Public consultations on the draft decision of the EAC Council “Amending the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 93”, concerning the issue of recognition of the results of inspections of drug production site during the period of 2020-2025 has begun on the 25th of December 2019. The document is published on the docs.eaeunion.org portal. Public consultation of the document will last until January 24, 2020.
In the framework of the transition to a single market, the EAEU legislation provides 3 transitional periods for drug manufacturers, following which the drugs registered in accordance with the laws of the Member States should be brought into compliance with the requirements of EAEU legislation. Rules of the Union will only be applicable to all manufacturing sites from January 1, 2026.
Registration of any medicinal product until December 31, 2020 may be carried out by the choice of the applicant either in accordance with the legislation of the Union or in accordance with the legislation of a Member State.
Simultaneously with the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 93 “On the Recognition of the Results of Inspection of the drugs manufacturing sites” it was established that the authorized bodies of the Member States mutually recognize the documents issued by the authorities of the Member States confirming the compliance of the drugs manufacturing site produced only in the Member States with the requirements of good manufacturing practices of the EAEU or the requirements of good manufacturing practices of the EAEU Member States during state registration (renewal, confirmation of registration, variations) of medicinal products, in accordance with the legislation of a Member State until December 31, 2020.
As explained in the informational and analytical reference to the draft decision, the document and the mechanisms presented therein are aimed for solving the problem of the possibility to provide documents issued by authorized bodies of the Member States confirming the compliance of the drugs manufacturing site requirements of the good manufacturing practice of the Union, in order to eliminate the need for duplication of repeated inspections of drug manufacturers by authorized bodies of Member States during renewal, confirmation of registration, variations in accordance with the legislation of the EAEU Member State until December 31, 2025. This will also impact (reduce) the time required for regulatory procedures.
According to the draft decision posted on the EAC portal,
- the authorized bodies of the EAEU Member States mutually recognize documents issued by authorized bodies of the Member States of the Union, confirming the compliance of the drugs manufacturing site requirements of the good manufacturing practice of the EAEU or for medicines manufactured in EAEU Member States to the requirements of good manufacturing practices of the EAEU Member States during state registration (renewal, confirmation of registration, variations) of medicines in accordance with national law until December 31, 2020.
- the authorized bodies of the EAEU Member States mutually recognize documents issued by authorized bodies of the EAEU member states confirming the compliance of the drugs manufacturing site requirements of the good manufacturing practice of the EAEU or medicines manufactured in EAEU Member States to the requirements of good manufacturing practices of the EAEU Member States during renewal, confirmation of registration, variations in accordance with the legislation of the EAEU member state from January 1, 2021 till December 31, 2025
The creators of the draft specify that among the previously presented alternative solutions termination of Council Decision No. 93 was considered upon reaching the specified period for the recognition of certificates. However, this alternative could lead to the resumption of the practice of conducting repeated inspections by the authorized bodies of the Member States of drug manufacturers and, accordingly, the need to conduct inspections of each production site at least 5 times (by each of the pharmaceutical inspectorates of the EAEU Member States). Such an approach threatened a significant burden on the pharmaceutical inspectorates of the EAEU Member States, conducting repeated inspections manufacturers of drugs by the authorized bodies of Member States, increasing costs of regulatory authorities and manufacturers, increasing the time for registration of drugs in Member States, had risks of drug defects.