{"id":3637,"date":"2022-12-28T09:32:10","date_gmt":"2022-12-28T09:32:10","guid":{"rendered":"https:\/\/bk.shalakany.ae\/?p=3637"},"modified":"2023-07-26T09:32:55","modified_gmt":"2023-07-26T09:32:55","slug":"supplements-and-complementary-medical-products-to-fall-under-eda-jurisdiction","status":"publish","type":"post","link":"https:\/\/shalakany.com\/fr\/supplements-and-complementary-medical-products-to-fall-under-eda-jurisdiction\/","title":{"rendered":"Supplements and Complementary Medical Products to Fall under EDA Jurisdiction"},"content":{"rendered":"

On 8 September 2022, the Egyptian Drug Authority (\u201cEDA<\/strong>\u201d) issued Decree No. 572 of 2022 (the \u201cDecree<\/strong>\u201d) transferring the registration of supplements and complementary medical products (collectively \u201cSupplements<\/strong>\u201d) from the EFSA to the EDA.<\/p>\n

We shall delve into the key highlights of the Decree as follows:<\/p>\n

Key highlights of the Decree<\/p>\n

Supplements are defined as\u00a0\u201cany substance or group of substances that has\/have a complementary medical effect used with the aim of treatment, prevention, restoration, correction or modification of physiological functions.\u201d<\/em><\/p>\n

The Decree prohibits the trade of Supplements outside any pharmaceutical establishments (e.g. trade of Supplements cannot occur in supplement stores).<\/p>\n

The Decree differentiates between the notification period of local and imported supplements whereas imported supplements have to pass through a transitional phase before being registered as local Supplements.<\/p>\n

The Decree is firm when it comes to Supplements\u2019 availability in the market. Their registration is revoked if they are not available for at least 18 consecutive months.<\/p>\n

The registration of all Supplements registered with other governmental entities such as EFSA must be submitted to the EDA within 6 months starting from 15 September 2022. Otherwise, manufacture or trade of any unduly registered Supplements will be prohibited.<\/p>\n

Following the issuance of the Decree, the EDA published on its\u00a0website<\/a>\u00a0executive guidelines on Supplements\u2019 registration (the \u201cGuidelines<\/strong>\u201d). The Guidelines detail the requirements and documentation needed for the approval of any supplements. The Guidelines differentiate between the registration of:<\/p>\n