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Certification drugs

Medicines (drugs) are funds made of synthetic, plant or animal materials which are intended for the prevention and treatment of various diseases.

Certification of drugs is a necessary condition for the implementation of the product in the territory of the Russian Federation. The result of this procedure serves as a proof of the product’s conformity to the characteristics established by Russian law. The applicant gets a supporting document – the certificate of conformity GOST R.

For some types of drugs it is a must to obtain the state registration certificate or expert opinion by Rosportebnadzor. For any advice on the need for registration of a document you can refer to the certification center in Novosibirsk.

How to certify drugs in Russia?

For certification of drugs you should contact a qualified certification authority with state accreditation for this activity. You must provide it with the following documents:

    • The application form for a certificate, completed by the applicant.
    • Constituent and statutory documents (certified copies).
    • Identification code and company’s BIN.
    • Medication description and documentation.
    • Specifications (if not covered by technical regulations state against which to check the characteristics of the product).
    • Rental documents or the document which confirms the ownership of the premises in which these drugs are produced.
    • The state registration certificate (for certain types of drugs).
    • The contract for the supply and detailed information on the manufacturer, if the client is a supplier and not a manufacturer of drugs.
    • If there is any, the previously issued certificates of conformity.

After receiving all the documents and samples needed for laboratory tests, the  experts of the center study the samples, perform laboratory researches and write the test protocols. In case of non-compliance of the product to the established norms and requirements the CA may reject the issuance of the supporting documents.

For any advice on the certification of all kinds of drugs, you can contact the experts of our CA in Novosibirsk.

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