to the following groups of medicines:
- Orphan medicines;
- Medicines registered by regulatory authorities that are members of the International Conference on Harmonization
of Technical Requirements for Registration of Human Pharmaceuticals;
- Medicines that have passed WHO prequalification procedures and included in the WHO List of prequalified
medicines.
The accelerated registration procedures are not permitted in relation to products of biological origin.
The Government of the Kyrgyz Republic establishes the accelerated registration procedures.
In order to ensure the needs in orphan medicines, treatment of rare diseases, and medicines from the WHO List of
prequalified medicines, the payment exemptions are allowed following the procedures as established by the
Government of the Kyrgyz Republic.
Article 12. Pharmaceuticals subject to mandatory registration
Registration is mandatory for the following:
- Original pharmaceuticals;
14
draft
- Generic pharmaceuticals;
- Pharmaceuticals of biological origin;
- Biosimilar medicines;
- Herbal pharmaceuticals;
- Homeopathic pharmaceuticals;
- Pharmaceutical substances and medicinal herbs not included in the Pharmacopoeia mentioned in this Act.
Pharmaceuticals are registerable in the Kyrgyz Republic conditioned that they have been registered in the country of
origin or passed the WHO prequalification.
Article 13. Pharmaceuticals marketable in the Kyrgyz Republic without registration
The following pharmaceuticals are not subject to registration in the Kyrgyz Republic:
- Medicines manufactured within pharmacies by prescription and at the request of healthcare facilities;
- Medicines for personal use by individuals;
- Medicines intended for clinical trials in the Kyrgyz Republic;
- Samples of medicines intended for registration and reference samples;
- Radiopharmaceuticals prepared exclusively from registered sources of radionuclides, radionuclide sets, or
radionuclide precursors following the manufacturer's instructions, applied by an individual or agency authorized to
use such medicines in healthcare facilities;
- Pharmaceutical substances included in the Pharmacopoeia, in accordance with this Act;
- Medicines intended for use as advertisement display samples.
Article 14. National Register of Medicines of the Kyrgyz Republic
The National Register of Medicines of the Kyrgyz Republic (hereinafter - the Register) is a unified information system
that contains information on as follows:
- Medicines that have passed the registration and pharmaceutical substances that are part of medicines;
- Pharmaceutical substances, including raw herbal drugs that have passed registration;
15
draft
- Pharmaceutical substances, including raw herbal drugs that have passed the quality assessment.
The authorized government body in public health formulates and operates the Register. The Register is published on
the official website of the government body of the Kyrgyz Republic authorized in public health and is updated on
daily basis.
The unified Register consists of the registry entries generated sequentially as registration and quality assessment
progress.
The following decisions make grounds for inclusion in the Register:
1) A pharmaceutical is registered;
2) Registration (re-registration) of the pharmaceutical is confirmed;
3) Documents contained in the registration dossier of the registered pharmaceutical are amended;
4) Pharmaceutical substances are registered;
5) Pharmaceutical substances have passed quality assessment.
Entries in the Register are added within a timeframe not exceeding one working day following the decision.
The Register maintains personified history of changed registry records, with date and time of creation of records, any
changes and cancellations. Removing data from the single Register is not allowed.
Registry entry contains the following information in relation to medicines:
- Number (ID) of the register entry and date of entering the pharmaceutical information in the Register;
- Status of the pharmaceutical (approved for use, registration certificate suspended or revoked, forbidden to use);
- International non-proprietary name (INN) and trademark brand name (if any); if a pharmaceutical is not assigned
an INN, then an indication of this is provided;
- Pharmaceutical form with dosage and quantity in the consumer packaging;
- Pharmacotherapeutic group or main indication for use;
- Indications and contraindications;
- Adverse effects;
16
draft
- Shelf life;
- Storage conditions;
- Sale conditions (prescription or non-prescription);
- Number of specification / pharmacopeia article / regulations;
- Registration number/code and date;
- Name and address of the manufacturer or developer;
- Name of the developer, if the applicant is the developer;
- Permit or prohibit of the pharmaceutical advertisement;
- Belonging to controlled medicines.
Registry entry contains the following information in relation to the pharmaceutical substances comprising the
pharmaceutical:
- Number of the registry entry and date of inclusion into the Register of information about the pharmaceutical
substance;
- Chemical, trademark brand and / or international non-proprietary name;
- Shelf life / test proof;
- Storage conditions;
- Number/code of specification / pharmacopeia article / regulations;
- Name and address of the manufacturer.
Registry entry contains the following information in relation to the registered pharmaceutical substances:
- Number of the register entry and date of inclusion in the Register of information about the pharmaceutical
substance;
- Chemical, trademark brand and / or international non-proprietary name;
- Pharmacotherapeutic group or main indications for use;
17
draft
- Shelf life / test proof;
- Storage conditions;
- Number/code of specification / pharmacopeia monograph / regulations;
- Registration number and date
- Name and address of the manufacturer or developer.
Registry entry contains the following information in relation to the registered herbal primary products:
- Number of the register entry and date of inclusion in the Register of information about the herbal primary
product;
- Name of herbal primary product;
- Indications;
- Shelf life
- Storage conditions;
- Number/code of specification / pharmacopeia monograph / regulations;
- Registration number and date;
- Name and address of the manufacturer or developer, place of collection and details of applicant.
The pharmaceuticals are included in the National Register following procedures established by the Government of
the Kyrgyz Republic.
The government body authorized for public health is required to backup copy the Registry at least once a month, in
order to protect the information contained therein.
Information in the Register is open, accessible to public, and is provided to involved parties, in accordance to the
legislation.
18
draft
Article 15. Certificate of the pharmaceutical registration
The fact of pharmaceutical registration is certified by the issuance of the Certificate of registration of the
pharmaceutical, in the form approved by the Government of the Kyrgyz Republic.
The Certificate of registration Subject to strict reporting that permits the medical use of the pharmaceutical.
Certificate of registration of the pharmaceutical with indication of forms and dosage is issued with no fixed term
(termless), except for the Certificate of registration issued for five years and for newly registered pharmaceuticals.
After five years following the newly registered drug are over, the authorized body issues termless registration
certificate conditioned that the registration status is confirmed.
Number of register entry corresponds to the number of Certificate of registration.
Each pharmaceutical form, dosage, and manufacturing form is issued a separate certificate of registration.
Article 16. Confirmation of pharmaceutical registration (re-registration)
Registration (re-registration) of the pharmaceutical is confirmed via issuing a termless registration certificate, based
on assessment of risks of application and pharmacological vigilance data, as well as quality assessment that is
conducted in case of changes in the specification of the pharmaceutical.
The Government of the Kyrgyz Republic sets procedures of confirming the registration (re-registration).
Article 17. Termination of the pharmaceutical registration
Registration of pharmaceuticals is terminable in the following cases:
- Expiry of the registration;
- Termination of the legal entity that held the registration certificate;
- Termination of the individual entrepreneur that held the registration certificate;
- Voluntary request of the holder to terminate the registration of pharmaceutical/s;
- Entry into force of the court decision to annul the registration of pharmaceutical/s.
Upon termination of the registration the public health authoritywill enter the information on termination of the
registration in the National Register of pharmaceuticals. Registration of pharmaceuticals is deemed terminated on
19
draft
the date of entry in the Register. Pharmaceuticals that are excluded from the National Register upon expiry of
registration will be circulated in the Kyrgyz Republic until their expiry date is due.
The registration certificate will be deemed invalid from the date of entry of information on registration termination
in the National Register of pharmaceuticals.
Article 18. Cancellation of the pharmaceutical registration
In case the registration (re-registration) is not timely confirmed or reasons of suspended registration are not solved,
the registration is canceled based on the decision of the public health authority of the Kyrgyz Republic.
Article 19. Quality assessment of the pharmaceutical substance for inclusion in the National Register of
Medicines
Pharmaceutical substances are included in the National Register of pharmaceuticals in two ways:
- During the registration of the pharmaceutical, as a component part, that is active ingredients;
- On the basis of quality assessment.
Quality assessment will be a basis for inclusion in the National Register only for those pharmaceutical substances
which are included in the Pharmacopoeia.
Quality of the pharmaceutical substance is assessed only by using pharmacopoeia methods of assays (studys) that
are included in the Pharmacopoeia.
Quality assessment of the pharmaceutical substance is carried out by government body authorized in public health
and is carried out in a timeframe not exceeding sixty days from the date of receipt of the application for inclusion of
a pharmaceutical substance into the National Register of pharmaceuticals.
For the quality assessment of the pharmaceutical substance, the applicant submits the following to the government
body authorized in public health:
- Application for inclusion of the pharmaceutical substance in the National Register of pharmaceuticals;
- Specification / pharmacopoeia article / regulations / indication of the relevant pharmacopoeia;
- Samples of the pharmaceutical substance in the quantity essential for quality assessment.
20
draft
Based on findings of the quality assessment, the public health authoritymakes decision on inclusion or rejection of
the pharmaceutical substance into the National Register of pharmaceuticals. It enters the pharmaceutical substance
in the National Register of pharmaceuticals and notifies the applicant in written form.
Rules and procedure of the quality assessment of the pharmaceutical substance are defined by the Government of
the Kyrgyz Republic.
Article 20. Post-registration overseeing of the pharmaceutical market
Post-registration overseeing the pharmaceutical market is carried out for the purpose of overseeing the compliance
with standards established by the legislation, rules and procedures imposed on pharmaceuticals and pharmaceutical
circulation entities following the pharmaceutical registration, including full compliance of pharmaceuticals in
circulation in the Kyrgyz Republic with the data in the registration dossier, with account to changes entered officially.
Post-registration overseeing will employ the following forms:
- Compliance assessment;
- Pharmaceutical inspection;
- Pharmacological vigilance.
The post-registration overseeing the pharmaceutical market should be carried out according to rules developed in
accordance to international standards and good pharmaceutical practices.
The Government of the Kyrgyz Republic sets rules and order of post-registration overseeing the pharmaceutical
market.
Article 21. Storage and destruction of pharmaceuticals
Pharmaceuticals should be kept in conditions that ensure unconditional quality, in accordance to requirements of
regulatory legal acts of the Kyrgyz Republic.
Extension of the expiry dates of pharmaceuticals is not allowed.
Destruction in the Kyrgyz Republic is not allowed for pharmaceuticals that have not undergone compliance
assessment with data of the registration dossier, with account to officially made changes.
The Government of the Kyrgyz Republic Procedures approves the procedures and rules of recycling and destruction
of pharmaceuticals not suitable for sale and use.
21
draft
Article 22. Dispute settlement in the field of pharmaceuticals
In case of disagreement between the pharmaceutical market entities and the body authorized to oversee
pharmaceutical quality, efficacy, and safety, the conciliation procedures will be employed, with participation of
experts of the pharmaceutical market entity.
The pharmaceutical market entity is entitled to know the results of conciliation.
Chapter IV. National Pharmacopeia of the Kyrgyz Republic
Article 23. Types of pharmacopeia monographs
The public health authorityof the Kyrgyz Republic approves the following pharmacopoeia monographs:
- General pharmacopoeia monograph
- Pharmacopeia monograph
- Temporary pharmacopoeia monograph
Article 24. Formulation of the National Pharmacopeia
National pharmacopeia monographs are developed and included in the National Pharmacopoeia of the Kyrgyz
Republic in accordance to procedures established by the Government of the Kyrgyz Republic.
Prior to the development of the National Pharmacopoeia of the Kyrgyz Republic, the universally recognized foreign
pharmacopeia, pharmacopoeia of national parties of intergovernmental agreements in the field of standardization,
metrology, and certification will be recognized and applied.
National Pharmacopoeia and annexes are issued by the public health authorityat the expense of the national budget
or other sources and published on its website following established procedures.
Chapter V. Rights and responsibilities of citizens and pharmaceutical market entities
Article 25. Rights of citizens
Citizens of the Kyrgyz Republic, foreign citizens and stateless persons residing in the Kyrgyz Republic have the right
to:
22
draft
- To provision of high-quality, effective, safe medicines, both on free-of-charge and privileged basis within the
amounts of state guarantees provided by the legislation of the Kyrgyz Republic;
- To receive complete and accurate information on safety, efficacy and quality of registered, prescribed, and sold
pharmaceuticals;
- Other rights stipulated by legislation of the Kyrgyz Republic.
Article 26. Responsibilities of citizens in the field of pharmaceuticals
Citizens of the Kyrgyz Republic, foreign citizens and stateless persons residing in the Kyrgyz Republic are responsible
to:
- Comply with pharmaceutical legislation of the Kyrgyz Republic;
- To follow doctor's prescriptions in the application of medicines;
- Follow rules of storage of purchased pharmaceuticals.
Article 27. Compensation of harm to health of citizens due to use of pharmaceuticals
Harm to health or life of citizens caused by the use of medicines is compensated as follows:
1. By the producer (manufacturer) of the pharmaceutical, if there is evidence that:
- the medicine was used for its intended purpose and following instructions for use, and the caused harm was due to
the medicine produced sub-standardly;
- harm to health was a result of inaccurate information provided in the instructions for use issued by the
manufacturer of the medicine;
2. By the entity who carried out wholesale delivery and sold the substandard drug.
3. In the event that the damage due to use of pharmaceuticals that have become unusable as a result of improper
storage, transport, wholesale and retail sale, the compensation is carried over by the entity who delivered the
wholesale or retail sale respectively.
4. In the event that the damage is due to improper or irrational prescribing, the compensation is carried over by the
public healthcare facility or by private healthcare professional.
23
draft
5. In the event of harm to health or life of citizens or to environment is due to violation of rules of pharmaceutical
destruction, the compensation is carried over by an entity hat committed these violations.
The damage to health and life of citizens as a result of use of medicines is compensated in accordance to the
legislation of the Kyrgyz Republic.
Article 28. Rights and obligations of pharmaceutical market entities
Entities of the pharmaceutical market are entitled to:
- Production, manufacture, import, export, and sale of pharmaceuticals, in accordance to the legislation of the Kyrgyz
Republic;
- Obtaining license for production, manufacture, and sale of pharmaceuticals, in accordance to the legislation of the
Kyrgyz Republic;
- Obtaining necessary information on the order of licensing, registration of pharmaceuticals, customs control;
- Appealing of actions or omissions of the competent authorities responsible for overseeing the quality of
pharmaceuticals, licensing, and registration;
- Improving qualifications of employees, certification and attestation.
Pharmaceutical market entities are obliged to:
- Operate based on the license issued by the government body authorized in public health;
- Comply with rules of production, manufacture, sale, import, and export of pharmaceuticals, conditions for
advertisement, and follow instructions and resolutions of authorized bodies of the Kyrgyz Republic that perform
pharmaceutical quality control;
- Operate sales if the certificate of compliance or declaration of compliance is available;
- Comply with rules of production and quality control;
- Operate retail sales of in pharmacies with ensured compliance with rules of dispensary and storage of
pharmaceuticals,
- Inform in writing the authorized agency of the Kyrgyz Republic about identified adverse effects, including those not
listed in the instructions for use, about facts of manifested pharmaceutical interactions, and about the lack of
efficacy at medical use.
24
draft
In cases of revealed facts of hiding such information, the persons who were aware of details for their professional
activities will bear liabilities in accordance to the legislation of the Kyrgyz Republic.
Chapter VI. System of ensuring access to pharmaceuticals
Article 29. Ensuring access to pharmaceuticals
In order to ensure access to medicines, the Government of the Kyrgyz Republic will develop and implement national
programs for provision of people of the Kyrgyz Republic with medicines.
Article 30. Order of provision of people of the Kyrgyz Republic with pharmaceuticals
Provision of people of the Kyrgyz Republic with medicines is carried out as follows:
- by licensed pharmacy organizations, regardless of ownership;
- by licensed health facilities, including clinics that are part of research institutes and medical schools.
The range of pharmacy organizations and pharmacies under healthcare facilities and the sale/dispensing procedures
are set up following procedures established by the Government of the Kyrgyz Republic.
Article 31. Financing the pharmaceutical provision to people of the Kyrgyz Republic
The pharmaceutical provision to people of the Kyrgyz Republic is financed from:
- National budget;
- Mandatory Health Insurance;
- Extra-budgetary funds;
- Own resources of citizens;
- Other sources not prohibited by the legislation of the Kyrgyz Republic.
Article 32. Use of funds for pharmaceutical provision to people of the Kyrgyz Republic
The funds allocated to finance the pharmaceutical provision of people in the Kyrgyz Republic are used for:
25
draft
- purchasing of pharmaceuticals, medical devices, and vaccines;
- formation of the national reserve of essential medicines, medical devices, and vaccines.
Chapter VII. Participation in the pharmaceutical activities
Article 33. Pharmaceutical activity
Pharmaceutical business activities are carried out by legal entities and individual entrepreneurs who are licensed for
pharmaceutical activities, in accordance to the legislation of the Kyrgyz Republic.
Pharmaceutical production, manufacture, and wholesale are operated by legal entities.
Pharmaceutical organizations should be equipped with staff of professionals with permits to practice pharmaceutical
activity.
Article 34. Permission to pharmaceutical practice
Pharmaceutical practice is allowed to persons who have a diploma of higher and secondary pharmaceutical
education. Pharmaceutical workers in the field of medicines are required every 5 years to improve their
qualifications.
Persons who have received pharmaceutical education in abroad, as well as foreign citizens are allowed to
pharmaceutical practice following the procedures established by the Government of the Kyrgyz Republic, unless
otherwise provided by international treaties where the Kyrgyz Republic is a party.
Persons with higher or secondary medical education may be permitted to sales of medicines following the order and
conditions established by this Act.
Chapter VIII. Development, preclinical and clinical trials (studies) of new medicines
Article 35. Development of new medicines
Development of pharmaceuticals involves searching for new pharmacologically active substances, with subsequent
studying of their pharmaceutical properties, preclinical and clinical trials (studies), and development of technologies
of producing pharmaceutical substances.
26
draft
Development of new medicines is financed from:
- National budget;
- Funds of pharmaceutical developers;
- Funds of enterprises who produce medicines as part of research work carried out under contracts between the
developer and producers of medicines;
- Other sources of financing, including charitable foundations and trust deposits of individuals and legal entities that
are not prohibited by the legislation of the Kyrgyz Republic.
Rights of pharmaceutical developers are protected by the patent Acts of the Kyrgyz Republic.
Article 36. Preclinical trials (studies) of medicines
To study efficacy and safety of pharmaceuticals are carried out with use of chemical, physical, biological,
microbiological, pharmacological, toxicological, and other preclinical trials (studies) that do not involve research on
human individuals.
Preclinical trials (studies) of pharmaceuticals are carried out according to rules and order established by the
Government of the Kyrgyz Republic.
Article 37. Clinical trials (studies) of medicines
The purpose of clinical trials (studies) of medicines is to obtain information to discover or verify the clinical,
pharmacokinetic, pharmacodynamics and / or other effects, including information on absorption, distribution,
metabolism, and excretion of one or more pharmaceutical and / or identification of adverse reactions of one or
more pharmaceutical under trial, in order to assess its /their safety and / or efficacy.
Clinical trials (testing) of medicines are carried out according to rules and order established by the Government of
the Kyrgyz Republic.
Clinical trials (testing) of medicines should be discontinued in the event of threat to life or health of people
participating in clinical trials (studies).
Violation of the order of clinical trials (studies) of medicines and running the clinical trials (studies) without obtained
permission in accordance to procedures established by the Government of the Kyrgyz Republic are punishable under
the Acts of the Kyrgyz Republic.
27
draft
All legal disputes arising over clinical trials (studies) of medicines are resolved in accordance to the legislation of the
Kyrgyz Republic.
Article 38. Rights of persons involved in clinical trials (studies) of medicines
Participation of people in clinical trials (studies) of medicines is voluntary and is based on the written informed
consent established in accordance with legislation.
The written and oral information, including the written informed consent form that is given to the participant of a
clinical trial (test) or to his/her legal representative following procedures established by the Government of the
Kyrgyz Republic shall include as follows:
-
pharmaceutical, nature and objectives of the clinical trial (test) of the medicine;
-
procedures of the clinical trial (test);
-
rights and responsibilities of the participant of the clinical trial (test);
-
expected efficacy of the medicine and extent of risk / discomfort for the participant of the clinical trial (test);
-
actions of the participant of the clinical trial (test) in cases of unforeseen effects of the medicine to his
health;
-
conditions for health insurance of the participant of the clinical trial (test);
-
other types of medicament or non-medicament treatment that can be indicated to the participant of the
clinical trial (test), as well as their potential benefits and risks;
-
compensation and / or treatment that the participant is entitled in the event of damage to his/her health
during the clinical trial (test);
-
amount of compensation to the participant of the clinical trial (test), if any;
-
if the clinical trial (test) is not of medical nature, then the information about it;
-
costs of the participant, if expected, associated with his/her participation in the clinical trial (test).
The Bioethical committee of the public health authoritywill run the expert assessment using criteria of biomedical
ethics and find solutions to ethical problems arising in clinical trials (studies) of medicines.
The clinical trials (studies) of medicines for medical use will mandatorily involve insurance of life and health of the
participant of the clinical trials (studies); the financier holds the insurance, in accordance to legislation of the Kyrgyz
Republic.
Participant of the clinical trial (trial) has the right to refuse participation in clinical trials (studies) of medicines at any
stage.
It is forbidden to conduct clinical trials (studies) of medicines:
28
draft
- on juvenile age individuals;
- servicemen;
- inmates of prisons and detention centres;
- pregnant;
- people with mental disorders and/or deemed incapable, as established by the Act of the Kyrgyz Republic ‘On
psychiatric care and guaranteed rights for care’.
Interests of participants of clinical trials (studies) should always prevail over the interests of science and society.
Chapter IX. Production and manufacturing of pharmaceuticals
Article 39. Production of pharmaceuticals
Pharmaceuticals are produced by entities licensed to produce pharmaceuticals.
Entities engaged in pharmaceutical production are obliged to organize their activities in accordance with established
rules of good manufacturing practices.
Rules of Good Manufacturing Practices for pharmaceuticals, including labeling are developed with participation of
pharmaceutical associations and are approved by the Government of the Kyrgyz Republic.
It is forbidden to produce pharmaceuticals that:
- are counterfeit;
- not registered in the Kyrgyz Republic, except for pharmaceuticals intended for clinical trials.
Article 40. Government overseeing the production and manufacturing of pharmaceuticals
The pharmaceutical production in the Kyrgyz Republic is overseen by the public health authorityfollowing rules of
inspection of production. The Government of the Kyrgyz Republic approves the terms of inspection of the
pharmaceutical production, including full list of violations of pharmaceutical production.
29
draft
The public health authoritycan issue instructions, suspend production and sale of already produced pharmaceuticals,
and cancel the Registration Certificate of pharmaceutical in case the producer violated rules of good manufacturing
practice.
Article 41. Labelling of pharmaceuticals
In the Kyrgyz Republic, the labeling of pharmaceuticals are imposed uniform requirements.
Pharmaceuticals (except for those manufactured within pharmacies) should enter the market with labeling applied
to packages with legible letters and should contain the following information:
- Primary packaging (except for primary packaging of herbal medicines) contains the name of the pharmaceutical
(international non-proprietary and / or chemical and / or trademark brand name), producer's name, batch number,
production date (relevant for biological medicines), expiry date, dosage or concentration, volume, activity in units or
number of doses;
- Secondary (consumer) packaging contains the legible font indication of the name of the pharmaceutical
(international non-proprietary and / or chemical and / or trademark brand names), pharmaceutical producer, batch
number, date of issue (relevant for biological medicines), number of the registration certificate, expiry date, method
of use, dosage or concentration, volume, activity in units or number of doses per pack, formulation, dispensing
conditions, storage conditions, and warnings;
- Serums should come into market with indication of the animal, blood, plasma, organs and tissues from which they
are derived;
- Secondary (consumer) packaging of pharmaceuticals derived from blood, plasma, organs and tissues should bear
the inscription: ‘Antibodies to HIV-1, HIV-2, hepatitis C virus and hepatitis B surface antigen are absent’;
- Primary packaging and secondary (consumer) packaging of radiopharmaceutical medicines should bear the
radiation warning sign;
- Secondary (consumer) packaging of homeopathic medicines should bear the inscription ‘Homeopathic’;
- Secondary (consumer) packaging of herbal medicines shall bear the inscription ‘Product passed radiation control’;
- Primary packaging and secondary (consumer) packaging of medicines intended for clinical trials must have
inscription ‘For clinical trial’.
Pharmaceutical substances should come to market with the following information on the consumer package: name
of substance, quantity, production date, expiry date or date of confirmed testing, serial number / batch, producer
name and address.
Medicinal plant materials should come into market circulation with the following information on the consumer
package: name of medicinal plants, quantity and units of measurement, date of collection / harvesting, expiry date
or date of confirmed testing, serial number / batch, information on radiation control, producer name and address.
Prescribed medicines should come into market with instructions for medical use put in the consumer packaging.
30
draft
Over-the-counter medicines should come into market with an package leaflet or instruction for medical use put in
the consumer package.
Pharmaceuticals intended for export will be labelled following the requirements of the importing country.
Article 42. Pharmaceutical manufacturing
Medicines in pharmacy organizations are manufactured based on doctor's prescription and according to the
nomenclature of intra-pharmacy manufacturing.
Pharmacy organizations entitled to manufacture medicines must comply with rules of good pharmacy practice of
pharmaceutical manufacturing. The Government of the Kyrgyz Republic establishes the rules of good pharmacy
practice and the nomenclature of intra-pharmacy manufacturing.
Chapter X. Import and export of pharmaceuticals
Article 43. Import of pharmaceuticals into the Kyrgyz Republic
Pharmaceuticals into the Kyrgyz Republic will be imported following procedures established by the Government of
the Kyrgyz Republic.
Article 44. Pharmaceuticals allowed for importation
Imported drugs into the territory of the Kyrgyz Republic should be included in the National Register of medicines.
Registered and / or unregistered pharmaceuticals are allowed to importation to the Kyrgyz Republic, provided the
permission of the public health authorityis available, following procedures established by the Government of the
Kyrgyz Republic, with intention to:
- Clinical trials (studies);
- Registration;
- Drug development, laboratory testing, control of quality, efficacy, and safety;
- Vital care for an individual patient;
- Provision of medical care in cases of threat to life and health, at the request of the body authorized in public health
in the Kyrgyz Republic and orders of the Government of the Kyrgyz Republic;
- Provision of humanitarian or emergency assistance.
31
draft
Unregistered pharmaceuticals are allowed to import into the Kyrgyz Republic, provided they are included in the list
of medicines that are registration-free importable and usable in the Kyrgyz Republic, with available confirmation by
the government body authorized in public health. The Government of the Kyrgyz Republic establishes procedures for
formation of the named list.
Importation of pharmaceuticals into the Kyrgyz Republic for personal and other non-commercial use without
permission by the public health authoritywill be permitted only in cases provided in Article 47 of this Act.
Article 45. Pharmaceuticals prohibited for import
Import into the Kyrgyz Republic of pharmaceuticals not registered in the country of origin is prohibited, except for
import with intention to:
- Clinical trials;
- Drug development, laboratory testing, control of quality, efficacy, safety;
- Provision of medical care in cases of threat to life and health, at the request of the public health authorityand
orders of the Government of the Kyrgyz Republic.
Import into the Kyrgyz Republic of the following is prohibited:
- Pharmaceuticals with expiry date less than 30% of the shelf-life;
- Substandard pharmaceuticals;
- Adulterated pharmaceuticals;
- Counterfeit pharmaceuticals.
Article 46. Entities entitled to import pharmaceuticals into the Kyrgyz Republic
The following are entitled to import pharmaceuticals into the Kyrgyz Republic:
- Pharmaceutical producers;
- Wholesalers;
- Research organizations and laboratories, higher and special educational institutions;
- Health organizations to carry out their statutory activities;
- Foreign pharmaceutical producers and wholesalers, provided they have own representations in the Kyrgyz
Republic.
32
draft
Article 47. Import of pharmaceuticals into the Kyrgyz Republic for personal use and other noncommercial purposes
Both registered and unregistered pharmaceuticals can be imported into the Kyrgyz Republic without license and
permission of the government body authorized in public health, if they are intended for:
- Personal use by individuals;
- Personal use by employees of diplomatic services and representatives of international organizations accredited in
the Kyrgyz Republic;
- Treatment of passengers and crew members of transport means, train crews and drivers of transport means
coming into the Kyrgyz Republic;
- Treatment of participants of international cultural and sports events and participants of international missions;
- Pharmaceutical exhibitions without the right to sell
Article 48. Export of pharmaceuticals
Pharmaceuticals will be exported from the Kyrgyz Republic in accordance to legislation of the Kyrgyz Republic. The
pharmaceuticals for medical use, for humanitarian aid (assistance) or assistance in emergencies will be exported
from the Kyrgyz Republic following procedures established by the Government of the Kyrgyz Republic.
Pharmaceuticals circulated in the Kyrgyz Republic that have not undergone the procedure of compliance assessment
with data in the registration dossier are subject to mandatory export in entire amount, with account to official
changes in the registration dossier, with the exception of samples taken for laboratory testing.
Article 49. Cooperation of the customs authorities and the public health authority of the Kyrgyz Republic
The public health authority of the Kyrgyz Republic shares the National Register of medicines with the customs
bodies, as well as the information on permits issued for imports of particular batches of pharmaceuticals.
The customs authorities of the Kyrgyz Republic will inform the public health authority on imports and exports of
pharmaceutical, following the forms and procedures established by the Government of the Kyrgyz Republic.
Chapter XI. Wholesale and retail sale of pharmaceuticals
Article 50. Wholesale of pharmaceuticals
Entities engaged in pharmaceutical production and wholesalers can sell pharmaceuticals as follows:
33
draft
- Individual entrepreneurs and legal entities licensed for production, manufacture and sale of pharmaceuticals and
medical devices;
- Healthcare organizations to carry out their statutory activities;
- Research organizations for research;
- Government organizations providing social services, provided they need these pharmaceuticals dispensed directly
within their organization;
- Individual entrepreneurs licensed for medical services
Article 51. Retail sales of pharmaceuticals
Retail sales of pharmaceuticals will run through pharmacies, pharmacy points and pharmacy kiosks.
The Government of the Kyrgyz Republic Rules will set rules and procedures of pharmaceutical dispensing.
Pharmaceuticals are subject to retail sales through pharmacies, pharmacy points and pharmacy kiosks only in readyto-use form.
The list of categories of goods sold through the pharmaceutical (pharmacy) organizations is set out by the
Government’s regulation.
Pharmaceutical retail sales in remote settlements where there are no pharmacies, pharmacy points or pharmacy
kiosks can employ individuals with medical education, specially trained to comply with requirements for
transportation, storage and dispensing of pharmaceuticals. The conditions of transportation, storage and dispensing
must comply with requirements of this Act.
Article 52. Pharmaceuticals prohibited for sale
Sales of the following pharmaceuticals are prohibited:
- Substandard;
- Counterfeit;
- Adulterated;
- Expired;
- Dilapidated;
Substandard pharmaceuticals are subject to return or destruction, in accordance with procedures established by the
Government of the Kyrgyz Republic.
34
draft
Counterfeit, adulterated, expired and dilapidated pharmaceuticals will be destructed following procedures
established by the Government of the Kyrgyz Republic.
Sale of pharmaceuticals imported into the Kyrgyz Republic for humanitarian purposes is prohibited, unless otherwise
specified in the conditions of supply of these drugs.
Article 53. Retail sale of prescription and over-the-counter medicines
Retail sale of pharmaceuticals will run by prescription or over the counter. Terms of prescription medicines and overthe-counter medicines are defined based on results of registration of the pharmaceutical and represent mandatory
information in the National Register of pharmaceuticals, leaflet, instructions for use, and the labeling of the
pharmaceuticals. Discrepancies in release conditions of the pharmaceutical between the registration dossier and the
National Register of pharmaceuticals are not allowed.
Conditions of dispensing of pharmaceuticals included in the list of registration-free importable and usable medicines
in the Kyrgyz Republic represent are integral piece of the list. This list of pharmaceuticals with indicated release
conditions from pharmacies will be mandatorily and regularly published on the official website of the public health
authority of the Kyrgyz Republic.
Sale of pharmaceuticals with labeling that does not contain information about conditions of release is prohibited,
with exception of medicines manufactured within pharmacies.
Pharmaceuticals with incorrect identification of release conditions are subject to seizure.
Sale of prescription medicines without prescriptions is prohibited.
Managers are liable for proper release of pharmaceuticals from pharmacies, pharmacy points and pharmacy kiosks.
Chapter XII. Provision of pharmaceutical information
Article 54. Pharmaceutical information
Any information about any stage of the circulation of pharmaceuticals in the market must be publicly available,
except for confidential information. Any information-carrying media for storage, transfer, and undistorted use of
pharmaceutical information is allowed.
The National Register of medicines of the Kyrgyz Republic is the main official source of reliable information about
medicines that are registered and / or authorized for use in the Kyrgyz Republic.
35
draft
The Government of the Kyrgyz Republic approves the rules and procedures of sharing the mandatory information on
pharmaceuticals registered in the Kyrgyz Republic.
The National Formulary is the official source of independent reliable information on pharmaceuticals for medical
use. The Formulary is periodically updated and approved through the Government’s regulations.
Information on over-the-counter medicines can be published in media, specialized and general newspapers,
instructions for use and other publications.
Information on prescription medicines is allowed only in specialized printed media designed for use by medical and
pharmaceutical workers. Information on pharmaceuticals for professionals in the pharmaceutical market can be
presented in the form of monographs, reference books, scientific articles, presentations at congresses, conferences,
symposia, and research councils.
Any information on safety, quality and efficacy of pharmaceuticals that constitutes the registration dossier is not
confidential, except for:
- Personal data of participants of clinical trials;
- Production technology;
- Methods of testing the pharmaceuticals that represent ownership of the manufacturer or developer;
- Information under patent protection.
Information from the registration dossier, except for confidential information, should be posted on the official
website of the government body authorized in public health.
The official website of the public health authority is required to contain the following information:
- National Register of medicines of the Kyrgyz Republic, following requirements of Article 14 of this Act;
- Decisions of expert bodies on registration or detailed information on refusal to register pharmaceuticals
and reasons of such decisions;
- Report on assessment of the registration dossier for pharmaceutical;
- List of registration-free importable and usable medicines in the Kyrgyz Republic,
- Register of certified and authorized manufacturers and distributors;
- Register of healthcare organizations entitled to conduct clinical trials of pharmaceuticals for medical use
and regulations confirming their accreditation status;
- Results of pharmaceutical inspection visits (inspection report) in the form approved by the Government of
the Kyrgyz Republic;
36
draft
- List of officials authorized to conduct the pharmaceutical inspection;
- Information database on identified adverse reactions (effects) of pharmaceuticals, including official reports
of inefficacy of pharmaceuticals
- Information database of pharmaceuticals that do not meet quality requirements, counterfeit and (or)
adulterated identified in the Kyrgyz Republic;
- List of wholesale pharmaceutical organizations with license;
- List of licensed pharmacies, including pharmacy points, pharmacy kiosks;
- Register of pharmacists permitted to operate in pharmaceutical activities;
- Information on volume and turnover of the pharmaceutical market of the Kyrgyz Republic and other
analytical information;
- List of healthcare workers permitted to work in the pharmaceutical sales in remote locations;
- List of remote settlements where medical workers sell pharmaceuticals;
- Legal and regulatory acts of the Kyrgyz Republic, orders, regulations, instructions and information letters of
the public health authority that affect the pharmaceutical business.
Chapter
XIII.
Advertisement
of
pharmaceuticals.
Specifics
of
pharmaceutical
advertisement
Article 55. Pharmaceutical advertisement
The content, form and place of pharmaceutical advertisement will be agreed with the public health authority of the
Kyrgyz Republic, in accordance with procedures approved by the Government of the Kyrgyz Republic.
Advertisement of pharmaceuticals registered in the Kyrgyz Republic and sold over-the-counter will be conducted in
accordance with the advertisement legislation of the Kyrgyz Republic.
Regardless of the form, the advertisement should correspond to pharmacological data on the medicine as described
in the instructions for medical use.
Advertisement should not present a pharmaceutical as a unique, most efficient, most safe, exclusive in terms of side
effects, misleading with respect to composition, origin, novelty or patent status of the pharmaceutical.
Pharmaceutical advertisement must not contain words such as ‘unique’, ‘effective’, ‘safe’.
37
draft
Pharmaceutical advertisement should contain information on the need of use only upon doctor’s prescription.
Pharmaceutical advertisement is prohibited to use the image of a doctor or a pharmacist, the image of people in
medical uniform, to attract medical professionals and pharmaceutical workers, to refer to opinions of famous
people, scientists, experts, cured patients and their relatives, in order to prevent the uncontrolled self-treatment.
It is prohibited to misrepresent the advertisement which has been agreed with the public health authority.
In the event the public health authority bans the production, supply, and manufacturing of the pharmaceutical, or
withdraws the pharmaceutical from sales, the advertiser must immediately stop the advertisement of the
pharmaceutical/ pharmaceuticals.
Chapter XIV. Concluding provisions
Article 56. Pharmaceuticals as humanitarian aid
Pharmaceuticals within international humanitarian aid (assistance), including humanitarian aid in emergency
situations are imported in the Kyrgyz Republic following the legislation of the Kyrgyz Republic.
International humanitarian aid (assistance) with pharmaceuticals (hereinafter - humanitarian aid) can be provided by
foreign countries, their federal or municipal institutions, international and foreign national institutions and / or nonprofit organizations, and other legal entities and individuals.
The following is the basis for provision of humanitarian aid:
- Upon official request by the Government of the Kyrgyz Republic;
- Upon official request by competent government authorities;
- A party proposes the provision of humanitarian assistance;
- Request by recipient / user of humanitarian assistance.
The request can be sent directly to individual nations, international humanitarian organizations, individuals and legal
entities, or be a request to the international community as a whole.
The request shall specify types and quantities of pharmaceuticals that the requestor needs.
In emergencies, the humanitarian aid can be provided without a request, provided that the contributions are
included in the list of emergency relief items recommended by the United Nations or in the national lists for use in
emergency situations.
38
draft
It is prohibited to import into the Kyrgyz Republic the humanitarian aid pharmaceuticals that are not registered in
the country of origin or in the donor country or not prequalified by WHO.
Pharmaceuticals imported under particular programs on grant basis are subject to mandatory registration in the
Kyrgyz Republic, in accordance with legislation.
The public health authority keeps a single national register of pharmaceuticals received as humanitarian aid.
Shelf life of pharmaceuticals intended for humanitarian aid should not be less than 12 months.
Pharmaceuticals received by healthcare organizations as humanitarian aid are subject to accounting and reporting,
following the order established by the Government of the Kyrgyz Republic.
When faced with the need to cover the requirements of specific medicines, the public health authority is entitled to
waive the registration fee, in accordance with procedures set out by the Government of the Kyrgyz Republic.
Article 57. Liability for violation of the pharmaceutical legislation of the Kyrgyz Republic
Violators of pharmaceutical legislation of the Kyrgyz Republic shall be liable, following the order provided by the
legislation of the Kyrgyz Republic.
Article 58. International cooperation of the Kyrgyz Republic in pharmaceutical sector
The Kyrgyz Republic participates in international cooperation in the field of pharmaceuticals.
The Government of the Kyrgyz Republic develops and supports all forms of international cooperation in the field of
pharmaceuticals, provided it does not contradict the legislation of the Kyrgyz Republic and international standards.
Article 59. Entry into force of this Act
This Act shall come into force from the date of publication.
The Government of the Kyrgyz Republic is to bring their legal regulatory acts into conformity with this Act.
The Act of the Kyrgyz Republic ‘On pharmaceuticals’ dated April 17, 2009 N 125 is deemed expired.
39