Definition of Organization, Powers and Duties of the Ethiopian Food and Drug Authority Council of Ministers Regulation (NO. 531/2023).

These Regulations provide for the definition of Organization, Powers and Duties of the Ethiopian Food and Drug Authority Council of Ministers. The objective of the Authority is to protect the public health by regulating food, medicine and medical devices, blood and blood products, traditional, complementary or alternative medicine, cosmetics, tobacco, quality control service provider, bioequivalence centers and other products and services entrusted to the Authority to regulate.
The Authority shall have the following powers and duties: 1) Initiate and submit to the Ministry a policy, strategy and law ideas in regulatory perspective for Regulation; 2) Register, acknowledge, issue market authorization, special regulatory license for regulated products and take appropriate administrative measures; 3) Issue and enforce regulatory criteria concerning regulated product; enforce Ethiopian mandatory standards; initiate national standards and implement same upon approval; 4) Issue certificate of competency or special regulatory license to importer, exporter, for ; 5) Inspect, investigate, including retail, any place or establishment in regions and collect sample of regulated products that entered into the market with authorization of the Authority or illicit product; take appropriate administrative measures against the product and cause the concerned body to take the appropriate measures against the establishment; 6) Issue import permit to regulated products, raw materials and packaging materials to be used for such products; 7) Issue certificate of health to raw, semi- processed or processed food; 8) Prohibit manufacturing, importing, or sale of food with unhealthy ingredient; cause the amount of unhealthy content or ingredient within a food be restricted; regulate health warning, labeling, advertisement and related matters; 9)Notify and create awareness, as appropriate, to the public and stakeholders about registered or authorized or illicit products, establishments, administrative measures taken and the Authority`s regulatory functions; 10) Establish response system, perspective to regulatory, to emergency caused by a regulated product; establish a system that enables utilization of regulated product for emergency response; work in collaboration with concerned bodies; among others.