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

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 1 — Unit 1.2.2
Scope	HM
Document part	Article 2 (a)
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Clinical trial, Definition, Investigational drug (IMP), Adverse reaction

Content

Definitions For the purposes of this Directive the following definitions shall apply:

(a)‘clinical trial’: any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy;