Issue a Certificate of Compliance with Good Manufacturing Practice Standards

Service Description

This service enables customers to request the issuance of a Certificate of Compliance with Good Manufacturing Practice (GMP) Standards.

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 a Certificate of Compliance with Good Manufacturing Practice Standards

Conditions & Requirements

• • First: Provision of All Requirements and Documents The pharmaceutical establishment must submit all official documents and required materials in full and correct form, in accordance with the approved templates and procedures of the Emirates Drug Establishment (EDE).
• • Second: Passing the On-Site Inspection An on-site inspection of the manufacturing facility must be conducted to verify its compliance with the approved technical and regulatory standards. All technical recommendations issued by EDE must be fully implemented.
• • Third: Periodic Renewal The certificate is valid for one year from the date of issuance. A renewal application must be submitted before the expiry date, accompanied by all required documents, and the site must undergo a new on-site inspection to confirm continued compliance with the standards.

Required Documents

• • Inspection visit report confirming the manufacturing plant's compliance with Good Manufacturing Practice (GMP) principles

FAQ’s

• Q: Based on which standards is the inspection conducted?
• A: The inspection is conducted in accordance with the Good Manufacturing Practice (GMP) guidelines issued by the United Arab Emirates, the Gulf Cooperation Council (GCC), and the World Health Organization (WHO).