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The Branded Health Service Medicines (Costs) Regulations 2018

S.I. 2018/345 · Made 8 March 2018 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 1 July 2026.

National Health Service, England And Wales

National Health Service, Scotland

Health And Personal Social Services, Northern Ireland

Made 8th March 2018

Laid before Parliament 9th March 2018

Coming into force 1st April 2018

The Secretary of State for Health and Social Care makes the following Regulations in exercise of the powers in sections 263(1), (2), (4), (5A) and (6), 264A(2), (5) and (7), 265(1), (3), (4), (5) and (5A), 266(1) and (2) and 272(7) and (8) of the National Health Service Act 2006 M1 and in accordance with sections 266(3), (4) and (4A) of that Act.

The Secretary of State has consulted in accordance with sections 263(1), 263(1A), 264C(1) and 265(9) of the National Health Service Act 2006.

Annotations to the whole text

Marginal citations

M1

2006 c. 41; section 263 was amended by the Health Service Medical Supplies (Costs) Act 2017 (c.23) (“the 2017 Act”), section 5 and 10(5). Section 264A was inserted by the 2017 Act, section 8. Section 265 was amended by the 2017 Act, section 6, 7 and 10. Section 266 was amended by the 2017 Act, section 6 and 7(6). See section 275(1) of the National Health Service Act 2006 (“the 2006 Act”) for the definition of “prescribed” and “regulations” that are relevant to the powers being exercised.

Contents

  1. 1Citation, commencement and interpretation
  2. 2Application
  3. Part 1: PAYMENT SCHEME
  4. 3Payment scheme
  5. 3AOlder presentation additional payments
  6. 3BMeaning of newer presentation and older presentation
  7. 3CReference prices for older presentations
  8. 3DDetermination of reference prices
  9. 4Direction to make a payment
  10. 5Interest payable on late payment
  11. 6Penalties
  12. 7Demands and appeals
  13. Part 2: MAXIMUM PRICES
  14. 8Maximum price
  15. 9New presentation
  16. 10Temporary exemptions
  17. 11Increases
  18. 12Decreases
  19. 13Former voluntary scheme members
  20. 14Recoverable sum
  21. 15Interest payable on late payment of the recoverable sum
  22. 16Penalties
  23. 17Demands and appeals
  24. Part 3: INFORMATION REQUIREMENTS
  25. 18Provision of information for payment scheme
  26. 19New manufacturer or supplier
  27. 20Small manufacturer or supplier
  28. 21Sales report
  29. 22Presentation report
  30. 23Audited information
  31. 24Written declaration of approval
  32. 25Review
  33. 26Penalties, demands and appeals
  34. Part 4: GENERAL PROVISIONS
  35. 27Appeals
  36. 28Revocation, saving and transitional provisions
  37. 29Annual review
  38. Signature
  39. Schedule 1: General provisions for payment scheme
  40. 1Payment scheme requirements
  41. 1AParagraph 1A
  42. 2Information requirements
  43. 3Rules
  44. 4Paragraph 4
  45. 5Paragraph 5
  46. 6Paragraph 6
  47. 7Paragraph 7
  48. 8Paragraph 8
  49. 9Paragraph 9
  50. Schedule 2: Small manufacturer or supplier
  51. 1Determination of small manufacturer or supplier
  52. 2Paragraph 2
  53. 3Paragraph 3
  54. 4Information requirements
  55. 5Paragraph 5
  56. 6Rules
  57. 7Paragraph 7
  58. 8Paragraph 8
  59. 9Paragraph 9
  60. Schedule 3: New manufacturer or supplier
  61. 1Information requirements
  62. 2Paragraph 2
  63. 3Rules
  64. 4Paragraph 4
  65. 5Paragraph 5
  66. 6Paragraph 6
  67. 7Paragraph 7
  68. 8Paragraph 8
  69. Schedule 4: Recoverable Sums
  70. 1Paragraph 1
  71. 2Paragraph 2
  72. 3Paragraph 3
  73. Schedule 5: Penalties
  74. 1Paragraph 1
  75. 2Paragraph 2
  76. 3Paragraph 3
  77. 4Paragraph 4
  78. Explanatory note