The first stage: Pre-import permit: The submission is made through the electronic system of import to obtain the initial approval for import before starting to ship from the country of origin, and it requires attaching the following documents:

• The invoice (Commercial Invoice or Invoice) issued by the manufacturer / marketing authorization holder, including the country of origin, production, and expiry dates for each batch. The remaining shelf life of the product must not be less than two-thirds of the total shelf life.

• Catalogue, or brochure or photos for each product arranged as mentioned in the invoice.

• Valid US Food and Drug Authority (FDA) registration certificate, or valid (ISO13485 and EC) quality certificates, or valid Free Sale Certificate (FSC) from the country of origin, or valid Good Manufacturing Practice certificate (GMP) (upon request).

• Product Minor Variation Certificate (MVC) - if any.

• Valid product classification certificate (upon request).

• Authorisation letter for distribution in the UAE from the manufacturer to the local agent - for the products that do not need to obtain marketing authorisation approval (as per their classificaiton).

• An import permit from the Federal Authority for Nuclear Regulation (FANR) - to import diagnostic radiological devices that emit ionizing radiation (X-ray and Gamma rays), for example: radiography, medical imaging and radiotherapy, fluoroscopy, mammography, Radiotherapy and CT scan.

• Batch Release Certificate (BRC) issued by MOHAP according to the batch number - in case the product contains human blood, plasma or tissue.

• European Directorate for Quality of Medicines and Healthcare (EDQM) Certificate of Suitability (if the product contains gelatin from an animal source).

• Import Authorization of Narcotic, Controlled or Semi-controlled Drugs - for Narcotic, controlled and semi-controlled drugs.

• In case of importing from the designated free zones in the country, the following must be provided:

  • A valid MOHAP marketing office license of Marketing Authorization Holder (MAH).

  • A valid certificate of Good Storage and Distribution Practice (GSDP) issued by MOHAP to MAH (Marketing Authorization Holder).

The second stage: Shipment Clearance Permission: The application is submitted when the freight bill is issued, and it requires attaching the following documents:

• Air Way Bill (Air) / Bill of Lading (Sea) / Truck Way Bill (Consignment Note) (Road), noting the necessity of shipping in temperature controlled containers, while adhering to the Ministerial decree No. 22 of 2022.

• The packing list must include the total weight and the number of packages.

• Original Certificates of Analysis (C.O.A) for all imported batches and must include production and expiry dates and be issued by the batch releaser (to be viewed upon request from MOHAP inspectors) (for medicated medical devices).

Obtaining marketing authorization approval from Ministry Of Health & Prevention.

Products may only be imported by the local agent mentioned in the product’s marketing authorization approval.

One commercial invoice is attached to each initial import permit application.

It is allowed to include more than one initial import permit application under the shipment clearance application, provided that they are all under the same Bill of Lading, Air Way Bill, Truck Way Bill (Consignment Note) provided that the shipment contains products subject to the Ministry of Health & Prevention only.

Obtaining electronic shipment clearance permits.

Inspection at the customs port by MOHAP inspectors.

Inspection to release the shipment for distribution in the local market (for medicated medical devices).