Renew a Medical Products Manufacturing Facility License

about-the-service

This service allows applications for the renewal of expired pharmaceutical facility licenses tomedical manufaturer

service-process

• Log in using UAE PASS to start the service
• Fill out the application form
• Attach the required documents
• Pay the application fees
• If the requirements are met, pay the renewal fees
• Renewal of License for Medical Products Factories and Contract Manufacturing Organizations for Medical Products

conditions-and-requirements

• The factory license is renewed annually, provided that the factory is ensured to adhere to good manufacturing practices after the inspection team visits the facility.
• An official request can be submitted to the competent department to renew the Good Manufacturing Practice certificates issued by Emirates Drug Establishment two months before their expiry date.
• If the factory continues its activity after the expiration of its license without renewing it, legal measures will be taken against the factory in accordance with the legislation in force in this regard.
• All necessary corrective actions must be taken regarding the comments that may be received from the inspection team regarding good manufacturing practice.

required-documents

• A copy of the valid Industrial License
• Valid licenses of the pharmacists (Production Manager, Quality Assurance Manager, and Quality Control Manager)
• A valid Good Manufacturing Practice (GMP) certificate
• A valid Environmental Permit certificate
• A valid Civil Defense certificate