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The Medicines (Products for Human Use — Fees) Regulations 1995

S.I. 1995/1116 · Made 20 April 1995

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

MEDICINES

Made 20th April 1995

Laid before Parliament 20th April 1995

Coming into force 21st April 1995

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, with the consent of the Treasury, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 1971f1, or, as the case may be, those conferred by the said provisions and now vested in themf2 and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulationsf3, hereby make the following Regulations:

Annotations to the whole text

Footnotes

f1

1971 c. 69, as amended by section 21 of the Health and Medicines Act 1988 (c. 49); by virtue of section 1(3) of the 1971 Act expressions in that section have the same meaning as in the Medicines Act 1968 (c. 67), as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388). The expression “the Ministers” is defined in section 1(1) of the 1968 Act as so amended. By virtue of regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), references in section 1(1) and (2)(b) to a licence under Part II of the 1971 Act include a reference to a marketing authorization under those Regulations.

f2

In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments by Virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

f3

See section 129(6) of the Medicines Act 1968 (c. 67) as extended to include regulations made under the Medicines Act 1971 by section 1(3)(b) of that latter Act.

Contents

  1. Part I: GENERAL
  2. 1Citation and commencement
  3. 2Interpretation
  4. 3Fees payable in connection with applications and inspections
  5. Part II: CAPITAL FEES F0R APPLICATIONS FOR AUTHORIZATIONS, LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS
  6. 4Applications for authorizations, licences or certificates
  7. 5Inspections in connection with multiple applications for authorizations or licences
  8. 6Applications for certificates by exporters of medicinal products
  9. Part III: CAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF AUTHORIZATIONS, LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS
  10. 7Variations of authorizations, licences and certificates
  11. 8Inspections in connection with multiple applications for variations of authorizations and licences
  12. 9Applications for multiple variations
  13. Part IV: CAPITAL FEES FOR APPLICATIONS FOR RENEWALS OF CLINICAL TRIAL CERTIFICATES AND FOR CERTAIN MANUFACTURER'S LICENCES AND FOR ASSOCIATED INSPECTIONS
  14. 10Renewals of clinical trial certificates
  15. 11Renewals of certain manufacturer’s licences
  16. 12Renewals in terms which are not identical to the existing authorization, licence or certificate
  17. Part V: FEES FOR INSPECTIONS MADE DURING THE CURRENCY OF A MARKETING AUTHORIZATION OR LICENCE
  18. 13Fees for inspections
  19. Part VI: PERIODIC FEES FOR MARKETING AUTHORIZATIONS AND LICENCES
  20. 14Periodic fees
  21. Part VII: ADMINISTRATION
  22. 15Payment of fees to Ministers
  23. 16Time for payment of capital fees in connection with applications or inspections
  24. 17Time for payment of capital fees applications made by small companies
  25. 18Time for payment of periodic fees
  26. 19Adjustment, waiver, reduction or refund of fees
  27. 20Suspension of licences and certificates
  28. 21Civil proceedings to recover unpaid fees
  29. Part VIII: REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS
  30. 22Revocation and savings
  31. 23Transitional provisions
  32. Signature
  33. Schedule 1: CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATES
  34. Part I: INTERPRETATION
  35. 1Paragraph 1
  36. Part II: CAPITAL FEES FOR APPLICATIONS FOR AUTHORIZATIONS, LICENCES AND CERTIFICATES
  37. 1Marketing authorizations
  38. 2Marketing authorizations
  39. 3Marketing authorizations
  40. 4Marketing authorizations
  41. 5Manufacturer’s licences
  42. 6Wholesale dealer’s licences
  43. 7Clinical trial certificates
  44. Part III: CAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF AUTHORIZATIONS, LICENCES AND CERTIFICATES
  45. 1Marketing authorizations
  46. 2Marketing authorizations
  47. 3Marketing authorizations
  48. 4Marketing authorizations
  49. 5Marketing authorizations
  50. 6Marketing authorizations
  51. 7Manufacturer’s licences
  52. 8Manufacturer’s licences
  53. 9Wholesale dealer’s licences
  54. 10Wholesale dealer’s licences
  55. 11Clinical trial certificates
  56. 12Clinical trial certificates
  57. 13Identical variations
  58. 14Identical variations
  59. Schedule 2: FEES FOR INSPECTIONS
  60. 1Interpretation
  61. 2Fees
  62. 3Fees
  63. 4Fees
  64. 5Fees
  65. 6Fees
  66. Schedule 3: PERIODIC FEES FOR LICENCES
  67. Part I: INTERPRETATION
  68. 1Paragraph 1
  69. Part II: CALCULATION OF TURNOVER
  70. 1Paragraph 1
  71. 2Paragraph 2
  72. 3Paragraph 3
  73. Part III: PERIODIC FEES FOR MARKETING AUTHORIZATIONS AND LICENCES
  74. 1Marketing authorizations
  75. 2Marketing authorizations
  76. 3Marketing authorizations
  77. 4Marketing authorizations
  78. 5Marketing authorizations
  79. 6Marketing authorizations
  80. 7Manufacturer’s licences
  81. 8Wholesale dealer’s licences
  82. 9Wholesale dealer’s licences
  83. Part IV: TYPES OF MARKETING AUTHORIZATION FOR WHICH ONLY ONE PERIODIC FEE IS PAYABLE
  84. 1Paragraph 1
  85. 2Paragraph 2
  86. Schedule 4: TIME FOR PAYMENT OF CAPITAL FEES — APPLICATIONS MADE BY SMALL COMPANIES
  87. 1Paragraph 1
  88. 2Paragraph 2
  89. 3Paragraph 3
  90. 4Paragraph 4
  91. 5Paragraph 5
  92. 6Paragraph 6
  93. Schedule 5: WAIVER, REDUCTION OR REFUND OF CAPITAL FEES
  94. 1Paragraph 1
  95. 2Paragraph 2
  96. 3Paragraph 3
  97. 4Paragraph 4
  98. 5Paragraph 5
  99. 6Paragraph 6
  100. Schedule 6: ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES
  101. 1Paragraph 1
  102. 2Paragraph 2
  103. Explanatory note