Approval of the Pharmacovigilance Plan for the Pharmaceutical Establishment and Its Subsidiaries

Service Description

This service allows pharmaceutical establishments and their subsidiaries to submit their pharmacovigilance plan for evaluation and approval, as a core requirement for the registration and marketing of medicines within the UAE.

Service Process

• 1. Log in using UAE PASS to start the service
• 2. Fill out the application form
• 3. Attach the required documents
• 4. Pay the fees
• 5. Submit the application
• 6. Approval of the Pharmacovigilance Plan for the Pharmaceutical Facility and Its Subsidiaries

Conditions & Requirements

• • The roles and responsibilities of the manufacturing company regarding pharmacovigilance must be fully and explicitly defined
• • The compliance monitoring and pharmacovigilance inspection plan must be clearly and comprehensively described
• • A qualified person must be appointed to serve as the responsible Pharmacovigilance Officer (QPPV)

Required Documents

• Section 1: Company Requirements and Organisational Structure
• • Roles and responsibilities of the manufacturing company regarding pharmacovigilance
• • Compliance monitoring and pharmacovigilance inspection plan
• • Role of the Qualified Person Responsible for Pharmacovigilance (QPPV)
• • Company pharmacovigilance plan
• • Quality Management System
• • QPPV training plan
• • Pharmacovigilance system documentation
• Section 2: Drug Safety Assessment and Reporting Requirements
• • Risk management system requirements: clinical and non-clinical drug safety studies.
• • Adverse events and adverse drug reactions
• • Identification and clarification of potential drug interactions with food and other medicines for each product
• • Epidemiology
• • Drug risk minimisation and management plan
• • Requirements for expedited reporting of individual patient side effects (Individual Case Safety Reports, ICSRs)
• • Requirements for reporting individual case safety special situations
• • Requirements for Periodic Safety Update Reports (PSUR) or Periodic Benefit-Risk Evaluation Reports (PBRER)

FAQ’s

• Q: Can I apply for this service manually?
• A: This service is exclusively an e-service. Submissions via email or manually will not be accepted.