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Evaluation of Pharmacovigilance Plan for Medical Products within UAE

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Service completion duration

  • 3 working days

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Service fees

  • Evaluation of PV Plan for pharmaceutical establish...
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About the Service

This service enables pharmaceutical companies and their subsidiaries to apply for their pharmacovigilance plan to be evaluated with the aim of registering and marketing medicines within the UAE.

Service Process

  • 1
    Login to the MoHAP website or smart app using the UAE PASS

    • 2
      Log in to the e-system to start the service

      • 3
        Apply for Evaluation of the Plan (within the Drug Registration File)

        • 4
          Application will be studied by the staff concerned, who will make the necessary recommendations

          • 5
            PV plan will be adopted

            • 6
              Approval will be issued and delivered to the applicant

              Conditions & Requirements

              1. Clarification of the roles and responsibilities of the manufacturer regarding pharmacovigilance.

              2. Clarification of plan for monitoring compliance and inspection of pharmaceutical products.

              3. Appointment of a qualified person to be the responsible pharmacovigilance officer.

              FAQ’s

              1. Can I apply for this service manually?
                This service is exclusively an e-service. submission via email or manually will not be obtained.
              Service completion duration

              3 working days

              Service fees

              Evaluation of PV Plan for pharmaceutical establishment and its subsidiaries: AED 1,000

              Service channels
              • MOHAP Website

              • MOHAP Smart App

              Payment channels
              • E- Payment

              Target audience
              • Marketing Offices

              • Medical drug stores

              • Local pharmaceutical factories

              Department name

              Drug

              Sector name

              Health Regulation

              Main service

              Pharmaceutical vigilance

              Service Code

              110-45-002-000

              Service Classfication

              Transactional

              Service Type

              Government to Business

              Sub Service Type

              Variation

              Number of Transactions

              658

              Notes

              The valid electronic seal is accepted for documents of government entities and companies.

              Required Documents
              • The role and responsibilities of the manufacturer regarding PV.

              • Compliance monitoring and pharmacovigilance inspections.

              • Role of the Qualified Person Responsible for Pharmacovigilance (QPPV).

              • Pharmacovigilance Plan of the company.

              • Organizational chart of the company.

              • Quality Management System.

              • Risk Management Systems requirement: Clinical & non-clinical studies of the drug's safety specifications.

              • Drugs' adverse events/adverse reactions.

              • Clarification and identification of potential interactions, including food-drug and drug-drug interactions.

              • Epidemiology.

              • Risk Minimization Plan.

              • Requirements for expedited reporting of the side effects of patients (Individual Safety reports).

              • Requirements for reporting for patients in special situations (Individual Case Safety Special Situation).

              • Requirements for Periodic Safety Update reports or Periodic Benefit Risk reports.

              • QPPV training plan.

              • Documentation of PV system.

              Sustainable Goals
              Good Health And Well-Being

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