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

S.I. 2012/504 · Made 23 February 2012 · 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 Part 1: General Repealed
2. 1Citation and commencement Repealed
3. 2Interpretation Repealed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 Part 2: Capital Fees for Pre-Application Meetings Repealed
5. 3Interpretation of Part 2 Repealed
6. 4Fee for scientific advice: application for, or variation to, EU marketing authorization Repealed
7. 5Fee for scientific advice: classification of a medicinal product Repealed
8. 6Fee for advertising advice Repealed
9. 7Fee for pharmacovigilance advice Repealed
10. 8Fee for advice on labelling or leaflets Repealed
11. 9Fee for regulatory advice Repealed
12. 10Fee for advice for other purposes Repealed
13. 11Time for payment of fees under regulations 4 to 10 Repealed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Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections Repealed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 Repealed
16. 13Fee for applications for copy certificates of good manufacturing practice Repealed
17. 14Fees for applications for certificates and copy certificates by exporters of medicinal products Repealed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 Part 4: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States Repealed
19. 15Meaning of “set of applications” Repealed
20. 16Fees for applications for regulatory assistance under the mutual recognition procedure Repealed
21. 17Time for payment of fees under regulation 16 Repealed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for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections Repealed
23. 18Fees for variations of authorizations, registrations, licences and authorisations Repealed
24. 19Fees for amendments to clinical trial authorisations Repealed
25. 20Applications for multiple variations Repealed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 Part 6: Capital Fees for Assessment of Labels and Leaflets Repealed
27. 21Meaning of “set of proposed changes” Repealed
28. 22Fees for assessment of a set of proposed changes to labels and leaflets Repealed
29. 23Time for payment of fees under regulation 22 Repealed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Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections Repealed
31. 24Fees for renewals of certain manufacturer's licences Repealed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: Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 Repealed
52. 39Interpretation Repealed
53. 40Fees for applications made at the invitation of the licensing authority Repealed
54. 41Fees for applications for certificates Repealed
55. 42Fees for variations of certificates Repealed
56. 43Time for payment of fees Repealed
57. Part 14: Administration Repealed
58. 44Payment of fees to Ministers Repealed
59. 45Time for payment of capital fees in connection with applications or inspections Repealed
60. 46Time for payment of capital fees – applications made by small companies Repealed
61. 47Payment of fees in respect of a traditional herbal registration Repealed
62. 48Time for payment of periodic fees Repealed
63. 49Penalty fees for late payment of periodic fees Repealed
64. 50Daily penalty fees for late payment of periodic fees Repealed
65. 51Refund or waiver of fees under regulation 49 or 50 Repealed
66. 52Adjustment, waiver, reduction or refund of fees Repealed
67. 53Suspension of licences and authorisations Repealed
68. 54Civil proceedings to recover unpaid fees Repealed
69. Part 15: Consequential Amendments Repealed
70. 55Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004 Repealed
71. 56Amendment of the Homoeopathic Regulations Repealed
72. Part 16: Revocations and Savings Repealed
73. 57The Medicines (Products for Human Use) (Fees) Regulations 2010 Repealed
74. 58The Homoeopathic Regulations Repealed
75. Signature
76. Schedule 1: INTERPRETATION Repealed
77. 1Interpretation Repealed
78. 2Paragraph 2 Repealed
79. 3Paragraph 3 Repealed
80. Schedule 2: CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES Repealed
81. Part 1: General: interpretation and categories of applications and variations Repealed
82. 1Interpretation Repealed
83. 2General: categories of Applications and Variations Repealed
84. 3Administrative variation application Repealed
85. 4Extension application Repealed
86. 5Complex application Repealed
87. 6Complex registration application Repealed
88. 7Complex variation application Repealed
89. 8Decentralised procedure application Repealed
90. 9Extended Type II Complex Variation Application Repealed
91. 10Major application Repealed
92. 11Mutual recognition procedure incoming application Repealed
93. 12New excipient variation application Repealed
94. 13New indication variation application Repealed
95. 14Parallel Import Licence application Repealed
96. 15Reclassification variation application Repealed
97. 16Reduced registration application Repealed
98. 17Simple application Repealed
99. 18Standard application Repealed
100. 19Standard registration application Repealed
101. 20Standard variation application Repealed
102. 21Standard variation application for a homoeopathic medicinal product Repealed
103. 22Type IB and Type II Applications Repealed
104. 23Type II Complex Variation Application Repealed
105. Part 2: Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates Repealed
106. 24Marketing authorizations Repealed
107. 25Fees where application includes reclassification Repealed
108. 26Fees where person holds clinical trial certificate Repealed
109. 27Joint development Repealed
110. 28Application for multiple authorizations Repealed
111. 29Authorisation for a national homoeopathic product Repealed
112. 30Manufacturer's licences and authorisations Repealed
113. 31Wholesale dealer's licences Repealed
114. 32Clinical trial authorisations Repealed
115. 33Traditional herbal registrations Repealed
116. Part 3: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States Repealed
117. 34Outgoing mutual recognition applications Repealed
118. Part 4: Capital Fees for Applications for Variations of Authorizations, Licences and Registrations Repealed
119. 35Marketing authorizations Repealed
120. 36Variation of marketing authorizations Repealed
121. 37Reclassification of marketing authorizations Repealed
122. 38Variation of marketing authorization: national homoeopathic products Repealed
123. 39Variation of parallel import licence Repealed
124. 40Manufacturer's authorisations and licences Repealed
125. 41Variation of manufacturer's authorisations and licences Repealed
126. 42Wholesale dealer's licences Repealed
127. 43Variation of wholesale dealer's licence Repealed
128. 44Clinical trial authorisations Repealed
129. 45Traditional herbal registrations Repealed
130. 46Identical variations Repealed
131. 47Complex Variation Applications Repealed
132. 48Multiple reclassification variation applications Repealed
133. Part 5: Capital Fees for Assessment of Labels and Leaflets Repealed
134. 49A set of changes Repealed
135. 50More than one set of changes proposed Repealed
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 Repealed
137. 51Regulatory assistance Repealed
138. 52Regulatory assistance – same manufacturer Repealed
139. Schedule 3: FEES FOR INSPECTIONS Repealed
140. 1General provisions relating to fees for inspections Repealed
141. 2Fees: general Repealed
142. 3Traditional herbal medicinal products Repealed
143. 4Sites concerned with starting materials for traditional herbal medicinal products Repealed
144. 5Wholesale dealer's licence: general Repealed
145. 6Wholesale dealer's licence: traditional herbal medicinal products Repealed
146. 7Wholesale dealer's licences: inspection of short duration Repealed
147. 8Office-based inspections Repealed
148. Schedule 4: PERIODIC FEES FOR LICENCES Repealed
149. Part 1: Interpretation Repealed
150. 1Paragraph 1 Repealed
151. Part 2: Value of the Product Sold or Supplied Repealed
152. 2Determining the total value of the product Repealed
153. 3Manufacturer's prices Repealed
154. 4Information requirements Repealed
155. Part 3: Periodic Fees for Marketing Authorizations and Licences Repealed
156. 5Marketing authorizations Repealed
157. 6Marketing authorization: where Part 2 of the Act applies Repealed
158. 7Marketing authorization: derivatives Repealed
159. 8Number of fee periods Repealed
160. 9Authorisation for two or more kinds of medicinal product Repealed
161. 10Reduced fees Repealed
162. 11Manufacturer's licences or manufacturing authorisations Repealed
163. 12Wholesale dealer's licences Repealed
164. 13Wholesale dealer's licences: evidence Repealed
165. 14Wholesale dealer's licences: exempt imported products Repealed
166. 15Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported products Repealed
167. 16Clinical trial authorisations Repealed
168. 17Traditional herbal registrations Repealed
169. Part 4: Types of Marketing Authorization for which only One Periodic Fee is Payable Repealed
170. 18Parallel import licences Repealed
171. Schedule 5FEES FOR CERTIFICATES OF REGISTRATION Repealed
172. Schedule 6: TIME FOR PAYMENT OF CAPITAL FEES: SMALL COMPANIES Repealed
173. 1Interpretation Repealed
174. 2Major application Repealed
175. 3Complex application Repealed
176. 4Multiple application Repealed
177. 5Outgoing mutual recognition application Repealed
178. 6Application for traditional herbal registration Repealed
179. 7Traditional herbal registration: complex variation Repealed
180. 8Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence Repealed
181. 9Inspection fees in connection with applications Repealed
182. Schedule 7: WAIVER, REDUCTION OR REFUND OF CAPITAL FEES Repealed
183. 1Interruptions of manufacture, assembly, sale or supply Repealed
184. 2Reclassification Repealed
185. 3Variation of a traditional herbal registration Repealed
186. 4Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation Repealed
187. 5Withdrawal of application in relation to a certificate of registration Repealed
188. 6Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence or manufacturer's licence Repealed
189. 7Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation Repealed
190. 8Parallel import licence Repealed
191. 9Surrender of marketing authorization at same time as a variation application Repealed
192. 10Clinical trial authorisation Repealed
193. 11Scientific advice: paediatric indications Repealed
194. 12Refunds: treated as having been paid on account Repealed
195. Schedule 8: ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES Repealed
196. 1Refund on surrender or revocation of authorization, registration or licence Repealed
197. 2Adjustment and refund: licences relating to exempt imported products Repealed
198. 3Refunds: treated as having been paid on account Repealed
199. Explanatory note