EMA updates GVP - Module III on pharmacovigilance inspections

Revision 2 of GVP Module III – Pharmacovigilance Inspections of the European Medicines Agency (EMA) entered into force on 10 September 2026. The update introduces a series of amendments to the European guidelines on the planning and conduct of pharmacovigilance inspections, taking into account the evolution of the regulatory framework and the experience gained by competent authorities.

Key updates

One of the most relevant aspects concerns the subcontracting of pharmacovigilance activities. The revision incorporates the changes introduced by Implementing Regulation (EU) 2025/1466 and clarifies certain aspects regarding inspections at third parties appointed by the Marketing Authorisation Holder (MAH) to carry out pharmacovigilance activities.

Indeed, the use of external providers does not preclude these entities from being involved in the inspection process. It therefore becomes particularly important for MAHs to ensure adequate oversight of activities delegated to third parties and to ensure that agreements and processes are structured to enable collaboration with authorities during an inspection.

A second element concerns remote inspections. Module III has been updated to reflect the experience acquired by authorities in the use of remote inspection methods. The objective is to provide a clearer framework for managing these activities, which may require specific arrangements for access to documentation, systems, and personnel involved.

Furthermore, the revision confirms the importance of a risk-based approach to inspection planning. Authorities can use the information available on the pharmacovigilance system to identify areas and entities requiring greater focus.

Procedural updates

Revision 2 also addresses several procedural aspects of inspections, including references to inspection fees, access to documentation, and the timelines for making it available to inspectors.

In addition, references to clinical trials have been removed from Module III, considering that these are now governed by Regulation (EU) No 536/2014 on clinical trials.

Implications for companies

For Marketing Authorisation Holders, the update represents an opportunity to verify the readiness of their pharmacovigilance system.

In particular, companies should evaluate:

• the management and oversight of activities delegated to third parties;


• the presence of adequate agreements with suppliers and subcontractors;


• the availability and accessibility of documentation requested during an inspection;


• the adequacy of internal processes, including in the event of a remote inspection;


• the alignment of company procedures with the latest updates to the GVP framework.

For Regulatory Affairs and Pharmacovigilance teams, the update therefore serves as a valuable opportunity to perform a gap assessment and ensure that processes, responsibilities, and documentation are appropriately prepared in view of potential inspection activities.

Sources and links:

Good pharmacovigilance practices (GVP) | European Medicines Agency (EMA) 

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