Point in time view as at 06/11/2023.
The Medicines for Human Use (Clinical Trials) Regulations 2004, PART 4 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.
1. The name and address of—U.K.
(a)the sponsor, and
(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.
Textual Amendments
F1Words in Sch. 3 Pt. 4 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(5); 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. 4 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(c)(ii)
3. The investigational medicinal product tested in the trial.U.K.
4.—(1) The date on which the trial ended in the United Kingdom.U.K.
(2) If the trial was conducted at more than one trial site in the United Kingdom, the dates on which the trial was ended at those sites, if different from the date referred to in sub-paragraph (1).
(3) If the trial was conducted at any trial sites outside the United Kingdom, a statement as to whether the trial has ended at any of those sites and, if so, the date on which the trial was so ended.
5. If the trial is terminated as specified in regulation 27(2), the reasons for terminating the trial early.U.K.
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