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The Medicines (Products for Human Use) (Fees) Regulations 2012

S.R. 2012/134 · Made 23 February 2012

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

Made 23rd February 2012

Laid before Parliament 29th February 2012

Coming into force 1st April 2012

The Secretary of State for Health and the Minister for Health, Social Services and Public Safety, 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 Minister, the powers conferred by those provisions and now vested in himf2.

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 and the Minister for Health, Social Services and Public Safety 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 regulation 45(2) of S.I. 2008/2297 and section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the Medicines Act 1971 (“the 1971 Act”), expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) (“the 1968 Act”). 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. Section 1(1) of the 1968 Act 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) (“the 1994 Regulations”), 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 2 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. In the case of the Minister for Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).

f3

1972 c.68.

f4

1973 c.51.

f5

S.I. 1972/1811.

f6

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, EU 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 Authorisations 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 Licences, Authorizations and Registrations 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 registration
  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. 31Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence
  41. 32Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence
  42. Part 10: Periodic Fees for Authorizations, Registrations, Licences and Authorisations
  43. 33Periodic fees
  44. 34Periodic fees for clinical trial authorisations
  45. Part 11: Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
  46. 35Meaning of “good clinical practice accreditation scheme”
  47. 36Fees for applications for membership and certificates
  48. Part 12: Capital Fee for a Person Appointed Hearing
  49. 37Fee for a person appointed hearing
  50. 38Time for payment under regulation 37
  51. Part 13: Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
  52. 39Interpretation
  53. 40Fees for applications made at the invitation of the licensing authority
  54. 41Fees for applications for certificates
  55. 42Fees for variations of certificates
  56. 43Time for payment of fees
  57. Part 14: Administration
  58. 44Payment of fees to Ministers
  59. 45Time for payment of capital fees in connection with applications or inspections
  60. 46Time for payment of capital fees – applications made by small companies
  61. 47Payment of fees in respect of a traditional herbal registration
  62. 48Time for payment of periodic fees
  63. 49Penalty fees for late payment of periodic fees
  64. 50Daily penalty fees for late payment of periodic fees
  65. 51Refund or waiver of fees under regulation 49 or 50
  66. 52Adjustment, waiver, reduction or refund of fees
  67. 53Suspension of licences and authorisations
  68. 54Civil proceedings to recover unpaid fees
  69. Part 15: Consequential Amendments
  70. 55Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
  71. 56Amendment of the Homoeopathic Regulations
  72. Part 16: Revocations and Savings
  73. 57The Medicines (Products for Human Use) (Fees) Regulations 2010
  74. 58The Homoeopathic Regulations
  75. Signature
  76. Schedule 1: INTERPRETATION
  77. 1Interpretation
  78. 2Interpretation
  79. 3Interpretation
  80. Schedule 2: CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES
  81. Part 1: General: interpretation and categories of applications and variations
  82. 1Interpretation
  83. 2General: categories of Applications and Variations
  84. 3Administrative variation application
  85. 4Extension application
  86. 5Complex application
  87. 6Complex registration application
  88. 7Complex variation application
  89. 8Decentralised procedure application
  90. 9Extended Type II Complex Variation Application
  91. 10Major application
  92. 11Mutual recognition procedure incoming application
  93. 12New excipient variation application
  94. 13New indication variation application
  95. 14Parallel Import Licence application
  96. 15Reclassification variation application
  97. 16Reduced registration application
  98. 17Simple application
  99. 18Standard application
  100. 19Standard registration application
  101. 20Standard variation application
  102. 21Standard variation application for a homoeopathic medicinal product
  103. 22Type IB and Type II Applications
  104. 23Type II Complex Variation Application
  105. Part 2: Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates
  106. 24Marketing authorizations
  107. 25Fees where application includes reclassification
  108. 26Fees where person holds clinical trial certificate
  109. 27Joint development
  110. 28Application for multiple authorizations
  111. 29Authorisation for a national homoeopathic product
  112. 30Manufacturer’s licences and authorisations
  113. 31Wholesale dealer’s licences
  114. 32Clinical trial authorisations
  115. 33Traditional herbal registrations
  116. Part 3: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
  117. 34Outgoing mutual recognition applications
  118. Part 4: Capital Fees for Applications for Variations of Authorizations, Licences and Registrations
  119. 35Marketing authorizations
  120. 36Variation of marketing authorizations
  121. 37Reclassification of marketing authorizations
  122. 38Variation of marketing authorization: national homoeopathic products
  123. 39Variation of parallel import licence
  124. 40Manufacturer’s authorisations and licences
  125. 41Variation of manufacturer’s authorisations and licences
  126. 42Wholesale dealer’s licences
  127. 43Variation of wholesale dealer’s licence
  128. 44Clinical trial authorisations
  129. 45Traditional herbal registrations
  130. 46Identical variations
  131. 47Complex Variation Applications
  132. 48Multiple reclassification variation applications
  133. Part 5: Capital Fees for Assessment of Labels and Leaflets
  134. 49A set of changes
  135. 50More than one set of changes proposed
  136. 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
  137. 51Regulatory assistance
  138. 52Regulatory assistance – same manufacturer
  139. Schedule 3: FEES FOR INSPECTIONS
  140. 1General provisions relating to fees for inspections
  141. 2Fees: general
  142. 3Traditional herbal medicinal products
  143. 4Sites concerned with starting materials for traditional herbal medicinal products
  144. 5Wholesale dealer’s licence: general
  145. 6Wholesale dealer’s licence: traditional herbal medicinal products
  146. 7Wholesale dealer’s licences: inspection of short duration
  147. 8Office-based inspections
  148. Schedule 4: PERIODIC FEES FOR LICENCES
  149. Part 1: Interpretation
  150. 1Paragraph 1
  151. Part 2: Value of the Product Sold or Supplied
  152. 2Determining the total value of the product
  153. 3Manufacturer’s prices
  154. 4Information requirements
  155. Part 3: Periodic Fees for Marketing Authorizations and Licences
  156. 5Marketing authorizations
  157. 6Marketing authorization: where Part 2 of the Act applies
  158. 7Marketing authorization: derivatives
  159. 8Number of fee periods
  160. 9Authorisation for two or more kinds of medicinal product
  161. 10Reduced fees
  162. 11Manufacturer’s licences or manufacturing authorisations
  163. 12Wholesale dealer’s licences
  164. 13Wholesale dealer’s licences: evidence
  165. 14Wholesale dealer’s licences: exempt imported products
  166. 15Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products
  167. 16Clinical trial authorisations
  168. 17Traditional herbal registrations
  169. Part 4: Types of Marketing Authorization for which only One Periodic Fee is Payable
  170. 18Parallel import licences
  171. Schedule 5FEES FOR CERTIFICATES OF REGISTRATION
  172. Schedule 6: TIME FOR PAYMENT OF CAPITAL FEES: SMALL COMPANIES
  173. 1Interpretation
  174. 2Major application
  175. 3Complex application
  176. 4Multiple application
  177. 5Outgoing mutual recognition application
  178. 6Application for traditional herbal registration
  179. 7Traditional herbal registration: complex variation
  180. 8Application for manufacturer’s licence, manufacturing authorisation or wholesale dealer’s licence
  181. 9Inspection fees in connection with applications
  182. Schedule 7: WAIVER, REDUCTION OR REFUND OF CAPITAL FEES
  183. 1Interruptions of manufacture, assembly, sale or supply
  184. 2Reclassification
  185. 3Variation of a traditional herbal registration
  186. 4Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation
  187. 5Withdrawal of application in relation to a certificate of registration
  188. 6Withdrawal of application in relation to manufacturing authorisation, wholesale dealer’s licence or manufacturer’s licence
  189. 7Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation
  190. 8Parallel import licence
  191. 9Surrender of marketing authorization at same time as a variation application
  192. 10Clinical trial authorisation
  193. 11Scientific advice: paediatric indications
  194. 12Refunds: treated as having been paid on account
  195. Schedule 8: ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES
  196. 1Refund on surrender or revocation of authorization, registration or licence
  197. 2Adjustment and refund: licences relating to exempt imported products
  198. 3Refunds: treated as having been paid on account
  199. Explanatory note