The main legislative act regulating the procedure for the registration of medicinal products in Armenia is the Law of the Republic of Armenia “On Medicines” dated May 17, 2016. The law regulates relationships involving the medicinal product circulation, public medicine supply, labeling and design, import, advertisement, state registration and quality control of medicinal products, pharmacovigilance, etc. According to article 4 of the Law, pharmacies have the right to purchase and sell medicinal products that are registered in the Republic of Armenia. 

The procedure for state registration of medicinal products, renewal and amendments, requirements for the registration dossier, the procedure for simplified registration (recognition procedure) have been approved by the Decree of the Government of the Republic of Armenia No. 162-N dated February 28, 2019 “On adopting the rules for state registration, re-registration, extension of the term of the certificate of medicinal product in the Republic of Armenia”, which entered into force on March 30, 2019.

The Applicant of registration (Marketing Authorization Holder) may be the manufacturer, or any other legal entity, resident or non-resident of Armenia. The Marketing Authorization Holder is responsible for the safety, efficacy and quality of the registered products, and is obliged to inform immediately in writing about changes or new information regarding the registered medicinal product.

The registration of medicinal products in the Republic of Armenia is carried out under “general” or “simplified” procedures. The simplified procedure is applicable for medicines registered in the countries of the European Union, USA, Japan or pre-qualified by the World Health Organization.

The registration of medicinal products is carried out by the Ministry of Health of the Republic of Armenia, and the competent authority for the registration materials expert evaluation is the Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan (website www.pharm.am, hereinafter referred to as the Scientific Center).

Requirements for the registration dossier:

The dossier is submitted in CTD format, in paper and electronic form. Part of the administrative documentation must be correctly legalized.

The dossier is submitted in Armenian, Russian or English. If the dossier materials contain information in other languages, their translation into the above-mentioned languages is required.

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

The package Labeling is approved in Armenian and/or Russian, and/or English.

The medicinal product registration procedure in Armenia can be briefly described in the following steps:

1. Payment of state fees. 
2. Filing of an Application for registration, registration dossier, submission of samples of a medicinal product and standards for laboratory control.
3. Preliminary expert evaluation (the preliminary assessment of materials).
4. Obtaining a conclusion on preliminary expert evaluation and an invoice on the cost of expert work.
5. Payment for expert work, receipt of confirmation of payment.
6. Specialized expert evaluation of documentation (assessment of quality, safety, efficacy, risk/benefit ratio, study of production conditions, documentation of ensuring the quality of drug substance and the final product, shelf life reports and stability studies, packaging labeling, instructions for use, etc.), during which questions may be asked about the submitted documentation or requests for additional documentation.
7. Responses to comments of the specialized expert evaluation.
8. Laboratory expert evaluation (testing the quality of samples of a medicinal product), issuance of an Opinion on laboratory expert evaluation.
9. Providing expert opinion to the Pharmacological Council.
10. Issuance of an opinion on registration.
11. Receipt of the notification of the opinion on registration.
12. Issuance of the Marketing Authorization, placement of mock-ups, instructions and general characteristics of the medicinal product on the web site.

For medicinal products that are registered in Armenia by a simplified procedure, laboratory expert evaluation of the samples is not required. For other medicinal products, with a new registration, renewal, and amendment in quality control methods, samples of the finished medicinal product and reference standards are required. To import samples and standards, the importer must obtain an Import Certificate.

During the registration, the GMP certificate of the manufacturing country is provided, and inspection of the production site is not required.

As a result of registration, a Marketing Authorization is issued in the name of the Holder. The Marketing Authorization is valid for 5 years. The packaging layout, instructions for use and the Summary of medicinal Product Characteristics (SmPC) are approved together with the Marketing Authorization.

Data on the registration of a medicinal product is entered into the state register, together with color packaging layouts (register address: http://pharm.cals.am/).

Registration period:  

The general registration procedure takes no more than 150 calendar days (including the time of laboratory tests), 3-5 days are given for responding to comments, otherwise the examination period may be extended. The time begins to run from the date of paying the bill and providing all the necessary documentation, samples and standards. Simplified registration procedure for medicinal products registered in the countries of the European Union, USA or Japan is no more than 31 calendar days.

Changes (variations) and renewal procedures:

During the period of validity of the Marketing Authorization, the Applicant (Holder) is obliged to inform immediately in writing about changes or new data regarding the quality, safety or efficacy of the medicinal product. The validity of the marketing authorization may be suspended or canceled if the Marketing Authorization Holder has not informed the competent authority of such changes.

Variations are divided according to the generally accepted classification into types IA, IB and II.

For variations, the Applicant submits the Application and accompanying documentation in the CTD format, pays the state fee and cost of expert evaluation. The Scientific Center carries out the expert evaluation of the documentation, and in case of a positive decision, it issues an annex to the Marketing Authorization, or renews the Marketing Authorization, and also updates the approved package leaflet, SmPC and color graphic images of the package (if necessary) on the website.

The term for the expert evaluation of documentation for amendments is 30-90 days.

The renewal procedure is carried out after the expiration of the Marketing Authorization and takes 31 calendar days (if there are no changes in the registration dossier of the finished medicinal product from the date of registration of the product on the Armenian market) and is initiated at the request of the Applicant by submitting a written application. If it is necessary to submit any changes that are not approved in the reference country, a complete set of documents in CTD format is submitted. 

After renewal, a Marketing Authorization is issued for the next 5 years.

Cratia provides professional services on state registration of healthcare products in Armenia. We have a deep knowledge of the national legislation, significant experience, and necessary resources.

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.