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

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{| class="wikitable gplx-infobox"
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Document part
| Annex III
2. ; 3.
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| EN
|-
! Original entry by
| Florian Adragna
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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 54: Line 20:
3.  Format of the final study report
3.  Format of the final study report
[...]
[...]
}}

Latest revision as of 13:50, 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 6 — Unit 6.4.2
Scope G
Document part Annex III

2. ; 3.

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

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 [...]

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