Armenia

The population of Armenia is about 3 million of people. Since 2015, the country is a member of the Eurasian Economic Union (EAEU), along with Belarus, Kazakhstan, Kyrgyzstan and Russia.

The import, sale and use of medicinal products in Armenia is authorized only after their registration.

Import and sale of medical equipment and medical devices are authorized without a state registration. However, due to the accedence into the EAEU, update and harmonization of the local legislation are planned.

Import and sale of special food products are authorized only after their registration.

Meantime, a Certificate of state registration of products (Marketing authorization), which is received under a “centralized” procedure in one of the EAEU member states, is also recognized.

Import and sale of cosmetic products are authorized without a state registration. However, due to the accedence into the EAEU, update and harmonization of the local legislation are planned.

Meantime, a Certificate of state registration of products/ product declaration, which have been received under a “centralized” procedure in one of the EAEU member states, are recognized.

Medicinal products

The main legislative act that regulates the registration of medicinal products in Armenia is the Law of the Republic of Armenia on “Medicinal Products” as of the 17^th of May, 2016 and the Requirements for the state registration of medicinal products in the Republic of Armenia as of 2016.

The registration applicant (the holder of the registration certificate) can be the manufacturer, or any other legal entity, resident or non-resident of Armenia. The holder of the registration certificate for the medicinal product is responsible for the safety, efficacy and quality of the registered products, and is obliged to immediately notify in writing of variations or new information regarding the registered medicinal product.

Registration of medicinal products in the Republic of Armenia is carried out according to general and simplified procedures. The simplified procedure is used to register medicinal products registered in the EU countries, the USA, Japan or prequalified by the World Health Organization.

The registration of medicinal products s is carried out by the Ministry of Health of the Republic of Armenia, and the competent body that performs the examination of registration materials is JSC “Scientific Center for Expertise of Medicinal Products and Medical Technologies named after Academician E. Gabrielyan” (website www.pharm.am, further – the Scientific Center).

Requirements to the registration dossier:

The dossier is to be submitted in CTD format, in paper and electronic format. A part of administrative documents shall be duly legalized.

The dossier is available in Armenian, Russian or English. In case if documents of the dossier contain information in other languages, their translation into the abovementioned languages ​​is required.

The instruction is submitted in Armenian, and/or Russian, and/or English.

The labeling is to be approved in Armenian, and/or Russian, and/or English.

The registration procedure of the medicinal product in Armenia can be briefly described by the following stages:

1. State fee payment.
2. Submission of the Application for registration, of the registration dossier, samples of the medicinal product and standards for laboratory control.
3. Preliminary examination (preliminary materials observation).
4. Obtaining an opinion on the preliminary examination and invoice on the cost of expert works.
5. Expert work payment, receipt of payment confirmation.
6. Specialized documents examination (quality, safety, efficacy assessment, risk/benefit ratio, manufacturing conditions observation, documentation on quality assurance of raw materials and finished product, shelf life and stability studies reports, labeling, instructions for use, etc.), during which questions on submitted documents may be asked or additional documents may be requested.
7. Answers to the remarks of the specialized expertise.
8. Laboratory examination (quality approbation of medicinal product samples), issuance of a Conclusion on laboratory examination.
9. Providing of the examination conclusion to the Pharmacological Board.
10. Issue of the registration conclusion.
11. Receipt of the registration conclusion notification.
12. Issuance of the registration certificate, disposition of artworks, instructions and general characteristics of the medicinal product on the site.

For medicinal products that are being registered in Armenia under the simplified procedure, no laboratory examination of samples is required. For other medicinal products under the procedure of new registration, renewal or introduction of changes along with introduction of variations into the Drug master file samples of the finished medicinal product and reference standards are required. To import samples and standards, the importer must obtain an Import certificate.

The GMP certificate of the manufacturing country is submitted during the registration procedure, and inspection of the manufacturing site is not required.

As a result of registration, the registration certificate is issued in the name of the owner. The registration certificate is valid during 5 years. Along with the registration certificate, artworks, the instructions for use and a summary of medicinal product characteristic (SmPC) are approved.

The data on the registration of the medicinal product is entered in the state register, along with the color artworks (the register link is http://pharm.cals.am/).

Period of registration:

The general registration procedure takes no more than 150 calendar days (includes laboratory analysis), 3-5 days are given for replying to remarks; otherwise the examination period may last. The time count starts after invoice payment and all necessary documents, samples and standards are provided. The simplified registration procedure for preparations registered in the EU, the USA or Japan takes the period within 31 calendar days.

Introduction of variations and renewal:

During the validity of the registration certificate, the Applicant (holder) is required to promptly notify in writing of variations or new data regarding the quality, safety or efficacy of the medicinal product. Validity of the registration certificate may be ceased or revoked if the certificate holder has not informed the competent authority of such variations.

Legislation describes 31 types of variations, other variations lead to necessary submission of the Application for new registration. To introduce variations the Applicant submits the Application and associated documents, pays for the expertise and the state fee. The Scientific Center examines the documents and, in case of positive decision, issues an annex to the registration certificate, or renews the certificate, as well as updates the approved leaflet, general characteristics of the medicinal product and the colored graphic images of the packaging (if necessary) on the website.

The term of the documents examination for introduction of variations is within 30 days.

The registration procedure is carried out after f the registration certificate validity expiration and takes 31 calendar days (providing there are no changes in the Drug master file of the finished medicinal product from the date of product registration in the Armenian market).

Pharmacovigilance:

According to the local legislation of the Republic of Armenia, Applicants for the registration of medicinal products, treatment and prophylactic establishments, pharmacies and institutions and organizations engaged in the consumption and use of medicinal products are obliged to immediately inform the authorized government body about cases of adverse reactions development.

According to the commission of the Ministry of Health, which is an authorized governmental body, the Examination of Medicines and Medical Technologies Scientific Center realizes constant monitoring of adverse reactions of medicinal products in Armenia. Since 1997, it has been a member of the WHO International Program for Monitoring of Adverse Reactions of Medicinal Products (Uppsala, Sweden).

The pharmacovigilance system in the territory of Armenia is regulated by Order of the Ministry of Health No. 23-H as of the 17^th of May, 2017 “On approval of the registration procedure, collection, submission of notifications and reports, suspected adverse reactions data monitoring and analysis related, lack of therapeutic efficacy, misuse and suspected falsification of medicinal products, as well as the form of a registration log and a message map regarding suspected adverse reactions, the lack of therapeutic efficacy, misuse and suspected falsification of medicinal products.” Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union make the basis of the pharmacovigilance system.

Medical devices and equipment:

According to the local legislation import and sale of medical equipment and medical devices are authorized without the state registration. However, in connection with Armenia’s accedence into the EAEU it is planned to update and harmonize local legislation.

Special food products:

According to the local legislation import and sale of special food products are authorized after their registration and obtaining of the registration certificate.

The registration applicant (the holder of the registration certificate) can be the manufacturer, or any other legal entity, resident or non-resident of Armenia. The registration of special food products is carried out by the Ministry of Health of the Republic of Armenia, and the competent body that performs the examination of registration materials is JSC “Scientific Center for Expertise of Medicinal Products and Medical Technologies named after Academician E. Gabrielyan”.

The dossier is to be submitted in Armenian, Russian or English. Administrative documents are to be submitted in the original with translation into Russian or in the form of notarized copies.

The instruction and labeling are to be approved in Armenian, and/or Russian, and/or English.

The documents are submitted in accordance with the approved list in duplicate along with samples of special food products.

The duration of the procedure is 3 months. An unlimited registration certificate is issued as a result of registration.

Cosmetic products:

According to the local legislation import and sale of cosmetic products are authorized without the state registration. However, due to the accedence into the EAEU, update and harmonization of the local legislation are planned.

Meantime, a Certificate of state registration of products and product declaration, which have been received under a “centralized” procedure in one of the EAEU member states, are recognized.

Company “Cratia” offers carrying out of state registration of medicinal products, developing and maintaining of the pharmacovigilance system, certification of medical devices, special food products and cosmetic products in Armenia.