Commercial practice

The common market for medicines and medical devices will start functioning in the near future Pepeliaev Group advises that the Kyrgyz Republic has ratified the protocols of accession of the Republic of Armenia* to the Agreement on common principles and rules of circulation of medicines in the Eurasian Economic Union (EAEU)** and the Agreement on common principles
and rules of circulation of medical products (medical devices and medical equipment) in the EAEU***.

Requirements have been adopted for the contents of the manufacturer’s technical and operating documentation in the registration dossier of a medical device Pepeliaev Group advises that a new legal regulation has been adopted for the state registration of medical devices

Amounts of state duties for the registration of medicines for human use and medical devices and the procedures for paying such duties have been established across the Eurasian Economic Union. Pepeliaev Group advises that the amounts and payment procedures have been established with respect to state duties to be paid for the registration by authorised agencies of medicines for human use and medical devices across the Eurasian Economic Union (EAEU)*.

The procedure for creating the registration dossier for a biomedical cell product and fees for the state registration of such products have been officially approved Pepeliaev Group advises that new legal regulation has been approved of the state registration of biomedical cell products (“BMCPs”).

New good practice for the storage and transportation of medicines intended for human use Law firm Pepeliaev Group advises that on 9 January 2017 the Russian Ministry of Justice registered Order No. 646n of the Russian Ministry of Healthcare “On approving the Good Practice for the Storage and Transportation of Medicines Intended for Human Use” dated 31 August 2016 (“GPST”).

New good pharmacy practice for medicines intended for human use Law firm Pepeliaev Group advises that, on 9 January 2017, the Russian Ministry of Justice registered Order No. 647n of the Russian Ministry of Healthcare “On approving Good Pharmacy Practice for medicines intended for human use” dated 31 August 2016 (“GPP”).

Law “On the Fundamentals of State Regulation of Trade in the Russian Federation” was adopted Federal Law No. 381-FZ “On the Fundamentals of State Regulation of Trade in the Russian Federation” was adopted on 28 December 2009. The Law enters into force on 1 February 2010.