GVP Module III establishes the framework for the planning, conduct, reporting, and follow-up of pharmacovigilance inspections within the European Union, ensuring that Marketing Authorisation Holders (MAHs) comply with their obligations and that medicinal product safety is effectively monitored. The previous version (Revision 1) has been in force since 16 September 2014, and is now replaced by Revision 2, effective as of 10 September 2026. After more than a decade, this update introduces meaningful regulatory and practical shifts.
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Revision 2 introduces several important updates, including significantly strengthened provisions on subcontracting. The GVP Module III now explicitly extends the scope of inspections to third parties performing pharmacovigilance activities, including further subcontracted entities within the outsourcing chain. Importantly, these entities may be inspected even if contractual agreements do not yet formally include inspection clauses.
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In parallel, the guidance on remote inspections has been substantially clarified. The inspectorate is expected to determine, on a case-by-case basis, whether a remote inspection provides sufficient oversight, taking into account the feasibility of conducting staff interviews and reviewing key documentation via remote access. This reflects a shift from ad hoc use of remote inspections to a structured and established inspection approach, without reducing the level of regulatory scrutiny.
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Regarding the Pharmacovigilance System Master File (PSMF), MAHs were required to maintain and make it available to inspectors upon request within a defined timeframe of no later than 7 calendar days. In contrast, Revision 2 removes this timeframe and introduces a significantly stricter requirement: the PSMF must be permanently and immediately available to inspectors. This represents a clear transition from a reactive, request-driven approach to continuous inspection readiness, enabling the pharmacovigilance system to be assessed at any time without delay.
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An additional important change in Revision 2 is the removal of the qualifier “which may pose a risk to public health” from the inspection objectives. Inspections are now clearly expected to “identify, record and address non-compliance” without linking enforcement actions to an immediate or perceived product risk. This reinforces a fundamental principle: compliance is not conditional.
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The update aligns the module with the latest EU legal framework, removes outdated references to clinical trials, reinforces a risk-based approach to inspection planning (including how inspections are prioritised and distributed across inspection cycles), and updates references related to inspection fees in line with the most recent EU regulatory framework governing cost recovery and administrative charges.
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Finally, Revision 2 includes general editorial improvements, clearer legal referencing, and alignment with other GVP modules and EU procedures, contributing to greater consistency and clarity of the document overall.
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Organisations should now assess their pharmacovigilance systems, outsourcing arrangements and PSMF accessibility to ensure they are fully prepared for this strengthened inspection framework.

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