The Medicines for Human Use (Clinical Trials) Regulations 2004

1. Introductory Text

2. PART 1 INTRODUCTORY PROVISIONS

   1. 1. Citation and commencement

   2. 2. Interpretation

   3. 3. Sponsor of a clinical trial

   4. 4. Responsibility for functions under the Directive

3. PART 2 ETHICS COMMITTEES

   1. 5. United Kingdom Ethics Committees Authority

   2. 6. Establishment of ethics committees

   3. 7. Recognition of ethics committees

   4. 8. Revocation of recognition

   5. 9. Constitution and operation of ethics committees

   6. 10. Other functions of the Authority

4. PART 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION

   1. 11. Interpretation of Part 3

   2. 12. Requirement for authorisation and ethics committee opinion

   3. 13. Supply of investigational medicinal products for the purpose of clinical trials

   4. 14. Application for ethics committee opinion

   5. 15. Ethics committee opinion

   6. 16. Review and appeal relating to ethics committee opinion

   7. 17. Request for authorisation to conduct a clinical trial

   8. 18. Authorisation procedure for clinical trials involving general medicinal products

   9. 19. Authorisation procedure for clinical trials involving medicinal products for gene therapy etc.

   10. 20. Authorisation procedure for clinical trials involving medicinal products with special characteristics

   11. 21. Clinical trials conducted in third countries

   12. 22. Amendments to clinical trial authorisation

   13. 23. Amendments by the licensing authority

   14. 24. Amendments by the sponsor

   15. 25. Modifying or adapting rejected proposals for amendment

   16. 26. Reference to the appropriate committee or the Medicines Commission

   17. 27. Conclusion of clinical trial

5. PART 4 GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS

   1. 28. Good clinical practice and protection of clinical trial subjects

   2. 29. Conduct of trial in accordance with clinical trial authorisation etc.

   3. 30. Urgent safety measures

   4. 31. Suspension or termination of clinical trial

6. PART 5 PHARMACOVIGILANCE

   1. 32. Notification of adverse events

   2. 33. Notification of suspected unexpected serious adverse reactions

   3. 34. Clinical trials conducted in third countries

   4. 35. Annual list of suspected serious adverse reactions and safety report

7. PART 6 MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

   1. 36. Requirement for authorisation to manufacture or import investigational medicinal products

   2. 37. Exemption for hospitals and health centres

   3. 38. Application for manufacturing authorisation

   4. 39. Consideration of application for manufacturing authorisation

   5. 40. Grant or refusal of manufacturing authorisation

   6. 41. Application and effect of manufacturing authorisation

   7. 42. Obligations of manufacturing authorisation holder

   8. 43. Qualified persons

   9. 44. Variation of manufacturing authorisation

   10. 45. Suspension and revocation of manufacturing authorisation

8. PART 7 LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS

   1. 46. Labelling

9. PART 8 ENFORCEMENT AND RELATED PROVISIONS

   1. 47. Application of enforcement provisions of the Act

   2. 48. Infringement notices

   3. 49. Offences

   4. 50. False or misleading information

   5. 51. Defence of due diligence

   6. 52. Penalties

10. PART 9 MISCELLANEOUS PROVISIONS

    1. 53. Construction of references to specified publications

    2. 54. Consequential and other amendments to enactments

    3. 55. Revocations

    4. 56. Transitional provisions

11. Signature

12. SCHEDULES

    1. 1.

       Conditions and principles of good clinical practice and the protection of clinical trial subjects

    2. 2.

       Additional provisions relating to ethics committees

    3. 3.

       Particulars and documents that must accompany an application for an ethics committee opinion, a request for authorisation, a notice of amendment and a notification of the conclusion of a trial

    4. 4.

       Appeal against unfavourable ethics committee opinion

    5. 5.

       Procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials

    6. 6.

       Particulars that must accompany an application for a manufacturing authorisation

    7. 7.

       Standard provisions for manufacturing authorisations

    8. 8.

       Procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations

    9. 9.

       Modification of the enforcement provisions of the Act subject to which those provisions are applied for the purposes of these Regulations

    10. 10.

        Consequential and other amendments of enactments

    11. 11.

        Revocations

    12. 12.

        Transitional provisions

13. Explanatory Note