EU QPPV Requirements

Legal Basis

The requirement to maintain a Qualified Person Responsible for Pharmacovigilance arises from European pharmacovigilance legislation applicable to marketing authorisation holders operating within the European Union.

The legal framework is supported by Directive 2001/83/EC, Regulation (EC) No 726/2004 and Good Pharmacovigilance Practices (GVP).

Requirement to Appoint a QPPV

Marketing authorisation holders are required to maintain a pharmacovigilance system and appoint a QPPV responsible for oversight of that system.

The QPPV serves as the individual with overall responsibility for pharmacovigilance oversight and is expected to maintain awareness of the operation and performance of the pharmacovigilance system.

Oversight Responsibilities

The QPPV is expected to maintain oversight of pharmacovigilance activities performed internally and activities delegated to external service providers.

Regulatory expectations extend beyond individual safety cases and include governance, compliance, quality systems, inspections and risk management.

Availability

The QPPV should be continuously and permanently available to fulfil pharmacovigilance responsibilities and to support interactions with regulatory authorities.

Organisations frequently establish deputy arrangements to support continuity of oversight and availability.

Relationship with the PSMF

The QPPV should maintain awareness of the content, location and operation of the Pharmacovigilance System Master File (PSMF).

The PSMF is a key document used to describe the pharmacovigilance system and may be reviewed during inspections and regulatory assessments.

Inspection Expectations

Regulatory authorities may inspect the pharmacovigilance system to assess compliance with applicable requirements.

QPPVs are commonly involved in inspection preparation, inspection conduct and management of inspection findings.

Related Guides

• What is a QPPV?
• QPPV Responsibilities
• How to Become a QPPV