Certificate of Amendment of Manufacturer’s Data for Medical Products

about-the-service

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-and-requirements

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

required-documents

• A legalized letter issued by the company on its original letterhead, signed and stamped by the responsible person in the company, authorizing a person or a local establishment to submit the registration file on its behalf, to the Drug Control Department, attested by UAE Embassy. This person / the local establishment will be responsible to receive the registration certificate from the Drug Control Department
• 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

faqs

• 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