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News of the russian legislation

On November 26, 2019, Prime Minister Dmitry Medvedev signed Resolution No. 1510, which approved the rules for the submission of documents and information on medicines introduced into civil circulation.

Now drug manufacturers receive a certificate confirming compliance with quality and safety standards issued by accredited organizations. The maximum validity of the certificate is three years. Vaccines and other immunobiological preparations are certified for serial production for one year.

Now, before entering the market of a drug (except immunobiological), first produced or first imported into the Russian Federation, it is necessary to obtain a test report on the compliance of the first three series/batches, according to the quality indicators provided by the regulatory documentation. Also changed the rules of issue of permission for the entry into circulation of the series/batches of immunological medicinal product and to make a statement about their compliance with state registration requirements as well as rules for making decisions on termination of civil turnover of a lot or batch of a drug.

Earlier in Russia there was already a procedure for preliminary control of the first three imported or produced series of medicines. But if earlier producers could work with any laboratories accredited for this purpose, now Roszdravnadzor narrowed their circle. For examination quality for the first time introduced drugs accredited two Federal institutions: "Scientific center of expertise of medical application products", Ministry of healthcare of Russia and Federal state budgetary institution "Information and methodological center for expertise, recording and analysis of circulation of medical products" of Roszdravnadzor. These institutions are also entitled to send samples of first-time drugs to other laboratories accredited in the national accreditation system for testing.

To enter into civil circulation of immunobiological drugs, it is envisaged to create a Commission on their quality, which will include representatives of the Ministry of health of Russia, Roszdravnadzor, the Ministry of industry and trade of Russia, pharmaceutical associations and leading experts in this field. On the basis of the decision of the Commission, the volume of necessary tests of an immunobiological drug may be changed.

The bill also proposes the separation of the term "medicines" into "medicines for medical use" and "medicines for veterinary use".

Ministry of industry and trade of the Russian Federation prepared and published on the website regulation.gov.ru draft Federal law "on amendments to the Federal law" on circulation of medicines "and the Federal law" on licensing of certain activities".

The document provides that from January 1, 2021, registration of new medicines for medical use will be carried out only within the rules of the Eurasian economic Union (EAEU). The possibility of using for this purpose the national legislation of the member States shall be abolished from this time.

The bill also regulates the issues of inspection of manufacturers of medicines: now manufacturers will receive a certificate of compliance with the requirements of good manufacturing practice of the Eurasian economic Union.

In terms of creating a legislative framework for the possibility of introducing compulsory licensing, the state Duma introduced Bill No. 842633-7 "on amending article 1360 of the Civil code of the Russian Federation". These amendments will allow the Government of the Russian Federation to make decisions on the use of an invention, utility model or industrial design without the consent of the patentee, notifying him about it as soon as possible and paying him commensurate compensation. The method of determining the amount of compensation and the procedure for its payment are approved by the Government of the Russian Federation.

The possibility of compulsory influence of the state of the right holder is provided by international acts. The following provisions shall be observed:

  • permission for such use must be based on the individual characteristics of the item;
  • the scope and duration of such use is limited to the purposes for which it has been authorized;
  • use is not exclusive and is not subject to assignment (assignment), except that part of the enterprise or its intangible assets, which carry out such use;
  • any such use shall be authorized predominantly for the supply of the domestic market of the member authorizing the compulsory license;
  • the validity of any decisions relating to the authorization of such use, as well as matters relating to remuneration, may be subject to judicial review or other independent review by a separate higher authority of the said member.

The right of compulsory licensing can be used in case of extreme necessity related to the provision of defense and security, including the protection of life and health of citizens.

  • The Russian government has approved the Decree of the RF Government dated 15.11.2019 № 1459 "About modification of some acts of the Government of the Russian Federation" allowing the conduct of Roszdravnadzor control of procurement of medicines and honey.products'.


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