Registration of medicines in EAEU will be performed online

Print 23 November 2017
GMP News

The Eurasian Economic Union (EAEU) is completing the development of a unified information system that will facilitate the registration of medicinal products by businesses in the common market and provide complete information about these drugs to consumers.

“The integration component of the system is ready, and creation of its national segments will be completed soon. In December, we are planning to start testing,” said Valery Koreshkov, the Member of the Board (Minister) for Technical Regulation of the Eurasian Economic Commission (EEC), at the international scientific and practical conference “Single Market of Medicines in the Eurasian Economic Union: Current Approaches to Regulation and Enforcement.”

In his opening remarks to the conference, Valery Koreshkov said, “The latest scientific approaches to regulation of safety, quality and efficacy of medicinal products, the desire to meet international standards not only in spirit but also in letter served as the basis for the Union’s documents that helped to launch the common market of medicines.” After stressing the importance and scope of work done in this area, the Minister of EEC illustrated this with some figures – the regulatory framework of the Eurasian Economic Union, that was established in a very short period, includes 28 regulatory documents regulating all stages of medicines circulation. Another 67 documents are still being developed.

The EAEU register of medicines will include not only information about these drugs and instructions for their medical use, as it is currently the case for the national registers, but also documents regulating quality control. Moreover, it is important that all this information will be available for all Internet users. The exception will be the segments closed to the public and containing specialized expert materials intended exclusively for the authorities of EAEU countries.

It is important to understand that the release into circulation and sales of a medicinal product in the EAEU market will become possible, only if that medicine is included in the unified EAEU register.

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