3. Key GxPs in Medicine

2.3. Good Pharmacovigilance Practices GVP

Pharmacovigilance has been defined by the World Health Organization (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Good pharmacovigilance practices (GVP) are a set of measures designed to facilitate the performance of pharmacovigilance in the EU. GVP apply to marketing-authorisation holders, the EMA and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the EMA as well as medicines authorised at national level.

In line with the general definition, underlying objectives of the applicable EU legislation for pharmacovigilance are:

• preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure; and
• promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.

Pharmacovigilance is therefore an activity contributing to the protection of patients’ and public health.

1. GVP and the European Union Pharmacovigilance System

The EU pharmacovigilance system arguably may be considered one of the most advanced and comprehensive systems in the world. The EU-GVP serves as a robust and transparent instrument that regulates and clarifies the processes of monitoring the safety of medicines on the European market, prevention, detection and assessment of adverse reactions (including medication errors and overdose). Such approach guarantees a high level of patient and public health protection throughout the EU.

The key elements of the EU Pharmacovigilance system as addressed in GVP:

• (EU)-Qualified Person for PV (QPPV) and the respective back-up procedures;
• Organisation of the pharmacovigilance system (the pharmacovigilance system master file (PSMF), a detailed description of the pharmacovigilance system used by the MAH with respect to one or more authorised medicine);
• Periodic safety update report;
• Databases, listing of the data bases used for pharmacovigilance services, registration with the EudraVigilance system and description of processes used for electronic reporting;
• Contractual arrangements with other contracted persons, organisations or service providers involved in the fulfilment of pharmacovigilance obligations;
• Training, records of regular education/training of staff involved in pharmacovigilance activities;
• Documentation, locations of different types of pharmacovigilance source documents, including archiving arrangements;
• Quality Management System;
• Inspections and Audits.

2. Guideline on GVP

In the past the European Commission published pharmacovigilance guidance for human medicinal products (Volume 9A). The most recent of this guidance documents dates from September 2008. With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guideline released by the European Medicines Agency. The guideline covers medicines authorised centrally via the EMA as well as medicines authorised at national level. The guideline on GVP is divided into chapters that fall into two categories:

• modules covering major pharmacovigilance processes;
• product- or population-specific considerations.

Such division allows independent update of the separate modules, assures that the system remains flexible, dynamic and sensitive to the changing requirements of the constantly developing health system. Any member of the EU regulatory network as well as any other stakeholder, including members of the public, and non-regulatory stakeholder organisations, can contribute their proposals for corrections, revision and/or addition of GVP Modules. Since their first version and adoption several Modules have being extensively revised and amended.

Modules covering major pharmacovigilance processes

GVP modules I to XVI cover major pharmacovigilance processes. The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the EMA's website. Annexes provide additional required information: definitions, templates, other guidelines. (including policy on access to EudraVigilance data), and also ICH topics and guidance.

Product- or population-specific considerations

The chapters on product- or population-specific considerations are available for vaccines, biological medicinal products and the paediatric population.

The following Table 2 provides an overview of the GVP Guideline and the adopted GVP modules therein.

Table 2. An overview of the adopted GVP modules

GVP adopted Modules	First published or Last updated (indicated by Rev. x)
Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 3 of Module XVI	2021
GVP Module I: Pharmacovigilance systems and their quality systems	2012
GVP Module II: Pharmacovigilance system master file (Rev. 2)	2017
GVP: Module III: Pharmacovigilance inspections	2014
GVP Module IV: Pharmacovigilance audits (Rev. 1)	2015
GVP Module V: Risk management systems (Rev. 2)	2017
GVP Module VI: Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2)	2017
GVP Module VI (Addendum I): Duplicate management of suspected adverse reaction reports	2017
GVP Module VII: Periodic safety update report	2013
GVP Module VIII: Post-authorisation safety studies (Rev. 3)	2017
GVP Module VIII Addendum I: Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 3 new text first published)	2020
GVP Module IX: Signal management (Rev. 1)	2017
GVP Module IX: Addendum I: Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions	GVP Module X:
GVP Module X: Additional monitoring	2013
GVP Module XV: Safety communication (Rev. 1)	2017
GVP Module XVI: Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2)	2017
GVP Module XVI: Addendum I: Educational materials	2015

For more information on Pharmacovigilance and Risk management processes and procedures Course 3: Pharmacovigilance - Risk management should be consulted.

Legal basis:

Directive 2001/83/EC as amended (with respect to nationally authorised medicines)

Regulation (EC) No. 726/2004 as amended (with respect to centrally authorised medicines)

The GVP Guideline
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices