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The Senate adopted the ratification of the protocols on the accession of Armenia to the agreement on rules of circulation of medicines and medical products in the EAEU

requirements of the quality management system of medical devices

Today at the plenary session of the Senate of Parliament of RK, deputies of chamber adopted the Law "About ratification of the Protocol on the accession of the Republic of Armenia to the Agreement on the unified principles and rules of circulation of medicines within the Eurasian Economic Union dated December 23, 2014" and "About ratification of the Protocol on the accession of the Republic of Armenia to the Agreement on common principles and rules of circulation of medical devices (medical products and medical equipment) within the Eurasian Economic Union dated December 23, 2014. 

The above mentioned agreement was signed at meeting of the Council of the Eurasian Economic Commission, held on December 23, 2014 in Moscow. The President of RK signed the Law of RK on ratification of these documents in October, 2015. Agreements establish uniform principles and rules of circulation on the territory of the member States of the Eurasian Economic Union (further EAEU) medicines in accordance with standards of appropriate pharmaceutical practices and medical devices that meet the requirements of the quality management system of medical devices.

After completing the registration procedure by the same rules, which are based on the principles and approaches of the European Union, medicines and medical devices will come into free circulation within the EAEU. This will be followed the requirements of national legislation on the use of the state language in the labeling of the drug, instructions for medical use and implementation of state control and supervision over the management.

The protocols on the accession of Armenia to the agreements approved by Presidential decree dated November 27, 2015.

Ratification of the protocols does not contradict to the national legislation of the Republic of Kazakhstan and promotes to the health of the population of the States members of EAEU by ensuring access to safe, effective and quality medicines and medical devices through adoption of measures necessary for the harmonization of legislation of member States of the EAEU in the field of circulation of medicines and medical products.

Ratification of these protocols will allow Kazakhstan to take its rightful place in the common market of medicines and medical devices in the Eurasian Economic Union and in the sphere of enhance the competitiveness of domestic pharmaceutical products. 

Changed on 23 June, 2016 - 11:33
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