Permit to Import Medical items and products

Service Description

This service allows obtaining authorization to import raw materials, pharmaceutical products, medical equipment, and chemical precursors for companies, factories, and medical warehouses.

Service Process

• Log in using UAE PASS to start the service.
• Fill out the application form.
• Attach the required documents.
• Pay the application fee.
• Submit the application.
• In case of rejection, the company owner will be notified of the Ministry of Interior’s refusal, and the file will be retained on the website.
• Upon obtaining security approval, the request will be forwarded to the applicant to complete requirements and pay the import permit fees Issue the Permit to Import Medical items and products.
• Issue the Permit to Import Medical items and products

Conditions & Requirements

• When importing medical equipment/ importing medical products:
• Obtain the product’s marketing authorization from the Authority.
• Importation must be carried out by the local agent mentioned in the product’s marketing authorization.
• One commercial invoice must be attached for each initial import permit request.
• It is permitted to include multiple initial import permit requests under a single shipment-clearance permit, provided they all fall under the same airway bill number and the shipment contains only products regulated by the Emirates Drug Authority.
• Obtain the electronic approval for the shipment-clearance permit from Customs to the licensed medical warehouse.
• Inspection at the customs port by inspectors from the Emirates Drug Authority.
• Inspection for the purpose of releasing the shipment for distribution in the local market (for medical equipment and supplies that contain medicines).
• The validity of the import permit is two months from the date of issuance.
• When importing chemical precursors:
• The Emirates Drug Authority registration certificate and the commercial license must be valid.
• The permit must be completed with full details of the requested substance by the authorized and approved person.
• Approval from the Ministry of Interior is required for the chemical precursor request.
• The validity of the import permit must be two months from the date of issuance.

Required Documents

• Import of chemical precursors:
• Valid commercial/industrial license
• Emirates Drug Establishment (EDE) registration certificate, indicating either Chemical Precursors Trading as an activity, or Import as an End User as an activity
• Air waybill or sea freight invoice.
• Delivery Order (DO) issued by the shipping company
• Purchase invoice, which must be issued from the country of origin
• Packing list, which must include net weight and gross weight
• Original customs declaration
• In case of importing Medicines / Medical Equipment from the Local Agent:
• Phase (1):
• Initial Import Approval
• Proforma invoice or commercial invoice issued by the Marketing Authorization Holder (MAH), including the country of origin, batch/lot numbers, and production and expiry dates for each batch. The remaining shelf life of the product upon arrival at UAE ports must not be less than two-thirds of the total shelf life
• Minor variation certificate for the product (if applicable)
• Import permit from those concerned with regulating the Narcotics, Controlled and Semi-Controlled Products (for narcotic, controlled, or semi-controlled items)
• Batch release certificate issued by the Emirates Drug Establishment for each batch, if the product is derived from biological substances or contains blood, plasma, or human tissue
• Import permit from the Federal Authority for Nuclear Regulation (FANR) for importing radioactive materials.
• Certificate of Suitability from the European Directorate for the Quality of Medicines & HealthCare (EDQM) (if the product contains gelatin from an animal source).
• If importing from fenced free zones within the UAE, the following must also be provided:
• Valid marketing office license for the Marketing Authorization Holder
• Valid Good Storage Practice (GSP) certificate issued by the Emirates Drug Establishment for the Marketing Authorization Holder and The product's shelf life must be at least 12 months
• Phase (2): Shipment Clearance Permit
• The application may be submitted after obtaining the preliminary approval and once the shipping document (bill of lading/air waybill) is issued. The following documents must be attached:
• Commercial invoice.
• Bill of lading / air waybill / road waybill, with emphasis on the requirement to comply with Ministerial Decision No. (227) of 2023 regarding the regulation of transportation, storage, and distribution of medical products or the raw materials used in their manufacture, whereby shipments must be transported in sealed and temperature-controlled containers
• Packing list including the gross weight and number of packages
• Original certificates of analysis (CoA) for all imported batches, including production and expiry dates, issued by the batch-releasing manufacturer (subject to verification by EDE inspectors)
• In case of importing Medical Devices / Medical Products from the local agent (in addition to the above requirements):
• Catalogue/leaflet/photos for each product, arranged in the same order as listed in the invoice
• Valid registration certificate with the US FDA, or quality certificates (ISO 13485 and EC), or a Free Sale Certificate issued from the country of origin, or a Good Manufacturing Practice certificate (upon request)
• Product classification certificate (upon request)
• Distribution authorization letter for the UAE from the manufacturer to the local agent, for products that do not require marketing authorization (depending on classification)
• In case of importing Raw Materials:
• Phase (1): Initial Import Approval
• Valid local factory license issued by the Emirates Drug Establishment
• Valid license for the responsible pharmacist of the factory
• Valid commercial license for the local factory
• Certificate of a Pharmaceutical Product (CPP) to confirm the use of the imported materials for manufacturing registered medicines
• Composition Formula (CF) in which active and inactive ingredients will be used to formulate the final products
• Manufacturing contract for semi-finished products
• Valid Good Manufacturing Practice (GMP) certificate from the manufacturer from whom the raw materials will be imported
• Purchase invoice must include the country of origin, batch numbers, and production and expiry dates
• Import permit from the Narcotics, Controlled and Semi-Controlled Products Regulation Section for narcotic/controlled/semi-controlled items, if the product is CDA / CDB / NP
• If the material is not packaged, the Product Registration Certificate (RC) issued by the Emirates Drug Establishment is mandatory
• If the raw material is imported for a pharmacy that performs pharmaceutical compounding, The formulation and the compounded product must comply with the conditions degree no. 228 of 2023 concerning compounding pharmacies
• A “Halal” certificate must be attached if the product contains gelatin from an animal source
• Phase (2): Shipment Clearance Permit
• Commercial invoice from the manufacturer addressed to the local factory
• Shipping invoice (air/land/sea) or Delivery Order (DO), in compliance with Ministerial Decision No. (227) of 2023 regarding the transportation, storage, and distribution of medical products or the raw materials used in their manufacture
• Packing list including the gross weight
• Original customs declaration
• Delivery order from the shipping company
• Certificates of Suitability (CoS)
• Original certificates of analysis for all imported batches, including production and expiry dates, issued by the manufacturer