Glossary:TAG-00331-Une-irk

Glossary > Unexpected adverse reaction

Unexpected adverse reaction
Tag-ID	TAG-00331-Une-irk
English	Unexpected adverse reaction / Unexpectedness
French	Effet indésirable inattendu / Imprévisibilité
German	Unerwartete Nebenwirkung / Unerwartbarkeit

References

	Scope	Document part	Language	Document
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p)	HM	Article 2 (p)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction	HM	Article 2 unexpected adverse reaction	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E2A Guideline 1994 II A. 3.	G	II A. 3.	EN	ICH ICH E2A Guideline 1994
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event	HM	§ 312.32 - Unexpected adverse event	EN	USA 21 CFR Part 312 09-Apr-2025