OREANDA-NEWS The rules for registering and examining medicines have been revised in the Eurasian Economic Union. The press service of the Eurasian Economic Commission announced this on Wednesday, citing the decision of the EEC Council on May 29th.

The administrative aspect of the process for making changes to a registered medicine's registration dossier has been updated to take into account compliance with the law. The list of changes has been expanded, and the types of amendments that do not require expert review and can be made on a notification basis have been clarified.

According to the EEC, this decision will also optimize the preparation of registration dossier materials by pharmaceutical manufacturers.

The simplified procedure for making changes to a medicinal product's registration dossier will be applied to applications submitted starting from March 1st, 2024. This means that the provisions of the decision adopted by the Council will apply to legal relationships that have arisen since that date.