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The Veterinary Medicines Regulations 2008

S.I. 2008/2297 · Made 26 August 2008 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 1 October 2009.

Medicines

Made 26th August 2008

Laid before Parliament 1st September 2008

Coming into force 1st October 2008

The Secretary of State is a Minister designatedf1 for the purposes of making Regulations under section 2(2) of the European Communities Act 1972f2 in relation to measures in the veterinary and phytosanitary fields for the protection of public health.

The Secretary of State has carried out the consultation required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyf3.

In accordance with section 56(1) of the Finance Act 1973f4, the Treasury consent to the making of these Regulations.

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973.

Annotations to the whole text

Textual amendments

F1

Regulations revoked (except reg. 45(2)) (1.10.2009) by The Veterinary Medicines Regulations 2009 (S.I. 2009/2297), regs. 1, 45 (with reg. 3)

Footnotes

f1

S.I. 1999/2027.

f2

1972 c. 68.

f3

OJ No. L31, 1.2.2002, p. 1.

f4

1973 c.51.

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 Part 1: Introduction Repealed
  2. 1Title and commencement Repealed
  3. 2Definition of “veterinary medicinal product”, interpretation and scope Repealed
  4. 3Products to which these Regulations do not apply Repealed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 Part 2: Authorised veterinary medicinal products Repealed
  6. 4Placing a veterinary medicinal product on the market Repealed
  7. 5Manufacture of veterinary medicinal products Repealed
  8. 6The finished product Repealed
  9. 7Classification, supply and possession of the product Repealed
  10. 8Administration of the product Repealed
  11. 9Importation of authorised veterinary medicinal products Repealed
  12. 10Advertising the product Repealed
  13. 11Advertising of prescription products and products containing psychotropic drugs or narcotics Repealed
  14. 12Defence of publication in the course of business Repealed
  15. 13Wholesale dealing Repealed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