EMA (Good Pharmacovigilance Practices) GVP Modules I to XVI

GVP Modules covering major pharmacovigilance processes:

GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency's website.

Click on the titles below for complete guidelines

Guideline on good pharmacovigilance practices: Module I – Pharmacovigilance systems and their quality systems 

(First published: 25/06/2012, Last updated: 25/06/2012)

Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev. 2) 

(First published: 25/06/2012, Last updated: 30/03/2017)

Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections 

(First published: 13/12/2012, Last updated: 15/09/2014)

Guideline on good pharmacovigilance practices (GVP) - Module IV – Pharmacovigilance audits (Rev.1) 

(First published: 12/12/2012, Last updated: 11/08/2015)

Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev.2) 

(First published: 25/06/2012, Last updated: 30/03/2017)

Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products(Rev. 2) 

(First published: 25/06/2012, Last updated: 02/08/2017)

Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum I – Duplicate management of suspected adverse reaction reports 

(First published: 28/07/2017, Last updated: 02/08/2017)

Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report

 (First published: 25/06/2012, Last updated: 12/12/2013)

Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3) 

(First published: 25/06/2012, Last updated: 12/10/2017)

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. 3) 

(First published: 23/06/2020)

Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev.1)  

(First published: 25/06/2012, Last updated: 12/10/2017)

Guideline on good pharmacovigilance practices (GVP): Module IX Addendum I –Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions 

(First published: 12/10/2017, Last updated: 12/10/2017)

Guideline on good pharmacovigilance practices: Module X – Additional monitoring 

(First published: 25/04/2013, Last updated: 25/04/2013)

Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1) 

(First published: 24/01/2013, Last updated: 12/10/2017)

Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2) 

(First published: 28/02/2014, Last updated: 30/03/2017)

Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials 

(First published: 15/12/2015, Last updated: 15/12/2015)

EMA (Good Pharmacovigilance Practices) GVP Modules I to XVI: