Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3

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
Scope	NIS
Document part	VIII.B.4.3
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Final study report requirements (PASS)

Content

VIII.B.4.3. Study reports [...] VIII.B.4.3.2. Final study report [...]