OpenLegislation

The Medicines (Products for Human Use) (Fees) Regulations 2010 (revoked)

S.I. 2010/551 · Made 26 February 2010

Up to date with all changes known to legislation.gov.uk, revised to 1 April 2012.

Medicines

Fees And Charges

Consumer Protection

Made 26th February 2010

Laid before Parliament 4th March 2010

Coming into force 1stApril 2010

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations to the whole text

Textual amendments

F1

Regulations revoked (1.4.2012) by The Medicines (Products for Human Use) (Fees) Regulations 2012 (S.I. 2012/504), regs. 1, 57(1) (with reg. 57(2)-(4)) and Regulations expressed to be revoked (N.I.) (1.4.2012) by The Medicines (Products for Human Use) (Fees) Regulations 2012 (S.R. 2012/134), regs. 1, 57 (with reg. 57(2)-(4))

Contents

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 Part 1: General Repealed
  2. 1Citation and commencement Repealed
  3. 2Interpretation Repealed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 Part 2: Capital Fees for Pre-Application Meetings Repealed
  5. 3Interpretation of Part 2 Repealed
  6. 4Fee for scientific advice: application for, or variation to, EU marketing authorization Repealed
  7. 5Fee for scientific advice: classification of a medicinal product Repealed
  8. 6Fee for advertising advice Repealed
  9. 7Fee for pharmacovigilance advice Repealed
  10. 8Fee for advice on labelling or leaflets Repealed
  11. 9Fee for regulatory advice Repealed
  12. 10Fee for advice for other purposes Repealed
  13. 11Time for payment of fees under regulations 4 to 10 Repealed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Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections Repealed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 Repealed
  16. 13Fee for applications for copy certificates of good manufacturing practice Repealed
  17. 14Fees for applications for certificates and copy certificates by exporters of medicinal products Repealed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 Part 4: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States Repealed
  19. 15Meaning of “set of applications” Repealed
  20. 16Fees for applications for regulatory assistance under the mutual recognition procedure Repealed
  21. 17Time for payment of fees under regulation 16 Repealed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for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections Repealed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