Approval of Pharmacovigilance Plan for Medical Products, Pharmaceutical companies and their subsidiaries

about-the-service

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

service-process

when-applying-through-the-website

• Log in using UAE PASS to start the service.
• Fill out the application form.
• Attach the required documents.
• Pay the fees.
• Submit the application.
• Approval of the Pharmacovigilance Plan for the Pharmaceutical Establishment and Its Affiliated Companies.

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.

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.

faqs

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