Draft law, which is going to add rules on state registration of medical drugs, has been developed

The Ministry of Healthcare of the Russian Federation (“Minzdrav”) has prepared Draft law1 on improvement of the medical drug circulation legislation with regard to the Treaty on unified principles and rules of medical drugs circulation within the Eurasian Economic Union (“EEU”) dated 03.11.2016 No. 78.

Draft law stipulates the necessity of indicating in the registration application the information on ownership of intellectual rights on medical drugs, protected by patents valid on the territory of EEU’s member-state.

Besides the documents, required by clause 2 art. 18 of the Federal law dated 12.04.2010 “On medical drugs circulation”, the applicant will have to file the following documents with the registry authority:

  • valid patent on the territory of the Russian Federation with indication of patent’s number, date of issuance, patent term and patent owner; or the license agreement copy, allowing to produce and sell registered medicinal drug;
  • document, confirming the registration of a trademark on the territory of the Russian Federation, with the indication of certificate number, date of issuance, duration of a trademark and rightsholder. A certified copy of license agreement or confirmation of registration of granting of right to use a trademark is subject to filing if the applicant is not the rightsholder;
  • written confirmation of no infringement of third party’s intellectual rights.

The aforementioned novelties will be in use to the applications for registration filed after the Draft law will come into force.

At the same time, the holders and owners of marketing authorizations, registered before the date when novelties will come into effect, will have to provide the information on intellectual property right on the registered medical drug before the 1st of January 2020.

Draft law is going to ensure the implementation of EEU rules into national legislation and improve the readiness for transfer to united market of medical drugs in EEU as well as to simplify the procedure of bringing the registration dossiers to conformity with the EEU requirements.

As of the date of this publication, the Draft law is going through public discussions regarding its text and anti-corruption expertise.