Regulatory framework

Decision of the Government of the Russian Federation No. 1314 of December 3, 2015 «On Determining Compliance of Pharmaceutical Producers with the Requirements of Good Manufacturing Practice»

Federal Law of the Russian Federation No 61-FZ of April, 12 2010 «On the Circulation of Medicines» (amended on 12/27/2018)
 

The Order of the Ministry of Industry and Trade of the Russian Federation of June 14, 2013 «On approval of the rules of good manufacturing practice" No. 916 (reg. in the Ministry of Justice of the Russian Federation on October 9, 2013 No. 29938…

Concerning approval of the application forms for issuing an opinion on GMP-compliance of the pharmaceutical manufacturer (foreign manufacturer), a GMP-inspection report on the results of the inspection of the pharmaceutical manufacturer and…

Rules of Good Manufacturing Practice of the Eurasian Economic Union approved by the Resolution of the Council of the Eurasian Economic Commission No. 77 dated 3 November 2016

Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in…

The Pharmaceutical Inspection Co-operation Scheme.