The Medicines (Products for Human Use) (Fees) Regulations 2009 (revoked)

S.I. 2009/389 · Made 23 February 2009 · Extends to United Kingdom

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 Part 1: General Repealed
2. 1Citation and commencement Repealed
3. 2Interpretation Repealed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 Part 2: Capital Fees for Pre-Application Meetings Repealed
5. 3Interpretation of Part 2 Repealed
6. 4Fee for scientific advice: application for or variation to EC marketing authorization Repealed
7. 5Fee for scientific advice: classification of a medicinal product Repealed
8. 6Fee for advertising advice Repealed
9. 7Fee for pharmacovigilance advice Repealed
10. 8Fee for advice on labelling or leaflets Repealed
11. 9Fee for regulatory advice Repealed
12. 10Fee for advice for other purposes Repealed
13. 11Time for payment of fees under regulations 4 to 10 Repealed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Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections Repealed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 Repealed
16. 13Fee for applications for copy certificates of good manufacturing practice Repealed
17. 14Fees for applications for certificates and copy certificates by exporters of medicinal products Repealed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 Part 4: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States Repealed
19. 15Meaning of “set of applications” Repealed
20. 16Fees for applications for regulatory assistance under the mutual recognition procedure Repealed
21. 17Time for payment of fees under regulation 16 Repealed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Applications for Variations of Authorizations, Registrations, Licences and Certificates and for Associated Inspections Repealed
23. 18Fees for variations of authorizations, registrations, licences and authorisations Repealed
24. 18AFees for a variation to the terms of a marketing authorization Repealed
25. 19Fees for amendments to clinical trial authorisations Repealed
26. 20Applications for multiple variations Repealed
27. 20AApplications for variations to the terms of a marketing authorization Repealed
28. Part 6: Capital Fees for Assessment of Labels and Leaflets Repealed
29. 21Meaning of “set of proposed changes” Repealed
30. 22Fees for assessment of a set of proposed changes to labels and leaflets Repealed
31. 23Time for payment of fees under regulation 22 Repealed
32. Part 7: Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections Repealed
33. 24Fees for renewals of certain manufacturer's licences Repealed
34. 25Fees for renewals in terms which are not identical to the existing authorization, licence or certificate 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 Authorizations Repealed
36. 26Fees for regulatory assistance for certain marketing authorizations Repealed
37. Part 9: Capital Fees for Inspections Repealed
38. 27Fees for inspections Repealed
39. 28Payer of inspection fee (contract laboratories and API manufacturing sites) Repealed
40. 29Inspections in connection with multiple applications Repealed
41. 30Fees for inspections relating to good clinical practice in clinical trials Repealed
42. 31Amount of and time for payment of inspection fees in respect of an application for a wholesale dealer's licence Repealed
43. 32Adjustment and refund of inspection fees in respect of a wholesale dealer's licence Repealed
44. Part 10: Periodic Fees for Marketing Authorizations and Licences Repealed
45. 33Periodic fees Repealed
46. 34Periodic fees for clinical trial authorisations Repealed
47. Part 11: Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership Repealed
48. 35Meaning of “good clinical practice accreditation” scheme Repealed
49. 36Fees for applications for membership and certificate Repealed
50. Part 12: Capital Fee for a Person Appointed Hearing Repealed
51. 37Fee for a person appointed hearing Repealed
52. 38Time for payment under regulation 37 Repealed
53. Part 13: Administration Repealed
54. 39Payment of fees to Ministers Repealed
55. 40Time for payment of capital fees in connection with applications or inspections Repealed
56. 41Time for payment of capital fees – applications made by small companies Repealed
57. 42Payment of fees in respect of a traditional herbal registration Repealed
58. 43Time for payment of periodic fees Repealed
59. 44Penalty fees for late payment of periodic fees Repealed
60. 45Daily penalty fees for late payment of periodic fees Repealed
61. 46Refund or waiver of fees under regulation 44 or 45 Repealed
62. 47Adjustment, waiver, reduction or refund of fees Repealed
63. 48Suspension of licences and authorisations Repealed
64. 49Civil proceedings to recover unpaid fees Repealed
65. Part 14 Repealed
66. 50Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 Repealed
67. Part 15: Revocations and Savings Repealed
68. 51Revocations and savings Repealed
69. Signature
70. Schedule 1: CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES 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. 4BROMI variations 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. 28Applications 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. 35AVariations to the terms of marketing authorizations Repealed
111. 36Variation of marketing authorizations Repealed
112. 37Reclassification of marketing authorizations Repealed
113. 38Variation of marketing authorization: national homoeopathic products Repealed
114. 39Variation of parallel import licence Repealed
115. 40Manufacturer's authorisations and licences Repealed
116. 41Variation of manufacturer's authorisations and licences Repealed
117. 42Wholesale dealer's licences Repealed
118. 43Variation of wholesale dealer's licence Repealed
119. 44Clinical trial authorisations Repealed
120. 45Traditional herbal registrations Repealed
121. 46Identical variations Repealed
122. 46AReduced fees for Type IB and Type II Applications, Minor Variation (Type IB) Group Applications and a Major Variation (Type II) Group Applications Repealed
123. 47Complex Variation Applications Repealed
124. 47AReduced Fees for identical Type II Complex Applications, Extended Type II Complex Variation Applications, Major Variation (Type II) Complex Group Applications and Major Variation (Type II) Extended Complex Group Applications Repealed
125. 48Multiple reclassification variation applications Repealed
126. Part 5: Capital Fees for Assessment of Labels and Leaflets Repealed
127. 49A set of changes Repealed
128. 50More than one set of charges proposed Repealed
129. 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
130. 51Regulatory assistance Repealed
131. 52Regulatory assistance – same manufacturer Repealed
132. Schedule 2: FEES FOR INSPECTIONS Repealed
133. 1General provisions relating to fees for inspections Repealed
134. 2Fees: general Repealed
135. 3Traditional herbal medicinal products Repealed
136. 4Sites concerned with starting materials for traditional herbal medicinal products Repealed
137. 5Wholesale dealer's licence: general Repealed
138. 6Wholesale dealer's licence: Traditional herbal medicinal products Repealed
139. 7Wholesale dealer's licences: inspection of short duration Repealed
140. Schedule 3: PERIODIC FEES FOR LICENCES Repealed
141. Part 1: Interpretation Repealed
142. 1Paragraph 1 Repealed
143. Part 2: Calculation of Turnover Repealed
144. 2Calculation of turnover Repealed
145. 3Manufacturer's prices Repealed
146. 4Evidence of turnover Repealed
147. Part 3: Periodic Fees for Marketing Authorizations and Licences Repealed
148. 5Marketing authorizations Repealed
149. 6Marketing authorization: where Part 2 of the Act applies Repealed
150. 7Marketing authorization: derivatives Repealed
151. 8Number of fee periods Repealed
152. 9Authorisation for two or more kinds of medicinal product Repealed
153. 10Reduced fees Repealed
154. 11Manufacturer's licences or manufacturing authorisations Repealed
155. 12Wholesale dealer's licences Repealed
156. 13Wholesale dealer's licences: evidence Repealed
157. 14Wholesale dealer licences: exempt imported products Repealed
158. 15Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported products Repealed
159. 16Clinical trial authorisations Repealed
160. 17Traditional herbal registrations Repealed
161. Part 4: Types of Marketing Authorization for which only One Periodic Fee is Payable Repealed
162. 18Specified parallel import licences Repealed
163. Schedule 4: TIME FOR PAYMENT OF CAPITAL FEES Repealed
164. 1Interpretation Repealed
165. 2Major application Repealed
166. 3Complex application Repealed
167. 4Multiple applications Repealed
168. 5Outgoing mutual recognition applications Repealed
169. 6Application for traditional herbal registration Repealed
170. 7Traditional herbal registration: complex variation Repealed
171. 8Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence Repealed
172. 9Inspection fees in connection with applications Repealed
173. Schedule 5: WAIVER, REDUCTION OR REFUND OF CAPITAL FEES Repealed
174. 1Interruptions of manufacture, assembly, sale or supply Repealed
175. 2Reclassification Repealed
176. 3Variation of a traditional herbal registration Repealed
177. 4Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation Repealed
178. 5Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's or manufacturer's licence Repealed
179. 6Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation Repealed
180. 7Parallel import licence Repealed
181. 8Surrender of marketing authorization at same time as a variation application Repealed
182. 9Clinical trial authorisation Repealed
183. 10Scientific advice: paediatric indications Repealed
184. Schedule 6: ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES Repealed
185. 1Refund on surrender or revocation of authorization, registration or licence Repealed
186. 2Adjustment and refund: licences relating to exempt imported products Repealed
187. 3Refunds: treated as having been paid on account Repealed
188. Schedule 7: INTERPRETATION Repealed
189. 1Interpretation Repealed
190. 2Paragraph 2 Repealed
191. 3Paragraph 3 Repealed
192. Explanatory note