Part 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION

1. 11Interpretation of Part 3
2. 11ADefinition of notifiable trial
3. 11BDefinition of Route B substantial modification
4. 12Requirement for authorisation and ethics committee opinion
5. 13Supply of investigational medicinal products for the purpose of clinical trials
6. 14Request for authorisation to conduct a clinical trial
7. 15Application for ethics committee opinion
8. 16Request for approval and combined procedure
9. 17Assessment of request for approval
10. 18Approval procedure for clinical trials
11. 18ARequest for further information regarding a request for approval
12. 18BApproval procedure for amended requests for approval
13. 18CApproval procedure time periods in special circumstances
14. 19Clinical trials conducted in countries other than the United Kingdom
15. 20Modifications to clinical trial approval
16. 21Modifications by the licensing authority or the ethics committee
17. 22Modifications by the sponsor
18. 22AApproval procedure for substantial modifications
19. 22BRequest for further information regarding proposed substantial modifications
20. 22CApproval procedure for amended requests regarding substantial modifications
21. 23Reference to the appropriate committee or the Medicines Commission
22. 24Review and appeal relating to ethics committee opinion
23. 25Transparency requirements
24. 26Lapse of clinical trial approval
25. 27Conclusion of clinical trial
26. 27AInformation sharing
27. 27BPublication of information