Medicines and Medical Devices Bill (HC Bill 90)

EXPLANATORY NOTES

Explanatory notes to the Bill, prepared by the Department of Health and Social Care,
are published separately as Bill 90—EN.

EUROPEAN CONVENTION ON HUMAN RIGHTS

Secretary Matt Hancock has made the following statement under section 19(1)(a) of
the Human Rights Act 1998:

In my view the provisions of the Medicines and Medical Devices Bill are compatible
with the Convention rights.

Contents

  1. Part 1

    Human medicines

    1. 1. Power to make regulations about human medicines

    2. 2. Manufacture, marketing and supply

    3. 3. Falsified medicines

    4. 4. Clinical trials

    5. 5. Fees, offences, powers of inspectors

    6. 6. Emergencies

    7. 7. Interpretation of Part 1

  2. Part 2

    Veterinary medicines

    1. 8. Power to make regulations about veterinary medicines

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

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

    4. 11. Interpretation of Part 2 and supplementary provision

  3. Part 3

    Medical devices

    1. Chapter 1

      Regulations

      1. 12. Power to make regulations about medical devices

      2. 13. Manufacture, marketing and supply

      3. 14. Fees, information, offences

      4. 15. Emergencies

    2. Chapter 2

      Enforcement

      1. Enforcement notices

        1. 16. Compliance notices

        2. 17. Suspension notices

        3. 18. Safety notices

        4. 19. Information notices

        5. 20. Applications to set notices aside etc

        6. 21. Compensation

        7. 22. Further appeals

      2. Offences

        1. 23. Offences

        2. 24. Defence of due diligence

        3. 25. Offences by bodies corporate

      3. Civil sanctions

        1. 26. Civil sanctions

      4. Forfeiture

        1. 27. Forfeiture of medical devices

        2. 28. Appeals against forfeiture decisions

      5. Recovery of expenses of enforcement

        1. 29. Recovery of expenses of enforcement

      6. Recall of medical device by enforcement authority

        1. 30. Recall of medical device by enforcement authority

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

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

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

      8. Civil proceedings

        1. 33. Civil proceedings

    3. Chapter 3

      Disclosure of information and consequential etc provision

      1. Disclosure of information

        1. 34. Disclosure of information

        2. 35. Offence relating to information

      2. Consequential etc provision

        1. 36. Consequential and supplementary provision

    4. Chapter 4

      Interpretation of Part 3

      1. 37. Interpretation of Part 3

  4. Part 4

    Regulations under Parts 1, 2 and 3

    1. 38. Power to make consequential etc provision

    2. 39. Scope of powers of Northern Ireland departments

    3. 40. Consultation

    4. 41. Procedure

  5. Part 5

    Extent, commencement and short title

    1. 42. Extent

    2. 43. Commencement

    3. 44. Transitional etc provision in connection with commencement

    4. 45. Short title

    1. Schedule 1

      Medical devices: civil sanctions

      1. Part 1

        Monetary penalties

      2. Part 2

        Enforcement undertakings

      3. Part 3

        Enforcement costs recovery notices

      4. Part 4

        Power to make supplementary provision etc by regulations

      5. Part 5

        General and supplemental

      6. Part 6

        Interpretation

    2. Schedule 2

      Offence of breaching provisions in the Medical Devices
      Regulations 2002

      1. Part 1

        Offence

      2. Part 2

        Provisions