Renewal of Marketing Authorization for a Drug or Biopharmaceutical Product

about-the-service

This service allows customers to submit applications to renew the registration of conventional, biological or other human pharmaceutical products for import and trading within the UAE.

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 renewal of the marketing authorization for a pharmaceutical or biological product

conditions-and-requirements

• Marketing Authorization Holder companies must be registered by EDE before they could register their products.
• The applicant must be a medical warehouse licensed by the Emirates Drug Establishment and have a valid license.

required-documents

• Application to renew the registration of pharmaceutical product signed and stamped [Part A from the MAH and part B from the manufacturing site]
• Certificate of registration of the original product issued by EDE (whenever requested)
• A recent copy of the certificate of pharmaceutical product [CPP] issued by the concerned authorities in the country of origin attested by the United Arab Emirates Embassy
• Valid copy of the registration certificate of the manufacturer issued by EDE
• A copy of all certificates of minor changes issued by EDE
• External packaging data, inner packaging, internal leaflet
• Samples of the pharmaceutical product submitted for renewal within the UAE with the certificate of analysis
• Documents related to the active substances (DMF) or approvals from the concerned authorities, letter from the source (factory) clarifying active ingredient
• Pharmacovigilance system of the company or medical product and risk management plan
• Price certificate (whenever requested)