Renewal of the Certificate of Compliance with Good Practices

about-the-service

This service allows companies to apply for the renewal of the Certificate of Compliance with Good Practices and Distribution Practices one year after the certificate is issued. It is intended for companies that store medical products in logistics warehouses located in free zones.

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 the good Practice Standards.

conditions-and-requirements

• Provision of All Requirements and Documents The pharmaceutical establishment shall submit all official documents and required materials in full and accurately, in accordance with the forms and procedures approved by the Emirates Drug Authority.
• Passing the Field Inspection A field inspection of the storage site is required to verify compliance with the approved technical and regulatory standards, with full commitment to implementing all technical recommendations issued by the competent authority.
• Periodic Renewal The certificate shall be valid for one year from the date of issuance. An application for renewal must be submitted before the expiry of the specified period, accompanied by all required documents, and the site shall undergo a new field inspection to ensure continued compliance with the standards.

required-documents

• First: To obtain the Good Storage and Distribution Practice (GSDP) Certificate for the purpose of exporting to the UAE market and outside:
• The agreement between the Marketing Authorization Holder or the manufacturer and the logistic warehouse.
• The manufacturing Site registration certificate (Mandatory) and the product registration (in case it's registered) in the EDE.
• A valid Good Manufacturing Practice (GMP) Certificate for all relevant manufacturing sites issued by the competent authority in the country of origin and legalized by the Embassy of the UAE in the country of origin.
• A copy of the Free Sale Certificate or the Certificate of Pharmaceutical Products for all products that are un-registered , issued by the competent authority in the COO legalized by UAE Embassy in the COO, along with the countries planning to export to.
• An authorization letter from a licensed pharmaceutical establishment with a valid license authorizing the pharmacist incharge of the assigned storage area in the logistic warehouse.
• A valid license for the pharmacist in charge of the assigned storage area in the logistic warehouse.
• The applicant's commercial license issued by the Free Zone Authority.
• The commercial license of the logistic warehouse issued by the Free Zone Authority.
• The marketing office license (formerly the scientific office) issued by the EDE.
• License of the pharmacist in charge of the marketing office.
• Biomedical engineer qualification certificate legalized by the UAE Ministry of Education in case dealing only with non-pharmaceutical medical equipment.
• List of the products that will be stored in the logistic warehouse (registered and un-registered in the EDE).
• Second: To obtain the GSDP Certificate for the purpose of exporting only (outside) the country:
• All of the above applies, plus:
• A copy of the marketing approval for medical products.