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A package of temporary measures to accelerate the launch of drugs on the market was adopted in the EAEU

The Council of the Eurasian Economic Commission (EEC) adopted a package of temporary special measures in the field of circulation of medicines. This was reported in the press service of the EEC.

The authorized bodies in the field of drug circulation of all countries of the Eurasian Economic Union (EAEU) have the right to establish a special procedure for registering drugs in the event of a shortage or risk of its occurrence in the context of external economic impact measures.

“The decision of the Council makes it possible to automatically extend until the end of 2023 the validity of all permits issued in accordance with the law of the Union, that is, registration certificates of medicines and certificates of GMP compliance of the Union of production sites. It is also allowed to simultaneously perform inspections of production sites for compliance with GMP requirements, including through remote inspection, and registration of medicines under the rules of the Union, as well as conducting such GMP inspections in the post-registration mode. These norms will reduce the period for bringing medicines to the market, eliminate the risks associated with the occurrence of a shortage of medicines at the registration stage,” the message says.

The adopted package of measures is temporary and will remain in effect until December 31, 2023.

In addition, the EEC Council approved the second protocol to amend the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the EAEU. The document provides for the possibility of registering medical devices according to national rules until December 31, 2022.

“The extension of the transitional period for the national registration of medical devices takes into account the proposals of their manufacturers, including the ability to promptly take special measures to support the market at the national level in connection with the introduction of economic restrictive measures against certain EAEU countries. The protocol begins to be applied in the states of the Union, which have a regime of temporary application of international acts from the moment of its official publication,” the press service explained.

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