Requirements
for State Registration of Drugs
in the Republic of Armenia
Yerevan 2006
While drafting the requirements the following Laws and
Resolutions have been considered: The
Laws of the Republic of Armenia “On Drugs”, “On State Tariffs”, and the
resolutions of the Government of the Republic of Armenia No 347 of 25 April
2001 “On the Approval of the Rule of State Registration of Drugs and
Examination Fees of Drugs for State Registration in the Republic of Armenia”,
the RA Government resolution #148N about changes in The resolutions of the
Government of the Republic of Armenia No 347dated 3 February, 2005, and the
Order No 123 of the Health Ministry of the RA dated 7 February 2006 on approval of “The Decree of Expertise for
State Registration of Drugs in the Republic of Armenia, Form and Description of
the Certificate of State Registration and the List of variations of drugs registered in the Republic of Armenia
that do not require new registration”
1.
General provisions
1.1.
It
is allowed to import, produce, maintain, distribute, sell and use the drugs on
the territory of the Republic of Armenia which are registered in the Republic
of Armenia.
1.2.
State
registration of drugs, validation and rejection of registration is carried out
by the Health Ministry of the RA, and of veterinary vaccines, serums and
diagnostics - by the Ministry of Agriculture of the RA.
1.3.
State
registration of drugs is carried out basing on the results of the
scientifically justified criteria and expertise of safety, efficacy and quality
of drugs. Expertise of drugs for registration is carried out by the Scientific
Centre of Drug and Medical Technology Expertise (hereinafter referred to as
“Scientific Center”[1]).
1.4.
Every
state registration of drugs is carried out according to each manufacturer
(firm), and also each country of origin, if the production of the same drug is
carried out in different countries by the same manufacturer.
1.5.
The
quality of drugs registered in the Republic of Armenia shall comply with the
requirements of Pharmacopoeias currently effective in the Republic of Armenia.
The following pharmacopoeias are considered effective in the Republic of
Armenia: The XI State Pharmacopoeia of USSR, the European Pharmacopoeia,
the
International
Pharmacopoeia, the American Pharmacopoeia (USP), the British Pharmacopoeia
(BP), the German Pharmacopoeia (DAP), the German Homeopathic Pharmacopoeia
(HAB), the French Pharmacopoeia (PhF) and in some cases- temporary
Pharmacopeial articles approved by the Ministry of Health
of RA.
1.6. The following are subject to registration in the Republic of Armenia:
· new original and generic drugs (including veterinary drugs),
·
other
dosages, dosage forms and new indications of state registered drugs,
·
new
combination of drugs,
·
herbal
preparations and other preparations of natural substance,
·
homeopathic
drugs,
· dietary supplements.
1.7. State registration is
not required for drugs, which are made in Pharmacies in
accordance with Prescriptions.
1.8.
The
period of validity of registration of drugs in the Republic of Armenia is 5
years. At the expiry date of the term the state registration of the drug is
subject to new registration.
1.9. In case of changes in the composition, manufacturing technology, international generic names of registered drugs as well as in case of revelation of new properties, new indications for application, drugs are subject to new state registration.
1.10. After the approval of the decision on the state registration of a drug, the latter is included in the State Register of Drugs of the Republic of Armenia.
2.
Application aimed at drug
registration
2.1. For the
purpose of state registration of drugs, the drug manufacturer or its authorized
representative (hereinafter applicant) submits a required package of documents
complied with the approved lists (Appendix 1.1-1.9), samples of drugs and standards of medicinal products to the
Scientific Centre. Documents are submitted Armenian, Russian or English and
also on CD, if available.
2.2. The applicant is
responsible for the authenticity of documents and accuracy of information.
2.3. Applicants shall submit
samples of drugs (for drugs requiring prescription) with accompanying records
in Armenian, or in Russian, or in English: two consumer packs
(checking-identification and laboratory-arbitrage) and in necessary quantities
(in consumer packs) required for laboratory expertise complied with the
specifications and methods of analyses (pharmacopeial article,
technical conditions, etc.)
3. The process of examination
3.1. Preliminary study of
documents and submitted samples is carried out by the Scientific Centre within
ad maximum 10 days. The conclusion is drawn based on the results, about which
the applicant receives a written notification with indication of the
examination fee (Appendix 3).
3.2. Specialized examination
takes place upon crediting the account of the Scientific Centre with the amount of the examination fee
(as a prepayment). The date of payment is regarded as the start point of the
expertise. Maximal duration of examination is 180 days.
3.3 The applicant can terminate the expertise at any time before conclusion of the process. In this case the submitted package of documents, other materials and the expertise fee are not returned to the applicant.
3.4 In case the applicant fails to pay the examination fee within 6 month upon receiving the
written notification on payment, he/she has to submit a new
application.
3.5
Specialized
examination carried out to define the compliance of a drug with the accepted
requirements of efficiency, safety, quality and manufacturing standards
includes pharmacological, toxicological, clinical and laboratory studies,
examination of Methods and Specifications of Analyses, Methods of manufacture
and quality monitoring.
3.6
If
the results of the laboratory expertise of the drug are negative, the applicant
is given a chance to submit new samples of the drug in two series different
from the previous one, in a sufficient quantity to carry out two laboratory
examinations in.
3.7
If the information
provided for the purpose of evaluating the safety, efficacy and quality of drugs is revealed insufficient during the
examination process, the Scientific Centre - may request additional materials, samples and documents. The period for providing of
the required supplementary documents, samples of drugs and information is not
included in the examination period. In case the applicant fails to submit
required materials within 6 months, the examination is terminated and the
application is regarded as void.
3.8
The
results of expertise are summarized by the Scientific Centre and submitted to
the Health Ministry of the RA.
3.9
The
manufacturer has to inform the Scientific Centre on any changes to the
registered drug by submitting relevant materials on the purposes and reasons of
changes. The submitted materials are analyzed and evaluated within 30 days, and
after the approval by the Health Ministry of the RA are included into the
package of registration documents. Alterations that do not require new
registration (see Application 2) are taken into notice and enclosed to the
package of registration documents, while in case of changes of the name of the
drug, of the name of manufacturer or the owner of manufacture license,
production form or packaging - the
registration license is rewritten with preserving of the number of license, and
by addition of a fraction denoting the number of alteration.
3.10
All
the documents and the sample (including the changes) approved following the
expertise serve as the basis for identification of authenticity, quality
control and official reporting at all stages of drugs turnover in the Republic
of Armenia. The sample of a drug includes, primary and/or exterior packaging,
labeling, marking, indications and colored design.
3.11
The
results of examination for registration of drugs can be appealed in the order
defined by the legislation or the Republic of Armenia.
3.12
After
conclusion of the expertise and approval of the registration by the Health
Ministry of the RA, the applicant shall pay state tax in accordance with the
Law of RA “On State Tariffs” (see Appendix 4) by remittance of appropriate sum
to the relevant account of the State Treasury of RA, and in case the payment is
made in foreign currency – in accordance with the actual at date exchange rate established by the Central Bank of
the RA.
3.13
Within
10 days after approval of registration of the drug issued by the Health
Ministry of the RA and after submitting
documentary evidence on payment of the state tax, the applicant is provided
with the Certificate of Registration.
4.
Rejecting the registration
of drugs and considering the registration void
4.1. The state registration of drugs is rejected if:
·
There
is a negative conclusion of the examination.
·
There
is justified and accurate negative information on the drug from international
specialized sources.
4.2.The applicant is informed on
the rejection of the drug registration within 10 days.
4.3.The drug registration may be
considered void and the circulation of the drug may be ceased, if:
·
There
is an application from the manufacturer informing about the cases of revealing
non-compliance with the recognized criteria of safety, efficacy and quality of
drugs, including new negative side-effects of drugs.
· There is justified and accurate negative information on the drug from international specialized sources.
4.4.The information on
considering the drug registration void is published through the
specialized and official press means within ten days.
4.5.The manufacturer covers the
expenses of withdrawing the drug from circulation,
the state registration of which is considered void.
4.6. Decisions on rejecting state registration of the drug and considering the registration
void may be appealed in a manner defined by the Legislation
of the Republic of
Armenia.
Appendix 1.1
of documents required for the registration of generic drugs
in the Republic of Armenia
1.
Application
form (Appendix 1.8).
2.
Registration
certificate of the drug in the country of origin (either original or verified
copy).
3.
Certificate
of Good Manufacturing Practice issued by the authorized body of the country of
origin (for manufacturers in the Republic of Armenia and CIS countries-license
of production if the certificate is not available) (either original or verified
copy).
4.
Information
on the registration in other countries.
5.
Summary
of Product Characteristic (Appendix 1.9).
6.
Instructions
on the medicinal use of the drug for doctors and consumers.
7.
Qualitative
and quantitative composition of the drug (including excipient ingredients).
8.
Pharmacopoeia
articles and/or control methods, specifications, quality indices and packaging
specifications of the drug or its ingredients (2 copies).
9.
Certificates
of quality of the drug and its ingredients.
10.
Comprehensive
minutes on the production of vaccines and serums and the certificate issued by
the authorized body for the particular serial.
11.
Details
of stability study of the drug and determination of its shelf life.
12.
Brief
description of the technological process, chemical, technological and equipment
schemes of the production, including control points.
13.
Pharmacokinetic
and/or bio-equivalency details and/or limited clinical studies of the drug. If
they are not available, for producers in the Republic of Armenia and CIS
countries- details of studies on acute toxicity.
14.
Information
on pharmacological, toxicological and clinical studies (literature and private
sources).
15.
For
veterinary drugs - information on the remains of the drug, as well as possible
availability of its metabolism outcomes and accumulation in the foodstuff
(meat, milk, egg, etc.).
16.
The
label and package of the drug and its colored designs.
17.
Registration
certificate (or verified copy) of the trademark issued by the Intellectual
Property Agency of the Ministry of Trade and Economic Development (if
available).
18.
Periodical
reporting on adverse effects of the drug.
19.
Certificate
on prion safety for active and excipient ingredients of animal origin.
Appendix 1.2
of documents required for the examination of drugs containing new medicinal products for registration in the Republic of Armenia
1.
Application
form (Appendix 1.8).
2.
Registration
certificate of the drug in the country of origin (original or verified copy).
3.
Certificate
of Good Manufacturing Practice issued by the authorized body of the country of
origin (for manufacturers in the Republic of Armenia and CIS countries-license
of production if the certificate is not available) (original or verified copy).
4.
Information
on the registration in other countries.
5.
Summary
of Product Characteristic (Appendix 1.9).
6.
Instruction
on the medicinal use of the drug.
7.
Qualitative
and quantitative composition of the drug (including excipient substances).
8.
Pharmacopeial
articles and/or control methods, specifications, quality indices and packaging
specifications of the drug or its ingredients (2 copies).
9.
Certificates
of quality of the drug and its ingredients.
10.
Details
of stability study of the drug and determination of its shelf life.
11.
Brief
description of the technological process, chemical, technological and equipment
schemes of production, including control points.
12.
Reports
on the pre-clinical studies of the specifications of pharmacological
activities, pharmacodinamic, pharmacokinetic and side effects of the drug.
13.
Reports on the pre-clinical studies of the
safety of the drug (impacts on acute, repeated dose and chronicle toxicity,
cancerogen, mutagen, allergic, teratogen, reproduction function and immune
system).
14.
Reports
on the clinical trials-researches on the specific activity, pharmacodinamic,
pharmacokinetic and side effects of the drug.
15.
For
veterinary drugs - information on the remains of the drug, as well as possible
availability of its metabolism outcomes and accumulation in the foodstuff
(meat, milk, egg, etc.). The expiry date of the foodstuff.
16.
The
label and package of the drug and its colored designs.
17.
Registration
certificate (verified copy) of the trademark issued by the Intellectual
Property Agency of the Ministry of Trade and Economic Development (if
available).
18.
Periodical
reporting on adverse effects of the drug.
19.
Certificate
on prion safety for active and auxiliary ingredients of animal origin.
Appendix 1.3
of documents required for examination of homeopathic drugs for registration
in the Republic of Armenia
1.
Application
form (Appendix 1.8).
2.
Registration
certificate of the drug in the country of origin (original or verified copy).
3.
The
certificate of Good Manufacturing Practice issued by the authorized body of the
country of origin (for manufacturers in the Republic of Armenia and CIS
countries-license of production if the certificate of is not available)
(original or verified copy).
4.
Information
on the registration in other countries.
5.
Summary
of Product Characteristic (Appendix 1.9).
6.
Instruction
on the medicinal use of the combined homeopathic drugs.
7.
Qualitative
and quantitative composition of the drug (including excipient ingredients).
8.
Specifications,
control methods, quality indices and packaging specifications of the drug, or
its ingredients (2 copies).
9.
Certificate
of quality of the drug.
10.
Details
of the drug stability and determination of its shelf life.
11.
Information
on the efficiency and safety of the drug.
12.
The
label and package of the drug and its coloured designs, CD versions (if
available) on all forms indicated in the application.
Appendix 1.4
of documents required for the registration examination of the drug registered in the Republic of Armenia and produced in other countries by the same manufacturer
1.
Application
form (Appendix 1.8).
2.
Registration
certificate of the drug in the country of origin (original or verified copy).
3.
Summary
of Product Characteristic (Appendix 1.9).
4.
Instruction
on the medicinal use of the drug.
5.
The
certificate of Good Manufacturing Practice issued by the authorised body of the
country of origin (for manufacturers in the Republic of Armenia and CIS
countries-license of production if the certificate is not availability)
(original or verified copy).
6.
Brief
description of the technological process, chemical, technological and equipment
schemes of production, including control points.
7.
Pharmacokinetic
and/or bioequivalence and acute toxicity details of the drug.
8.
Reference
stating that Good Manufacturing Practice of the newly registered drug has not
been modified compared with the Good Manufacturing Practice of the previously
registered drug.
9.
The
label and package of the drug and its colored designs, CD versions (if
available) on all forms indicated in the application.
Appendix 1.5
of documents required for the registration examination of the subsequent dosages of the drug registered in the Republic of Armenia
1.
Application
form (Appendix 1.8).
2.
Registration
certificate of the drug in the country of origin.
3.
Summary
of Product Characteristic (original or verified copy).
4.
Instruction
on the medicinal use of the drug.
5.
Qualitative
and quantitative composition of the drug (including excipient substances).
6.
Pharmacopeial
articles and/or control methods, specifications, quality indices and packaging
specifications of the drug or its ingredients (2 copies).
7.
Certificates
of quality of the drug, its active and excipient ingredients.
8.
Details
of stability studies of the drug and determination of its shelf life.
9.
For
veterinary drugs-information on the remains of the drug, as well as possible
availability of its metabolism outcomes and accumulation in the foodstuff
(meat, milk, egg, etc.). The expiry date of the foodstuff.
10.
The
label and package of the drug and its colored designs, CD versions (if available)
on all forms indicated in the application.
11.
Certificate
on prion safety for active and excipient ingredients of animal origin.
Appendix 1.6
of documents required for the registration examination of the subsequent dosage forms of the drug registered in the Republic of Armenia
1.
Application
form (Appendix 1.8).
2.
Registration
certificate of the drug in the country of origin (original or verified copy).
3.
Summary
of Product Characteristic (Appendix 1.9).
4.
Instruction
of the medicinal use of the drug.
5.
Qualitative
and quantitative composition of the drug (including excipient substances).
6.
Pharmacopeial
articles and/or control methods, specifications, quality records and packaging
specifications of the drug, or its ingredients (2 copies).
7.
Certificates
of quality of the drug.
8.
Details
of stability studies of the drug and determination of its shelf life.
9.
Pharmaco-
kinetic and/or bio-equivalence detail and/or limited clinical studies of the
drug.
10.
Information
on toxicity studies of the drug.
11.
Details
of clinical studies.
12.
For
veterinary drugs - information on the remains of the drug, as well as possible
availability of its metabolism outcomes and accumulation in the foodstuff
(meat, milk, egg, etc.). The expiry date of the foodstuff.
13.
The
label and package of the drug and its colored designs, CD versions (if
available) on all forms indicated in the application.
14.
Certificate
on prion safety for active and excipient ingredients of animal origin
of documents required for the registration examination of the new prescriptions of the drug registered in the Republic of Armenia.
1.
Application
form (Appendix 1.8).
2.
Registration certificate of the drug in the country
of origin (original or verified copy).
3.
Summary
of Product Characteristic (Appendix 1.9).
4.
Instruction
of the medicinal use of the drug.
5.
Information
on clinical efficiency.
Data should be
included in the application form
1. Name of the drug
2. International name
3. Ingredients
* active ingredients
* excipients
4. Dosage
5. Dosage form and instruction for use
6. Anatomical-clinical- chemical code (ATC)
7. Production form and packaging
8. Instruction for use
9. Shelf-life
10. Storage conditions
11. Supply conditions in the country of origin
12. Owner of the License (name, address)
13. Number of copyright and trade mark registration
certificate, expiry date.
14. Applicant (manufacturer or its authorized
representative), address, phone number(s), fax, signature, stamp or seal, date
of signing.
Appendix 1.9
The summery of the product characteristics
4.1 indications
4.2 usage forms and dosages (if necessary – for different
age groups)
4.3 warnings
4.4 precautions
4.5 interactions
4.6 usage during pregnancy and breast feeding
4.7 influence at activities requiring concentration
4.8 adverse reactions
4.9 measures at overdose
5.1. Dynamics of the drug action
5.2 Kinetics of the drug action
5.3 Pre-clinical safety data
6. Pharmaceutical characteristics
6.1 Excipient ingredients
6.2 Incompatibility
6.3 Shelf-life
6.4 Storage conditions
6.5 Package characteristics
6.6. special usage instructions and
warnings
7. Manufacturer (name, address, country)
8. Owner of the license (name, address,
country)
9. Date of final revision of the
documents.
Appendix 2
List
of changes of drugs registered in the Republic of
Armenia that do not require new registration
Appendix
3
Payment amount for drug state registration expertise
in
the Republic of Armenia
|
№ |
Instances of State registration |
Expertise Fee
(including VAT) (thousand dramm) |
|
1 |
The first dosage form and dosage strength of
generic drugs |
900 |
|
450 |
|
|
240 |
|
|
450 |
|
|
2 |
New
combination of known drugs |
1200 |
|
3 |
The first dosage form and dosage strength of the new original drugs |
2250 |
|
1200 |
|
|
4 |
The first dosage form and dosage strength of
Homeopathic drugs |
240 |
|
60 |
|
|
5 |
Herbal
preparations and other preparations of natural substances and Dietary supplements |
240 |
|
6 |
Re-drawing of the State Registration
Certificates, in cases of the following changes, connecting with production,
name of manufacturing company, packaging and other changes which do not
affecting on the quality, effectiveness, safety of the production. |
24 |
If the same manufacturer’s
drug, already registered in the Republic of Armenia, is also
manufacturing in other countries, the payment amount for every next
country-manufacturer’s drug state registration will be half of the approved
amount indicated in the table above.
Appendix
4
Rate of the State Tax for State registration
in the Republic of Armenia
|
№ |
Instances
of State registration |
Rate of the State Tax AMD |
|
1. |
Fist and next dosage form and dosage strength
of new original drugs |
70,000 |
|
2. |
New
combination of known drugs |
40000 |
|
3. |
First and next dosage form and dosage strength
of generic drugs |
40000 |
|
4. |
New indications |
10000 |
|
5. |
Herbal
preparations and other preparations of natural substance |
10000 |
|
6. |
Homeopathic drugs |
2000 |
|
7. |
Dietary
supplements |
20000 |
|
8. |
Re-drawing of the State Registration
Certificates, in cases of the following changes, connecting with production,
name of manufacturing company, packaging and other changes which do not
affecting on the quality, effectiveness, safety of the production. |
5000 |
[1] Address: 15 Moskovyan street, Yerevan 375001, Armenia, Tel.: +3741-584020, Fax: +3741-542406, E-mail: admin@pharm.am, website: www.pharm.am