About this service
Service process
Login to the MoHAP website or smart app using the UAE PASS
Submit the request online, meet all conditions and pay the required fees
The registration officer will review the online application and notify the applicant online
The company should complete the requirements requested by the officer
The customer will follow up with the Analysis Section of at the Drug Department (whenever requested)
The certificates of registration renewal will be issued provided all conditions and requirements are fulfilled. They will be valid for five years effective from the last expiry date of the last registration certificate
Required documents
Application to renew the registration of pharmaceutical product a signed and stamped [Part A from the MAH and part B from the manufacturing site].
Certificate of registration of the original product issued by the Ministry of Health & Prevention.(whenever requested).
A recent copy of the certificate of pharmaceutical product [CPP] issued by the concerned authorities in the country of origin attested by the United Arab Emirates Embassy.
Valid copy of the registration certificate of the manufacturer issued by the Ministry of Health & Prevention.
A copy of all certificates of minor changes issued by the Ministry of Health & Prevention.
External packaging data, inner packaging, internal leaflet.
Samples of the pharmaceutical product submitted for renewal within the UAE with the certificate of analysis.
Documents related to the active substances (DMF) or approvals from the concerned authorities, letter from the source (factory) clarifying active ingredient.
Pharmacovigilance system of the company or medical product and risk management plan.
Price certificate (whenever requested).
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
5 working days
Service fees
Application: AED 100
Registration of a conventional biological pharmaceutical product: AED 3,500
Service channels
- MOHAP website: www.mohap.gov.ae
- MOHAP smart app
SDGs Goals
Service locations
Payment channels
- E-payment
Target audience
Medical warehouses
Local pharmaceutical manufacturers
Service category
Sub service category
Factories & companies services
Main service
Medical, Pharmaceutical and Drug Licencing and Registration
Service code
110-04-007-007
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
5 working days
Service fees
Application: AED 100
Registration of a conventional biological pharmaceutical product: AED 3,500
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