Registration of a Conventional Pharmaceutical Product

Service completion duration

  • 45 working days

Service fees

  • Application: AED 100
  • Registration of a conventional pharmaceutical prod...

Service Rating

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About the Service

This service enables clients to submit applications to register conventional, biological or other human pharmaceutical products for importation and trading within the UAE.

Service Process

  • 1
    Register in the e-services, create a user name and password (if not already registered), and access the electronic system.

    • 2
      Submit the request through the electronic service and complete the payment to meet all conditions and required fees.

      • 3
        After submitting online, registration dossier is studied and discussed by the concerned technical committee and then submit report to the concerned ministerial committee.

        • 4
          Study registration file and discuss the pricing of product by the concerned technical committee and then submit report to the concerned ministerial committee.

          • 5
            Follow up to be done online to complete the Stability, Bioequivalence (if required) & Pharmacovigilance section and Analysis through Quality Control Lab.

            • 6
              Completion of the file requirements and submission on agreed date.

              • 7
                Re-discuss the registration of products that have been previously delayed on completion of requirements by the relevant technical and ministerial committees.

                • 8
                  Price approval letter will be issued after committee approval and Price decree after sign by HE The Minister.

                  • 9
                    Issuing certificates of registration of products that have been approved for registration after satisfying all conditions and requirements valid for five years from the date of committee approval.

                    • 10
                      Pharmaceutical certification (for local pharmaceutical products) is valid for one year from the date of issue.

                      Conditions & Requirements

                      1. Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.

                      2. The applicant must be a medical warehouse licensed by the Ministry of Health and have a valid license.

                      FAQ’s

                        • Application: AED100.

                        • Registration of a conventional or biological medicine product etc.: AED7,000.

                        • Analysis or re-analysis of a medical product: AED3,500.

                        • Pricing certificate after committee approval: AED500.

                        • For PV plan evaluation – AED1000.

                      1. 45 working days.
                        • Drug warehouses.

                        • Local pharmaceutical manufacturers.

                        • Marketing officers.

                      2. The Applications can be submitted through MOHAP Website and Smart Application.
                      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

                      Service channels
                      • MOHAP Website

                      • MOHAP Mobile App

                      Payment channels
                      • E- Payment

                      Target audience
                      • Medical warehouses

                      • Local pharmaceutical manufacturers

                      • Marketing officers

                      Department name

                      Drug Department

                      Sector name

                      Health Regulation Sector

                      Main service

                      Medical, Pharmaceutical and Drug Licencing and Registration

                      Service Code

                      110-04-007-000

                      Service Classfication

                      Transactional

                      Service Type

                      Government to Business

                      Sub Service Type

                      Variation

                      Related Services
                      • Medical Store licensing: related to licensing Department

                      • Local Manufacturer licensing

                      • Registration of a conventional pharmaceutical product is a pre-requisite for import service.

                      Service Bundle

                      This service is not linked with any service packages

                      Number of Users

                      46

                      Number of Applications

                      815

                      Notes

                      Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.

                      Required Documents
                      • The required documents are to be submitted in accordance to the requirements of the standard technical file (eCTD). For the required documents.

                      Sustainable Goals
                      Good Health And Well-Being

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