Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2.

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	Schedule 7 Part 2 2.
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Manufacturing, Investigational drug (IMP), Good manufacturing practice, Competent authority

Content

PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS [...] 2. The holder of the authorisation shall— (a)provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the investigational medicinal products which he handles, stores or distributes under his authorisation as are necessary to maintain the quality of the investigational medicinal products; (b)not use for such purposes premises other than those specified in the authorisation or which may be approved from time to time by the licensing authority; and (c)ensure that any arrangements he makes with a person for the storage and distribution of the investigational medicinal products are adequate to maintain the quality of those products.