Issuance of Marketing Authorization for a Healthcare Product

about-the-service

This service enables applicants to register healthcare products, including general pharmaceutical products, which are used for the promotion of general human health and are not intended for the diagnosis, treatment, cure, or prevention of any disease. Such products do not require a prescription or direct medical supervision for their use. The scope includes dietary supplements, antiseptics and disinfectants, herbal products, and cosmetics with a medical effect.

service-process

• Log in using UAE PASS to start the service.
• Fill out the application form.
• Attach the required documents.
• Pay the fees.
• Submit the application.
• Issue the marketing authorization certificate for healthcare products, valid for five years from the date of the committee’s approval.

conditions-and-requirements

• Marketing authorization holder companies must be registered by Emirates Drug Establishment before they could register their products.

required-documents

• Certificate of pharmaceutical product (in accordance with the WHO system) or a certificate of free sale of the product issued by the competent authorities in the country of origin and certified by the Embassy of the United Arab Emirates. It should contain the following information:
• Product Brand Name: If the brand name required to be registered in UAE is different from the name in the country of origin, this shall be made clear in the certificate, besides stating the reason for that and making both names clear with an emphasis on their conformity in terms of formulation and other specifications
• Name of the company entitled to marketing/ manufacturing/ manufacturing sites/ subcontract manufacturers along with their addresses
• One sample of the product
• A valid registration certificate of the manufacturing company issued by EDE-UAE with intended production line
• Halal certificate issued by certified authorities and organizations
• A statement issued by the company confirming that the product to be registered is free of hormones, heavy metals, antibiotics, steroids, pig derivatives and any other natural or chemical substances that have a harmful impact on human beings biologically and behaviorally
• If the product contains animal derived substances, the animal type and the part extracted from it should be mentioned with the percentage of alcohol used "if any and why it is used"
• A copy of the certified contract signed between the marketing company and local agent indicating the products for which the agent will be responsible
• A certified certificate from the competent authorities of the country of origin stating that the materials used in manufacturing the product is free from mad cow disease and its causes (if the product contains substances classified as potential substances for transmitting the disease) (BSE/TSE free certificate)
• A copy of the outer and inner cover and the leaflet printed on letterhead paper stamped by the company and signed by the authorized person
• Detailed composition certificate (active & inactive ingredients with their quantities)
• Summary of product characteristics (SPC)