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Confirmation of GMP compliance as part of the transition to a single EAEU market

Starting January 1, 2021, only GMP certificates issued under the EAEU rules will be accepted and recognized within the EAEU. But national GMP certificates will be valid until their expiration date is 3 years; thus, if the pharmaceutical manufacturer received the national GMP certificate on 12/30/2020, this certificate will be valid until 2023. Thus, in accordance with the EAEK Decision No. 93 [1] until December 31, 2020, the authorized bodies in the process of state registration (re-registration, confirmation of registration, amendments to the registration dossier of a medicinal product) of medicines in accordance with the legislation of the Member State of the Eurasian Economic Union mutually recognize documents issued by authorized bodies of the Member States of the Eurasian Economic Union, confirming the conformity of drug production military preparations produced in the Member States of the Eurasian Economic Union, the requirements of good manufacturing practice of the Eurasian Economic Union, or the requirements of good manufacturing practice of the Member States of the Eurasian Economic Union. In this regard, manufacturers of pharmaceutical products in circulation on the EAEU market have many questions related to the GMP conformity assessment procedure.

Currently, all member states of the Eurasian Economic Union have formed their GMP-inspectorate. Almost all states conduct checks on pharmaceutical production for compliance with good practices in national law. Work is underway to harmonize national laws and bring local procedures to common EAEU rules. However, the actions of pharmaceutical companies - residents of the EAEU member states and non-residents within the framework of the current legislation of the member states remain not entirely clear. According to Madina Sotttaeva, Head of the International Cooperation Division of

Pharmaceutical Inspectorates of the Inspection and Expertise Department of the Federal State Institution “GILS and NP”, who will present Russia's position and proposals in the panel discussion “Confirmation of GMP compliance within the framework of the transition to a single market”, the EAEU law actually provides for 3 periods:

• “Until December 31, 2020, within the framework of which it is still difficult for the manufacturer to navigate where, to which inspectorate to apply for inspection, and to which Ministry of Health, and with which documents to go for registration (re-registration, confirmation of registration, amendments to the registration dossier of a medicinal product );
• January 1, 2021 - December 31, 2025 - a kind of transitional period, where a new registration is carried out only according to uniform rules, and re-registration, confirmation of registration, amendments to the registration dossier of a medicinal product are carried out in accordance with the laws of the Member States.
• January 1, 2026 from this period only the EAEU Rules will apply. Medicines registered in accordance with the laws of the Member States must be brought into compliance with the requirements of international treaties and acts constituting the law of the Union by December 31, 2025.

At the same time, for most manufacturers, the validity period of a nationally recognized GMP certificate will end. And the manufacturer is already thinking where and by what procedure to apply for re-registration, confirmation of compliance so that by 2026 he does not have to go through an inspection again, ”explains the representative of the Russian state GMP inspectorate.

Considering the indicated questions and requests from the pharmaceutical industry, on September 24, representatives of the EAEU member states' inspectors will gather at a panel discussion of the IV All-Russian GMP conference with international participation “Confirmation of GMP compliance as part of the transition to a single market”, where they will try to develop tactics and an action strategy for manufacturers medicines.

Date and place of the conference: September 23-25, 2019, Svetlogorsk (Kaliningrad region), the Yantar-Hall ICC (Lenin St., 11).

ATTENTION! Registration for the conference is held until September 13. Hurry up to choose the optimal conditions for participation on the event website.

[1] On the Procedure for the Recognition of Industrial Goods Jointly Produced by the Member States of the Eurasian Economic Union

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