Launch of the EAEU unified medicine and medical device markets

12.05.2017

Legal Update No. 597

Goltsblat BLP advises that, on 26 April 2017, the Eurasian Economic Commission (EEC) was notified that the Kyrgyz Republic had completed the domestic procedures for enactment of two protocols on the Republic of Armenia's accession to the agreements on common principles of and requirements on circulation of medicines and medical devices within the Eurasian Economic Union.

As of 6 May, an extensive set of the EEC decisions regulating the functioning of the unified medicine market came into effect ("On the Rules for Registration and Expert Review of Medicines for Medical Purposes", "On Approval of Dosage Form Classification", "On the Procedures for Forming and Maintaining a Unified Register of Registered Medicines of the Eurasian Economic Union and Information Data Bases on Medicine Circulation", "On Approval of the Requirements on Medical Prescription Information of Medicines and on the General Characteristics of Medicines for Medical Use", "On Approval of the Requirements on Labelling Medicines for Medical Use and Veterinary Medicines", "On Approval of the Rules for Good Manufacturing Practice of the Eurasian Economic Union" and other decisions).

Medical devices will be covered by the EEC decisions establishing the rules for classifying medical devices, forming and maintaining a unified information system, including the unified register of medical devices, rules for conducting trials (tests), requirements on special labelling, safety and effectiveness, and rules for classifying medical devices and other documents.

So the conditions have been created for the unified medicine and medical device markets in Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia.

As you probably remember, both the agreements on the common principles of and requirements on circulation of medicines and medical devices within the Eurasian Economic Union were signed on 23 December 2014 in Moscow. Medicines registered in the member states before the agreements on the unified principles came into effect are to be aligned with the EAEU requirements and rules by 31 December 2025. Documents confirming state registration of medical devices and issued by a competent authority before the agreement came into effect remain valid until their expiry but not beyond 31 December 2021.

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