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The Veterinary Medicines Regulations 2007

S.I. 2007/2539 · Made 30 August 2007

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

MEDICINES

Made 30th August 2007

Laid before Parliament 4th September 2007

Coming into force 1st October 2007

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.

He 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 on him 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

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