Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product

Document information
Reference	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
Validity area	GBR
Scope(s)	HM
Document name	The Medicines for Human Use (Clinical Trials) Regulations 2004
Version / Revision	01-May-2004
Status	Current
Document type	Legal act
Language(s)	EN
Description	The Medicines for Human Use (Clinical Trials) Regulations 2004
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 3 — Unit 3.4.2
Scope	HM
Document part	Article 2 investigational medicinal product
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Investigational drug (IMP), Definition, Placebo

Content

“investigational medicinal product” means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial— (a)used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization, (b)used for an indication not included in the summary of product characteristics under the authorization for that product, or (c)used to gain further information about the form of that product as authorised under the authorization;