Registration of a Conventional Pharmaceutical Product
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
Study the registration file and discuss the pricing of product with the concerned technical committee and then submit report to the concerned ministerial committee
Follow up shall be done online to complete the Stability, Bioequivalence (if required) & Pharmacovigilance section and Analysis through Quality Control Lab
Meet all the requirements and submit the file on the agreed date
The registration of products that have been previously delayed on completion of requirements shall be discussed by the relevant technical and ministerial committees
Price approval letter will be issued after committee approval and price decree after sign by HE The Minister
The certificates of registration of products that have been approved for registration will be issued, which is valid for five years from the date of committee approval
Pharmaceutical certification (for local pharmaceutical products) is valid for one year from the date of issuance
Required documents
The required documents are to be submitted in accordance with the requirements of the standard technical file eCTD (Electronic Common Technical Document)
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
45 working days
Service fees
Application: AED 100
Registration of a conventional pharmaceutical product: AED 7,000
Analysis or re-analysis of a medical product: AED 3,500
Pricing certificate after committee approval: AED 500
For PV plan evaluation: AED 1000
SDGs goals
Service locations
- Mohab Website
- MOHAP Smart Application
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
110-04-007-000
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
45 working days
Service fees
Application: AED 100
Registration of a conventional pharmaceutical product: AED 7,000
Analysis or re-analysis of a medical product: AED 3,500
Pricing certificate after committee approval: AED 500
For PV plan evaluation: AED 1000
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