Russian Ministry receives authority to approve drugs for circulation in EAEU

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The Russian Government amended the Statute of the Ministry of Health of the Russian Federation. The corresponding Decree No. 1159 was signed by Prime Minister Dmitry Medvedev on September 25, 2017.

The new powers include the following:

  • Registering medicinal products intended for circulation in the common market of EAEU;
  • Approving the summary of product characteristics of the medicinal product, instructions for medical use (package insert), regulatory document on quality, layouts of packages, reconciliation of the risk management plan for the medicinal product during the registration of medicines intended for circulation in the common market of medicines within the Eurasian Economic Union (EAEU);
  • Collaborating with competent authorities of EAEU member states in the area of circulation of medicines, the Eurasian Economic Commission (EEC) and the Expert Committee on Medicinal Products under the EEC during the registration of medicines intended for circulation in the common market of medicines and on other issues of circulation of medicines within the Eurasian Economic Union (EAEU).

In addition, it was established that the Ministry of Health of Russia will issue (in accordance with the Decision of EEC Board No. 30 of April 21, 2015) its conclusion on imports of the following to the Russian Federation:

  • Unregistered medicines intended for providing medical care to a particular patient in accordance with the vital indications, or for providing medical assistance to a limited number of patients with a rare and/or extremely severe pathology;
  • Unregistered medicines intended for preventing and/or eliminating the effects of emergency situations;
  • Specific batches of drugs intended for use in clinical trials and/or tests.
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