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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| | | [[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]] | ||
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Revision as of 17:29, 15 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 |
| 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 [...]
