Armenia

The population of Armenia is about 3 million people. Since 2015, the country has been a member of the Eurasian Economic Union (EAEU), along with Belarus, Kazakhstan, Kyrgyzstan and Russia. Membership in the Union means that the Armenian legislation is constantly changing to harmonize with the legislative acts of the EAEU.

The state language is Armenian. Although Russian is not in official use, it is widespread, it is spoken by about 70% of the country’s population, and is a compulsory subject in schools.

Import, sale and use of medicinal products in Armenia is allowed only after their state registration. Registration is carried out according to the national procedure, which provides for simplified registration, as well as to the EAEU Unified Rules. Any company, resident or non-resident of Armenia can act as a Marketing Authorization Holder (MAH) for registration; it is not required to set up a representative office or local company. The MAH must establish and maintain a pharmacovigilance system in Armenia, appoint a local contact person responsible for pharmacovigilance.

Import and sale of medical equipment and medical devices are allowed without state registration. However, in view of the entrance into the EAEU, it is planned to update and harmonize local legislation.

Import and sale of special food products are allowed only after their registration according to the “unified” procedure in one of the EAEU member countries.

Import and sale of cosmetics are permitted without state registration. However, in connection with the entrance into the EAEU, it is planned to update and harmonize local legislation. Currently, a Certificate of State Registration of Products/Products Declaration obtained according to the “centralized” procedure in one of the EAEU member states, is recognized.

 

Competent authorities:

Ministry of Health of the Republic of Armenia
The central executive authority that implements public healthcare policy
Web site: http://www.moh.am/

Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan at the Ministry of Health of the Republic of Armenia
The competent authority responsible for expert work to register medicinal products and medical devices, as well as responsible for pharmacovigilance
Web site: http://www.pharm.am 

 

The main legislative acts:

  1. The Law of the Republic of Armenia “On Medicines”;
  2. 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”;
  3. Decree of the Government of the Republic of Armenia No. 166-N dated February 28, 2019 “On adopting the fees in the Republic of Armenia for assessments in the field of medicinal products state regulation”;
  4. Decree of the Government of the Republic of Armenia No. 156-N dated February 28, 2019 “Օn adopting the rules of inspection in the scope of distributor certification and issuance a Good Distribution Practice certificate, the assessment rule for the purpose of licensing the medicinal products wholesale realization and the list of necessary documents in the Republic of Armenia”;
  5. Decree of the Government of the Republic of Armenia No. 199-N dated February 28, 2019 “Օn adopting the rules of compliance inspection with the requirements of Good Manufacturing Practice of medicinal products and pharmaceutical substance, the issuance of the Good Manufacturing Practice Certificate, as well as the assessment rule for the purpose of licensing the manufacturing of medicinal products and the list of necessary documents; and on repeal of the Decree of the Government of the Republic of Armenia N 1603-N of November 25, 2010 and the Decree of the Government of the Republic of Armenia N 1089-N of September 23, 2013”;
  6. Decree of the Government of the Republic of Armenia No. 150-N dated February 28, 2019 “On designation a body responsible for the organization and conduction the assessment and inspection in the field of state regulation of medicinal products circulation”;
  7. Order of the Ministry of Health No. 23-N of May 17, 2017 “The order of recording and reporting cases of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines; collecting, reporting, monitoring, submitting reports and analyzing data on adverse reactions of medicines, approving the form of the register of adverse reaction and form of reporting of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines”.

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. We offer:

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(name, formulation, dose and route(s) of administration, date of therapy start)