Renewal of the Certificate of Compliance with Good Manufacturing Practices

about-the-service

This service allows customers to renew the Certificate of Compliance with Good Manufacturing Practices (GMP) standards one year after the date of issuance.

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 a Certificate of Compliance with good Manufacturing Practice Standards.

conditions-and-requirements

• The pharmaceutical facility is required to submit all official documents and required materials completely and accurately, in accordance with the forms and procedures approved by the Emirates Drug Establishment.
• An on-site inspection of the manufacturing site is mandatory to verify its compliance with the approved technical and regulatory standards, with full adherence to the technical recommendations issued by the Emirates Drug Establishment.
• The validity of the certificate is one year from the date of issuance. A renewal request must be submitted before the expiry of the specified period, accompanied by all required documents, and the site must undergo a new on-site inspection to ensure continued compliance with the standards.

required-documents

• The inspection visit report, indicating the factory's compliance with Good Manufacturing Practice (GMP) guidelines.