This service allows obtaining a permit to import medicinal products, narcotic drugs, controlled or semi-controlled drugs, or pharmaceutical preparations for the local agent holding a valid medical store license issued by the Ministry of Health and Prevention.

• The first stage: Initial approval for import: 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 marketing authorization holder, including the country of origin, production and expiry dates for each batch, and the remaining shelf life of the product must not be less than two-thirds of the total shelf life.

  • Minor Variation Certificate (MVC) - if any

  • Import authorization from the Regulation of Controlled Substances and Products section- for Narcotic, Controlled or semi-controlled Drugs.

  • Batch Release Certificate (BRC) - if the product is a biological derivative and vaccine - issued by the Ministry of Health & Prevention for each batch.

  • Import permit from the Federal Authority for Nuclear Regulation - mandatory for radioactive products and materials

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

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

    • A valid MOHAP Marketing Office License of MAH (Marketing Authorization Holder)

    • A valid certificate of Good Storage and Distribution Practice (GSDP) issued by MOHAP (Ministry Of Health & Prevention) to the 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).

• Obtaining marketing authorization approval from the Ministry of Health and Prevention.

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

• One commercial invoice must be 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 waybill, or truck waybill (consignment note). The shipment must contain products that are under the purview of the Ministry of Health and Prevention.

• Obtaining electronic shipment clearance permits.

• Inspection at the customs port by MOHAP inspectors.

• Inspection to release the shipment for distribution in the local market.