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

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(6) - (11)
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{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}

{| class="gplx-infobox"
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| HM
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! Document part
| Article 3
(6) - (11)
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags (EN)
| 
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! Tags (original language)
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! Tags (FR)
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! Comment
| Sponsor obligations after trial authorisation
|}

== 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.