UK Pharmacovigilance Governance: QPPV Responsibilities and the PSMF Framework

1. Regulatory background and purpose

In the United Kingdom, pharmacovigilance obligations apply to all marketing authorisation holders (MAHs) for human medicines. These obligations are designed to ensure the continuous monitoring of benefit–risk balance throughout a product’s lifecycle and to protect public health. Central to this framework are the roles of the Qualified Person for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF).
Source: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

2. Requirement to appoint a QPPV

Every MAH must appoint a QPPV who has overall responsibility for establishing and maintaining the pharmacovigilance system in the UK. The QPPV must be appropriately qualified, have sufficient experience in pharmacovigilance, and be able to fulfil their duties continuously. The appointment of a QPPV is a legal requirement and cannot be delegated to another function.
Source: Guidance on QPPV and PSMF

3. Core responsibilities of the QPPV

The QPPV has overall oversight of the pharmacovigilance system and is responsible for ensuring that:

• The MAH complies with UK pharmacovigilance legislation
• Safety data are collected, evaluated, and reported in a timely manner
• Risk management measures are implemented and monitored
• The pharmacovigilance system is adequately resourced and effective

The QPPV must be available at all times and able to respond promptly to requests from the Medicines and Healthcare products Regulatory Agency (MHRA).
Source: Guidance on QPPV and PSMF

4. Pharmacovigilance System Master File (PSMF)

The PSMF is a detailed description of the MAH’s pharmacovigilance system. It must provide MHRA with a clear and accurate overview of how pharmacovigilance activities are organised, managed, and controlled. The PSMF is a living document that must be kept up to date and reflect the current system in operation.
Source: Guidance on QPPV and PSMF

5. Minimum content of the PSMF

According to MHRA guidance, the PSMF should include:

• Information on the QPPV and their responsibilities
• Organisational structure and governance of pharmacovigilance
• Description of safety data collection and reporting processes
• Risk management systems and signal detection activities
• Quality system, audits, and corrective actions

The PSMF must be readily accessible to the MHRA upon request and during inspections.
Source: Guidance on QPPV and PSMF

6. Location and accessibility requirements

The MAH must ensure that the PSMF location is declared to the MHRA and that the file can be made available without delay. While the PSMF may be maintained electronically, it must remain under the control of the MAH and accurately reflect UK pharmacovigilance activities.
Source: Guidance on QPPV and PSMF

7. MHRA oversight and inspections

The MHRA may inspect the pharmacovigilance system at any time to verify compliance. During inspections, the MHRA will assess the effectiveness of the QPPV’s oversight, the accuracy and completeness of the PSMF, and the implementation of corrective and preventive actions where deficiencies are identified.
Source: Guidance on QPPV and PSMF