Renewal of Marketing Authorization for a Healthcare Product

about-the-service

This service enables applicants to register healthcare products, including general pharmaceutical products, which are used for the promotion of general human health and are not intended for the diagnosis, treatment, cure, or prevention of any disease. Such products do not require a prescription or direct medical supervision for their use. The scope includes dietary supplements, antiseptics and disinfectants, herbal products, and cosmetics with a medical effect

service-process

• Log in using UAE PASS to start the service.
• Fill out the application form.
• Attach the required documents.
• Pay the fees.
• Submit the application.
• Issue the marketing authorization certificate for healthcare products, valid for five years from the date of the committee’s approval.

conditions-and-requirements

• Marketing Authorization Holder companies must be registered by Emirates Drug Establishment before they could register their products.

required-documents

• Application form for renewal of registration of pharmaceutical products with general sale, signed and stamped by company
• A valid manufacturing certificate of the factory issued by EDE.
• The original registration certificate issued by EDE.
• A new copy of the product registration certificate issued by the competent authorities in the country of origin, certified by the UAE Embassy.
• A valid GMP registration certificate.
• A copy of the detailed product formulation, including active and inactive ingredients, along with their quantities and the functions of the inactive ingredients.
• A copy of all minor changes certificates issued by EDE
• The outer cover, the inner poster and the internal leaflet