OpenLegislation

The Medicines (Products for Animal Use—Fees) Regulations 1997

S.I. 1997/1469 · Made 9 June 1997

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 9th June 1997

Laid before Parliament 10th June 1997

Coming into force 1st July 1997

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, 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 the powers conferred by section 1(1) and (2) of the Medicines Act 1971f1 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, and the Secretary of State and the Minister of Agriculture, Fisheries and Food, being Ministers designatedf4 for the purpose of section 2(2) of the European Communities Act 1972f5 in relation to medicinal products and the common agricultural policy of the European Community, acting jointly, in exercise of the powers conferred on them by the said section 2(2), 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.

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 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 as extended to include Regulations made under the Medicines Act 1971 by section 1(3)(b) of that latter Act.

f4

S.I. 1972/1811.

f5

1972 c. 68.

Contents

  1. 1Citation, commencement and scope
  2. 2Interpretation
  3. 3Fees relating to applications for the grant of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates
  4. 4Fees relating to applications for assistance in connection with mutual recognition applications
  5. 5Fees relating to applications for the variation of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates
  6. 6Applications relating to multiple variations
  7. 7Variations at the invitation of the relevant authority
  8. 8Fees relating to application for the renewal of marketing authorisations, product licences, manufacturer’s licences and animal test certificates
  9. 9Fees relating to applications for the renewal of marketing authorisations, product licences, manufacturer’s licences and animal test certificates in terms which are not identical to the existing marketing authorisation, licence or certificate
  10. 10Fees relating to site inspections
  11. 11Marketing authorisations and product licences: annual fees
  12. 12Manufacturer’s licences: annual fees
  13. 13Wholesale dealer’s licences: annual fees
  14. 14Fees payable for the registration of Homoeopathic Veterinary Medicinal Products
  15. 15Marketing authorisations, product licences and animal test certificates: fees for references to the Veterinary Products Committee or to the Medicines Commission
  16. 16Payment of fees to the Minister
  17. 17Time for payment of fees in connection with applications or inspections and refunds of such fees
  18. 18Late payment of annual fees
  19. 19Suspension of licences and certificates
  20. 20Waiver, reduction or refund of fees
  21. 21Revocation and savings
  22. 22Transitional provisions
  23. Signature
  24. Schedule 1: FEES RELATING TO APPLICATIONS FOR THE GRANT AND THE VARIATION AND RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES
  25. IINTERPRETATION
  26. Part II: FEES RELATING TO APPLICATIONS FOR THE GRANT OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES
  27. 1Marketing authorisations and product licences
  28. 2Marketing authorisations and product licences
  29. 3Marketing authorisations and product licences
  30. 4Marketing authorisations and product licences
  31. 5Marketing authorisations and product licences
  32. 6Animal test certificates
  33. 7Manufacturer’s licences
  34. 8Wholesale dealer’s licences
  35. 9Marketing authorisation (parallel import)
  36. Part III: FEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS
  37. 1Paragraph 1
  38. 2Paragraph 2
  39. 3Paragraph 3
  40. 4Paragraph 4
  41. 5Paragraph 5
  42. 6Paragraph 6
  43. Part IV: FEES RELATING TO APPLICATIONS FOR THE VARIATION OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES
  44. 1Marketing authorisations (other than mutually recognised marketing authorisations) and product licences
  45. 2Marketing authorisations (other than mutually recognised marketing authorisations) and product licences
  46. 3Marketing authorisations (other than mutually recognised marketing authorisations) and product licences
  47. 4Manufacturer’s licences
  48. 5Wholesale dealer’s licences
  49. 6Animal test certificates
  50. Part V: FEES RELATING TO APPLICATIONS FOR THE RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES AND ANIMAL TEST CERTIFICATES
  51. 1Marketing authorisations and produce licences
  52. 2Manufacturer’s licences
  53. 3Animal test certificates
  54. 4Article 15.2 marketing authorisations
  55. Schedule 2: FEES RELATING TO SITE INSPECTIONS
  56. 1Interpretations
  57. 2Fees
  58. 3Fees
  59. 4Fees
  60. 5Fees
  61. Schedule 3: MARKETING AUTHORISATIONS AND PRODUCT LICENCES: ANNUAL FEES
  62. Part I
  63. 1Calculation of turnover
  64. 2Calculation of turnover
  65. 3Calculation of turnover
  66. 4Calculation of turnover
  67. 5Calculation of turnover
  68. 6Calculation of turnover
  69. Part II: CALCULATION OF ANNUAL FEES
  70. 1Paragraph 1
  71. 2Paragraph 2
  72. 3Paragraph 3
  73. 4Paragraph 4
  74. 5Paragraph 5
  75. IIICALCULATION OF ANNUAL FEE—EMERGENCY VACCINES
  76. Schedule 4: MARKETING AUTHORISATIONS AND PRODUCT LICENCES: ADJUSTMENT OR REFUND OF ANNUAL FEES
  77. 1Paragraph 1
  78. 2Paragraph 2
  79. Schedule 5: FEES RELATING TO APPLICATIONS FOR REGISTRATION OF HOMOEOPATHIC VETERINARY MEDICINAL PRODUCTS
  80. IINTERPRETATION
  81. Part II: FEES RELATING TO APPLICATIONS FOR REGISTRATION
  82. 1Paragraph 1
  83. 2Paragraph 2
  84. Part III: WAIVER OR REFUND OF FEES
  85. 1Paragraph 1
  86. 2Paragraph 2
  87. Schedule 6: MARKETING AUTHORISATIONS, PRODUCT LICENCES AND ANIMAL TEST CERTIFICATES: FEES FOR REFERENCES TO THE VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION
  88. 1Paragraph 1
  89. 2Paragraph 2
  90. Schedule 7: WAIVER, REDUCTION OR REFUND OF FEES
  91. 1Paragraph 1
  92. 2Paragraph 2
  93. 3Paragraph 3
  94. 4Paragraph 4
  95. Explanatory note