PhEB: Pre-authorization Issues of Placing Pharmaceuticals on the Market

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This is a Special Video Series describing principles of operation of the Russian Market of Human Medicinal Products.

PhED highlights what is happening in this area for foreign companies and other interested parties for whom Russian is not the mother tongue.

This video describes general regulatory framework and main pre-authorization issues, including GMP certification, non-clinical, and clinical testing.

PhED hopes that the provided information will help you to understand the basics of placing medicinal products for human use on Russian pharmaceutical market. The rules are not that stringent but rather protective. At the same time, great efforts are being made to develop a robust rules and procedures in the EAEU legal framework.

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