GVP

GVP is the EU’s codified set of pharmacovigilance expectations, published by EMA as modules rather than a single text. Modules I–XVI cover the process areas — quality systems, the PSMF, inspections, audits, risk management, adverse-reaction collection, PSURs, post-authorisation safety studies, signal management, additional monitoring, safety communication, and product- or population-specific considerations.

The core obligation is a system, not a mailbox. A marketing-authorisation holder must be able to detect, assess, understand, and act on safety information across the product lifecycle, with a QPPV accountable for it and a quality system wrapped around it. Regulators inspect the system, and the PSMF is the document they inspect it against.

The parts most often cited in inspection are the operational ones: signal management under Module IX (detecting and validating signals, then acting within defined timeframes), adverse-reaction handling and case processing under Module VI, and risk-minimisation effectiveness under Module V. Late case processing and undocumented signal decisions are perennial findings.

• —GVP is modular (Modules I–XVI) plus product- and population-specific considerations.
• —Module I — pharmacovigilance systems and quality systems; Module II — PSMF; Module V — risk management.
• —Module VI — collection, management, and submission of adverse reactions; Module IX — signal management.
• —A QPPV resident in the EU/EEA is personally accountable for the system.
• —Obligations run across the whole lifecycle, not just at approval — the benefit-risk balance is continuously re-assessed.

Directive 2001/83/EC and Regulation (EC) No 726/2004 as amended by the 2010 pharmacovigilance legislation; Commission Implementing Regulation (EU) No 520/2012; EMA Good Pharmacovigilance Practices Modules I–XVI.