Final GVP modules

Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices: Module I – Pharmacovigilancesystems and their quality systems (English only) adopted 25/06/2012 02/07/2012
Guideline on good pharmacovigilance practices: Module II – Pharmacovigilancesystem master file (Rev. 2) (English only) adopted 25/06/2012 30/03/2017 31/03/2017
Guideline on good pharmacovigilance practices: Module III – Pharmacovigilanceinspections (English only) adopted 13/12/2012 15/09/2014 16/09/2014
Guideline on good pharmacovigilance practices(GVP) – Module IV –Pharmacovigilance audits (Rev. 1) (English only) adopted 11/08/2015
Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev. 2) (English only) adopted 25/06/2012 30/03/2017 31/03/2017
Guideline on good pharmacovigilance practices(GVP) – Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products(Rev. 2) (English only) adopted 25/06/2012 02/08/2017 22/11/2017
Guideline on good pharmacovigilance practices(GVP) – Module VI Addendum I – Duplicate management of suspected adverse reaction reports (English only) adopted 25/06/2012 02/08/2017 22/11/2017
Guideline on good pharmacovigilance practices(GVP): Module VII – Periodic safety update report (English only) adopted 25/06/2012 12/12/2013 13/12/2013
Guideline on good pharmacovigilance practices(GVP) – Module VIII – Post-authorisation safety studies (Rev. 3) (English only) adopted 25/06/2012 12/10/2017 13/10/2017
Guideline on good pharmacovigilance practices(GVP) – Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 2) (English only) adopted 25/06/2012 08/08/2016 09/08/2016
Guideline on good pharmacovigilance practices(GVP): Module IX – Signal management (Rev. 1) (English only) adopted 25/06/2012 12/10/2017 22/11/2017
Guideline on good pharmacovigilance practices(GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions (English only) adopted 12/10/2017 22/11/2017
Guideline on good pharmacovigilance practices: Module X – Additional monitoring (English only) adopted 25/04/2013 25/04/2013
Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1) (English only) adopted 24/01/2013 12/10/2017 13/10/2017
Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2) (English only) adopted 28/02/2014 30/03/2017 31/03/2017