View source for Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3.

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{{:Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12}}

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 6 — Unit 6.4.2
|-
! Scope
| G
|-
! Document part
| Annex III
2. ; 3.
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags
| [[Glossary:TAG-00285-Pha-enk|Post-authorisation safety study]], [[Glossary:TAG-00274-Fin-Spo|Sponsor final report]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00340-Req-nfo|Requirements]]
|-
! Comment
| PASS protocol, abstract and final study report content
|}

== Content ==
ANNEX III

Protocols, abstracts and final study reports for post-authorisation safety studies
[...]
2.   Format of the abstract of the final study report
[...]
3.   Format of the final study report
[...]