EAEU GMP is no longer required for submitting registration dossiers for medicines

A GMP quality certificate is an official document confirming that the industrial facility itself and the medicinal products it produces comply with the requirements of good manufacturing practice. Certificates are issued by the Ministry of Industry and Trade.

A draft decision has been adopted according to which, when registering or applying for a registration certificate in accordance with the requirements of the EAEU, pharmaceutical companies will receive an indefinite right to provide a package of supporting documents instead of the EAEU GMP certificate, but they will have to commit to an inspection within three years after receiving the certificate:

Instead of the EAEU GMP certificate, it will be possible to provide:

1. valid documents confirming the compliance of the production site (production sites) producing the finished dosage form and producing the quality control of the medicinal product with the requirements of good manufacturing practice, issued to the manufacturer of the medicinal product by the authorized body of the country of origin of the medicinal product;
2. a copy of the report on the results of the last inspection of the production site (production sites at the production stages) conducted by the authorized body of the country of origin and (or) other authorized body during the last 3 years;
3. information on the results of all inspections of this production site (production sites) for compliance with the requirements of good manufacturing practices conducted over the past 3 years;
4. information on complaints regarding the quality of medicines produced at this production site (production sites) for the last 3 years;
5. consent to conduct pharmaceutical inspection for compliance with the requirements of good manufacturing practice of the Union;
6. a copy of the main dossier (master file) of the production site (production sites).

The draft of the 14th edition of the “Rules for the registration and examination of medicinal products for medical use”, published on the legal portal of the Eurasian Economic Union, will also affect other changes:  

• registration certificates that were not re-registered before the end of 2025 in accordance with the EAEU rules, but documents for re-registration were submitted, will be extended for three years (if submitted in the state of recognition) and for two years (if submitted in the territory of the reference state).
• The format of the expert report and its appendices has been revised and expanded in accordance with established law enforcement practice and the actual experience of member countries.
• It has become possible to make changes to the registration dossier in the reference state during the recognition procedure in the recognition states.
• The approaches to making changes that concern only the recognition states have been clarified.

The draft will enter into force 30 calendar days after its official publication on the EAEU legal portal. The draft is expected to be published at the end of April.