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

about-the-service

This service enables clients to submit their applications for certificate of Amendment to the Registered Marketing Authorization Data for Medical Products that received Marketing Authorization

service-process

when-applying-through-the-website

• 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-and-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