Renewal of Registration of a Pharmaceutical Product for General Sale
About this service
Service process
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Login to the MoHAP website or smart app using the UAE PASS
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Submit the request online, complete the payment and meet all conditions
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The registration renewal file will be examined and companies will receive a letter stating the specific requirements
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The customer shall follow up with the Analysis Section of at the Drug Department
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The company should complete the requirements and submit them online
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The certificates of registration of products that have been approved for registration will be issued, provide all the conditions and requirements are met. Registration certificates are valid for five years effective from the last expiry date of the last registration certificate
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The pharmaceutical certificates (for locally manufactured pharmaceutical products) will be issued, valid for one year effective the date of issuance
Required documents
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Filling out the application form for renewal of registration of pharmaceutical products with general sale completely and to be signed and stamped by company.
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A copy of a valid certificate of a pharmaceutical/ free sale product.
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A valid manufacturing certificate of the factory issued by MOHAP.
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The original registration certificate issued by MOHAP.
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The original registration certificate of the product issued previously by the Drug Department.
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A new copy of the product registration certificate issued by the competent authorities in the country of origin certified by the Embassy of the United Arab Emirates.
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A valid registration certificate of manufacturing location issued by the Drug Control Department.
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A copy of all minor changes certificates issued by the Drug Department.
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The outer cover, the inner poster and the internal leaflet.
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Original 2 samples of the product used in UAE.
Conditions and requirements
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Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.
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The applicant must be a medical warehouse licensed by the Ministry of Health and have a valid license.
Service completion duration
15 Working days
Service fees
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Application: AED 100
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Renewal of the registration of pharmaceutical product for general sale: AED 2,500
SDGs goals
Service locations
Payment channels
- E-payment
Target audience
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Medical warehouses
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Local pharmaceutical manufacturers
Resources
Infographic - Registration of Pharmaceutical Product for General Sale - PDF 384KB
Drug Registration - External User Manual-381
Service category
Sub service category
Factories & companies services
Main service
Medical, Pharmaceutical and Drug Licencing and Registration
Service code
110-04-011-011
Service classification
- Government to business
Service type
Transactional
Sub service type
Auxiliary
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
15 Working days
Service fees
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Application: AED 100
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Renewal of the registration of pharmaceutical product for general sale: AED 2,500
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