Renewal of a Medical Products Manufacturing Facility License

Service Description

This service enables the renewal of an expired licence for pharmaceutical and medical device manufacturing plants registered within the UAE.

Service Process

• 1. Log in using UAE PASS to start the service
• 2. Fill out the application form
• 3. Attach the required documents
• 4. Pay the fees
• 5. Submit the application
• 6. Issue the Medical Products Manufacturing Facility License renewal

Conditions & Requirements

• • The manufacturing facility license is renewed annually, subject to verifying compliance with Good Manufacturing Practice following an inspection visit by the inspection team, and submission of a valid Good Practice certificate
• • A formal renewal request for Good Manufacturing Practice certificates issued by EDE may be submitted to the relevant department up to two months before the certificate's expiry date
• • If the manufacturing facility continues operating after its license expires without renewal, legal measures will be taken in accordance with applicable legislation
• • All corrective actions required by the inspection team's Good Manufacturing Practice observations must be completed

Required Documents

• 1. Copy of a valid Industrial Licence
• 2. Valid licences of manufacturing facility staff (Production Manager, Quality Assurance Manager, Quality Control Manager)
• 3. Valid Good Manufacturing Practice (GMP) certificate
• 4. Valid Environmental Permit
• 5. Valid Civil Defence Certificate confirming compliance with fire prevention and safety requirements