Regulation of circulation of medicines and medical devices in the EAEU

The Eurasian Economic Commission (EEC) hosted meetings of working groups to regulate the circulation of medicines and medical devices in the Eurasian Economic Union (EAEU). The meeting participants considered the preparation of new documents in these areas and topical issues related to the beginning of the enforcement of the already adopted normative legal acts of the Commission.

“We are faced with the priority tasks related to the implementation of the documents adopted by the Commission into the regulatory practice of the EAEU countries,” said Valery Koreshkov, member of the Board of the Commission (Minister) for Technical Regulation, “the development of the Union Pharmacopoeia, the preparation of custom sets of regulatory documents and the translation of the adopted documents into English. … This will allow market participants not only on the territory of the Union, but also outside it to effectively use the adopted regulatory system. “

The EEC Minister stressed that the pharmaceutical community, state authorized bodies of the four states of the Union and business representatives are awaiting the ratification by Kyrgyzstan of the protocols on Armenia’s accession to the Agreements on the regulation of the circulation of medicines and medical devices in the EAEU. The entry into force of the documents of the Commission on Medicines and Medical Devices depends on the decision of the Kyrgyz side.

The participants in the meeting of the working group on medicines reviewed the draft documents of the Commission on good practice in the cultivation and collection of medicinal plants, quality requirements for medicinal products from herbal raw materials, requirements for aseptic rooms and guidelines for the validation of analytical methods.

At the meeting of the working group on medical devices, proposals and comments to the draft regulations on the EEC Medical Devices Advisory Committee and the list of standards were considered, as a result of which, on a voluntary basis, compliance of the medical device with the General Requirements for the Safety and Efficiency of Medical Devices, the requirements for their labeling and operational documentation is ensured on th

em. Source: http://www.eurasiancommission.org/