The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

SCHEDULE 3 U.K. PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL

PART 3 U.K. NOTICE OF AMENDMENT

1.  The name and address of— U.K.

(a) the sponsor,

(b) if the sponsor is not established in [F1 the 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

F1 Words 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) [F2 any number] allocated to the trial on the European database referred to in Article 11 of the Directive.

Textual Amendments

F2 Words 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.