20.10.2023 (Обновлено: 26.10.2023 17:08)

EAEU Rules for registration and examination of medicines amended

The Eurasian Economic Union's Council updated the Rules for Registration and Examination of Medicines in the EAEU, taking into account the experience of their enforcement in the procedure for bringing marketing authorization applications for medicinal products into compliance with the requirements of the Union and registration of medicinal products. The rules for issuing indefinite marketing authorizations for medicines within the framework of the relevant procedure are now adjusted.

Additional safety measures were established for the use of medicinal products, which can be introduced at the request of the authorized authority.

Duplication of documents submitted for registration or control and inspection procedures when assessing the procedure and quality of clinical trials is excluded.

The decision will allow to optimize administrative procedures related to bringing marketing authorization applications for medicines into compliance with the EAEU requirements. Ultimately, this will help ensure the availability of medicines to the population.