The Government of the Russian Federation has approved the latest rules for licensing the production of pharmaceuticals, along with the list of works that comprise this activity. As before, the Ministry of Industry and Trade is responsible for licensing the production of pharmaceuticals for medical use, while the Ministry of Agriculture is responsible for licensing those for veterinary use.

The latest additional requirements stipulate that a licence applicant must adhere to (i) organisational rules; (ii) quality control; and (iii) the technical regulations. Among other things, a licensee must now also (i) follow rules for storing pharmaceuticals; and (ii) destroy poor-quality, adulterated, or counterfeit products.

The term “flagrant violation of the licensing requirements” has been clarified. Unlike in the previous provision, the following are considered “flagrant violations”:

  1. not breaching just any requirement, but, rather, violating a specific provision indicated in the rules (for example, lack of state registration of limiting the selling price of vital medicines); and
  2. permitting a threat or inflicting harm to the life and health of citizens; harming animals, plants, the environment, objects of cultural heritage; also causing an emergency situation of a technogenic nature, etc.

The decree was published on 16 July 2012 in the official publication “Collected Legislation of the Russian Federation”, and it came into force on 24 July 2012.

[Decree No. 686 of the Government of the Russian Federation “On Adopting the Provisions on Licensing the Production of Pharmaceuticals”, dated 06 July 2012]