Point in time view as at 06/11/2023.
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 10 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,
(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.
Mae’r holl gynnwys ar gael dan Drwydded Llywodraeth Agored v3.0 ac eithrio ble nodir yn wahanol. Yn ychwanegol mae’r safle hwn â chynnwys sy’n deillio o EUR-Lex, a ailddefnyddiwyd dan delerau Penderfyniad y Comisiwn 2011/833/EU ar ailddefnyddio dogfennau o sefydliadau’r UE. Am ragor o wybodaeth gweler ddatganiad cyhoeddus Swyddfa Gyhoeddiadau’r UE ar ailddefnyddio.
