Glossary:TAG-00269-Wit-der

Glossary > Authorisation revocation

Authorisation revocation
Tag-ID	TAG-00269-Wit-der
English	Withdrawal of CTA / Withdrawal of clinical trial authorisation / Suspension of clinical trial authorisation / Revocation of authorisation
EN Abbr.	CTA
French	Retrait de l'autorisation d'essai clinique / Suspension de l'autorisation d'essai clinique / Révocation de l'autorisation
FR Abbr.	AEC
German	Rücknahme der klinischen Prüfungsgenehmigung / Aussetzung der klinischen Prüfungsgenehmigung / Widerruf der Genehmigung

References

	Scope	Document part	Language	Document
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42	HM	§ 42	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76	MD	Article 76	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 77	HM	Article 77	EN	EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002	MD	Article 15 6. - 7.	EN	GBR Directive 93/42/EEC 11-Oct-2007
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
USA 21 CFR Part 812 09-Apr-2025 § 812.30 (b) - (c)	MD	§ 812.30 (b) - (c)	EN	USA 21 CFR Part 812 09-Apr-2025