Certificate of Amendment of Manufacturer’s Data for Medical Products

Service Description

This service allows medical companies and manufacturers to submit their applications to amend their registration data.

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 data of a manufacturer of medical products.

Conditions & Requirements

• The company must provide the valid approval of the competent authorities in the country of origin regarding such submitted changes

Required Documents

• An original legalized letter issued by the company on its official letterhead, duly signed and stamped by the authorized person of the company, and attested by the Embassy of the United Arab Emirates in the country of origin, authorizing a person or a local entity to submit the registration files, under its responsibility, to the Emirates Drug Establishment.
• Legalized current GMP certificate issued by the competent authority in country of origin. (Attested by the UAE Embassy in country of origin)
• Legalized valid manufacturing license issued by the competent authority in country of origin. (Attested by the UAE Embassy in country of origin)
• List of medical products manufactured at the manufacturing site
• Site Master File
• Certified copies of certificates of registration/ certificates of good manufacturing practice of the manufacturing site in other countries
• A declaration letter issued by the company on its original letterhead, signed and stamped by the responsible person in the company, showing the details of minor change with existing details & proposed minor changes
• Current registration certificate issued by EDE UAE

FAQ’s

• What are the fees for the issuance of an amendment certificate concerning any registration date of a medical company or a manufacturer holding the marketing rights? Amendment certificate concerning any registration date of a medical company or a manufacturer holding the marketing rights
• 2,000 AED
• What is the average length of time for the issuance of an amendment certificate concerning any registration date of a medical company or a manufacturer holding the marketing rights?
• 10 working days
• What channels are available to apply for the issuance of an amendment certificate concerning any registration date of a medical company or a manufacturer holding the marketing rights?
• EDE website