Glossary:TAG-00069-Imm-rhe

Glossary > Urgent safety measure

Urgent safety measure
Tag-ID	TAG-00069-Imm-rhe
English	Imminent danger / Immediate safety risk / Urgent safety measure
French	Danger imminent / Risque immédiat pour la sécurité / Mesure de sécurité urgente
German	Unmittelbare Gefahr / Unmittelbares Sicherheitsrisiko / Dringende Sicherheitsmaßnahme

References

	Scope	Document part	Language	Document
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5	HM	§ 40b Absatz 5	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 66	MD	§ 66	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001	MD	8	EN	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002	MD	8	EN	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68	MD	Article 68	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6	MD	Article 72 Paragraph 6	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1	HM	Article 35 Paragraph 1	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3	HM	Article 35 Paragraph 2-3	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53	HM	Article 53	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54	HM	Article 54	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001	MD	2.	FR	FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001	HM	Article 30	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 Article 30-002	HM	Article 30	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) II 2.4	G	II 2.4	EN	ICH ICH E6 Guideline R3 (2025)
USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii)	HM	§ 312.30 (b) (ii)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.23	G	§ 50.23	EN	USA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.24	G	§ 50.24	EN	USA 21 CFR Part 50 09-Apr-2025