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  • Legislation on registration of medicines in Russia

Russia is a part of the Eurasian Economic Union (EAEU), and most registration, marketing, manufacturing, import and export requirements are now being harmonized between Russia, Kazakhstan, Armenia, Belarus and the Kyrgyz Republic. A common market of medicinal products was formed by the Agreement on Common Principles and Rules of Circulation of Medicinal Products within the Eurasian Economic Union (Moscow, 23 December 2014). This document also launched the harmonization of pharmacopoeial monographs of the member states and creation of the Single Register of registered medicinal products of the Eurasian Economic Union.

The Russian drug (medicine) registration process is primarily shaped by the Federal Law of April 12, 2010 No. 61-FZ on circulation of medicines (pharmaceutical law) with the Ministry of Healthcare of the Russian Federation being the main regulatory body and the Federal Service for Surveillance in Healthcare (Roszdravnadzor) as the enforcement authority. The most recent English version of the Pharmaceutical Law in effect since 2019 can be found here.

The active requirements for the manufacture of medicinal products are set forth in the Russian state standard GOST R 52249-2009, which is identical to the EC Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use as of January 31, 2009 excluding Annex 20.

State registration of a medicinal product normally takes up to 160 business days, but this term is reduced to 80 business days in case of orphan medicines, the first three generic products registered in Russia and for drugs to be used by minors only. The registration dossier is prepared in the standard CTD format. The administrative part includes application, confirmation of state duty payment, power of attorney, manufacturing license and/or GMP certificate, patient information list (PIL) or summary of product characteristics (SmPC ), normative documentation and other documents depending on the medicinal product status.

The state duties related to medicinal products registration are provided by the articles 333.32.1 of the Russian Tax Code as follows and range from 25 000 RUB to confirm status of orphan medicine to 325 000 RUB for quality and risk-benefit examination. For medical devices, the fees for examination, depending on the class, may range from 45 000 to 115 000 RUB (see article 333.33.2 of the Russian Tax Code).

The Ministry of Healthcare and Roszdravnadzor are authorized to monitor drugs safety. The marketing authorization can be suspended or revoked if it is evident that a risk to health exists.

All documents included in the registration dossier shall be translated into the Russian language. Certified translation may also be required. Alba Translation Agency has extensive experience in translation registration dossiers. Our specialists can organize a work process on each job in the most optimal and therefore cost-effective manner for our customers.

Helpful Resources:

Russian Register of registered medicinal products: http://grls.rosminzdrav.ru/