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UK Coat of Arms, Contains public sector information licensed under the Open Government Licence v3.0.

Medicines and Medical Devices Act 2021 (c. 3)

Medicines and Medical Devices Act 2021 2021 CHAPTER 3 An Act to make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices; confer power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; make provision about the enforcement of regulations, and the protection of health and safety, in relation to medical devices; and for connected purposes. [11th February 2021] B e it enacted by the Queen's most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:—

Legislation

Table of Content

1. Establishment and core duties etc U.K.

2. Power to make regulations about human medicines U.K.

3. Manufacture, marketing and supply U.K.

4. Falsified medicines U.K.

5. Clinical trials U.K.

6. Fees, offences, powers of inspectors U.K.

7. Emergencies U.K.

7. Information systems U.K.

7. Offence of disclosing information U.K.

8. Disclosure of information in accordance with international agreements U.K.

9. Interpretation of Part 2 U.K.

10. Power to make regulations about veterinary medicines U.K.

11. Manufacture, marketing, supply and field trials U.K.

12. Fees, offences, powers of inspectors, costs U.K.

13. Disclosure of information in accordance with international agreements U.K.

14. Interpretation of Part 3 and supplementary provision U.K.

15. Power to make regulations about medical devices U.K.

16. Manufacture, marketing and supply U.K.

17. Fees, information, offences U.K.

18. Emergencies U.K.

19. Information systems U.K.

20. Enforcement notices U.K.

21. Compliance notices U.K.

22. Suspension notices U.K.

23. Safety notices U.K.

24. Information notices U.K.

25. Applications to set notices aside etc U.K.

26. Compensation U.K.

27. Offences U.K.

28. Offences U.K.

29. Defence of due diligence U.K.

30. Civil sanctions U.K.

31. Forfeiture U.K.

32. Forfeiture of medical devices U.K.

33. Recovery of expenses of enforcement U.K.

34. Recall of medical device by enforcement authority U.K.

35. Power of officer of Revenue and Customs to detain medical device U.K.

36. Power of officer of Revenue and Customs to detain medical device U.K.

37. Civil proceedings U.K.

38. Disclosure of information U.K.

39. Disclosure of information U.K.

40. Consequential etc provision U.K.

41. Consequential and supplementary provision U.K.

42. Interpretation of Part 4 U.K.

43. Power to make consequential etc provision U.K.

44. Scope of powers of Northern Ireland departments U.K.

45. Consultation U.K.

46. Reporting requirements U.K.

47. Procedure U.K.

48. Report on operation of medicines and medical devices legislation U.K.

49. Extent U.K.

50. Commencement U.K.

51. Transitional etc provision in connection with commencement U.K.

52. Offences by bodies corporate U.K.

1. Establishment and core duties etc U.K.

2. Power to make regulations about human medicines U.K.

3. Manufacture, marketing and supply U.K.

4. Falsified medicines U.K.

5. Clinical trials U.K.

6. Fees, offences, powers of inspectors U.K.

7. Emergencies U.K.

7. Information systems U.K.

7. Offence of disclosing information U.K.

8. Disclosure of information in accordance with international agreements U.K.

9. Interpretation of Part 2 U.K.

10. Power to make regulations about veterinary medicines U.K.

11. Manufacture, marketing, supply and field trials U.K.

12. Fees, offences, powers of inspectors, costs U.K.

13. Disclosure of information in accordance with international agreements U.K.

14. Interpretation of Part 3 and supplementary provision U.K.

15. Power to make regulations about medical devices U.K.

16. Manufacture, marketing and supply U.K.

17. Fees, information, offences U.K.

18. Emergencies U.K.

19. Information systems U.K.

20. Enforcement notices U.K.

21. Compliance notices U.K.

22. Suspension notices U.K.

23. Safety notices U.K.

24. Information notices U.K.

25. Applications to set notices aside etc U.K.

26. Compensation U.K.

27. Offences U.K.

28. Offences U.K.

29. Defence of due diligence U.K.

30. Civil sanctions U.K.

31. Forfeiture U.K.

32. Forfeiture of medical devices U.K.

33. Recovery of expenses of enforcement U.K.

34. Recall of medical device by enforcement authority U.K.

35. Power of officer of Revenue and Customs to detain medical device U.K.

36. Power of officer of Revenue and Customs to detain medical device U.K.

37. Civil proceedings U.K.

38. Disclosure of information U.K.

39. Disclosure of information U.K.

40. Consequential etc provision U.K.

41. Consequential and supplementary provision U.K.

42. Interpretation of Part 4 U.K.

43. Power to make consequential etc provision U.K.

44. Scope of powers of Northern Ireland departments U.K.

45. Consultation U.K.

46. Reporting requirements U.K.

47. Procedure U.K.

48. Report on operation of medicines and medical devices legislation U.K.

49. Extent U.K.

50. Commencement U.K.

51. Transitional etc provision in connection with commencement U.K.

52. Offences by bodies corporate U.K.

Section 1

1. Establishment and core duties etc U.K.

(1) The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as “ the Commissioner ”) to exercise the functions set out in this Part in relation to England. (2) The Commissioner's core duties are to— (a) promote the safety of patients with regard to the use of medicines and medical devices, and (b) promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices. (3) The Commissioner is not to be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown. (4) Schedule 1 makes further provision about the Commissioner. PART 2 U.K. Human medicines CHAPTER 1 U.K. [ F1 Regulations: general ] Textual Amendments F1 Pt. 2 Ch. 1 heading substituted (1.7.2022) by Health and Care Act 2022 (c. 31) , ss. 101(2) , 186(6) ; S.I. 2022/734 , reg. 2(a) , Sch. (with regs. 13 , 29 , 30 )

Section 2

2. Power to make regulations about human medicines U.K.

(1) The appropriate authority may by regulations make provision specified in sections 3 to 7 amending or supplementing the law relating to human medicines. (2) In making regulations under subsection (1), the appropriate authority's overarching objective must be safeguarding public health. (3) In considering whether regulations under subsection (1) would contribute to this objective, the appropriate authority must have regard to— (a) the safety of human medicines; (b) the availability of human medicines; (c) the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to— (i) carry out research relating to human medicines, (ii) conduct clinical trials, or (iii) manufacture or supply human medicines. (4) Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks. (5) In subsection (3)(c), “ relevant part of the United Kingdom ” means— (a) so far as the regulations relate to England and Wales and Scotland, those parts of the United Kingdom, and (b) so far as the regulations relate to Northern Ireland, that part of the United Kingdom. (6) In this Part, “ appropriate authority ” means— (a) in relation to England and Wales and Scotland, the Secretary of State, and (b) in relation to Northern Ireland— (i) the Department of Health in Northern Ireland, or (ii) the Department of Health in Northern Ireland and the Secretary of State acting jointly.