Tuesday, August 28 2018 14:20

ArmInfo. The Eurasian Economic Commission (EEC) has completed the formation of a single market of medicines for the Eurasian Economic Union(EEU).  According to the press service of the EEC, this was stated by Valery Koreshkov, member of the Board (Minister) for Technical Regulation of the Eurasian Economic Commission (EEC) at the All-Russian GMP conference with international participation "Russia and the World. Management of the growth potential of the pharmaceutical market''.

 

"We fulfilled the main task that we were given  in the framework of the Eurasian Economic Union (EEU) - to ensure access of the population and health professionals to safe, high-quality and effective medicines. A legal and information base for the work of a single market of medicines has been established, "the EEC minister said.

 

According to him, the complex testing of the information system of the Union was successfully completed, which is intended to ensure all processes of registration of medicines. The authorized bodies of the EEU countries checked and confirmed the possibility of a single electronic registration. As of August of this year, the first six applications for registration of medicines under Union rules have been adopted in Kazakhstan, and two more - in Belarus. In the near future, other member states are ready to start actively using the Union information system.

 

Valery Koreshkov noted that the inspection of the GMP rules of the Union has been fully developed. The first two applications for conducting such an inspection have been adopted in Belarus. The manufacturer, ready to undergo the corresponding procedure, can send an application to any of the inspectors of the EEU countries.

 

As the Minister of the EEC  has stated, the Union normative base in the field of drug circulation represents a system of 35 normative acts. These are the 22 decisions of the Council of the EEC, which have adopted all the appropriate practices in the field of drug circulation - GMP, GCP, GLP, GDP, GVP. This group also includes the main documents on the inspection of production, the confirmation of the equivalence of copied drugs, the development and study of biological medicinal products.

 

Six decisions of the Board of the Commission established requirements for lists of prescription and non- prescription drugs, a nomenclature of ready-made dosage forms, approaches to validation of analytical techniques, and uniform rules for the study of drug stability. Thanks to unified approaches to the validation of analytical methods, the results of drug quality control will be recognized by all control laboratories of the Union. Unified rules for the study of stability will preserve the properties of the medicinal product throughout the declared shelf life, and thus ensure access to the market for quality products.  The seven recommendations of the EEC Collegium establish approaches to water treatment and validation of production processes, which allows confirming the stability of the production process in accordance with uniform principles and rules.

 

Thus, all conditions have been established for the free movement in the Union of safe, high-quality and effective medicines that will help to preserve health for millions of citizens of the EEU states.