|Market Executive Summary
- Full EAEU member and follow on the EAEU resolutions, included N 72, 127, 128,129, 130 (2019) on serialization of shoes, light industry, tiers, cameras and parfums. All these documents are signed by Armenia
- Ministry of Health of the Republic of Armenia Order N02-Nsets out plans to introduce medicines traceability (date and details to be confirmed) to align with the System e-mark that already covers a number of industries: light industry, tyres, cameras, perfumes.
- The first concrete steps that have now been set out with pilots for Tobacco and Alcohol products leading into mandatory compliance. While pharmaceutical products are not yet in scope, the approach in EAEU / CIS markets has typically started with a few products categories this will be expanded over time to include medicines. We consider this recent expansion of scope an advance notice that the time when the traceability mandate in Armenia will be extended to include pharmaceutical products is moving closer.
- Based on the previous EAEU resolutions, countries who can’t provide their own labelling codes, should be helped with serialization codes by other countries, such as Russia.
- System and Operator announced: State Information system e-Mark, regulator: State Revenue Committee of the Republic of Armenia, which involves the ordering of crypto codes in Russia. Operator: Center for Development of Advanced Technologies – LLC Armenia.
- In parallel, 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”
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:
- 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.” This will introduce medicines traceability (date and details to be confirmed) to align with the System e-mark that already covers a number of industries: light industry, tiers, cameras, parfums.
- December 12, 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)
- March 28, 2018: NoZP-171: inspection organ, enforced by the Government of Armenia will perform the state control the drugs’ circulation