EMA GVP Annex III

EMA GVP Annex III - Other Pharmacovigilance Guidance

These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.

Click on the links below for full annex details

Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data 

First published: 14/11/2005, Last updated: 14/11/2005

Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)

First published: 03/08/2004, Last updated: 22/10/2010

Overview of comments received on draft note for guidance: EudraVigilance version 7.1 - Processing of safety messages and individual case safety reports (ICSRs)

First published: 20/11/2009, Last updated: 20/11/2009

Draft note for guidance: EudraVigilance Human version 7.1 - Processing of safety messages and individual case safety reports (ICSRs) 

First published: 01/02/2008, Last updated: 01/02/2008

EMA GVP Annex III: