Issuance of Marketing Authorization for a Drug or Biopharmaceutical Product

about-the-service

This service allows customers to submit applications to register conventional, biological or other human pharmaceutical products to be imported and traded 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.
• Complete stability and bioequivalence (if required), as well as pharmacovigilance and pharmaceutical analysis through the EDE quality control laboratory.
• Issue the marketing authorization certificate for the pharmaceutical or biological product, valid for five years or for the granted validity by EDE.

conditions-and-requirements

• Marketing Authorization Holder companies must be registered by EDE before they could apply for marketing authorization of their products.
• The applicant must be a medical warehouse licensed by Emirates Drug Establishment and have a valid license, or a local medical product manufacturer, or a marketing office.

required-documents

• The required documents are to be submitted in accordance with the requirements of the standard technical file (eCTD)

faqs

• What is the fees for obtaining a registration service for an Issuance of Marketing Authorization for a Drug or Biopharmaceutical Product?
• Application: AED 100.
• Marketing Authorization of a conventional pharmaceutical product: AED 7,000
• Analysis or re-analysis of a medical product: AED 3,500.
• Pricing certificate after committee approval: AED 500.
• For PV plan evaluation – AED 1000.
• What is the average length of time for the Issuance of Marketing Authorization for a Drug or Biopharmaceutical Product?
• 45 Working Days
• What is the target group for a conventional pharmaceutical product registration service?
• Drug Warehouses.
• Local Pharmaceutical Manufacturers.
• Marketing Offices.
• What channels are available to apply for Issuance of Marketing Authorization for a Drug or Biopharmaceutical Product service?
• The applications can be submitted through EDE website.