View source for Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1.

{{ReferenceData
|has_document=Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12
|module=2
|unit=2.1.3
|scope=G
|doc_part=Annex III
1.
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00285-Pha-enk ++ TAG-00033-Pro-oto ++ TAG-00340-Req-nfo ++ TAG-00274-Fin-Spo
|tags_display=[[Glossary:TAG-00285-Pha-enk|Post-authorisation safety study]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00340-Req-nfo|Requirements]], [[Glossary:TAG-00274-Fin-Spo|Sponsor final report]]
|comment=PASS protocol, abstract and final study report requirements
|content=ANNEX III

Protocols, abstracts and final study reports for post-authorisation safety studies

1.   Format of the study protocol
[...]
}}