The Law that simplifies the drug registration

25 October 2018

The Law "On Amendments to the Federal Law 'On Drugs Circulation' was adopted by the State Duma of the Russian Federation at third final reading on 17 May 2018. Introducing the new bill, a member of the State Duma's special-purpose committee for healthcare, MP Alexander Petrov, stressed the importance of the adopted document for all spheres of the Russian pharmaceutical industry.

He particularly stressed the fact that this federal law will shorten the terms of access of medicinal products to the country's markets and stimulate their contract production, which in turn will allow Russian producers to manufacture medicinal products of other manufacturers in addition to their own pharmaceutical products.

One of the advantages of the new law, of course, is the simplification of the procedure for registration of medicinal products for foreign manufacturers. In this case, the condition for ensuring the quality and safety of medicinal products will be mandatory inspection of foreign manufacturers for compliance with the requirements of the Rules of Good Manufacturing Practice (GMP).

These changes will affect the access to the Russian markets of medicinal products with the same international non-proprietary name, but with different trade names produced at the same production site. For them it is possible to get registered.

The adopted bill also provides for the suspension of use of medicinal products that caused (or could cause) damage to human life and health.

Thus, the amendments made to the prior law are generally aimed at improving the entire system of circulation of medicinal products on the territory of the Russian Federation.