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The Medicines (Products for Human Use-Fees) Regulations 2008

S.I. 2008/552 · Made 28 February 2008

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

Fees And Charges

Consumer Protection

Made 28th February 2008

Laid before Parliament 7th March 2008

Coming into force 1st April 2008

The Secretary of State for Health, the Minister for Health, Social Services and Public Safety and the Minister for Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971f1 or, in the case of the Ministers, the powers conferred by those provisions and now vested in themf2.

In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on him by section 2(2) of the European Communities Act 1972f3 and section 56(1) and (2) of the Finance Act 1973f4. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal productsf5.

The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.

In accordance with section 129(6) of the Medicines Act 1968f6, the Secretary of State for Health, the Department of Health, Social Services and Public Safety Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these 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 used in that section have the same meaning as in the Medicines Act 1968 (c.67); see therefore section 1(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 and by regulation 44 of, and Schedule 8 to, S.I. 2006/2407, which contains a definition of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence or for the variation or renewal of such a licence under Part II of the 1968 Act include reference to an application for a marketing authorization under the 1994 Regulations or for the variation or renewal of such an authorization.

f2

In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142 and article 3(7) of S.I. 2002/794. In the case of the Minister for Health, Social Services and Public Safety and the Minister for Agriculture and Rural Development, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Departments for which the Ministers are responsible were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I. 1).

f3

1972 c.68.

f4

1973 c.51.

f5

S.I.1972/181.

f6

C.67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

Contents

  1. Part 1: General
  2. 1Citation and commencement
  3. 2Interpretation
  4. Part 2: Capital Fees for Pre-Application Meetings
  5. 3Interpretation of Part 2
  6. 4Fee for scientific advice: application for or variation to EC marketing authorization
  7. 5Fee for scientific advice: classification of a medicinal product
  8. 6Fee for advertising advice
  9. 7Fee for pharmacovigilance advice
  10. 8Fee for advice on labelling or leaflets
  11. 9Fee for regulatory advice
  12. 10Fee for advice for other purposes
  13. 11Time for payment of fees under regulations 4 to 10
  14. Part 3: Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections
  15. 12Fees for applications for authorizations, licences or certificates, etc
  16. 13Fee for applications for copy certificates of good manufacturing practice
  17. 14Fees for applications for certificates and copy certificates by exporters of medicinal products
  18. Part 4: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
  19. 15Meaning of “set of applications”
  20. 16Fees for applications for regulatory assistance under the mutual recognition procedure
  21. 17Time for payment of fees under regulation 16
  22. Part 5: Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Certificates and for Associated Inspections
  23. 18Fees for variations of authorizations, registrations, licences and authorisations
  24. 19Fees for amendments to clinical trial authorisations
  25. 20Applications for multiple variations
  26. Part 6: Capital Fees for Assessment of Labels and Leaflets
  27. 21Meaning of “set of proposed changes”
  28. 22Fees for assessment of a set of proposed changes to labels and leaflets
  29. 23Time for payment of fees under regulation 22
  30. Part 7: Capital Fees for Applications for Renewals of Certain Manufacturer’s Licences and for Associated Inspections
  31. 24Fees for renewals of certain manufacturer’s licences
  32. 25Fees for renewals in terms which are not identical to the existing authorization, licence or certificate
  33. Part 8: Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations
  34. 26Fees for regulatory assistance for certain marketing authorizations
  35. Part 9: Capital Fees for Inspections
  36. 27Fees for inspections
  37. 28Payer of inspection fee (contract laboratories and API manufacturing sites)
  38. 29Inspections in connection with multiple applications.
  39. 30Fees for inspections relating to good clinical practice in clinical trials
  40. Part 10: Periodic Fees for Marketing Authorizations and Licences
  41. 31Periodic fees
  42. 32Periodic fees for clinical trial authorisations
  43. Part 11: Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
  44. 33Meaning of “good clinical practice accreditation” scheme
  45. 34Fees for applications for membership and certificate
  46. Part 12: Capital Fees for Persons Appointed Hearing
  47. 35Fees for persons appointed hearing
  48. 36Time for payment under regulation 35
  49. Part 13: Administration
  50. 37Payment of fees to Ministers
  51. 38Time for payment of capital fees in connection with applications or inspections
  52. 39Time for payment of capital fees – applications made by small companies
  53. 40Time for payment of periodic fees
  54. 41Penalty fees for late payment of periodic fees
  55. 42Daily penalty fees for late payment of periodic fees
  56. 43Refund or waiver of fees under regulation 41 or 42
  57. 44Adjustment, waiver, reduction or refund of fees
  58. 45Suspension of licences and certificates
  59. 46Civil proceedings to recover unpaid fees
  60. Part 14
  61. 47Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
  62. Part 15: Revocationand Savings
  63. 48Revocation and savings
  64. Signature
  65. Schedule 1: CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATES
  66. Part 1: Interpretation
  67. 1Paragraph 1
  68. Part 2: Capital Fees for Applications for Authorizations, Licences and Certificates
  69. 2Marketing authorizations
  70. 3Fees where application includes reclassification
  71. 4Fees where person holds clinical trial certificate
  72. 5Joint development
  73. 6Applications for multiple authorisations
  74. 7Authorisation for a national homoeopathic product
  75. 8Manufacturer’s licences and authorisations
  76. 9Wholesale dealer’s licences
  77. 10Clinical trial authorisations
  78. 11Traditional herbal registrations
  79. Part 3: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
  80. 12Interpretation
  81. 13Outgoing mutual recognition applications
  82. Part 4: Capital Fees for Applications for Variations of Authorizations, Licences and Registrations
  83. 14Interpretation
  84. 15Marketing authorizations
  85. 16Variation of marketing authorizations
  86. 17Reclassification of marketing authorizations
  87. 18Variation of marketing authorization: natural homoeopathic products
  88. 19Variation of parallel import licence
  89. 20Manufacturer’s authorisations and licences
  90. 21Variation of manufacturer’s authorisations and licences
  91. 22Wholesale dealer’s licences
  92. 23Variation of wholesale dealer’s licence
  93. 24Clinical trial authorisations
  94. 25Traditional herbal registrations
  95. 26Identical variations
  96. 27Complex Variation Applications
  97. 28Multiple reclassification variation applications
  98. Part 5: Capital Fees for Assessment of Labels and Leaflets
  99. 29Interpretation
  100. 30Single set of changes
  101. 31More than one set of charges purposed
  102. Part 6: Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations
  103. 32Regulatory assistance
  104. 33Regulatory assistance – same manufacturer
  105. Schedule 2: FEES FOR INSPECTIONS
  106. 1Paragraph 1
  107. 2Fees: general
  108. 3Third country traditional herbal medicinal products
  109. 4Sites concerned with starting materials for traditional herbal medicinal products
  110. 5Wholesale dealer’s licence: general
  111. 6Wholesale dealer’s licence: third country traditional herbal medicinal products
  112. 7Wholesale dealer’s licences: inspection of short duration
  113. Schedule 3: PERIODIC FEES FOR LICENCES
  114. Part 1: Interpretation
  115. 1Paragraph 1
  116. Part 2: Calculation of Turnover
  117. 2Calculation of turnover
  118. 3Manufacturer’s prices
  119. 4Evidence of turnover
  120. Part 3: Periodic Fees for Marketing Authorizations and Licences
  121. 5Marketing authorizations
  122. 6Marketing authorization: where Part 2 of Act applies
  123. 7Marketing authorization: derivatives
  124. 8Number of fee periods
  125. 9Authorisation for two or more kinds of medicinal product
  126. 10Reduced fees
  127. 11Manufacturer’s licences or manufacturing authorisations
  128. 12Wholesale dealer’s licences
  129. 13Wholesale dealer’s licences: evidence
  130. 14Wholesale dealer licences: exempt imported products
  131. 15Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products
  132. 16Clinical trial authorisations
  133. 17Traditional herbal registrations
  134. Part 4: Types of Marketing Authorization for which only One Periodic Fee is Payable
  135. 18Specified parallel import licences
  136. Schedule 4: Time for Payment of Capital Fees
  137. 1Application by or on behalf of a small company
  138. 2Major application
  139. 3Complex application
  140. 4Multiple applications
  141. 5Outgoing mutual recognition applications
  142. 6Application for traditional herbal registration
  143. 7Traditional herbal registration: complex variation
  144. 8Application for manufacturer’s licence, manufacturing authorisation or wholesale dealer’s licence
  145. 9Inspection fees in connection with applications
  146. Schedule 5: WAIVER, REDUCTION OR REFUND OF CAPITAL FEES
  147. 1Interruptions of manufacture, assembly, sale or supply
  148. 2Reclassification
  149. 3Traditional herbal registration
  150. 4Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation
  151. 5Withdrawal of application in relation to manufacturing authorisation, wholesale dealer’s or manufacturer’s licence
  152. 6Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
  153. 7Parallel import licence
  154. 8Surrender of marketing authorization at same time as a variation application
  155. 9Clinical trial authorisation
  156. 10Scientific advice: paediatric indications
  157. Schedule 6: ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES
  158. 1Refund on surrender or revocation of authorization, registration or licence
  159. 2Adjustment and refund: licences relating to exempt imported products
  160. 3Refunds: treated as having been paid on account
  161. Schedule 7REVOCATION SCHEDULE
  162. Explanatory note