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The procedure for circulation of biosimilars for research has been developed

The Ministry of Health of the Russian Federation has developed a procedure for the circulation of generic drugs, biosimilar (biosimilar) drugs (biosimilars) before the end of the period established by the Ministry of Health of the Russian Federation for conducting studies of bioequivalence or therapeutic equivalence with respect to a reference drug or for setting indications for use and contraindications for use in instructions for medical use of the medicinal product in accordance with the instructions for medical use of the reference product. The draft document was published on the regulation.gov.ru portal, its discussion will last until June 10, 2020.

- When the holder or owner of the reproduced medicinal product, biosimilar (biosimilar) medicinal product (biosimilar) receives a request from the Ministry for the need to submit reports on the results of relevant clinical trials of this medicinal product with the established federal state budgetary institution for the examination of medicinal products specified in Article 15 of the Federal Law dated April 12, 2010 No. 61-FZ "On Circulation of Medicines" for a period sufficient for their implementation, but not more than three years, the holder or owner of a generic medicinal product, biosimilar (biosimilar) medicinal product (biosimilar) within twenty working days from the date of receipt of this request, he applies to the Ministry for permission to conduct a clinical trial of a generic medicinal product, biosimilar (biosimilar) medicinal product (biosimilar) in accordance with stat th 39 of the Federal Law.

- When the holder or owner of the reproduced medicinal product, biosimilar (biosimilar) medicinal product (biosimilar) receives a request from the Ministry for the need to bring indications for use and contraindications for use in the instructions for medical use of the medicinal product in accordance with the instructions for medical use of the reference medicinal product, the holder or the owner of a generic medicinal product, biosimilar (biosimilar) medicinal product (biosimilar), within five working days from the date of receipt of this request, applies to the Ministry with an application for amending the documents contained in the registration dossier for a registered medicinal product for medical use, in accordance with Article 30 of the Federal Law.

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