Issuance of Marketing Authorization for a Drug or Biopharmaceutical Product

Service Description

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

• 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 & 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)

FAQ’s

• 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.