The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024

1. Introductory Text

2. Part 1 General

   1. 1. Citation, commencement and extent

   2. 2. Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

3. Part 2 Amendment to Part 1 (Introductory Provisions)

   1. 3. Amendment to regulation 2

   2. 4. Amendment to regulation 3

   3. 5. Insertion of new regulation 3B

4. Part 3 Amendment to Part 2 (Ethics Committees)

   1. 6. Amendment to regulation 5

   2. 7. Amendment to regulation 6

   3. 8. Omission of regulations 7 and 8

   4. 9. Substitution of regulation 9

5. Part 4 Amendment to Part 3 (Authorisation for Clinical Trials and Ethics Committee Opinion)

   1. 10. Substitution of regulation 11

   2. 11. Insertion of new regulations 11A and 11B

   3. 12. Amendment to regulation 12

   4. 13. Amendment to regulation 13

   5. 14. Substitution of regulations 14 to 26

   6. 15. Amendment to regulation 27A

   7. 16. Substitution of regulation 27B

6. Part 5 Amendment to Part 4 (Good Clinical Practice and the Conduct of Clinical Trials)

   1. 17. Amendment to regulation 28

   2. 18. Amendment to regulation 29

   3. 19. Amendment to regulation 29A

   4. 20. Amendment to regulation 30

   5. 21. Amendment to regulation 31

   6. 22. Amendment to regulation 31A

7. Part 6 Amendment to Part 5 (Pharmacovigilance)

   1. 23. Insertion of new regulation A32

   2. 24. Amendment to regulation 32

   3. 25. Amendment to regulation 33

   4. 26. Amendment to regulation 35

8. Part 7 Amendment to Part 6 (Manufacture and Importation of Investigational Medicinal Products)

   1. 27. Amendment to regulation 36

   2. 28. Insertion of new regulation 37A

   3. 29. Amendment to regulation 40

   4. 30. Amendment to regulation 43

9. Part 8 Insertion of new Part 6A (Non-Investigational Medicinal and Non-Medicinal Products)

   1. 31. Insertion of new Part 6A

10. Part 9 Substitution of Part 7 (Labelling of Investigational Medicinal Products)

    1. 32. Substitution of Part 7

11. Part 10 Amendment to Part 8 (Enforcement and Related Provisions)

    1. 33. Amendment to regulation 48

    2. 34. Amendment to regulation 49

    3. 35. Amendment to regulation 50

12. Part 11 Amendment to Part 9 (Miscellaneous Provisions)

    1. 36. Amendment to regulation 58

13. Part 12 Amendment to the Schedules

    1. 37. Amendment to Schedule 1

    2. 38. Omission of Schedule 2

    3. 39. Amendment to Schedule 3

    4. 40. Amendment to Schedule 4

    5. 41. Amendment to Schedule 5

    6. 42. Amendment to Schedule 7

14. Part 13 Consequential provisions

    1. 43. Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

15. Part 14 Transitional provisions

    1. 44. Amendment to regulation 56

    2. 45. Insertion of Schedule 14

16. Signature

17. Explanatory Note