Document:GBR Directive 2001/20/EC 04-Apr-2001

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

References

	Scope	Document part	Language	Preview
GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001	HM	Article 10 (b)	EN	Conduct of a clinical trial […] (b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating…
GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002	HM	Article 10 (b)	EN	Conduct of a clinical trial […] (b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating…
GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (c)	HM	Article 10 (c)	EN	Conduct of a clinical trial […] (c)within 90 days of the end of a clinical trial the sponsor shall notify the competent authorities of the Member Stat…
GBR Directive 2001/20/EC 04-Apr-2001 Article 16	HM	Article 16	EN	Notification of adverse events 1. The investigator shall report all serious adverse events immediately to the sponsor except for those that the protoc…
GBR Directive 2001/20/EC 04-Apr-2001 Article 17	HM	Article 17	EN	Notification of serious adverse reactions 1.(a)The sponsor shall ensure that all relevant information about suspected serious unexpected adverse reac…
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l)	HM	Article 2 (l)	EN	(l)‘inspection’: the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, …
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m)	HM	Article 2 (m)	EN	(m)‘adverse event’: any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessa…
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n)	HM	Article 2 (n)	EN	(n)‘adverse reaction’: all untoward and unintended responses to an investigational medicinal product related to any dose administered;…
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o)	HM	Article 2 (o)	EN	(o)‘serious adverse event or serious adverse reaction’: any untoward medical occurrence or effect that at any dose results in death, is life-threateni…
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p)	HM	Article 2 (p)	EN	(p)‘unexpected adverse reaction’: an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.…
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a)	HM	Article 2 (a)	EN	Definitions For the purposes of this Directive the following definitions shall apply: (a)‘clinical trial’: any investigation in human subjects intend…
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c)	HM	Article 2 (c)	EN	(c)‘non-interventional trial’: a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the mark…
GBR Directive 2001/20/EC 04-Apr-2001 Article 3	HM	Article 3	EN	Protection of clinical trial subjects […] 2. A clinical trial may be undertaken only if, in particular: […] (f) provision has been made for insurance …