The Cabinet of Ministers allowed to import medicines in foreign packaging within a year after registration in Russia

Within 12 months after registration in Russia, drugs for the treatment of orphan (rare) diseases and high-tech medicines can be supplied in foreign packages with a sticker in Russian. The corresponding resolution was issued by the Russian government, the press service of the Ministry of Health told Kommersant. This will increase the availability of these drugs for patients and allow them to start therapy in a timely manner, without waiting for foreign manufacturers to print packages and instructions in Russian.

Before the registration of the drug in Russia, it can be imported under a special procedure for unregistered drugs, including packaged in a foreign language. However, as soon as the drug receives a registration certificate, this mechanism automatically stops working. The release of Russified packaging takes several months, during which the drug may not be available, since it cannot be imported under any of the current schemes. At the same time, such drugs in some cases have no analogues on the market. The decree of the Government of the Russian Federation is aimed at resolving this issue, the Ministry of Health emphasized.

The press service of the Ministry added that the acceleration of the import of orphan drugs does not affect the quality control and safety of drugs, since control remains mandatory at all stages.

Natalia Kostarnova