The Medicines for Human Use (Clinical Trials) Regulations 2004

PART 3 NOTICE OF AMENDMENT

1.  The name and address of—

(a) the sponsor,

(b) if the sponsor is not established in the European Community, his legal representative, and

(c) if any person has been authorised by the sponsor to send the notice on his behalf, that person.

2.  Particulars identifying the trial, including—

(a) the title of the trial; and

(b) the number allocated to the trial on the European database referred to in Article 11 of the Directive.

3.  A description of the proposed amendment.

4.  A statement of the reasons for proposing that amendment.

5.  A copy of the proposed changes to—

(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—

(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.