Foreign manufacturers will be permitted to register medicines without GMP certification

Foreign producers who have not received a Russian certificate of GMP compliance will be able to apply for registration of a drug without this document. However, the applicant must be in possession of the Ministry of Industry and Trade’s resolution on conducting inspections of the production site. These rules are contained in the draft law “On Amending the Federal Law ‘On Circulation of Medicines,'” posted on the site regulation.gov.ru. The ministry proposes to amend paragraph 4 of article 18 of Federal Law 61 “On Circulation of Medicines.”

http://www.pharmvestnik.ru/publs/lenta/v-rossii/inostrannym-proizvoditeljam-razreshat-registrirovatj-lp-bez-sertifikata-gmp.html