Since January 1, 2015, citizens of the Russian Federation, the Republic of Belarus, the Republic of Kazakhstan, the Republic of Armenia, and the Kyrgyzstan have been working in the conditions of the Eurasian Economic Union. In the Russian health care, as in every Union country, a national regulatory system has been established. Currently, within the EAEU, a supranational system for regulating the circulation of medicines and medical devices is being created to protect consumers from fraud and substandard medicines, including in the veterinary pharmaceuticals industry.
This topic raised an active wave of discussions in the veterinary community, as the approval of the bill will be followed by significant changes in the pharmaceutical industry.
We have prepared for you an informational material, where you set out the essence of the upcoming changes.
The first thing that consumers need to know: until December 31, 2020, a drug manufacturer decides independently how its products will be registered – these may be national or unified registration regulations.
To date, pharmaceutical manufacturers who sell pharmaceutical products throughout the Union, are working with a single registration. Given that the EAEC countries follow the principle of mutual recognition, after having passed the registration procedure in one of the Union countries (for example, in Kazakhstan), the manufacturer is able to trade freely throughout the Union territory (for example, in Russia, Belarus, etc., except Kyrgyzstan).
What will happen after December 31, 2020?
All pharmaceutical companies that registered their products according to national regulations, will have to bring their products in compliance with the EAEU’s requirements to sell them in the Customs Union. After January 2021, every medicine marketed in the EAEU must meet the Union’s requirements; otherwise, its sale will be possible only in the country where the registration procedure has been passed. Manufacturers shall bring the registration of their medicines in accordance with the EAEU’s regulations before the end of 2025.
What is the difficulty, and where will it lead us?
For efficient operation of the single medicine market, the EAEU Commission has developed documents which affect the production, preclinical and clinical tests, the quality control, the preparation of registration files, and the drug distribution.
To meet the start of the full functioning of the single market with a high level of readiness and compliance, pharmaceutical manufacturers need to join the process of production facilities modernization. The procedure for adapting to new environment is resource-intensive, requiring the attraction of financial assets to purchase equipment and to implement modern technology in manufacturing practice. Not every manufacturer will be able to meet new supranational requirements, and probably, many players will leave the Russian pharmaceutical market.
Russian consumers should consider such an innovation only in a positive light: the market will be cleared of drugs whose efficacy and safety have not been confirmed, and the production conditions do not meet the standards of good manufacturing practice. Today we can say that the EAEU, by analogy with the European Union, is creating a unified system where registration processes will be carried out according to supranational regulations.