Registration of Pharmaceutical Product for General Sale
About this service
Service process
Login to the MoHAP website or smart app using the UAE PASS
Submit the request through the electronic service and complete the payment to meet all conditions
The competent technical committees will deliberate the registration of products and recommendations will be submitted to the competent ministerial committee
Declarations shall be addressed to the concerned companies stating the committee's decisions via the e- system
The customer will follow up with the Pharmacological Analysis Section of at the Drug Department
The company should complete the requirements and submit them online
The relevant technical and ministerial committees will re-deliberate the registration of products that have been deferred in advance as soon as companies complete the requirements
Issuing certificates of registration of products that have been approved for registration following fulfilling all conditions and requirements. Registration certificates are valid for five years effective the date of committee approval
Issuing pharmaceutical certificates (for locally manufactured pharmaceutical products) valid for one year effective the date of issuance
Required documents
Certificate of pharmaceutical product in accordance with the WHO (World Health Organization) 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
The detailed formulation of the product contains active and inactive substances with their quantities and functions of inactive substances
Name of the company entitled to marketing/ manufacturing/ manufacturing sites/ subcontract manufacturers along with their addresses
One samples of the product.
A valid registration certificate of the manufacturing company issued by MOHAP-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) (Bovine Spongiform Encephalopathy (BSE)/ Transmissible Spongiform Encephalopathies (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).
Conditions and requirements
Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.
The applicant must be a medical warehouse licensed by the Ministry of Health and have a valid license.
Service completion duration
Service fees
Application: AED 100
Registration of a pharmaceutical product for general sale: AED 5,000
SDGs goals
Service locations
- Mohab Website
- MOHAP smart app
Payment channels
- E-payment
Target audience
Medical warehouses
Local pharmaceutical manufacturers
Marketing officers
Service category
Sub service category
Factories & companies services
Main service
Medical, Pharmaceutical and Drug Licencing and Registration
Service code
110-04-011-000
Service classification
- Government to business
Service type
Transactional
Sub service type
Variation
Number of transactions
0
Notes
Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.
This service accepts documents authenticated with the UAE PASS Digital Seal.
Service completion duration
Service fees
Application: AED 100
Registration of a pharmaceutical product for general sale: AED 5,000
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