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The Medicines for Human Use (Clinical Trials) Regulations 2004
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Rhagor o Adnoddau
Changes over time for: PART 3
Alternative versions:
- 01/05/2004- Amendment
- 29/08/2006- Amendment
- 31/12/2020- Amendment
- 06/11/2023
Point in time
Status:
Point in time view as at 06/11/2023.
Changes to legislation:
The Medicines for Human Use (Clinical Trials) Regulations 2004, PART 3 is up to date with all changes known to be in force on or before 04 March 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
Changes to Legislation
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PART 3U.K.NOTICE OF AMENDMENT
1. The name and address of—U.K.
(a)the sponsor,
(b)if the sponsor is not established in [F1the United Kingdom or a country that is included in the list referred to in regulation 3(11A)] , his legal representative, and
(c)if any person has been authorised by the sponsor to send the notice on his behalf, that person.
Textual Amendments
F1Words in Sch. 3 Pt. 3 para. 1(b) substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 24(4); 2020 c. 1, Sch. 5 para. 1(1)
2. Particulars identifying the trial, including—U.K.
(a)the title of the trial; and
(b)[F2any number] allocated to the trial on the European database referred to in Article 11 of the Directive.
Textual Amendments
F2Words in Sch. 3 Pt. 3 para. 2(b) substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 29(b)(ii)
3. A description of the proposed amendment.U.K.
4. A statement of the reasons for proposing that amendment.U.K.
5. A copy of the proposed changes to—U.K.
(a)the clinical trial protocol; or
(b)any other particulars or documents accompanying the request for authorisation or the application for an ethics committee opinion.
6. Summaries of—U.K.
(a)any data submitted in support of the proposed amendment; and
(b)any change to the assessment referred to in paragraph 11(2) of Part 2.
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