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

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
Module	Module 5 — Unit 5.1.1
Scope	HM
Document part	Article 2 (m)
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Adverse event, Definition, Causality, Medicinal product
Comment	Definition of adverse event (medicinal products, EU directive)

Content

(m)‘adverse event’: any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment;