Evaluation of Pharmacovigilance Plan for Medical Products within UAE
About this service
Service process
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Login to the MoHAP website or smart app using the UAE PASS
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Log in to the e-system to start the service
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Apply for Evaluation of the Plan (within the Drug Registration File)
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Application will be studied by the staff concerned, who will make the necessary recommendations
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PV plan will be adopted
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Approval will be issued and delivered to the applicant
Required documents
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The role and responsibilities of the manufacturer regarding PV.
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Compliance monitoring and pharmacovigilance inspections.
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Role of the Qualified Person Responsible for Pharmacovigilance (QPPV).
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Pharmacovigilance Plan of the company.
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Organizational chart of the company.
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Quality Management System.
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Risk Management Systems requirement: Clinical & non-clinical studies of the drug's safety specifications.
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Drugs' adverse events/adverse reactions.
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Clarification and identification of potential interactions, including food-drug and drug-drug interactions.
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Epidemiology.
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Risk Minimization Plan.
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Requirements for expedited reporting of the side effects of patients (Individual Safety reports).
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Requirements for reporting for patients in special situations (Individual Case Safety Special Situation).
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Requirements for Periodic Safety Update reports or Periodic Benefit Risk reports.
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QPPV training plan.
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Documentation of PV system.
Conditions and requirements
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Clarification of the roles and responsibilities of the manufacturer regarding pharmacovigilance.
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Clarification of plan for monitoring compliance and inspection of pharmaceutical products.
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Appointment of a qualified person to be the responsible pharmacovigilance officer.
Service completion duration
3 working days
Service fees
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Evaluation of PV Plan for pharmaceutical establishment and its subsidiaries: AED 1,000
Service channels
- MOHAP website: www.mohap.gov.ae
- MOHAP smart app
SDGs goals
Service locations
Payment channels
- E-payment
Target audience
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Marketing Offices
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Medical drug stores
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Local pharmaceutical factories
Resources
User Manual - Registration Services-848
Service category
Sub service category
Factories & companies services
Main service
Pharmaceutical vigilance
Service code
110-45-002-000
Service classification
- Government to business
Service type
Transactional
Sub service type
Variation
Number of transactions
0
Notes
This service accepts documents authenticated with the UAE PASS Digital Seal.
Service completion duration
3 working days
Service fees
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Evaluation of PV Plan for pharmaceutical establishment and its subsidiaries: AED 1,000
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