The Association of International Pharmaceutical Manufacturers (AIPM) proposes introducing a three-year transitional period for pharmaceutical companies, during which importers will be able to present Good Manufacturing Practice (GMP) certification documents issued in other countries, the executive director of Janssen Pharmaceutical Companies in Russia, Katerina Pogodina, said within the framework of the Russian Pharmaceutical Forum.
GMP is the fundamental industry quality standard and includes a broad range of requirements that must be met by pharmaceutical companies. From 2016, foreign pharmaceutical plants must receive a certificate of GMP compliance issued by the Russian Ministry of Industry and Trade. Prior to that, they could provide certificates issued in other countries, according to PRIME.
Also, in 2016 companies that are registering their products in Russia for the first time must present Russian GMP certification. From 2017 companies must provide such a certificate when re-registering pharmaceutical products that are already available in the Russian market.