22.05.2023 (Обновлено: 24.05.2023 09:36)

EEC Council approved Protocol on Amending Agreement on Common Principles and Rules for Circulation of Medicinal Products

The Eurasian Economic Commission's Council approved the Protocol on Amendments to the Agreement on Common Principles and Rules for the Circulation of Medicinal Products (Medical Devices and Equipment) within the Eurasian Economic Union providing for an extended list of medicinal products that are exempt from registration within the Union (Article 4, paragraph 11 of the Agreement).

The Protocol was developed on proposals from the Eurasian Economic Union countries taking into account the practice of applying regulatory legal acts in this area.

The document stipulates that registration requirements do not apply to all custom-made medicinal products intended solely for the personal use of patients; medicinal products imported for a particular patient to treat their life-threatening conditions; medicinal products manufactured for export; medicinal products in the form of packs, kits, sets and first aid kits made up from registered medicinal products and pharmaceuticals in accordance with the legislation of a Member State and intended for circulation in the territory of that Member State.

The Protocol will be submitted for internal legal procedures required for its signing.