Armenia

v. 19 – Q3 2021

Market Executive Summary
  • Reports about private – public initiative involving collaboration between Armenian company AM-PG Group and Tax and Customs authorities to create the information system “VERO CODE” to generate unique code. Details are still outstanding though it is claimed that this system would be “compliant with EC and EEU requirements”
  • Packaging label shall be either on Armenian or/ and Russian or/ and English:
  • Reports in Feb 2016 that lawmakers are considering a bill “On Drugs” to provide for strict control over the entire supply chain – from the production of medicines to their sales. The amendments are designed to bring the Armenian pharmaceutical products in line with international standards. The bill also aims to introduce price regulation mechanisms under the umbrella of Eurasian Economic Union
  • Following EAEU rules for medicines registration and assessments (from 2018)
  • The requirements for package labeling and instructions for use have been brought in line with the requirements of the EAEU. The guide on the monitoring of adverse reactions, the rules for the implementation and maintenance of the pharmacovigilance system has been published
  • Order N02-N dated 21 January 2020 brings the requirements of national legislation to the labeling of medicinal products, instructions for use (leaflet) and trade names of medicinal products in line with the requirements of the EAEU:
    1. Information on the packaging of medicinal products is compiled in accordance with the requirements of the Decision of the Council of the Eurasian Economic Commission No. 76 dated November 3, 2016
    2. Instructions for medical use (leaflet) and general characteristics of medicinal products are compiled in accordance with the requirements of the Decision of the Council of the Eurasian Economic Commission No. 88 dated November 3, 2016
    3. Trade names of medicinal products must comply with the Recommendation of the Board of the Eurasian Economic Commission No. 2 dated January 29, 2019 “On the Guidelines for the Selection of Trade Names of Medicinal Products” and the Recommendation of the Board of the Eurasian Economic Commission No. 13 dated April 23, 2019 “On the Rules for the Preparation of Group Names of Medicinal Products”
Key Dates 2004: Law on goods labelling is in force in Armenia from 24 November 2004 for 42 categories of products, including medicines.
Other main regulatory document dated 17 May 2016: Bill “On Drugs” NoZP – is published, amendments to the Bill:

  • 28 March 2018, NoZP-171: inspection organ, enforced by the Government of Armenia will perform the state control the drugs’ circulation
  • 12 December 2019, NoZP-268: obligation of license for wholesalers and certificate of activity for the proper distribution of medicine (within 4 years after the license obtention)
  • From 07 February 2020, NoZP -42
  • January 21, 2020, the Ministry of Health of the Republic of Armenia approved Order N02-N “On Approval of Requirements for the Labelling of Medicinal Products, Pharmaceutical Substances, Medicinal Plant Materials, an Investigational Medicinal Product, as well as Instructions for Medical Use, General Characteristics and Trade Names of Medicinal Products for Human Use, and about Excipients Mandatorily Indicated on the Secondary Packaging.”

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