About this service
Service process
Login to the MoHAP website or smart app using the UAE PASS
Log in to the e-system to start the service
Apply for Evaluation of the Plan (within the Drug Registration File)
Application will be studied by the staff concerned, who will make the necessary recommendations
PV plan will be adopted
Approval will be issued and delivered to the applicant
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.
Conditions and requirements
Clarification of the roles and responsibilities of the manufacturer regarding pharmacovigilance.
Clarification of plan for monitoring compliance and inspection of pharmaceutical products.
Appointment of a qualified person to be the responsible pharmacovigilance officer.
Service completion duration
3 working days
Service fees
Evaluation of PV Plan for pharmaceutical establishment and its subsidiaries: AED 1,000
Service channels
- MOHAP smart app
SDGs Goals
Service locations
Payment channels
- E-payment
Target audience
Marketing Offices
Medical drug stores
Local pharmaceutical factories
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
Evaluation of PV Plan for pharmaceutical establishment and its subsidiaries: AED 1,000
Average rating
Main service
Pharmaceutical vigilance
Service code
110-45-002-000
Service classification
- Government to business
Service type
Transactional
Service process
Login to the MoHAP website or smart app using the UAE PASS
Log in to the e-system to start the service
Apply for Evaluation of the Plan (within the Drug Registration File)
Application will be studied by the staff concerned, who will make the necessary recommendations
PV plan will be adopted
Approval will be issued and delivered to the applicant
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.
Conditions and requirements
Clarification of the roles and responsibilities of the manufacturer regarding pharmacovigilance.
Clarification of plan for monitoring compliance and inspection of pharmaceutical products.
Appointment of a qualified person to be the responsible pharmacovigilance officer.
Service channels
- MOHAP smart app
Service completion duration
3 working days
Payment channels
- E-payment
Target audience
Marketing Offices
Medical drug stores
Local pharmaceutical factories
Service locations
Service fees
Evaluation of PV Plan for pharmaceutical establishment and its subsidiaries: AED 1,000
SDGs Goals
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