News
14.12.2022 (Обновлено: 28.12.2022 11:29)
Roadmap for transiting to registration of medical products according to EAEU law approved
The Eurasian Economic Commission's Council has approved an action plan (roadmap) for transiting to registration of medical products according to the Union law. The roadmap enables considering all issues identified in the work of the common market of medical products since January 1, 2022, and includes activities of the Union countries' authorized bodies, as well as joint activities with the Eurasian Economic Commission.
The authorized bodies' activities for developing test capabilities include:
- constant analysis of problematic issues in the work of testing laboratories (centers);
- preparing proposals on measures to support the activities of testing laboratories (centers) and medical organizations (clinical trial sites);
- training of experts and inspectors required for work according to the Union's rules.
Joint activities with the Commission include:
- ensuring stable information exchange within the Union in the field of medical products circulation;
- further optimization of the procedure for registering medical products.
As Viktor Nazarenko, EEC Minister in charge of Technical Regulation, has noted, according to the plan the main part of the activities should be completed by year-end 2023. This will enable ensuring an unconditional transition to registering medical products under the Union's rules after the expiration of the agreement's transition period with due regard to its planned extension until the end of 2025.
The authorized bodies' activities for developing test capabilities include:
- constant analysis of problematic issues in the work of testing laboratories (centers);
- preparing proposals on measures to support the activities of testing laboratories (centers) and medical organizations (clinical trial sites);
- training of experts and inspectors required for work according to the Union's rules.
Joint activities with the Commission include:
- ensuring stable information exchange within the Union in the field of medical products circulation;
- further optimization of the procedure for registering medical products.
As Viktor Nazarenko, EEC Minister in charge of Technical Regulation, has noted, according to the plan the main part of the activities should be completed by year-end 2023. This will enable ensuring an unconditional transition to registering medical products under the Union's rules after the expiration of the agreement's transition period with due regard to its planned extension until the end of 2025.
