EAEU extended circulation of medical products previously registered under national rules

The Eurasian Economic Union countries have completed the procedures for signing a protocol on amending the Agreement on Common Principles and Rules for the Circulation of Medical Products in the EAEU dated December 23, 2014. It has been applied in a temporary mode since December 28 this year and until all States complete the ratification procedures. 

The amendments provide that medical products, previously registered in the manner prescribed by the national legislation of the Union countries, may be put into circulation before expiration of the documents, confirming their registration, and circulate on the territory of this State. Amendments to the registration documents of such medical products are allowed given that the relevant application is

submitted before December 31, 2026. The amendments are aimed to ensure smooth and natural formation of a common market for medical products within the Union, which allows maintaining the provision of healthcare systems of the Union Member States with medical products at an appropriate level. At the same time, the requirements established by Union's law for the quality, safety and efficacy of newly introduced medical products are ensured. Along with that, since January 1, 2022 new medical devices will only be registered under the Eurasian Economic Union's rules.