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The Medicines (Products for Human Use) (Fees) Regulations 2013 (revoked)

S.I. 2013/532 · Made 7 March 2013 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 1 April 2016.

Medicines

Fees And Charges

Made 7th March 2013

Laid before Parliament 11th March 2013

Coming into force in accordance with regulation 1

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Annotations to the whole text

Textual amendments

F1

Regulations revoked (1.4.2016) by The Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190), reg. 63(1) (with reg. 63(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 Part 1: General Repealed
  2. 1Citation and commencement Repealed
  3. 2Interpretation Repealed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 Part 2: Capital Fees for Pre-Application Meetings Repealed
  5. 3Interpretation of Part 2 Repealed
  6. 4Fee for scientific advice: application for, or variation to, EU marketing authorisation Repealed
  7. 5Fee for scientific advice: classification of a medicinal product Repealed
  8. 6Fee for advertising advice Repealed
  9. 7Fee for pharmacovigilance advice Repealed
  10. 8Fee for advice on labelling or leaflets Repealed
  11. 9Fee for regulatory advice Repealed
  12. 10Fee for advice for other purposes Repealed
  13. 11Time for payment of fees under regulations 4 to 10 Repealed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Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections Repealed
  15. 12Fees for applications for authorisations, registrations, licences or certificates etc. Repealed
  16. 13Fee for applications for additional copy certificates Repealed
  17. 14Fees for applications for certificates and copy certificates by exporters of medicinal products Repealed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 Part 4: Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States Repealed
  19. 15Meaning of “set of applications” Repealed
  20. 16Fees for applications for regulatory assistance under the mutual recognition procedure Repealed
  21. 17Time for payment of fees under regulation 16 Repealed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for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities Repealed
  23. 18Fees for variations of authorisations, registrations and licences Repealed
  24. 19Fees for amendments to clinical trial authorisations Repealed
  25. 20Fees for notification of changes and reports for broker's registrations Repealed
  26. 21Fees for notification of changes and compliance Reports for active substance registrations Repealed
  27. 22Applications for multiple variations Repealed
  28. Part 6: Capital Fees for Assessment of Labels and Leaflets Repealed
  29. 23Meaning of “set of proposed changes” Repealed
  30. 24Fees for assessment of a set of proposed changes to labels and leaflets Repealed
  31. 25Time for payment of fees under regulation 24 Repealed
  32. Part 7: Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections Repealed
  33. 26Fees for renewals of certain manufacturer's licences Repealed
  34. 27Fees for renewals in terms which are not identical to the existing authorisation, licence or registration Repealed
  35. 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 Authorisations Repealed
  36. 28Fees for regulatory assistance for certain marketing authorisations Repealed
  37. Part 9: Capital Fees for Inspections Repealed
  38. 29Fees for inspections Repealed
  39. 30Fees for inspections of pharmacovigilance service providers Repealed
  40. 31Payer of inspection fee (contract laboratories and API manufacturing sites) Repealed
  41. 32Inspections in connection with multiple applications Repealed
  42. 33Fees for inspections relating to good clinical practice in clinical trials Repealed
  43. 34Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence Repealed
  44. 35Adjustment and refund of inspection fees in respect of a wholesale dealer's licence Repealed
  45. 36Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration Repealed
  46. Part 10: Periodic Fees for Authorisations, Registrations and Licences Repealed
  47. 37Periodic fees Repealed
  48. Part 11: Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership Repealed
  49. 38Meaning of “good clinical practice accreditation scheme” Repealed
  50. 39Fees for applications for membership and certificates Repealed
  51. Part 12: Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing Repealed
  52. 40Fee for a review upon oral representations or a person appointed hearing Repealed
  53. 41Time for payment under regulation 40 Repealed
  54. Part 13: Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products) Repealed
  55. 42Interpretation Repealed
  56. 43Fees for applications made at the invitation of the licensing authority Repealed
  57. 44Fees for applications for certificates Repealed
  58. 45Fees for variations of certificates Repealed
  59. 46Time for payment of fees Repealed
  60. Part 14: Administration Repealed
  61. 47Payment of fees to Ministers Repealed
  62. 48Time for payment of capital fees in connection with applications or inspections Repealed
  63. 49Time for payment of capital fees – applications made by small companies Repealed
  64. 50Payment of fees in respect of a traditional herbal registration Repealed
  65. 51Time for payment of periodic fees Repealed
  66. 52Penalty fees for late payment of periodic fees Repealed
  67. 53Daily penalty fees for late payment of periodic fees Repealed
  68. 54Refund or waiver of fees under regulation 52 or 53 Repealed
  69. 55Adjustment, waiver, reduction or refund of fees Repealed
  70. 56Suspension of licences and authorisations Repealed
  71. 57Civil proceedings to recover unpaid fees Repealed
  72. Part 15: Consequential Amendments Repealed
  73. 58Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004 Repealed
  74. Part 16: Revocations and Savings Repealed
  75. 59The Medicines (Products for Human Use) (Fees) Regulations 2012 Repealed
  76. 60The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012 Repealed
  77. 61Other Revocations Repealed
  78. Signature
  79. Schedule 1: General interpretation provisions Repealed
  80. 1Paragraph 1 Repealed
  81. 2Paragraph 2 Repealed
  82. 3Paragraph 3 Repealed
  83. Schedule 2: Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates Repealed
  84. Part 1: General: interpretation and categories of applications and variations Repealed
  85. 1Interpretation Repealed
  86. 2General: categories of applications and variations Repealed
  87. 3Administrative variation application Repealed
  88. 4Extension application Repealed
  89. 5Complex application Repealed
  90. 6Complex registration application Repealed
  91. 7Complex variation application Repealed
  92. 8Decentralised procedure application Repealed
  93. 9Extended Type II Complex Variation Application Repealed
  94. 10Major application Repealed
  95. 11Mutual recognition procedure incoming application Repealed
  96. 12New excipient variation application Repealed
  97. 13New indication variation application Repealed
  98. 14Parallel import licence application Repealed
  99. 15Reclassification variation application Repealed
  100. 16Reduced registration application Repealed
  101. 17Simple application Repealed
  102. 18Standard application Repealed
  103. 19Standard registration application Repealed
  104. 20Standard variation application Repealed
  105. 21Standard variation application for a homoeopathic medicinal product Repealed
  106. 22Type IB and Type II Applications Repealed
  107. 23Type II Complex Variation Application Repealed
  108. Part 2: Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates Repealed
  109. 24Marketing authorisations Repealed
  110. 25Fees where application includes reclassification Repealed
  111. 26Fees where person holds clinical trial certificate Repealed
  112. 27Joint development Repealed
  113. 28Application for multiple authorisations Repealed
  114. 29Authorisation for a national homoeopathic product Repealed
  115. 30Manufacturer's licences and authorisations Repealed
  116. 31Wholesale dealer's licences Repealed
  117. 32Broker's registrations Repealed
  118. 33Active substance registrations Repealed
  119. 34Clinical trial authorisations Repealed
  120. 35Traditional herbal registrations Repealed
  121. Part 3: Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States Repealed
  122. 36Outgoing mutual recognition applications Repealed
  123. Part 4: Capital Fees for Applications for Variations of Authorisations, Licences and Registrations Repealed
  124. 37Marketing authorisations Repealed
  125. 38Variation of marketing authorisations Repealed
  126. 39Reclassification of marketing authorisations Repealed
  127. 40Variation of marketing authorisation: national homoeopathic products Repealed
  128. 41Variation of parallel import licence Repealed
  129. 42Manufacturer's authorisations and licences Repealed
  130. 43Variation of manufacturer's authorisations and licences Repealed
  131. 44Wholesale dealer's licences Repealed
  132. 45Variation of wholesale dealer's licence Repealed
  133. 46Variation of a broker's registration Repealed
  134. 47Variation of an active substance registration Repealed
  135. 48Clinical trial authorisations Repealed
  136. 49Traditional herbal registrations Repealed
  137. 50Identical variations Repealed
  138. 51Complex Variation Applications Repealed
  139. 52Multiple reclassification variation applications Repealed
  140. Part 5: Capital Fees for Assessment of Labels and Leaflets Repealed
  141. 53A set of changes Repealed
  142. 54More than one set of changes proposed Repealed
  143. 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 Authorisations Repealed
  144. 55Regulatory assistance Repealed
  145. 56Regulatory assistance – same manufacturer Repealed
  146. Part 7: Relevant Substances Repealed
  147. 57Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 37(2)(b) Repealed
  148. Schedule 3: Fees for inspections Repealed
  149. 1General provisions relating to fees for inspections Repealed
  150. 2Fees: general Repealed
  151. 3Traditional herbal medicinal products Repealed
  152. 4Sites concerned with starting materials for traditional herbal medicinal products Repealed
  153. 5Wholesale dealer's licence: general Repealed
  154. 6Wholesale dealer's licence: traditional herbal medicinal products Repealed
  155. 7Wholesale dealer's licences: inspection of short duration Repealed
  156. 8Broker's registrations Repealed
  157. 9Active substance registrations Repealed
  158. 10Office-based inspections Repealed
  159. Schedule 4: Periodic fees for licences Repealed
  160. Part 1: Interpretation Repealed
  161. 1Paragraph 1 Repealed
  162. Part 2: Value of the Product Sold or Supplied Repealed
  163. 2Determining the total value of the product Repealed
  164. 3Manufacturer's prices Repealed
  165. 4Information requirements Repealed
  166. Part 3: Periodic Fees for Marketing Authorisations and Licences Repealed
  167. 5Marketing authorisations Repealed
  168. 6Marketing authorisation: where Part 2 of the Act applies Repealed
  169. 7Marketing authorisation: derivatives Repealed
  170. 8Number of fee periods Repealed
  171. 9Authorisation for two or more kinds of medicinal product Repealed
  172. 10Reduced fees Repealed
  173. 11Manufacturer's licences or manufacturing authorisations Repealed
  174. 12Wholesale dealer's licences Repealed
  175. 13Wholesale dealer's licences: evidence Repealed
  176. 14Wholesale dealer's licences: special medicinal products Repealed
  177. 15Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products Repealed
  178. 16Traditional herbal registrations Repealed
  179. Part 4: Types of Marketing Authorisation for which only One Periodic Fee is Payable Repealed
  180. 17Parallel import licences Repealed
  181. Schedule 5Fees for certificates of registration Repealed
  182. Schedule 6: Time for payment of capital fees: small companies Repealed
  183. 1Interpretation Repealed
  184. 2Major application Repealed
  185. 3Complex application Repealed
  186. 4Multiple application Repealed
  187. 5Outgoing mutual recognition application Repealed
  188. 6Application for traditional herbal registration Repealed
  189. 7Traditional herbal registration: complex variation Repealed
  190. 8Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence Repealed
  191. 9Inspection fees in connection with applications Repealed
  192. Schedule 7: Waiver, reduction or refund of capital fees Repealed
  193. 1Interruptions of manufacture, assembly, sale or supply Repealed
  194. 2Reclassification Repealed
  195. 3Variation of a traditional herbal registration Repealed
  196. 4Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation Repealed
  197. 5Withdrawal of application in relation to a certificate of registration Repealed
  198. 6Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration Repealed
  199. 7Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation Repealed
  200. 8Parallel import licence Repealed
  201. 9Surrender of marketing authorisation at same time as a variation application Repealed
  202. 10Clinical trial authorisation Repealed
  203. 11Scientific advice: paediatric indications Repealed
  204. 12Refunds: treated as having been paid on account Repealed
  205. Schedule 8: Adjustment, reduction or refund of periodic fees Repealed
  206. 1Refund on surrender or revocation of authorisation, registration or licence Repealed
  207. 2Adjustment and refund: licences relating to imported special medicinal products Repealed
  208. 3Refunds: treated as having been paid on account Repealed
  209. Schedule 9Further revocations Repealed
  210. Explanatory note