Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o)

Document Information

Document information
Reference	GBR Directive 2001/20/EC 04-Apr-2001
Validity area	GBR
Scope(s)	HM
Document name	Directive 2001/20/EC
Version / Revision	04-Apr-2001
Status	Current
Document type	Legal act
Language(s)	EN
Description	DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use The European Directive (2001/20/EC) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU.
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	HM
Document part	Article 2 (o)
Language	EN
Original entry by	Florian Adragna
Contributors
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Tags (FR)
Comment	Definition of serious adverse event or reaction (EU directive)

Text

(o)‘serious adverse event or serious adverse reaction’: any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect;