Chapter II AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL

United Kingdom

1. 4Prior authorisation
2. 5Submission of an application
3. 6Assessment report — Aspects covered by Part I
4. 7Assessment report — Aspects covered by Part II
5. 8Decision on the clinical trial
6. 9Persons assessing the application
7. 10Specific considerations for vulnerable populations
8. 11Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
9. 12Withdrawal
10. 13Resubmission
11. 14Subsequent addition of a Member State concerned