ANIMAL CONTROL & HEALTH DIRECTORATE

control of Veterinary preparations and medicines

Customs clearance and prior import license procedures for veterinary products, laboratory materials, and medical devices) Ministry of Municipalities and Agriculture - Department of Animal Health, Pharmacy, and Veterinary Laboratories (under CODE 2313).

The following documents are required in the OFOQ system for granting prior import license for veterinary product:

1. A list (table) of the products to be imported, their components (active ingredients), their quantities, packaging, the manufacturing company and the supplier company signed and stamped by the Licensed veterinarian approved as pharmacy in-charge.
2. Manufacturer Leaflets or Product insert for each product (In English or Arabic) contains all necessary standard information for the product.
   • - Scientific and trade name of the veterinary product.
   • - Composition and active ingredients.
   • - Uses, administration method, and recommended dosages of the product.
   • - Potential side effects, warnings, and withdrawal period (for medications).
   • - Storage conditions.
   • - Manufacturer's name, address, and contact information.
3. A copy of the registration certificate for the product in one of the GCC countries, if the product is GCC registered.

If the product is not registered in one of the GCC countries, documents to include:

1. A copy of the Good Manufacturing Practice certificate (cGMP), issued by the competent official/governmental authority, and if the cGMP is in a language other than Arabic or English., a certified translation from an accredited office must be presented.
2. Good Quality Certificate for Storage and Distribution (GSDP); in case of goods that will be import from a distributor and not from the original manufacturer.
3. Product registration certificate (CPP) in the country of origin.
4. Certificate of Free Sale (CFS) stamped by the competent authority (verifiable).
5. Pharmaceutical or Quality Registration Certificate (FDA approval USA)
6. Approved free sale certificate and laboratory analysis certificate; in case of supplements or medicated feed additives.

The packaging of the final product that arrives in the Kingdom must include the following:

1. All important information, such as the scientific name of the medicine, production date, and expiration date, must be written in Arabic or English.
2. The package leaflet should be written in Arabic or English and contain the mentioned above information.

Controlled Narcotic drugs (Ministry of Health), In addition to the above, you must:

1. Attach the purchase order from the clinic or veterinary hospital.
2. Obtaining a license from the Ministry of Health to use these substances.

For Laboratory materials, diagnostics, instruments; documents to include:

1. An official purchase order /Request from the Vet clinic or hospital or vet laboratory shall be attached.
2. A detailed product insert - catalog and copy of the device's user manual.
3. Quality certificates for the device.

For Medical devices & instruments; documents to include:

1. An official purchase order /Request from the Vet clinic or hospital or vet laboratory shall be attached.
2. A detailed product insert - catalog and copy of the device's user manual.
3. quality certificates for the device.
4. In the case of Radiological devices, a valid license from the Supreme Council for Environment must be attached.

Definitions: The term "veterinary product" includes the following):

1. veterinary drugs
2. veterinary vaccines
3. veterinary supplements
4. medicinal herbs for veterinary use with therapeutic effects
5. veterinary medicinal feed additives
6. veterinary cosmetic products with therapeutic Indications