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The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 in Northern Ireland

S.I. 2025/538 · Made 28 April 2025 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 28 April 2026.

MEDICINES

Made 28th April 2025

Coming into force in accordance with regulation 1(2)

The Secretary of State in relation to England and Wales and Scotland, and the Department of Health in Northern Ireland and the Secretary of State acting jointly in relation to Northern Ireland, make the following Regulations in exercise of the powers conferred by sections 2(1), 5(1)(a) to (e), 6(1)(b) and 43(2)(a) to (d) of the Medicines and Medical Devices Act 2021f1.

The Secretary of State and the Department of Health in Northern Ireland have carried out a public consultation in accordance with section 45(1) of that Act.

In accordance with section 2(2) to (4) of that Act, the overarching objective of the Secretary of State and the Department of Health in Northern Ireland in making these Regulations is safeguarding public health. The Secretary of State and the Department of Health in Northern Ireland have had regard to the matters specified in section 2(3) of that Act and consider that, where these Regulations may have an impact on the safety of human medicines, the benefits of making these Regulations outweigh the risks.

In accordance with section 47(3) and (6)(c) of that Act, a draft of this instrument was laid before Parliament and the Northern Ireland Assembly and approved by a resolution of each House of Parliament and the Northern Ireland Assembly.

Annotations to the whole text

Footnotes

f1

2021 c. 3. The powers in section 2(1) of the Medicines and Medical Devices Act 2021, and the provisions that relate to it, are exercisable by the “appropriate authority”. As defined in section 2(6)(a) of the Act, the appropriate authority for England and Wales and Scotland is the Secretary of State. In relation to Northern Ireland, as defined in section 2(6)(b)(ii), the appropriate authority can mean the Secretary of State and the Department of Health in Northern Ireland acting jointly.

Contents

  1. Part 1: General
  2. 1Citation, commencement and extent
  3. 2Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
  4. Part 2: Amendment to Part 1 (Introductory Provisions)
  5. 3Amendment to regulation 2
  6. 4Amendment to regulation 3
  7. 5Insertion of new regulation 3B
  8. Part 3: Amendment to Part 2 (Ethics Committees)
  9. 6Amendment to regulation 5
  10. 7Amendment to regulation 6
  11. 8Omission of regulations 7 and 8
  12. 9Substitution of regulation 9
  13. Part 4: Amendment to Part 3 (Authorisation for Clinical Trials and Ethics Committee Opinion)
  14. 10Substitution of regulation 11
  15. 11Insertion of new regulations 11A and 11B
  16. 12Amendment to regulation 12
  17. 13Amendment to regulation 13
  18. 14Substitution of regulations 14 to 26
  19. 15Amendment to regulation 27A
  20. 16Substitution of regulation 27B
  21. Part 5: Amendment to Part 4 (Good Clinical Practice and the Conduct of Clinical Trials)
  22. 17Amendment to regulation 28
  23. 18Amendment to regulation 29
  24. 19Amendment to regulation 29A
  25. 20Amendment to regulation 30
  26. 21Amendment to regulation 31
  27. 22Amendment to regulation 31A
  28. Part 6: Amendment to Part 5 (Pharmacovigilance)
  29. 23Insertion of new regulation A32
  30. 24Amendment to regulation 32
  31. 25Amendment to regulation 33
  32. 26Amendment to regulation 35
  33. Part 7: Amendment to Part 6 (Manufacture and Importation of Investigational Medicinal Products)
  34. 27Amendment to regulation 36
  35. 28Insertion of new regulation 37A
  36. 29Amendment to regulation 40
  37. 30Amendment to regulation 43
  38. Part 8: Insertion of new Part 6A (Non-Investigational Medicinal and Non-Medicinal Products)
  39. 31Insertion of new Part 6A
  40. Part 9: Substitution of Part 7 (Labelling of Investigational Medicinal Products)
  41. 32Substitution of Part 7
  42. Part 10: Amendment to Part 8 (Enforcement and Related Provisions)
  43. 33Amendment to regulation 48
  44. 34Amendment to regulation 49
  45. 35Amendment to regulation 50
  46. Part 11: Amendment to Part 9 (Miscellaneous Provisions)
  47. 36Amendment to regulation 58
  48. Part 12: Amendment to the Schedules
  49. 37Amendment to Schedule 1
  50. 38Omission of Schedule 2
  51. 39Amendment to Schedule 3
  52. 40Amendment to Schedule 4
  53. 41Amendment to Schedule 5
  54. 42Amendment to Schedule 7
  55. Part 13: Consequential provisions
  56. 43Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
  57. Part 14: Transitional provisions
  58. 44Amendment to regulation 56
  59. 45Insertion of Schedule 14
  60. Signature
  61. Explanatory note