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Registration of a Conventional Pharmaceutical Product

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Service completion duration

  • 45 working days

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Service fees

  • Application: AED 100
  • Registration of a conventional pharmaceutical prod...
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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
    Login to the MoHAP website or smart app using the UAE PASS

    • 2
      Submit the request online, meet all conditions and pay the required fees

      • 3
        Study the registration file and discuss the pricing of product with the concerned technical committee and then submit report to the concerned ministerial committee

        • 4
          Follow up shall be done online to complete the Stability, Bioequivalence (if required) & Pharmacovigilance section and Analysis through Quality Control Lab

          • 5
            Meet all the requirements and submit the file on the agreed date

            • 6
              The registration of products that have been previously delayed on completion of requirements shall be discussed by the relevant technical and ministerial committees

              • 7
                Price approval letter will be issued after committee approval and price decree after sign by HE The Minister

                • 8
                  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

                  • 9
                    Pharmaceutical certification (for local pharmaceutical products) is valid for one year from the date of issuance

                    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

                    1. What are the fees for obtaining a registration service for a conventional pharmaceutical product?

                      • 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.

                    2. What is the average length of time for the registration of a conventional pharmaceutical product?
                      45 working days.
                    3. What is the target group for a conventional pharmaceutical product registration service?

                      • Drug warehouses.

                      • Local pharmaceutical manufacturers.

                      • Marketing officers.

                    4. What channels are available to apply for a conventional pharmaceutical product registration service?
                      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

                    Sector name

                    Health Regulation

                    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 Transactions

                    673

                    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 with the requirements of the standard technical file eCTD (Electronic Common Technical Document)

                    Sustainable Goals
                    Good Health And Well-Being

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