The Veterinary Medicines Regulations 2011 (revoked)

S.I. 2011/2159 · Made 25 August 2011 · Extends to United Kingdom

Contents

1. Part 1: Introduction Repealed
2. 1Title and commencement Repealed
3. 2Definition of “veterinary medicinal product”, interpretation and scope Repealed
4. 3Products to which these Regulations do not apply Repealed
5. Part 2: Authorised veterinary medicinal products Repealed
6. 4Placing a veterinary medicinal product on the market Repealed
7. 5Manufacture of veterinary medicinal products Repealed
8. 6The finished product Repealed
9. 7Classification, supply and possession of the product Repealed
10. 8Administration of the product Repealed
11. 9Importation of authorised veterinary medicinal products Repealed
12. 10Advertising the product Repealed
13. 11Advertising of prescription products and products containing psychotropic drugs or narcotics Repealed
14. 12Defence of publication in the course of business Repealed
15. 13Wholesale dealing Repealed
16. 14Feedingstuffs Repealed
17. 15Exemptions Repealed
18. 16Fees Repealed
19. Part 3: Records Repealed
20. 17Food-producing animals: proof of purchase of veterinary medicinal products Repealed
21. 18Food-producing animals: records of administration by a veterinary surgeon Repealed
22. 19Food-producing animals: records of acquisition and administration Repealed
23. 20Food-producing animals: retention of records Repealed
24. 21Records by a holder of a manufacturing authorisation Repealed
25. 22Records by a holder of a wholesale dealer’s authorisation Repealed
26. 23Records of the receipt or supply of prescription products Repealed
27. 24Records of products administered to a food-producing animal under the cascade Repealed
28. Part 4: Unauthorised veterinary medicinal products Repealed
29. 25Importation of an unauthorised veterinary medicinal product Repealed
30. 26Possession of an unauthorised veterinary medicinal product Repealed
31. 27Supply of an unauthorised veterinary medicinal product Repealed
32. Part 5: Miscellaneous provisions, enforcement and offences Repealed
33. 28The Veterinary Products Committee Repealed
34. 29Veterinary Products Committee appeals procedure Repealed
35. 30Appeals to an appointed person Repealed
36. 31Exports Repealed
37. 32Time limits Repealed
38. 33Appointment of inspectors Repealed
39. 34Powers of entry Repealed
40. 35Powers of an inspector Repealed
41. 36Inspection of pharmacies Repealed
42. 37Obstruction Repealed
43. 38Improvement notices Repealed
44. 39Appeals against improvement notices Repealed
45. 40Powers of a court on appeal Repealed
46. 41Seizure notices Repealed
47. 42Publication Repealed
48. 43Penalties Repealed
49. 44Northern Ireland Repealed
50. 45Review Repealed
51. 46Revocations Repealed
52. Signature
53. Schedule 1: Marketing authorisations Repealed
54. Part 1: Application for a marketing authorisation Repealed
55. 1Application for a marketing authorisation Repealed
56. 2Information with the application Repealed
57. 3Summary of product characteristics Repealed
58. 4Supply of a copy of the summary of product characteristics Repealed
59. 5Time limits for applications for products for use in food-producing animals Repealed
60. Part 2: Derogations from some of the requirements in Part 1 Repealed
61. 6Scope Repealed
62. 7Bibliographic application Repealed
63. 8Application for a product using a new combination of active substances Repealed
64. 9Application using existing data Repealed
65. 10Application for a pharmacologically equivalent medicinal product Repealed
66. 11Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product Repealed
67. 12Extension of time limits Repealed
68. 13Parallel imports Repealed
69. 14Specific batch control scheme Repealed
70. 15Similar immunological products Repealed
71. 16Marketing a product authorised in another country Repealed
72. Part 3: Grant of a marketing authorisation Repealed
73. 17Time limits Repealed
74. 18Place of establishment of applicant Repealed
75. 19Procedure Repealed
76. 20Products authorised in another Member State Repealed
77. 21Assessment reports Repealed
78. 22Grant of a marketing authorisation Repealed
79. 23Marketing authorisations for food-producing species Repealed
80. 24Refusal of a marketing authorisation Repealed
81. 25Publication following the grant of a marketing authorisation Repealed
82. 26Marketing authorisations in exceptional circumstances Repealed
83. 27Provisions of samples and expertise Repealed
84. 28Supply of information Repealed
85. 29Duties on the holder of a marketing authorisation relating to an immunological product Repealed
86. 30Control tests Repealed
87. 31Placing on the market Repealed
88. 32Duration and validity of a marketing authorisation Repealed
89. Part 4: Variations of marketing authorisations on the application of the holder Repealed
90. 33Variation of a marketing authorisation Repealed
91. 34Refusal of a variation of a marketing authorisation Repealed
92. 35Administrative variations Repealed
93. 36Changes after a marketing authorisation has been issued Repealed
94. 37Compulsory variation Repealed
95. Part 5: Suspension, etc. of a marketing authorisation Repealed
96. 38Suspension of a marketing authorisation: grounds Repealed
97. 39Suspension of a marketing authorisation: procedure Repealed
98. 40Revocation Repealed
99. 41Prohibiting the supply of veterinary medicinal products Repealed
100. Part 6: Mutual recognition and multiple applications Repealed
101. 42Application for a marketing authorisation where one already exists in another member State Repealed
102. 43Application in another Member State Repealed
103. 44Application for a marketing authorisation in multiple Member States where a marketing authorisation does not exist in any member State Repealed
104. Part 7: Labelling and package leaflets Repealed
105. 45Approval by the Secretary of State Repealed
106. 46Reference to being authorised Repealed
107. 47Language Repealed
108. 48Labelling with all the information on the immediate packaging Repealed
109. 49Products with immediate and outer packaging Repealed
110. 50Package leaflets Repealed
111. 51Ampoules Repealed
112. 52Small containers other than ampoules Repealed
113. 53Homeopathic remedies Repealed
114. 54Variations Repealed
115. Part 8: Pharmacovigilance Repealed
116. 55Qualified persons responsible for pharmacovigilance Repealed
117. 56Duties relating to the qualified person Repealed
118. 57Adverse reactions to a veterinary medicinal product administered in the United Kingdom Repealed
119. 58Adverse reactions to a veterinary medicinal product administered in a third country Repealed
120. 59Periodic safety update reports Repealed
121. 60Release of information by the marketing authorisation holder Repealed
122. 61Action taken on account of pharmacovigilance Repealed
123. Part 9: Homeopathic remedies Repealed
124. 62Meaning of “homeopathic remedy” Repealed
125. 63Placing a homeopathic remedy on the market in accordance with a registration Repealed
126. 64Application for registration Repealed
127. 65Procedure for registration Repealed
128. 66Products on the market before 1994 Repealed
129. 67Classification Repealed
130. Schedule 2: The manufacture of veterinary medicinal products Repealed
131. Part 1: Manufacturing authorisations Repealed
132. 1Application Repealed
133. 2Time limits Repealed
134. 3Granting the authorisation Repealed
135. 4The authorisation Repealed
136. 5Suspension, variation or revocation of the authorisation Repealed
137. 6Inspection of premises Repealed
138. 7Report following inspection Repealed
139. 8Duties on the holder of a manufacturing authorisation Repealed
140. 9Qualified persons for manufacture Repealed
141. 10Refusal or revocation of appointment Repealed
142. 11Duties on a qualified person Repealed
143. 12Register Repealed
144. 13Test sites Repealed
145. Part 2: Authorisation of manufacturers of autogenous vaccines Repealed
146. 14Authorisation to manufacture autogenous vaccines Repealed
147. 15Types of authorisation Repealed
148. 16Labelling Repealed
149. 17Records Repealed
150. 18Adverse reactions Repealed
151. 19Inspection of premises Repealed
152. Part 3: Authorisation of blood banks Repealed
153. 20Authorisation of blood banks Repealed
154. 21Supply and administration of blood from a blood bank Repealed
155. 22Labelling Repealed
156. 23Records Repealed
157. 24Inspection of premises Repealed
158. Part 4: Authorisation of manufacturers of products for administration under the cascade Repealed
159. 25Authorisation to manufacture products for administration under the cascade Repealed
160. 26Labelling Repealed
161. 27Records Repealed
162. 28Adverse reactions Repealed
163. 29Inspection of premises Repealed
164. Part 5: Authorisation of equine stem cell centres Repealed
165. 30Authorisation of stem cell centres Repealed
166. 31Supply and administration of stem cells Repealed
167. 32Labelling Repealed
168. 33Records Repealed
169. 34Inspection of premises Repealed
170. Schedule 3: Classification and supply, wholesale dealers and sheep dip Repealed
171. Part 1: Classification and supply of authorised veterinary medicinal products Repealed
172. 1Classification of veterinary medicinal products Repealed
173. 2Wholesale supply of veterinary medicinal products Repealed
174. 3Retail supply of veterinary medicinal products Repealed
175. 4Prescriptions by a veterinary surgeon Repealed
176. 5Prescriptions Repealed
177. 6Written prescriptions Repealed
178. 7Duties when a product is prescribed or supplied Repealed
179. 8Supply by a veterinary surgeon from registered premises Repealed
180. 9Supply by a veterinary surgeon Repealed
181. 10Supply by a pharmacist Repealed
182. 11Supply of a veterinary medicinal product for incorporation into feedingstuffs Repealed
183. 12Labelling at the time of retail supply Repealed
184. 13Supply of veterinary medicinal products for use under the cascade Repealed
185. 14Supply by a suitably qualified person Repealed
186. 15Annual audit Repealed
187. Part 2: Requirements for a wholesale dealer’s authorisation Repealed
188. 16Application Repealed
189. 17Time limits Repealed
190. 18Granting the authorisation Repealed
191. 19The authorisation Repealed
192. 20Suspension, variation or revocation of the authorisation Repealed
193. 21Duties on the holder of a wholesale dealer’s authorisation Repealed
194. Part 3: Sheep dip Repealed
195. 22Supply of sheep dip Repealed
196. 23Use of sheep dip Repealed
197. Schedule 4: Administration of a veterinary medicinal product outside the terms of a marketing authorisation Repealed
198. 1Administration under the cascade Repealed
199. 2Withdrawal periods Repealed
200. 3Administration to food-producing horses Repealed
201. 4Immunological products for serious epizootic disease Repealed
202. 5Immunological products for an imported or exported animal Repealed
203. 6Administration by veterinary surgeons from other Member States Repealed
204. 7Treatment in exceptional circumstances Repealed
205. 8Administration of a homeopathic remedy Repealed
206. 9Administration under an animal test certificate Repealed
207. Schedule 5: Medicated feedingstuffs and specified feed additives Repealed
208. 1Scope and interpretation Repealed
209. 2Enforcement of Regulation (EC) No 178/2002 Repealed
210. 3Enforcement of Regulation (EC) No 1831/2003 Repealed
211. 4Enforcement of Regulation (EC) No 882/2004 Repealed
212. 5Enforcement of Regulation (EC) No 183/2005 Repealed
213. 6Enforcement of Regulation (EC) No 767/2009 Repealed
214. 7Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products Repealed
215. 8Incorporation of a veterinary medicinal product into a premixture Repealed
216. 9Top dressing Repealed
217. 10Incorporation of a veterinary medicinal product into feedingstuffs Repealed
218. 11Additional record keeping requirements relating to veterinary medicinal products Repealed
219. 12Labelling a premixture containing a veterinary medicinal product Repealed
220. 13Labelling of feedingstuffs containing a specified feed additive Repealed
221. 14Labelling of feedingstuffs containing a veterinary medicinal product Repealed
222. 15Supply of specified feed additives Repealed
223. 16Supply of premixture Repealed
224. 17Supply of a complementary feedingstuff Repealed
225. 18Supply of feedingstuffs containing a veterinary medicinal product Repealed
226. 19Prescriptions for feedingstuffs containing a veterinary medicinal product Repealed
227. 20Writing the prescription Repealed
228. 21Possession Repealed
229. 22Sampling and analysis Repealed
230. 23Storage Repealed
231. 24Packages and other containers Repealed
232. 25Transport Repealed
233. 26Possession, placing on the market and use of feedingstuffs Repealed
234. 27Imports from third countries Repealed
235. 28Trade between Member States Repealed
236. 29Import for incorporation into premixture or feedingstuffs for export Repealed
237. 30Animals on domestic premises Repealed
238. Schedule 6: Exemptions for small pet animals Repealed
239. 1Animals to which this Schedule applies Repealed
240. 2Placing on the market, importing and administering the product Repealed
241. 3Manufacture Repealed
242. 4Approval of the active substance Repealed
243. 5The product Repealed
244. 6Labelling Repealed
245. 7Administration Repealed
246. 8Pack size Repealed
247. 9Adverse reactions Repealed
248. Schedule 7: Fees Repealed
249. Part 1: Introduction Repealed
250. 1Interpretation Repealed
251. 2Payment of fees Repealed
252. 3Time of payment Repealed
253. 4Multiple inspections Repealed
254. 5Expenses for inspections outside the United Kingdom Repealed
255. 6Translation Repealed
256. Part 2: Fees relating to marketing authorisations Repealed
257. 7Fees for specified pharmaceutical applications Repealed
258. 8Decentralised pharmaceutical application where the United Kingdom is the reference Member State Repealed
259. 9Application for a marketing authorisation for an immunological product Repealed
260. 10Decentralised immunological application where the United Kingdom is the reference Member State Repealed
261. 11Application for a marketing authorisation using identical data Repealed
262. 12Application for an exceptional marketing authorisation (pharmaceutical) Repealed
263. 13Fees for an application for an exceptional marketing authorisation (immunological) Repealed
264. 14Fee for the conversion from an exceptional to a full marketing authorisation Repealed
265. 15Application for a marketing authorisation relating to a parallel import Repealed
266. 16Application to change the distribution category of a product authorised through the centralised procedure Repealed
267. 17Application for a variation to a marketing authorisation dealt with under national or mutual recognition variation procedures. Repealed
268. 18Application for a variation to a marketing authorisation dealt with under worksharing procedures Repealed
269. 19Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference Member State Repealed
270. 20Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension Repealed
271. 21Exception for a variation relating to animal testing Repealed
272. 22Application for the renewal of a national marketing authorisation Repealed
273. 23Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure Repealed
274. 24Registration of a homeopathic remedy Repealed
275. 25Annual fees for marketing authorisations Repealed
276. 26Auditor’s certificate Repealed
277. Part 3: Fees payable by manufacturers Repealed
278. 27Application for a manufacturing authorisation Repealed
279. 28Application for a variation of a manufacturing authorisation Repealed
280. 29Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade Repealed
281. 30Annual fees Repealed
282. 31Site inspections – type of site Repealed
283. 32Inspection of a site where immunological veterinary medicinal products are manufactured Repealed
284. 33Inspection of a site where sterile veterinary medicinal products are manufactured Repealed
285. 34Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured Repealed
286. 35Inspection of a site where veterinary medicinal products are assembled Repealed
287. 36Test sites Repealed
288. 37Animal blood bank or equine stem cell centre authorisations Repealed
289. Part 4: Fees relating to a wholesale dealer’s authorisation Repealed
290. 38Application for a wholesale dealer’s authorisation Repealed
291. 39Variation of a wholesale dealer’s authorisation Repealed
292. 40Annual fee for a wholesale dealer’s authorisation Repealed
293. 41Inspection of a wholesale dealer’s premises Repealed
294. Part 5: Fees relating to feedingstuffs Repealed
295. 42Fees relating to feedingstuffs Repealed
296. 43Fees relating to premises for supply by suitably qualified persons Repealed
297. 44Reduced fees Repealed
298. Part 6: General Repealed
299. 45Testing samples Repealed
300. 46Animal test certificates Repealed
301. 47Importation of a veterinary medicinal product for treatment under the cascade Repealed
302. 48Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 1986 Repealed
303. 49Wholesale dealer’s import certificate Repealed
304. 50Specific batch control Repealed
305. 51Submission of control tests of an immunological product Repealed
306. 52Export certificates Repealed
307. 53Provision of advice Repealed
308. 54Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates Repealed
309. 55Appeals to the Veterinary Products Committee: variations Repealed
310. 56Appeal to the Veterinary Products Committee: suspensions Repealed
311. 57Appeal to the Veterinary Products Committee: active substance under Schedule 6 Repealed
312. 58Fee relating to an appointed person Repealed
313. 59Fees relating to a veterinary surgeon’s practice premises Repealed
314. 60Refund of fees relating to the Veterinary Products Committee or appointed persons Repealed
315. 61Fees relating to an improvement notice Repealed
316. 62Non-payment of fees Repealed
317. 63Waiver or reduction of fees Repealed
318. 64Reduction of fees when an application is withdrawn Repealed
319. Explanatory note