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Main  >  News  >  The EAEU extended the mutual recognition of national GMP certificates until 2025

The EAEU extended the mutual recognition of national GMP certificates until 2025

These changes will make it possible to exclude the resumption of repeated inspections of drug manufacturers from January 1, 2021.

On September 4, the Council of the Eurasian Economic Commission expanded the provisions of the Decision of the Council of the Commission dated November 3, 2016 No. 93 "On recognition of the results of inspection of drug production" in terms of mutual recognition during the national registration of GMP certificates of the Union due to their use for drugs manufactured outside the Eurasian economic union.

For the period from 2021 to 2025, mutual recognition has been established,

• firstly, national GMP certificates of the states of the Eurasian Economic Union,

• secondly, the Union's GMP certificates when making changes to the registration dossier and renewing national registration certificates for medicines produced in the EAEU,

• thirdly, at the national registration of the Union's GMP certificates for medicines produced in third countries.

 These changes will make it possible to exclude the resumption of repeated inspections of drug manufacturers by the authorized bodies of the EAEU states from January 1, 2021. Their goal is to reduce the costs of regulators and manufacturers, and increase the availability of medicines.

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