EMA GVP Annex II

Final GVP Annex II - Templates

Click on the links below for full annex details

Guideline on good pharmacovigilance practices (GVP) Annex II – Templates: Cover page of Periodic Safety Update Report (PSUR) (Rev 1)

First published: 25/06/2012, Last updated: 25/04/2013

Guideline on good pharmacovigilance practices (GVP) Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev 1) 

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

Guideline on good pharmacovigilance practices (GVP) Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)

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

EMA GVP Annex II: