Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1): Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 | ||
| | |module=1 | ||
| | |unit=1.5.4 | ||
|scope=NIS | |||
|doc_part=Article 107m | |||
(1) | (1) | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00285-Pha-enk ++ TAG-00315-Spo-des ++ TAG-00276-Mar-inh ++ TAG-00329-Saf-lne | ||
|tags_display=[[Glossary:TAG-00285-Pha-enk|Post-authorisation safety study]], [[Glossary:TAG-00315-Spo-des|Sponsor oversight]], [[Glossary:TAG-00276-Mar-inh|Marketing authorisation holder]], [[Glossary:TAG-00329-Saf-lne|Safety]] | |||
|comment=Supervision of post-authorisation safety studies (PASS) | |||
|content=CHAPTER 4 | |||
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CHAPTER 4 | |||
Supervision of post-authorisation safety studies | Supervision of post-authorisation safety studies | ||
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1. This Chapter applies to non-interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed in accordance with Articles 21a or 22a, and which involve the collection of safety data from patients or healthcare professionals. | 1. This Chapter applies to non-interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed in accordance with Articles 21a or 22a, and which involve the collection of safety data from patients or healthcare professionals. | ||
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Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | EU Directive 2001/83/EC -
Community code relating to medicinal products for human use 20-Jun-12 |
| Validity area | EU |
| Scope(s) | NIS |
| Document name | Directive 2001/83/EC -
Community code relating to medicinal products for human use |
| Version / Revision | 20-Jun-12 |
| Status | Current |
| Document type | Regulatory requirement |
| Language(s) | EN |
| Description | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.5.4 |
| Scope | NIS |
| Document part | Article 107m
(1) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Post-authorisation safety study, Sponsor oversight, Marketing authorisation holder, Safety |
Content
CHAPTER 4 Supervision of post-authorisation safety studies
Article 107m
1. This Chapter applies to non-interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed in accordance with Articles 21a or 22a, and which involve the collection of safety data from patients or healthcare professionals.
