On February 25, a working meeting of experts was held at the Russian Union of Industrialists and Entrepreneurs (RSPP) to develop proposals for amending the Decision of the Council of the Eurasian Economic Commission of January 21, 2022 “On the Rules for regulating the circulation of veterinary medicinal products in the customs territory of the Eurasian Economic Union”.
At the beginning of the event, it was especially emphasized that the authors of the proposals support the initiatives of the authorized bodies of the EAEU member states aimed at extending the transition period for bringing registration dossiers into compliance with the requirements of the EAEU Rules, effective since March 13, 2024.
Many of the proposals presented to the experts relating to Annex 26 to the EAEU Rules – “Rules for conducting pharmaceutical inspections”, in particular:
1) Bring paragraph 5 into line with the approved form of the EAEU GMP Certificate in Annex 1: remove from the list of documents that are submitted to the authorized body to obtain a certificate, the list of veterinary medicinal products manufactured (planned for manufacturing) at the manufactured site, since the Certificate is issued for manufacturing operations and dosage forms.
2) Supplement paragraph 6: within 20 working days from the date of receipt of the relevant notification, the applicant shall provide the missing documents, to provide the applicant with additional time to correct the discrepancies in the submitted documents instead of having to submit a new application.
3) In paragraph 15, at the EAEU level, regulate the deadlines for the procedure for conducting a pharmaceutical inspection from the moment the authorized body makes a decision to conduct it: within a period not exceeding 160 working days, in order to avoid delays in the inspection process and allow participants in the circulation sphere to more accurately plan the cycles for bringing the dossier into compliance with the requirements of the EAEU Rules, registration, and confirmation of registration of veterinary medicines.
4) In paragraph 17, increase the period for sending the inspection program to the inspected entity: no later than 20 working days before the start of the inspection, to improve the preparation of the parties for the inspection and optimize the timing of the inspection.
5) In paragraph 32, change the conditions for issuing the EAEU GMP Certificate: subject to the elimination of Major non-conformities within the period specified in the CAPA plan, but not exceeding the validity period of the Certificate in the event of the elimination of Critical non-conformities by the manufacturer, or in the event of the absence of Critical non-conformities by the manufacturer (OR: subject to the elimination of all Critical non-conformities by the entity in the field of circulation of veterinary medicinal products).
6) Supplement with the following paragraph: the possibility of conducting inspections using remote interaction tools, since the absence of such a possibility creates additional difficulties when conducting joint inspections, which require synchronizing the participation of representatives of all Member States.
7) Supplement with a clause on the possibility of issuing a new EAEU GMP Certificate with the expiration date of the previously issued Certificate, to provide the opportunity to update information (in terms of administrative changes that do not affect the actual place of manufacturing) in the current Certificate without the need to conduct a repeat pharmaceutical inspection.
Interested members of the RSPP Commission on the Agro-Industrial Complex and Food Security, representatives of industry unions and associations, leading agro-industrial companies and federal executive bodies were invited to participate in this event.
