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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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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Document part
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| EN
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! Original entry by
| Florian Adragna
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! Contributors
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== Content ==
Appendix I – Examples of serious breaches

Latest revision as of 13:50, 16 July 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
Module Module 4 — Unit 4.1.4
Scope G
Document part Appendix I
Language EN
Original entry by Florian Adragna
Contributors
Tags Serious breach, Examples

Content

Appendix I – Examples of serious breaches

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