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

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|has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
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(6) - (11)
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|tags_display=[[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00040-Sub-Γ„nd|Substantial modification]], [[Glossary:TAG-00183-Aut-Ver|Authorised representative]]
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|comment=Sponsor obligations after trial authorisation
{{:Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004}}
|content=Sponsor of a clinical trial
Β 
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
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! Module
| Module 2 β€” Unit 2.2.1
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! Scope
| HM
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! Document part
| Article 3
(6) - (11)
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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| [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00245-Spo-ten|Sponsor responsibilities]], [[Glossary:TAG-00040-Sub-Γ„nd|Substantial modification]], [[Glossary:TAG-00183-Aut-Ver|Authorised representative]]
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== Content ==
Sponsor of a clinical trial
3.β€” (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.
3.β€” (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.


Line 73: Line 42:
(a)be established in the European Community, or
(a)be established in the European Community, or
(b)have a legal representative who is so established.
(b)have a legal representative who is so established.
}}

Revision as of 12:55, 16 July 2026



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 β€” 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.β€” (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 inβ€”

(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 inβ€”

(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 inβ€”

(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 mustβ€”

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

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