Issuance of a Certificate of Amendment to the Registered Marketing Authorization Data for a Medical Product

Service Description

This service enables applicants to submit requests for the issuance of the necessary approvals to amend any of the details of medical products that have been granted marketing authorization

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 certificate for amendment of marketing authorization data for a medical product.

Conditions & Requirements

• Minor variation requests for medical products shall not be accepted after the expiry of the issued marketing authorization, unless there is an active application for its renewal.
• No documents shall be accepted unless they are submitted on official papers bearing the name and logo of the concerned company.
• Proposed variations shall not be accepted unless evidence is provided confirming their approval by the competent authorities in the country of origin, where applicable.

Required Documents

• Application of minor variation of the pharmaceutical product signed and stamped by the company.
• Documents required for minor variations in:
• Medicines (Conventional & Biological)
• Healthcare Products
• Medical Device
• Relevant minor change documentation, according to the current Minor Change Guidelines for Medical Products Registered in the United Arab Emirates
• A copy of the valid marketing authorization certificate issued by EDE.
• A copy of valid manufacturing site registration certificate issued by EDE
• The outer and inner packaging and leaflet.
• A sample of the product with a certificate of analysis (for certain minor variation categories).
• Active ingredient requirements