Medicines and Medical Devices Act 2021

1. Introductory Text

2. PART 1 The Commissioner for Patient Safety

   1. 1. Establishment and core duties etc

3. PART 2 Human medicines

   1. CHAPTER 1 Regulations: general

      1. 2. Power to make regulations about human medicines

      2. 3. Manufacture, marketing and supply

      3. 4. Falsified medicines

      4. 5. Clinical trials

      5. 6. Fees, offences, powers of inspectors

      6. 7. Emergencies

   2. CHAPTER 1A Regulations: information systems

      1. 7A. Information systems

      2. 7B. Offence of disclosing information

   3. CHAPTER 2 International agreements: disclosure of information

      1. 8. Disclosure of information in accordance with international agreements

   4. CHAPTER 3 Interpretation

      1. 9. Interpretation of Part 2

4. PART 3 Veterinary medicines

   1. CHAPTER 1 Regulations

      1. 10. Power to make regulations about veterinary medicines

      2. 11. Manufacture, marketing, supply and field trials

      3. 12. Fees, offences, powers of inspectors, costs

   2. CHAPTER 2 International agreements: disclosure of information

      1. 13. Disclosure of information in accordance with international agreements

   3. CHAPTER 3 Interpretation etc

      1. 14. Interpretation of Part 3 and supplementary provision

5. PART 4 Medical devices

   1. CHAPTER 1 Regulations: general

      1. 15. Power to make regulations about medical devices

      2. 16. Manufacture, marketing and supply

      3. 17. Fees, information, offences

      4. 18. Emergencies

   2. CHAPTER 2 Regulations: information systems, advisory committee

      1. 19. Information systems

      2. 20. Advisory committee

   3. CHAPTER 3 Enforcement

      1. Enforcement notices

         1. 21. Compliance notices

         2. 22. Suspension notices

         3. 23. Safety notices

         4. 24. Information notices

         5. 25. Applications to set notices aside etc

         6. 26. Compensation

         7. 27. Further appeals

      2. Offences

         1. 28. Offences

         2. 29. Defence of due diligence

         3. 30. Offences by bodies corporate

      3. Civil sanctions

         1. 31. Civil sanctions

      4. Forfeiture

         1. 32. Forfeiture of medical devices

         2. 33. Appeals against forfeiture decisions

      5. Recovery of expenses of enforcement

         1. 34. Recovery of expenses of enforcement

      6. Recall of medical device by enforcement authority

         1. 35. Recall of medical device by enforcement authority

      7. Power of officer of Revenue and Customs to detain medical device

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

         2. 37. Offence of obstructing an officer of Revenue and Customs

      8. Civil proceedings

         1. 38. Civil proceedings

   4. CHAPTER 4 Disclosure of information and consequential etc provision

      1. Disclosure of information

         1. 39. Disclosure of information

         2. 40. Offences relating to information

      2. Consequential etc provision

         1. 41. Consequential and supplementary provision

   5. CHAPTER 5 Interpretation of Part 4

      1. 42. Interpretation of Part 4

6. PART 5 Regulations under Parts 1, 2, 3 and 4

   1. 43. Power to make consequential etc provision

   2. 44. Scope of powers of Northern Ireland departments

   3. 45. Consultation

   4. 46. Reporting requirements

   5. 47. Procedure

7. PART 6 Report on operation of medicines and medical devices legislation

   1. 48. Report on operation of medicines and medical devices legislation

8. PART 7 Extent, commencement and short title

   1. 49. Extent

   2. 50. Commencement

   3. 51. Transitional etc provision in connection with commencement

   4. 52. Short title

9. SCHEDULES

   1. SCHEDULE 1

      Further provision about the Commissioner for Patient Safety

      1. Principles relating to core duties

         1. 1. (1) The Commissioner must prepare and publish a set of...

      2. Involvement of patients

         1. 2. (1) The Commissioner must take reasonable steps to involve patients...

      3. Supplementary functions and information

         1. 3. (1) For the purposes of carrying out the core duties,...

      4. Individual cases

         1. 4. (1) The Commissioner may not exercise functions in relation to...

      5. Amendments to primary legislation

         1. 5. (1) In Part 1 of the Table at the end...

      6. Regulations about appointment and operation

         1. 6. (1) The Secretary of State may by regulations make such...

   2. SCHEDULE 2

      Medical devices: civil sanctions

      1. PART 1 Monetary penalties

         1. Imposition of monetary penalty

            1. 1. (1) The Secretary of State may impose a monetary penalty...

         2. Notices, representations and appeals etc

            1. 2. (1) Where the Secretary of State proposes to impose a...

         3. Information to be included in notices under paragraph 2

            1. 3. (1) A notice under paragraph 2(1) must include information as...

         4. Monetary penalties: criminal proceedings and conviction

            1. 4. (1) Where a notice under paragraph 2(1) is served on...

      2. PART 2 Enforcement undertakings

         1. 5. (1) This paragraph applies where— (a) the Secretary of State...

      3. PART 3 Enforcement costs recovery notices

         1. Imposition of enforcement costs recovery notices

            1. 6. (1) The Secretary of State may serve an enforcement costs...

         2. Information to be included in enforcement costs recovery notices

            1. 7. (1) An enforcement costs recovery notice must specify the amount...

         3. Appeals

            1. 8. (1) A person served with an enforcement costs recovery notice...

      4. PART 4 Power to make supplementary provision etc by regulations

         1. Supplementary regulations: general

            1. 9. (1) The Secretary of State may by regulations (“supplementary regulations”)—...

         2. Monetary penalties and costs

            1. 10. (1) Supplementary regulations may make provision of any of the...

         3. Enforcement undertakings

            1. 11. Supplementary regulations may make provision of any of the following...

         4. Appeals

            1. 12. (1) Supplementary regulations may make provision of any of the...

      5. PART 5 General and supplemental

         1. Guidance as to enforcement

            1. 13. (1) The Secretary of State must prepare and publish guidance...

         2. Pre-commencement consultation

            1. 14. If, before the day on which this Schedule comes into...

         3. Reports on use of civil sanctions

            1. 15. (1) The Secretary of State must from time to time...

         4. Disclosure of information

            1. 16. (1) Information may be disclosed to the Secretary of State...

      6. PART 6 Interpretation

         1. 17. In this Schedule— “enforcement costs recovery notice” has the meaning...

   3. SCHEDULE 3

      Offence of breaching provisions in the Medical Devices Regulations 2002

      1. PART 1 Offence

         1. 1. In the Medical Devices Regulations 2002 (S.I. 2002/618), after regulation...

      2. PART 2 Provisions

         1. 2. In the Medical Devices Regulations 2002 (S.I. 2002/618), after the...