Pharma and medical devices
As of 15 May 2018, importers and manufacturers of veterinary medicines and feed additives are required to comply with the provisions of the adopted Technical Regulation (TR) on the Safety of Veterinary Medicines and Feed Additives.
The adopted TR applies to ready-to-use chemical-pharmaceutical and biological medicines and feed additives.
Manufacturers and importers of medical devices that submit a registration application for these devices after 24 March 2017, have to ensure that their technical documentation contains all required information, as prescribed by the adopted Order No. 11n dated 19 January 2017. This technical documentation is to be submitted as a part of a registration dossier for any medical devices.
Adopted Code of Conduct for storage and transportation of pharmaceutical products
Amended rules for importing pharmaceuticals into Russia
According to the amendment, all pharmaceuticals (both registered and not registered in Russia) may be imported into Russia without a permit (issued by the Ministry of Healthcare), provided that they are intended to be used for private purposes by individuals arriving into Russia.
The Ministry of Finance has proposed draft law that would require certain products (the exact lists of these products are to be adopted at a later stage) with special identification and tracking marks (RFID).
The declared aims of this requirement are to protect the consumer from counterfeit and illegally imported or manufactured products and to unify the procedure of product tracking.