Russian/EEU GMP

In accordance with the current legislation of the Russian Federation, as well as the legal framework of the Eurasian Economic Union (EAEU), manufacturers of medicinal products located in the territory of the EAEU countries, or supplying their products to the EAEU countries, must confirm that their production conditions comply with the standards of good manufacturing practice (GMP).

This requirement is established by both national and union regulatory legal acts:

Federal Law of 12.04.2010 No. 61-FZ “On the circulation of medicines:

The production of medicines must comply with the requirements of the rules of good manufacturing practice approved by the authorized federal executive body

(clause 1 of Article 45 of Chapter 8)

Decision of the EEC Council of 03.11.2016 No. 77 “On approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union”:

A permit (license) for production is mandatory for the manufacturer of medicines of the member states, regardless of whether these products are sold in the territories of the member states or outside them.

Compliance with these Rules is taken into account when obtaining permits (licenses) for the production of medicinal products, and it is the basis for inspection of medicinal product manufacturers

(Introduction, paragraphs 1, 2)

On the territory of the EAEU, confirmation of compliance of production conditions with GMP requirements is carried out through the inspection procedure. Inspection of the production site for the purpose of confirming production conditions with GMP requirements is carried out by authorized bodies of the EAEU member states.

In the Russian Federation, such authorized body is the “State Institute of Medicines and Good Practices” (FBU “GILS and NP”) – a subordinate institution of the Ministry of Industry and Trade of the Russian Federation.