Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -

Document information
Reference	EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
Validity area	EU
Scope(s)	NIS
Document name	GVP: Module VIII EMA/813938/2011
Version / Revision	Rev. 3 (2017)
Status	Current
Document type	Official guideline
Language(s)	EN
Description	Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3)
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 2 — Unit 2.1.3
Scope	NIS
Document part	-
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Post-authorisation safety study, Protocol, Requirements
Comment	Format and content of PASS study protocol (GVP Module VIII)

Content

[...] VIII.B.3. Study protocol [...] VIII.B.3.1. Format and content of the study protocol [...]