UK QPPV Requirements

Overview

Following the United Kingdom's departure from the European Union, specific pharmacovigilance requirements were established for products authorised within the UK.

Marketing Authorisation Holders operating in the United Kingdom are expected to maintain appropriate pharmacovigilance oversight and comply with MHRA requirements.

Requirement for a UK QPPV

Products authorised within the United Kingdom may require a UK QPPV depending on the applicable regulatory framework and marketing authorisation arrangements.

The UK QPPV acts as a key point of responsibility for pharmacovigilance oversight within the UK pharmacovigilance system.

Oversight Responsibilities

The UK QPPV is expected to maintain oversight of the pharmacovigilance system and remain aware of important safety concerns, compliance risks and governance activities.

Responsibilities frequently include oversight of quality systems, safety processes, vendor arrangements and inspection readiness activities.

Availability Requirements

The UK QPPV should be appropriately available to support pharmacovigilance activities and regulatory interactions.

Organisations often establish deputy arrangements and documented business continuity procedures to support uninterrupted pharmacovigilance oversight.

MHRA Inspections

The MHRA may inspect pharmacovigilance systems to assess compliance with applicable requirements.

UK QPPVs are commonly involved in inspection preparation, inspection support and management of inspection findings and corrective actions.

Relationship with the PSMF

The UK pharmacovigilance system documentation and associated records remain important components of inspection readiness and system oversight.

QPPVs should maintain awareness of how the pharmacovigilance system is documented and governed.

Related Guides

• EU QPPV Requirements
• QPPV Responsibilities
• PSMF Oversight