As of 5 October 2017, the Ministry of Health of the Russian Federation (the Ministry) is appointed as a designated authority for registering medical preparations (pharmaceuticals) that are to be placed on the EurAsian Economic Union market.
The Ministry is also empowered to:
- approve the general characteristic of a pharmaceutical, its user instruction, the risk assessment plan, etc.; and
- suspend or terminate a registration certificate for a pharmaceutical, restricting the use of a pharmaceutical or amending its registration dossier.
Law: Decree No. 1159 of 25 September 2017