Russia approves the mechanism for introducing the medicines into circulation

A draft federal law on the introduction of medicinal products for human use into civil circulation was prepared by the Russian Ministry of Health.

The bill proposes to establish a more effective legal regulation of relations associated with the elaboration, application and enforcement of requirements in the area of circulation of medicinal products for human use, namely, by establishing a mechanism for release control of medicines coming into the civil circulation in Russia.

For medicinal products imported to Russia, the organization handling these imports will have to submit to Roszdravnadzor the manufacturer’s certificate and confirmation by the authorized official of that organization stating that the imported medicinal product complies with the requirements established at its state registration.

For the first three batches of medicinal product for human use, which was for the first time manufactured in Russia or imported for the first time to Russia, the bill proposes to additionally submit to Roszdravnadzor the protocol of tests conducted by the federal state budgetary institutions accredited in accordance with the laws on accreditation and subordinated to the Russian Ministry of Health. The procedure for issuing such protocol will be established by the Government of Russia.

The bill proposes that each batch of immunobiological medicinal products (both Russian-made and imported) will be introduced into the civil circulation based on the permit issued by Roszdravnadzor which in turn will be based on the conclusion issued by the federal institution on whether that batch complies with the requirements established at the state registration of the medicinal product. The procedure for issuing all these documents will be established by the Government of Russia.