Issuance of Clearance Certificate for Biological Products.

3 working days.

500 AED Fees for issuing a release certificate for a shipment of pharmaceutical products extracted from biological sources.

Service Process

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 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.