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Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1.: Difference between revisions

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! colspan="2" class="gplx-infobox-header" | Reference Details
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|-
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! Document part
| Annex III
1.
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| EN
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| [[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]]
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== Content ==
ANNEX III


Protocols, abstracts and final study reports for post-authorisation safety studies
Protocols, abstracts and final study reports for post-authorisation safety studies
Line 49: Line 18:
1.  Format of the study protocol
1.  Format of the study protocol
[...]
[...]
}}

Latest revision as of 13:49, 16 July 2026



Document information
Reference EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12
Validity area EU
Scope(s) G
Document name Regulation (EU) No 520/2012 - performance of pharmacovigilance activities
Version / Revision 20-Jun-12
Status Current
Document type Regulatory requirement
Language(s) EN
Description Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council Text with EEA relevance

(Including NIS)

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 2 — Unit 2.1.3
Scope G
Document part Annex III

1.

Language EN
Original entry by Florian Adragna
Contributors
Tags Post-authorisation safety study, Protocol, Requirements, Sponsor final report

Content

ANNEX III

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

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

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