In general, the
Eurasian Economic Commission (EEC) has completed formation of regulatory
framework of the Eurasian Economic Union (EAEU) for launching the common market
of medical products. On the legal portal of the EAEU, Rules for registration
and examination of safety, quality and efficacy of medical products approved by
Decision of the EEC Council No. 46 of February 12, 2016.
The document
establishes legal regulation of relations in the field of applying mandatory
requirements for medical products and conducting by the EAEU countries the
examination for compliance with these requirements.
Regulatory framework
for launching the common market of medical products is formed in accordance
with the Treaty on the EAEU and the Agreement on common principles and rules
for circulation of medical products (medical devices and equipment) within the
Eurasian Economic Union.
A unified regulation of
the market of medical products circulated in the Union countries requires the
use of best practices. This will improve the quality of medical products. At
the same time, a unified regulation of this market will reduce the barriers
associated with the peculiarities of national markets of medical products.
The procedure for
registration of medical products involves the mutual recognition by the
authorised authorities of the Union of research and expertise (testing) results
acquired during execution of medical product registration procedures, and the
possibility of simultaneous release of products to the markets of all the
Member States.
This procedure will
reduce the costs of manufacturers for medical product registration by
eliminating the duplication of evaluation of safety and efficiency of medical
products, reducing registration period. It will also increase the availability
of medical products for the EAEU citizens.
It is expected that operation of the common
market of medical products in full will begin before the end of this year. Its
launch will not be a challenge for manufacturers of medical products. Until
December 31, 2021 within the EAEU two procedures for releasing medical products
in circulation will coexist - under uniform requirements of the Union and in
accordance with the legislation of the EAEU countries. During the six-year
transitional period, manufacturers will not only be able to bring manufacture
of medical products in compliance with the new requirements, but also to
critically look at the portfolio of manufactured medical products, which they
own.