Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11)

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 2 — Unit 2.2.1
Scope	HM
Document part	Article 3 (6) - (11)
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Sponsor, Sponsor responsibilities, Substantial modification, Authorised representative

Content

Sponsor of a clinical trial 3.— (6) After the clinical trial has been authorised by the licensing authority in accordance with regulation 18, 19 or 20, a different person may be specified as responsible for carrying out the functions of the sponsor under Part 3, 4 or 5 by making a substantial amendment to the terms of a clinical trial authorisation in accordance with regulations 24 to 26.

(7) Where a person is responsible for carrying out the functions of the sponsor under Part 3 by virtue of paragraph (5), or is specified in accordance with paragraph (6) as responsible for those functions, any reference to the sponsor in—

(a)that Part, except regulation 15, (b)Parts 2 to 4 of Schedule 3, (c)Schedule 5, in so far as it relates to decisions of the licensing authority under Part 3, and (d)Schedule 12, shall, in relation to the trial, be construed as a reference to that person.

(8) Where a person is specified in accordance with paragraph (5) or (6) as responsible for carrying out the functions of the sponsor under Part 4, any reference to the sponsor in—

(a)that Part, except regulation 28(1), or (b)Schedule 5, in so far as it relates to notices under regulation 31(1), shall, in relation to the trial, be construed as a reference to that person.

(9) Where a person is specified in accordance with paragraph (5) or (6) as responsible for carrying out the functions of the sponsor under Part 5, any reference to the sponsor in that Part shall, in relation to the trial, be construed as a reference to that person.

(10) Any reference to the sponsor in—

(a)regulations 15 and 28(1), (b)Parts 2 and 6 to 9, and (c)Schedules 1 and 7, and Part 1 of Schedule 3, shall, in relation to the trial, include a reference to a person specified in accordance with paragraph (5) or (6).

(11) A person who is a sponsor of a clinical trial in accordance with this regulation must—

(a)be established in the European Community, or (b)have a legal representative who is so established.