Creation of Union market for pharmaceuticals in the EAEU
The Union market of medicines and medical products will enter into force on May 6, 2017. It will facilitate the procedure of application for drug sale and distribution registration certificate, as well as reduce administrative costs.
The Commission and the best experts of the five states of the EAEU have prepared all necessary documents to create the effective Union market of medicines. It provides for registration of medicines and medical devices, uniform production standard, uniform rules for clinical studies etc. These documents will also help to detect and remove medicinal products, the safety and effectiveness of which are not fully studied, and the production of which does not meet the standards of good manufacturing practices.
There will be a transition period that will ensure a smooth transition from national to unified regulation. It will prevent disruptions in the health systems of the EAEU countries and help pharmaceutical companies adapt to new requirements as comfortable as possible. In addition, up to December 31, 2020 the manufacturer is entitled to choose according to which regulation (national or single) the medicines will be registered. All drugs that will registered under national regulations before December 31, 2020, must be re-registered under the rules of the Union market until December 31, 2025. When submitting a dossier for drug registration up to December 31, 2018, the manufacturer has a right to provide national documents confirming the conformity of its production with the requirements of the national GMP rules, instead of the EAEU GMP certificate.
If you would like to receive more information on the list of required documents for import of your goods into the Russian Federation please contact us via email email@example.com