Glossary:TAG-00039-Tem-ung

Glossary > Temporary halt

Temporary halt
Tag-ID	TAG-00039-Tem-ung
English	Temporary halt of a clinical trial / Temporary suspension / Clinical hold
French	Arrêt temporaire d'un essai clinique / Suspension temporaire de l'essai
German	Vorübergehende Unterbrechung einer klinischen Prüfung / Vorübergehende Aussetzung / Temporäre Unterbrechung

References

	Scope	Document part	Language	Document
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77	MD	Article 77	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1 – 3	MD	Article 77 Paragraph 1 – 3	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1, 3 & 4	MD	Article 77 Paragraph 1, 3 & 4	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 1, 3, 4	IVD	Article 73 Paragraph 1, 3, 4	EN	EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 1 – 7	HM	Article 37 Paragraph 1 – 7	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 38	HM	Article 38	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001	HM	Article 10 (b)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002	HM	Article 10 (b)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 31	HM	Article 31	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5)	HM	Schedule 5 (5)	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.6	G	III. Annex 1 2.6	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1	G	III. Annex 1 3.17.1	EN	ICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.2	MD	8.2	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.42	HM	§ 312.42	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.45	HM	§ 312.45	EN	USA 21 CFR Part 312 09-Apr-2025