Registration of medications in Armenia

The common market of medications in the EAEU

The common markets of medications and medical wares in EAEU will start to function from January 1, 2016. At December, 23, 2014, in Moscow were signed corresponding agreements that establish the common principles and rules of appeal of medications and medical wares in the framework of the Eurasian Economic Union.

The authorized organs of Member States of Union will register the medications and medical devices, applying to the EAEU. The creation of a special supranational organ which would issue the registration certificates of the medications or medical wares is not envisaged by agreements from December, 23, 2014. Selecting of the reviewer country during the registration of a medication or medical ware for the appeal on the territory of the Union remains after the applicant and will be carried out in accordance with the rules of registration and examination which accepted by Decision of ECE.

The transition periods for the appeal of the products that registered before January, 1, 2016, is 10 years for medications and 5 years – for medical wares, by this term it’s necessary to bring them into conformity with the unified requirements and rules that established in the framework of the Union.

There will apply the national pharmacopoeias of the Member States of the Union before the approval of the EAEU Pharmacopeia, taking into account the provisions of the Concept of the harmonization of state pharmacopoeias of Member States of the Union, prepared in accordance with the Agreement about the common principles and rules of appeal of medications and medical wares in the framework of the Eurasian Economic Union signed December, 23, 2014.

 

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