Issuance of Clearance Certificate for Biological Products.

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 the clearance certificate for biological products.

conditions-and-requirements

• The registration certificate (product marketing authorization) must be submitted if the final product is registered with the EDE.
• The registration certificate in the country of origin and the purchase order from the requesting party must be submitted if the product is not registered in the country.

required-documents

• Required documents for the products derived from human blood and vaccines:
• Original batch release certificate issued by OMCL in country of origin / legalized copy.
• Original Certificate of Final Product Analysis signed, stamped and duly authenticated / legalized copy.
• Invoice.
• Report of the production process flow, from beginning to final product (Protocol of manufacturing and Analysis).
• LPO, Declaration and Technical report about consumption from end user.
• A copy of pharmacist's and warehouse licenses.
• Certificate of Pharmaceutical Product.
• WHO prequalification certificate for vaccines.
• Required documents for the products of human tissue origin:
• Valid Tissue Bank Certificate of the exporter.
• FDA/Authority License for the manufacturer and product.
• Storage and handling temperature details.
• Invoice.
• Copy of pharmacist's and warehouse licenses.

faqs

• None.