EMA Guideline: Good Pharmacovigilance Practices (GVP): Module III on Pharmacovigilance Inspections
Effective pharmacovigilance is essential for protecting patients and supporting the safe and effective use of medicinal products. The Guidelines on Good Pharmacovigilance Practices (GVP) provide a framework for pharmacovigilance activities in the European Union. The latest introductory cover note announces the publication of Revision 2 of Module III on Pharmacovigilance Inspections, reflecting recent changes to the applicable European pharmacovigilance legislation.
Background to GVP
The GVP framework was developed following amendments to EU pharmacovigilance legislation that applied from July 2012. It replaced the previous pharmacovigilance guidance contained in Volume 9A of the Rules Governing Medicinal Products in the European Union.
GVP is organised into two types of chapters: Modules covering pharmacovigilance processes and Product- or Population-Specific Considerations. The framework has been progressively developed and revised to support implementation of pharmacovigilance requirements.
Development of Pharmacovigilance Inspection Guidance
Module III, covering pharmacovigilance inspections, was initially released for public consultation in 2012 and subsequently published in its final version in December 2012. A revision was published in September 2014, including a reference to the Union procedures for pharmacovigilance inspections.
The latest update is Revision 2 of Module III, which reflects amendments to Commission Implementing Regulation (EU) No 520/2012 through Commission Implementing Regulation (EU) 2025/1466. These amendments came into application on 12 February 2026.
Objectives of Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
The objectives of EU pharmacovigilance legislation include preventing harm from adverse reactions in humans arising from the use of authorised medicinal products, including use outside the terms of the marketing authorisation or occupational exposure.
Another objective is to promote the safe and effective use of medicinal products by providing timely information on medicine safety to patients, healthcare professionals, and the public. Pharmacovigilance therefore contributes to the protection of patients and public health.
Roles Within EU Pharmacovigilance
Pharmacovigilance in the EU involves a regulatory network consisting of the competent authorities of Member States, the European Commission, and the European Medicines Agency. The Agency has a central role in coordinating activities within this network.
EU legislation also places pharmacovigilance responsibilities and specific obligations on marketing authorisation holders.
The participation of patients and healthcare professionals in pharmacovigilance has increased over time. This includes patient reporting of suspected adverse reactions and participation of patient and healthcare professional representatives in relevant regulatory processes, including the Pharmacovigilance and Risk Assessment Committee and public hearings on pharmacovigilance and benefit-risk matters.
Legal Basis and Scope of GVP
The EU legal framework for pharmacovigilance of medicinal products for human use is established through Regulation (EC) No 726/2004, Directive 2001/83/EC, and the relevant amending legislation and Commission Implementing Regulation.
The GVP guidelines are developed by the Agency in cooperation with competent authorities in Member States and interested parties. The pharmacovigilance legal requirements and GVP apply to medicinal products authorised in the EU, whether centrally or nationally authorised.
GVP is intended to facilitate the performance of pharmacovigilance activities within the EU and applies to marketing authorisation holders, the Agency, and competent authorities in Member States.
Structure and Development of GVP
GVP has been developed through collaboration between the Agency, Member States, the European Commission, and stakeholders. Draft GVP documents are prepared by teams consisting of experts from Member States and the Agency, taking stakeholder input into account before documents are agreed for public consultation.
The framework has undergone multiple revisions and additions since its initial implementation, reflecting changes in legislation, regulatory experience, and developments in pharmacovigilance activities.
Referencing Legal Requirements in GVP
The GVP documents refer to the relevant EU legislation in its latest amended form. References to specific Articles of Regulation (EC) No 726/2004 and Directive 2001/83/EC use defined abbreviations, while references to other Regulations or Directives provide their full references.
The guidance distinguishes between legal requirements and guidance for implementation. Text describing legal requirements uses the modal verb “shall”, while guidance for implementation generally uses “should.”
Public Consultation
GVP documents may be released for public consultation to obtain stakeholder comments on guidance intended to support practical implementation of the applicable legislation.
Participants in a GVP public consultation are asked to provide comments through the EU survey tool associated with the relevant consultation document. Comments should focus on the proposed guidance rather than the underlying legal requirements, as the legal requirements themselves cannot be changed through the GVP consultation process.
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