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Amendments to the Law on Circulation of Medicines

Russian President Vladimir Putin signed a federal law that establishes the ability of manufacturers of medical devices to purchase the pharmaceutical substance ethanol for their manufacture, the document was published on the official Internet portal of legal information publication.pravo.gov.ru.

The federal law was adopted by the State Duma on December 9, 2020 and approved by the Federation Council on December 16, 2020.

According to part 11 of Article 18 of the Federal Law "On the Circulation of Medicines", a generic medicinal product for medical use (in some cases) must contain the same excipients in the same quantities as the reference medicinal product (the drug with which the generic drug is compared when state registration). If the compositions of the excipients differ, the applicant for the medicinal product must provide evidence that the excipients used do not affect the safety and / or efficacy of the medicinal product. If the applicant is unable to provide such evidence and (or) does not have access to the relevant data, he must, in the manner prescribed by the authorized federal executive body, conduct appropriate studies to prove the absence of the effect of various excipients or assistive devices on safety and ( or) the effectiveness of the medicinal product.

The Ministry of Health of the Russian Federation has not established such a procedure, but in practice the norms of the Eurasian Economic Union are applied (in particular, the Rules for conducting bioequivalence studies of medicinal products within the Eurasian Economic Union, approved by the decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 85), therefore, the Federal the law establishes that the relevant studies of the medicinal product must be carried out in accordance with the acts constituting the law of the Eurasian Economic Union.

In addition, the Federal Law amends Article 45 of the Federal Law “On Circulation of Medicines”, according to which the procedure and conditions for the sale of the pharmaceutical substance of ethyl alcohol (ethanol) established for drug manufacturers will also apply to manufacturers of medical devices.

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