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Mutual recognition of national GMP certificates of EAEU States extended

Mutual recognition of national GMP certificates of EAEU States extended

9/4/2020

On September 4, the Eurasian Economic Commission’s Council expanded the provisions of Decision No. 93 of the Commission’s Council dated November 3, 2016 "On recognizing inspection results of manufacturing operations" in terms of mutual recognition of the Union’s GMP certificates upon national registration through their application for pharmaceuticals manufactured outside the Eurasian Economic Union.


Mutual recognition has been established for the period from 2021 till 2025
first in respect of national GMP certificates of the Eurasian Economic Union States, second, the Union’s GMP certificates when amending master files and extending national registration certificates for medicines manufactured in the EAEU and
third the national registration of the Union's GMP certificates for medicines manufactured in third countries.

These amendments will enable preventing the resumption of repeated inspections of pharmaceutical manufacturers by the EAEU States' authorized bodies since January 1, 2021. Their objective is to reduce costs of regulatory authorities and manufacturers as well as increase the availability of pharmaceuticals



BEFORE

 

before December 31, 2020

from January 01, 2021 till December 31, 2025

 

Registration, making amendments and re-registration

Making amendments and re-registration

Union's pharmaceuticals

EAEU GMP and Member States' GMP

derecognition

Third countries' pharmaceuticals

no recognition

no recognition

 

NOW

 

before December 31, 2020

from January 01, 2021 till December 31, 2025

 

Registration, making amendments and re-registration

Making amendments and re-registration

Union's pharmaceuticals

EAEU GMP and Member States' GMP

EAEU GMP and Member States' GMP

Third countries' pharmaceuticals

EAEU GMP

EAEU GMP