CRITERIA OF REGISTRATION OF DRUGS
ARTICLE 1:
These criteria are called the criteria of
registration of drugs, serums, vaccines and
biological materials, the renewal of its
registration and the cancellation of any of them
and shall become in force from date of its
publishing in the Official Gazette.
ARTICLE 2:
For the purposes, of implementing these criteria,
the definitions mentioned in Article (2) of the
Drugs and Pharmacology Act No. 80 of 2001 shall
be relied upon in addition to the following:
The Committee: The Technical Committee for the registration of
new drugs, the Technical Committee for the
registration of the drugs that have a registered
equivalent, the Committee of the renewal of
registration, the Committee of serums, vaccines
and biological materials or the Committee of
radioactive drugs as the case may be.
Country of Origin: the following parties are considered a country
of origin:
a- The country of the company producing the drug.
b- The country of the holder of the right of
marketing and the following are considered to be
holding the right of marketing:
1- The office owned by the producing company.
2- The holder of the right of marketing mentioned in
the Free Sales Certificate for a new drug or for a
drug originally registered in the Kingdom.
3- The holder of the right of marketing of the drugs
the import of which or its alternatives has been
CRITERIA OF REGISTRATION OF DRUGS-
discontinued for the purposes of achieving the
drug safety with the consent of the Higher
Commission.
The Biological Products: They are the materials that are produced
by any of the following methods:
a- Development of Bacterial Colonies (Microbial Strains)
and Eukaryotic Cells.
b- Extraction of materials from bio-tissues including
Human, Animal or Plant tissues.
c- rDNA
d- Methods of Hybridization of Cells.
e- Development of micro-organisms in embryos or
animals.
The biological products produced by these methods include:
Allergens, Antigens, Vaccines, Hormones, Cytokinesis, Enzymes,
constituents of blood and plasma, immunological serums,
immunoglobulins including mono-clonal antibodies , Allergen,
components produced by Fermentation including rDNA .
The Registration
ARTICLE 3:
It is prohibited to market the drug except after its
registration, pricing and the issuance of a registration
number for it.
ARTICLE 4:
It is prohibited to register drugs except after
approving its manufacturing sites in accordance with
the approved principles thereof.
ARTICLE 5: a- The application for registering a new drug and the
equivalent drug registered at the Directorate shall be
submitted by the concerned pharmacist in the drug
store or by the technical manager of the local factory
attaching thereto the file containing the completed
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documents by virtue of the requirements mentioned
in Appendix No. (1).
b- The application for registering the equivalent drug the
data of which are protected or which is protected by a
Patent Right during the last year at the latest before
the expiry of the protection, shall be submitted by the
concerned pharmacist in the drug store or the
technical manager of the local
factory attaching thereto the file containing the
completed documents by virtue of the requirements
mentioned in Appendix No. (1) and shall be placed in
a sequence within the files of the equivalent drug the
data of which are protected or which is protected by a
Patent Right.
c- If the drug which is being submitted for registration is
being contractually manufactured, then the applicant
must fulfill the requirements mentioned in Appendix
(2) in addition to those mentioned in Appendix (1).
d- If the drug which is being submitted for registration is
being manufactured under license, then the applicant
must fulfill the requirements mentioned in Appendix
(3) in addition to those mentioned in Appendix (1).
ARTICLE 6: a- After reviewing the registration application file of
completed documents, by virtue of the appendices
mentioned in these criteria, the Committee shall
pursue the following criteria upon the registration of
the drug:
1-The potency of the drug.
2-The safety of the drug intended.
3-The quality of the drug.
4-The drug which is required to be registered is
actually being marketed in the Country of Origin with
the same composition, and in the event that it is not
being marketed, to demonstrate the reasons for such
and to submit a Free Sale Certificate with
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the same composition from any of the approved
countries by the Directorate.
5- The drug which is required to be registered has been
marketed in the Country of Origin for a year at least
or in any of the countries approved by the
Administration.
6- The serums, vaccines and the biological
products including the allergy products which are
required to be licensed are permitted to be used
and are actually used in the Country of Origin
with the same composition.
7- In the event that the serums, vaccines and
biological products including the allergy products
are registered but not marketed in the Country of
Origin for reasons accepted by the Committee,
then the Committee shall depend that the drug is
registered and marketed in a country approved by
the Ministry.
b- the Director General, by a recommendation from the
Committee, is entitled to exempt the drugs used for
the treatment of epidemics and the drugs having a
therapeutic advantage from the stipulations of Item
(5) of Article (6-a) above.
ARTICLE 7:
Drugs in large packages (ie packages in a final form
not designated for sale to the public) shall be
registered if its units (capsules, tablets or others) are
packed in an outer packing insulating it from climatic
influence.
ARTICLE 8:
The information referred to in Appendices (4) and (5)
must be mentioned on the inner and outer containers
of the drug as well as in its inner information provided
the information is clearly typed and difficult to
remove.
CRITERIA OF REGISTRATION OF DRUGS-
ARTICLE 9: a- The Committee decides on any application for
registering new drugs and the drugs that have a
registered equivalent, that it receives, within a
maximum period of one hundred and eighty days
(180) from the date of the submission of the
application of completed documents to the
Directorate.
b- The Committee decides on any application of
completed documents for registration of equivalent
drugs the information of which is protected or which
is protected by a Patent Right within a maximum
period of (180) days before the expiry of the
protection, provided that the resolution for registration
is issued on the next day of the expiry of protection.
a- The applicant has the right to object to the
Committee’s decision to reject the registration of the
drug within a maximum period of 30 days from the
date of the notification of such decision.
b- The Committee must review the objection and make
a decision thereon within 30 days of its submission
and such shall be considered a final decision.
c-
The Administration shall inform the concerned parties
of the registered drugs such as the Association of
Pharmacists, Doctors and others about every drug
that has been registered.
ARTICLE 10: The registration of a drug shall not be construed to
mean the acceptance of its registration in all its
pharmaceutical forms and its entire concentrations,
but an application for registration for each of it must
be submitted and an approval therefor is obtained.
ARTICLE 11: a- With due observance to achieve the drug safety, the
Director General, through a recommendation from
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the Committee, has the right to take any or all of the
following measures: prohibit the imports, discontinue
the distribution, discontinue the sale, prohibit the
marketing suspend or revoke the
registration or recall the drug in any of the following
cases:
1- If the drug’s toxicity or its inferior quality becomes
evident to the Committee or if it lacks potency or its
potency is less than what is required based on a
report from, the World Health Organization, the
manufacturing company or from any other party
approved by the Committee.
2- If it becomes evident that it is not permissible to
market or its marketing is discontinued after it has
been marketed in the country which was relied on for
registration to obtain a Free Sale Certificate.
3- If it becomes evident that its price to the public in the
Country of Origin has been reduced without reflecting
such reduction on the selling price to the Jordanian
Public and the Committee was not advised of this
within four months from the date of the reduction.
4- If the registration was done on the basis of false
information.
5- If the applicant does not register the drug anew upon
conducting any of the alternations, in accordance
with the stipulations of clause (a) of Article (12) of
these Criteria.
6- If the applicant does not obtain the approval upon
carrying out any of the alterations mentioned in
Article (12) of these Criteria.
b- the concerned party shall notify the applicant of the
Director General’s decision referred to in (11-a)
together with the period granted to him, through the
recommendation of the Committee, to rectify the
situation.
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b- The concerned party has the right to object to the
Director General’s decision mentioned in Article (11a) within a period of 30 days from the date of its
notification of the decision.
c- The Committee must revise the objection and give a
recommendation to the Director General to make a
decision within a maximum period of 30 days from
the date of submission of the objection, the decision
of the Director General will then be considered final.
ALTERATIONS ON THE REGISTERED DRUG
ARTICLE 12: a- Upon conducting any alteration on the active
substance or the pharmaceutical form, the drug must
be registered anew.
b- The agreement of the competent Committee must be
obtained upon conducting any of the following
alterations on the registered drug:
1.
2.
3.
4.
5.
6.
7.
8.
Country of Origin.
Site of manufacturing.
The major steps of the manufacturing method.
The inactive substances in the drug’s composition.
Primary packing materials.
the expiry period.
The Information mentioned in the internal information.
The information mentioned on the internal and
external container which is connected with the
internal information.
9. The drug’s specifications and its analysis methods.
10. The Drug’s trading name.
11. The name and/or address of the manufacturing
company.
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12. Any amendment of the numbering system or the
amendment of information in the production files
and the quality control of the products of serums,
vaccines and the biological products including
the allergy products.
c- the applicant must obtain the approval of the
Directorate for any other amendments other than
those mentioned in Article (12-b) above .
d- the applicant must submit all the required documents
in support of any alteration or amendment.
e- the Committee determines any alteration request
within 90 days from the date of submission of the
application of completed documents and the
Directorate determines any alteration request within
30 days from the date of submission of the
application of completed documents by repudiation or
acceptance.
f- The Committee may grant a transitional period to
implement any of the alterations as the case may be.
ARTICLE 13: The applicant must submit the required documents for
the acceptance of the contractual production of a
registered drug or the transfer of its manufacturing
site based on what is mentioned in Appendix No. (6).
RENEWAL OF REGISTRATON
ARTICLE 14:a- the registration of a drug shall be cancelled by a
decision of the Director General, based on a
recommendation from the competent Committee,
after 5 years from the date of its registration or its
CRITERIA OF REGISTRATION OF DRUGS-
renewal unless a request is filed to renew such
registration.
b- the responsible pharmacist in the drug store or the
technical manager in the local factory must submit a
new request to renew the registration of any drug
three months before the expiry of its registration.
c- the applicant of renewal of the registration of any drug
must submit the documents mentioned in Appendix
(7) of the Criteria.
d- the Director General issues a decision whether to
renew the registration or not, based on a decision
from the Committee demonstrating the reason for
such decision.
d- the applicant may object to the Director General’s
decision not to renew the registration of the drug
within a maximum period of 30 days from the date of
being notified of the decision.
e- the Committee must review the objection and make
its recommendations to the Director General [who]
[shall] issue a decision for such within 30 days from
the date of the submission of the request and [then]
his decision is considered final.
ARTICLE 15:a- A registration file for every group of the below
mentioned shall be submitted provided that the
technical file shall contain the necessary technical
details for every kind that went in the group:
1. Pollens:
a- Trees
b- Grass
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c- Weeds
2. Animals, Insects and Venoms
3. Food
4. Moulds and Yeasts
5. Mites
b- the Diluent of Serums and vaccines products shall be
registered and appended to the relative product if it
were from the same company, but if the solvent
is produced from another company, then it is
registered on its own as a separate drug.
ARTICLE 16: Article No. (6) Item (5) shall not apply to Serums,
Vaccines and Biological Products including Allergy
Products.
Also Article No. (11) Item No. (3) shall not apply to
Serums and Vaccines Products only.
CRITERIA OF REGISTRATION OF DRUGS-
APPENDIX NO (1)
Requirements of the Drug Registration File
FIRST;
The application for registration shall be submitted duly completed
together with the documents listed below by the responsible
pharmacist at the drug store or the technical manager at the local
manufacturing company filed in the order mentioned below in a box
file or the like, typed on its side in Arabic and English, the drug’s
trading name, its pharmaceutical form and the active substance and
its concentration on its secondary package.
First Part: Organizational and Administrative Information
1-a Numbered Index of Contents.
1-b Information about the company, the site and the
drugstore:
1- Name of Drug Store.
2- Name of the responsible pharmacist.
3- Name and address of the holder of the marketing
right.
4- Name and address of the manufacturing site(s).
5- Approved specimen – Application of registration of
serums, vaccines and biological products signed and
duly legalized from the manufacturing company.
Second Part: Certificates, Information and Administrative
Documents about the product:
2-a Free Sale Certificate from the Country of Origin
issued by the competent parties in accordance with
the approved list of the Administration duly legalized
with due observance to the text of Article (6)
containing the following:
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1. The trading name of the drug in the Country of Origin
(in case the trading name differs from that in
2.
3.
4.
5.
the Country of Origin, a clarification from the official
competent parties is requested).
Number and date of registration or permission of
marketing in the Country of Origin.
Names of the active and non active substance(s) and
their concentrations.
A statement that the product is actually being sold in
the Country of origin with the same composition, in
case that it is not being sold there, to demonstrate
the reasons for such, provided a Free Sale Certificate
duly legalized is submitted showing that it is being
actually sold in a country approved by the
Administration with the same composition.
Name and address of the holder of the right of
marketing and names and addresses of
manufacturing sites and their role in the
manufacturing.
2-b A list prepared by the producing company containing
the names of the countries that permitted the
marketing of the product with a proof that it has been
marketed for a year in any of such countries, as well
as a list containing the names of the countries where
the product was submitted for registration together
with the countries where the registration of the
product has been rejected showing the reasons for
such rejection.
2-c Showing the names of the substances of human or
animal origin entering in the composition of the
product and its source and the related certificates
thereto.
2-d Pricing certificates of the product in accordance with
the Criteria mentioned in Appendix No. (8).
CRITERIA OF REGISTRATION OF DRUGS-
2-e The internal drug information approved in the Country
of Origin in English legalized by the competent
parties.
Third Part: The Technical File shall be Classified and Indexed
containing the following in the proper order, in
addition to an electronic copy thereof:
3-a Formula and the major steps in the method of
manufacturing.
3-b Specifications and methods of analyzing the active
substance.
3-c Specifications and methods of analyzing the nonactive substance.
3-d Specifications of the finished product.
3-e Specifications of the primary and secondary package.
3-f Methods of analyzing the product in its final form.
3-g Validation studies of the routine methods of analyzing
the product.
3-h Validation studies of stability indicating methods and
to methods of analyzing the degradation products.
3-i analysis certificate of the primary active substance
from the source of its import and from the company
utilizing it.
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3-j Analysis certificate of the finished product submitted
for registration (for the same batch of submitted
samples).
3-k 1. The actual and accelerated stability studies of the
drug showing the validity period and the
circumstances of its storage in accordance with the
instructions issued for such purpose.
2. A commitment to provide the Directorate with an
annual report containing the results of long-term
stability studies whereby it covers the validity period
of the product.
3-l A commitment to provide the Directorate with the
results of the stability studies for produced batches in
accordance with the instructions issued for such
purpose.
3-m Batch Record for three consecutive produced
batches showing the method of production and
the tests that were conducted and its results for
serums and vaccines products and biological
products including allergy products.
3-n Two specimens of the primary and secondary
packages and the internal information.
3-o Plasma Master File for products containing
plasma products regardless of its percentage in
the finished product.
Fourth Part: Clinical Studies
4.a New Drugs
1. Bio-availability study according to the instructions
issued for this purpose, excluding therefrom, serums
and vaccines products and biological products
including allergy products.
CRITERIA OF REGISTRATION OF DRUGS-
2. Clinical Studies.
3. Scientific Studies published in global magazines.
4. Periodic Safety Update Report from the producing
company.
4.b Drugs that have a registered equivalent:
Bio-equivalence study comparing the drug that has a
registered equivalent being submitted for registration
with the original drug of reference. In the event of the
inability to conduct the bio-
equivalence study, such shall be compensated for by
clinical studies. In all events, such is done in
accordance with the instructions issued for such
purpose.
SECOND
The following shall be attached to the registration file:
1. 15 copies of the internal information in Arabic and
English.
2. Two samples of the finished product which shall be
returned to the applicant after the registration of the
drug.
3. Fifteen copies of the specimen of the approved
information form of the drug duly completed.
THIRD
Submission of a separate copy of the technical file for analysis
purpose at the Drug Control Laboratory enclosing:
1. Samples of the finished product, the number of which
will be determined in accordance with the drug
testing system.
2. An adequate quantity for analysis of the primary
active substance(s) of reference and degradation
products.
CRITERIA OF REGISTRATION OF DRUGS-
CRITERIA OF REGISTRATION OF DRUGS-
APPENDIX NO (2)
Registration of drugs that are
Manufactured Contractually
1. Determination of the major steps for the manufacturing process
and the site where each step is done.
2. A signed copy from the Principal and the Contractor containing
the following items which were mentioned in the technical
contract.
a- Agreement from the Contractor to the Principal regarding the
ability to examine the production, control and storage areas
and the methods of manufacturing and analysis and the
batch records and all technical capabilities.
b- The responsibility of the Principal and the Contractor
regarding the manufacturing and monitoring steps.
c- The name of the person responsible for approving the
batches.
d- The period of the validity of the contract.
3. A letter from the Principal advising his responsibility for the
drug.
4. A pledge from the pharmacist responsible for the drug store or
the technical manager of the Principal to advise the
Administration about any change in the information mentioned
in items 1 and 2 before initiating the change.
5. If the product contains (plasma products) a Plasma Master
File for the product must be submitted or a declaration
from the manufacturing company showing no change in
the source of plasma which is approved at the Directorate
and that the previously submitted file is the approved one.
6. Complete the specimen form relating to serums, vaccines
and biological products approved by the Principal or the
Contactor with the seal and signature of the responsible
person on each page.
CRITERIA OF REGISTRATION OF DRUGS-
CRITERIA OF REGISTRATION OF DRUGS-
APPENDIX NO (3)
REGISTRATION OF DRUGS
MANUFACTURED UNDER LICENCE
FIRST:
1. If the licensor is not registered in Jordan, the technical file
should contain a part designated to information about such
company by completing a specimen form related thereto.
2. A letter from the manufacturer granting the licensing to the
concerned company.
3. An official letter from the licensor’s agent [advising] that the
product intended to be manufactured under license shall not be
imported under the same Trade Name.
4. If the product contains (plasma products), a Plasma Master
File for the product must be submitted or a declaration
from the manufacturing company showing no change in
the source of plasma which is approved at the Directorate
and that the previously submitted file is the approved one.
5. Complete the specimen form relating to serums, vaccines
and biological products approved by the Principal or the
Contactor with the seal and signature of the responsible
person on each page.
SECOND
The bio-availability and bio-equivalence studies are accepted from
the Licensor as long as the product has been manufactured with the
same composition and by similar machinery with compliance with the
instructions issued for such, provided that the documents confirming
this are attached, serums and vaccines products and biological
products including allergy products are excluded.
CRITERIA OF REGISTRATION OF DRUGS-
APPENDIX NO. (4)
The information required to be mentioned on the
Primary and secondary container
First:
The following information must be mentioned on the secondary
container in Arabic and/or English.
1. The Trade Name of the product and its concentration as a part
of the name in the event that the product is registered with
more than one concentration. Other terms may be used as an
indicative substitute to concentration eg.(Forte, Baby)
2. Names of active substances entering into the composition of the
drug and its concentrations.
3. Names of non-active substances entering into the composition
of the of the drug if they have a known effect. In the case of
Injectable, Tropicals and Eyedrops, the entire non-active
substances in the drug’s composition must be mentioned.
4. The pharmaceutical form and the capacity of the container.
5. Route of administration where necessary.
6. Batch number.
7. Date of expiry (month/year)
8. Storage conditions in accordance with the instructions issued in
that regard.
9. Name and address of the holder of the right of marketing and/or
the manufacturing company (country, city or district).
10. To have a Vaccine Vial Monitor for serums, vaccines and
biological products when required.
SECOND:
The information mentioned under (first) above must be mentioned on
all primary containers or internal information except for small
sections, containers and information labels the following information
must be mentioned in Arabic and /or English:
CRITERIA OF REGISTRATION OF DRUGS-
a- Sections:
1. The Trading Name.
2. The scientific name if the product contains one or two
active substances.
3. Date of expiry.
4. Batch Number.
5. Name of the holder of the right of marketing and/or the
manufacturing company.
b- Small containers and information labels (for containers of a
capacity 2 ml or less):
1. The Trade Name of the product with the concentration if it
is registered with more than once concentration.
2. Route of Administration.
3. Expiry date.
4. Batch Number.
5. Capacity of container where applicable.
6. The name of the holder of the right of marketing and/or
the manufacturing company in the absence of a Trade
Name.
7. To have a Vaccine Vial Monitor for serums, vaccines
and biological products where required.
CRITERIA OF REGISTRATION OF DRUGS-
APPENDIX NO (5)
The information required to be mentioned
in the internal Drug information sheet
accompanying the drug
a-
The following information must be mentioned in Arabic and
English in the internal information sheet of the product:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
The Trade Name of the drug and its concentration(s),
other phrases may be used to indicate the concentration
such as Forte, Baby.
The names of the active substances entering into the
composition of the drug and its concentrations.
The names of the non-active substance entering into the
composition of the drug if they have a known effect.
Description of the effectiveness of the drug or the
pharmaceutical group.
Indications.
Contra-indications.
Warnings for use.
Interactions with other medicaments and other
interactions if available.
Special precautions and warnings in the event of usage
for children, pregnant woman, breast-feeding, elderly
people and special illness cases that are affected by the
treatment. Also warnings about driving or operating
machinery.
Overdose and the action to be taken to deal with it.
Route of administration.
Mode of administration clarifying the following:
a- the dosage.
b- period of treatment.
c- procedures in the event of missing a dose.
d- special measures in the event of sudden
discontinuance of taking the drug.
Side effects
CRITERIA OF REGISTRATION OF DRUGS-
14. Pharmaceutical form(s) and capacity of the container(s).
15. Warnings about keeping the drug away from children.
16. Name and address of the holder of the right of
marketing (country, city or district).
17. Date of the most recent review of the drug information.
b- If all the required information under (a) above has
been mentioned on the external container, then there
is no need to enclose the internal information sheet.
In the event that the products are sold over the
counter, the written language must be simple and
legible.
CRITERIA OF REGISTRATION OF DRUGS-
APPENDIX NO (6)
Sanctioning the contractual production for a registered
Drug or relocation of the manufacturing site
a-
The application for relocating the manufacturing site of the
drug shall be submitted by the responsible pharmacist or
the technical manager enclosing the following:
1.
2.
3.
4.
The major steps of the manufacturing process and the
location where every step taken place.
A copy signed by the Principal and the Contractor
containing the following items which were mentioned in
the technical contract (such document is dispensed with
in the event of relocating the manufacturing site to a
location owned by the company).
a-Agreement from the Contractor to the Principal
regarding the ability to examine the production, control
and storage areas and the methods of manufacturing
and analysis and the batch record and all technical
capabilities.
b- The responsibility of the Principal and the Contractor
regarding the manufacturing and monitoring steps.
c-The name of the person responsible for approving the
batches.
d-The period of the validity of the Contract.
The specifications and composition from the executing
company, approved by the Principal, with a clarification
about the changes from what has been registered in a
detailed comparison manner or an admission from the
Principal that no change has taken place in the
specifications, composition and the manufacturing
process.
An admission from the Principal advising its
responsibility for the product.
CRITERIA OF REGISTRATION OF DRUGS-
5.
a pledge from the technical manager of the Company to
advise the Administration of any change in the
information mentioned in items (2-a) and (2-b) and
before proceeding with the execution.
6. Free Sale Certificate from the Country of the company
holding the right of marketing with a price certificate of
the product in accordance with Appendix No. (8).
7. Free Sale Certificate and Price Certificate of the product
from the country of the Contractor or the country of the
new manufacturing site or a certificate from the
Principal duly legalized from the concerned party
advising that the product is not sold in the country of
the Contractor or the country of the manufacturing site
wherever such is applicable and by citing reasons.
8. The submission of Accelerated Stability Studies of the
drug from the new site in accordance with the
instructions issued for such purpose.
9. A pledge to submit Real Stability Studies covering the
period of validity of the product in accordance with the
instructions issued for such purpose.
10. Comparative Dissolution Studies in accordance with the
instructions in force in that regard excluding therefrom,
the serums, vaccines and biological products.
11. The Director General, by a recommendation from the
Directorate, has the right to suspend the marketing or
suspend the import of the drug in case the studies
mentioned in item (9) have not been submitted.
12. If the product contains plasma products, a Plasma
Master File must be submitted for the product or an
admission from the manufacturing company
demonstrating no change in the source of plasma
approved by us.
13. Complete the specimen form relating to serums,
vaccines and biological products approved by the
Principal or the Contactor with the seal and signature of
the responsible person on each page.
CRITERIA OF REGISTRATION OF DRUGS-
b- The competent Committee decides on the application of
completed documents to relocate the manufacturing site of
a registered drug to a new location within a maximum period
of ninety days. If it fails to decide thereon within the said
period, the Director General grants the applicant a license to
import or manufacture the product, as the case may be, for a
period not exceeding nine months for a price not exceeding
the previously determined one.
CRITERIA OF REGISTRATION OF DRUGS-
APPENDIX NO. (7)
RENEWAL OF REGISTRATION REQUIREMENTS
FIRST: Certificates, Information and Administrative
Documents about the product.
a- Free Sale Certificate from the Country of Origin issued by the
competent parties in accordance with the approved list of the
Administration duly legalized with due observance to the text of
Article (6) containing the following:
1- The Trade Name of the drug in the Country of Origin (in case
the Trade Name differs from that in the Country of Origin, a
clarification from the official competent parties is requested).
2- Number and date of registration or permission of marketing in
the Country of Origin.
3- Names of the active and non-active substance(s) and their
concentrations.
4. A statement that the product is actually being sold in the
Country of Origin and in the event that it is not, to cite such
reasons.
5. Name and address of the holder of the right of marketing and
names and addressees of manufacturing sites and their role in
the manufacturing.
b- A list prepared by the producing company containing the names
of the countries that permitted the marketing of the product with
a proof that it has been marketed for a year in any of such
countries, as well as a list containing the names of the countries
where the product was submitted for registration together with
the countries where the registration of the product has been
rejected showing the reasons for such rejection.
c- Showing the names of the substances of human or animal
origin entering in the composition of the product and its source
and the related certificates thereto.
CRITERIA OF REGISTRATION OF DRUGS-
d- Pricing certificates of the product in accordance with the
determined pricing Criteria by virtue of the requirements of
Appendix No. (8).
e- The internal drug information approved in the Country of Origin
in English legalized by the competent parties.
SECOND: The Technical File
a- All alteration requests approved by the Directorate or the
competent Committee from the registration date or from the
date of the last renewal of registration in chronological order.
b- Update of the part concerning the Stability Studies.
c- Submitting any amendments that occurred on the requested
items in the technical contract of the products that are
contractually manufactured.
d- If the product contains plasma products, a Plasma Master
File must be submitted for the product or an admission
from the manufacturing company demonstrating no
change in the source of plasma approved by us.
e- Complete the specimen form relating to serums, vaccines
and biological products approved by the Principal or the
contactor with the seal and signature of the responsible
person on each page.
THIRD; CLINICAL STUDIES
All available information about (PSUR) of the drug’s side effects from
the date of its registration or its renewal and based thereon, any
suggested alteration on the approved drug’s information.
FOURTH:
A separate update copy of the technical file shall be submitted to the
Drug Control Laboratory in an electronic manner.
CRITERIA OF REGISTRATION OF DRUGS-
Appendix (8-A)
The Required Certificates of Prices
The applicant must submit the following prices certificates in
light of what was mentioned in the pricing criteria:
FIRST: Drug Registration, Renewal of its Registration or its
Pricing:
a-
An invoice issued by the party designated to issue
invoices in accordance with Article (2) of the Pricing
Criteria.
b-
A certificate duly legalized by the party responsible for the
pricing in the Country of Origin or from the approved
country for the purpose of registering the drug, showing
the prices structure * in accordance with Article (17) of the
Pricing Criteria.
c-
A certificate from the manufacturing company showing the
selling prices of the Factory in the following countries
(Britain, France, Spain, Italy, Germany, Greece and the
Netherlands) in addition to the selling prices to the public
thereat upon the submission of the application for
registration initially, as well as upon the renewal of the
registration.
d-
A certificate from the manufacturing company showing the
export price of the drug to Saudi Arabia, if the drug is not
registered, the ministry must be provided with the price
immediately upon its registration there.
CRITERIA OF REGISTRATION OF DRUGS-
SECOND: Relocation of manufacturing a registered drug from a
country to another:
A certificate duly legalized by the party responsible for pricing
showing the prices structure* in accordance with Article (17) of
the Pricing Criteria from both countries or from any of them
unless the drug is only sold in one country.
THIRD: Production of any drug contractually:
A certificate duly legalized by the party responsible for pricing in
the country of the manufacturer showing the prices structure in
accordance with Article (17) of the pricing Criteria as well as the
country of the company holding the right of marketing or any of
them unless it is only sold in one country.
FOURTH: Registration of a New Container:
a-
A certificate duly legalized by the party responsible for the
pricing showing the prices structure* in accordance with
Article (17) of the Pricing Criteria of the price of the new
container requiring registration, in the event that the new
size is not being sold in the Country of Origin or the
approved country for the purpose of registering the drug,
then a certificate of the price of the container that is being
sold there, must be submitted.
b-
A certificate for the required export price in accordance
with Article (2) of the Pricing Criteria.
* Prices Structure: includes the selling price of the drug to the public, the
pharmacy, the wholesaler and the ex-factory and the amount of tax if existing.
CRITERIA OF REGISTRATION OF DRUGS-
FIFTH: Raising the price of a Registered Drug:
a-
A certificate duly legalized by the party responsible for the
pricing in the Country of Origin or the approved country for
the purpose of registering the drug showing the prices
structure in accordance with Article (17) of the Pricing
Criteria.
b-
A certificate for the required export price in accordance
with Article (2) of the Pricing Criteria.
c-
Certificate of prices from the manufacturer showing the
drug prices in accordance with clause (c) of Item (First) of
this Appendix.
d-
A letter from the manufacturer showing the prompting
reasons for the request of raising the price.
Appendix (8-B)
THE CERTIFICATES OF PRICES REQUIRED
FROM LOCAL MANUFACTURERS
The applicant must submit the following documents:
FIRST: Registration of the Local Drug, Renewal of its
Registration or production of any drug contractually at a local
company.
CRITERIA OF REGISTRATION OF DRUGS-
A letter showing the required selling price to the public in
Jordan.
SECOND: Request to raise the price of a Registered Drug:
a-
An official letter showing the required price in addition to
the prompting reasons for the request to raise the price.
b-
Prices of available equivalents in the local market.
CRITERIA OF REGISTRATION OF DRUGS-