Amendments to 61-FZ regarding the application of standards of Russian GMP

19 April 2019

The Ministry of Industry and Trade of the Russian Federation together with the State Institute of Medicines and Good Practices (GIMGP) initiated drafting of a new law, which involves amendments to the Federal Law No. 61 “Circulation of Medicines” now demanding that both Russian and foreign manufacturers of pharmaceutical substances and medicines should have a Russian GMP certificate. These amendments are planned to be adopted this year.

Alexander Semenov, President of Active Component JSC, spoke about this new legislative initiative in his speech about new preferences for pharmaceutical manufacturers at a plenary meeting of the IPheB Russia 2019 international forum.

“The background for this legislative initiative is the so-called “ambiguity” of the Federal Law No. 61, under which companies with production licenses and companies with GMP certificate have the right to circulate medicines,” said Alexander Semenov. He also remarked that Active Component supports this draft.

As a result, companies that received a Russian GMP certificate from the Ministry of Industry and Trade of the Russian Federation face an unequal competition with Russian or foreign manufacturers that have not been tested for compliance with good manufacturing practice. For instance, Active Component has a Russian GMP certificate and has confirmed it twice.

“We underwent a lot of inspectors and now are sure that in terms of quality our substances are on a par with foreign analogues. However, at the market we can still see substances that do not match high quality standards” said the President of Active Component. Thus, they may affect quality of life and health of consumers who may purchase low quality unsafe medicines.

The Ministry of Industry and Trade of the Russian Federation reports that the State Institute of Medicines and Good Practices has issued 998 GMP certificates. 298 companies received negative reviews and were blacklisted. So, they cannot circulate their medicines in any part of the world. However, the information from the Register of Refused Conclusions on Compliance of Manufacturers with Good Manufacturing Practice, and from the State Register of Medicinal Products, 62 manufacturers of pharmaceutical substances keep supplying their products to Russia. For instance, Bioiberica, Spain, supplies substances for 23 manufacturers, Pharmabios, Italy - for 9 manufacturers of medicines. Due to a gap in the legislation, these companies may legally continue delivering pharmaceutical substances or medicinal preparations to the Russian market, despite the fact that they are manufactured in breach or requirements.

Uniform international and Russian quality requirements to medicines are also necessary for coming out to foreign markets and increasing exports. In a new version of Federal Law No. 61 Russian norms are replaced with Eurasian ones.

“Obviously, we must apply uniform requirement to Russian and foreign companies/contractors, it will help the Russian manufacturing market to become more competitive and be on equal terms with competitors at foreign markets,” said Alexander Semenov in his speech.