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Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I: Difference between revisions

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== Document Information ==
{{:Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021}}
{{:Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021}}


== Reference Details ==
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! scope="row" style="width:200px;" | Document part
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| Appendix I
| Appendix I
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! scope="row" style="width:200px;" | Language
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| EN
| EN
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! scope="row" style="width:200px;" | Original entry by
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| Florian Adragna
| Florian Adragna
|-
|-
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! scope="row" style="width:200px;" | Tags (EN)
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| Examples of serious breaches
| Examples of serious breaches
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== Text ==
== Content ==
Appendix I – Examples of serious breaches
Appendix I – Examples of serious breaches

Revision as of 14:27, 29 June 2026



Document information
Reference EU EMA/698382/2021

- Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021

Validity area EU
Scope(s) G
Document name EMA/698382/2021

- Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

Version / Revision 2021
Status Current
Document type Official guideline
Language(s) EN
Description EMA/698382/2021

Quality and Safety of Medicines Department Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

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


Reference Details
Scope G
Document part Appendix I
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Examples of serious breaches

Content

Appendix I – Examples of serious breaches

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