In this Part—

• “amendment to the clinical trial authorisation” means an amendment to—

  1. a

     the terms of the request for authorisation to conduct that trial or the application for an ethics committee opinion in relation to that trial,

  2. b

     the protocol for that trial, or

  3. c

     the other particulars or documents accompanying that request for authorisation or application for ethics committee approval;

• “substantial amendment to the clinical trial authorisation” means an amendment to the clinical trial authorisation which is likely to affect to a significant degree—

  1. a

     the safety or physical or mental integrity of the subjects of the trial,

  2. b

     the scientific value of the trial,

  3. c

     the conduct or management of the trial, or

  4. d

     the quality or safety of any investigational medicinal product used in the trial;

• “valid application” means an application for an ethics committee opinion which complies with the provisions of regulation 14; and

• “valid request for authorisation” means a request to the licensing authority for authorisation to conduct a clinical trial which complies with the provisions of regulation 17, and “valid amended request” shall be construed accordingly.