From 1 January 2016 a general market of medicinal drugs and medical devices for the countries of the Eurasian Economic Union (Kazakhstan, Russia, Belarus, Kyrgyzstan and Armenia) will start functioning. Only medicinal products that comply with GMP standard («gold standard» confirming the efficacy, safety and quality of the drug) will be sold in the territory of the EAEU. This will provide the Kazakhs with an access to effective drugs at lower prices due to competition between producers from all over the EAEU.
Medicines and medical devices will have free circulation in the territory of the Eurasian Economic Union after registration by the uniform rules, which are based on principles and approaches of the European Union. At the same time, the national requirements for use of the state language when labeling the product, instructions for medical use, for implementation of state control and supervision over the management are followed.
In Kazakhstan, the main functions of safety, efficacy and quality control of drugs, medical devices and medical equipment are entrusted to the National Center for Expertise of medicines, medical devices and medical equipment of MHSD of Kazakhstan (hereinafter - NCEM).
This year, the Test Center of NCEM will be accredited by the European Directorate for the Quality Control of Medicines of the Council of Europe (EDQM); such membership will ensure the recognition of the results of tests carried out by NCEM at the international level, as well as the exchange of experiences with European countries in testing of medicines.
For the mutual recognition of inspections in the field of pharmaceuticals, medical products and medical equipment, all the countries of the EAEU should enter into PIC / S - the Pharmaceutical Inspection Convention and the System of Cooperation of Pharmaceutical Inspections - two international agreements between regulatory bodies of pharmaceutical sectors of the countries providing joint active and constructive cooperation in the field of GMP. Kazakhstan and Belarus have already applied to enter into PIC / S.
Let’s recall that on May 29, 2014 the Treaty on the Eurasian Economic Union, which provides for the creation of a general market of goods, services, capital and labor of the member states of the Union, was signed. The agreements on uniform principles and rules of circulation of medicines and medical devices were signed on December 23, 2014.