Pharmacovigilance: Regulatory and procedural guidance

The European Medicines Agency developed the good-pharmacovigilance-practice (GVP) guideline to facilitate the performance of pharmacovigilance activities in the European Union. GVP is a key deliverable of the 2010 pharmacovigilance legislation to replace earlier guidance drawn up by the European Commission.

Until July 2012, the European Commission drew up pharmacovigilance guidelines in accordance with Article 106 of Directive 2001/83/EC of the European Parliament and the Council, known as volume 9A. With the application of the new pharmacovigilance legislation as of July 2012, volume 9A has now been replaced by the good-pharmacovigilance-practice (GVP) guideline, published by the Agency. Where GVP modules have not yet been finalised, and for some transitional measures, the relevant parts of volume 9A of the rules governing medicinal products in the European Union remain applicable.

For more information on transitional measures, see questions and answers on implementation of pharmacovigilance legislation.

Other guidelines not incorporated in the GVP guideline, as well as current and historical concept papers and draft guidelines under public consultation, are listed below.

Guidance is also available on withdrawn products notification and risk-management plans.

Guidance for marketing-authorisation holders

Reporting requirements of individual case safety reports applicable to marketing-authorisation holders during the interim period

Reference Number: EMA/321386/2012 Rev. 9

European Union individual case safety report (ICSR) implementation guide

Adopted Consultation dates: 30/04/2014 to 30/06/2014 Reference Number: EMA/51938/2013 Rev. 2 Summary:

This guidance specifies the technical requirements and the process of transmission of individual case safety reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the European Economic Area.

Questions and answers on signal management

Reference Number: EMA/261758/2013 Rev.5

Pharmacovigilance practices

Reflection paper on collecting and reporting information on off-label use in pharmacovigilance

Draft: consultation closed Consultation dates: 29/04/2016 to 29/07/2016 Reference Number: EMA/293194/2016 Summary:

This paper outlines a proposal for the collection and reporting of information on off-label use by Marketing Authorisation Holders (MAHs) in relation to their pharmacovigilance obligations provided in Title IX of Directive 2001/83/EC.

Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency

Adopted Reference Number: EMA/161530/2014

Overview of comments received on 'Detailed Guide regarding the Monitoring of Medical Literature and the Entry of Relevant Information into the EudraVigilance Database by the European Medicines Agency on Literature Monito...

Reference Number: EMA/716877/2014

Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency

Draft: consultation closed Consultation dates: 05/06/2014 to 27/07/2014 Reference Number: EMA/161530/2014 Summary:

Scientific and medical literature is an important source of information on suspected adverse-reaction case reports (also referred to as individual case safety reports). This detailed guide describes the technical aspects of the literature-monitoring services to be provided by the Agency in line with the requirements set out in Article 27 of Regulation (EC) 726/2004 and good-pharmacovigilance-practice guideline, module VI, 'management and reporting of adverse reactions to medicinal products'.

List of substances and products subject to worksharing for signal management

Reference Number: EMA/563056/2014 Rev. 14

CHMP guideline on detection and management of duplicate individual cases and individual case safety reports

Adopted Reference Number: EMA/13432/2009 Legal effective date: 02/07/2012 Summary:

Duplicate cases can pose significant problems for analysing signals arising from pharmacovigilance

databases, both artificially inflating and masking signals of disproportionate reporting.

Draft guideline on detection and management of duplicate individual cases and individual case safety reports

Draft: consultation closed Consultation dates: 29/06/2010 to 29/09/2010 Reference Number: EMA/13432/2009

EudraLex – Volume 9A – Questions and answers on implementation - Version 5.4

Adopted Reference Number: EMA/46003/2011 Summary:

This document supersedes document version 3.2 published in October 2008 (EMEA/560457/2008). New questions and answers (numbers 038 to 064) have been included.

EudraVigilance Expert Working Group: Volume 9A implementation questions and answers - Version 3.2

Adopted Reference Number: EMEA/560457/2008

EudraVigilance Expert Working Group: Volume 9A implementation questions and answers - Version 1.2

Adopted Reference Number: EMEA/111972/2008

Implementation plan for the 'Note for guidance - EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)'

Adopted Reference Number: EMEA/665231/2008 Rev. 1

Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety reports (ICSRs) - Revision 2

Adopted Reference Number: EMA/H/20665/04/Final Rev. 2