This page lists the European Medicines Agency's guidance related to pharmacovigilance.
In the past, 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 With the application of the new pharmacovigilance legislation as of July 2012, volume 9A has now been replaced by the good-pharmacovigilance-practice (GVP) guideline, published by the Agency.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 the reference.
For more information on transitional measures, see questions and answers on implementation of pharmacovigilance legislation.
Other guidelines not incorporated in volume 9A, as well as current and historical concept papers and draft guidelines under public consultation, are listed below.
Table of contents
Guidance for marketing-authorisation holders
|Document(s)||Language||Status||First published||Last updated||Effective Date|
|Questions and answers on variations to an existing pharmacovigilance system as described in the detailed description of the pharmacovigilance system||(English only)||adopted||02/03/2011||02/08/2013|
|Reporting requirements of individual case safety reports applicable to marketing-authorisation holders during the interim period||(English only)||23/05/2012||08/11/2013|
|European Union individual case safety report (ICSR) implementation guide||(English only)||adopted||30/04/2014||21/01/2015|