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The Veterinary Medicines Regulations 2006

S.I. 2006/2407 · Made 5 September 2006 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 1 April 2022.

MEDICINES

Made 5th September 2006

Laid before Parliament 8th September 2006

Coming into force 1st October 2006

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. 29Procedure for suspending, etc. a marketing authorisation or animal test certificate
  35. 30Duties on the Secretary of State relating to exports
  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 of notices
  47. 42Penalties
  48. 43Northern Ireland
  49. 44Revocations and amendments
  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, etc. of a marketing authorisation
  95. 39Suspension, etc. of a marketing authorisation of a product authorised in more than one member State
  96. 40Prohibiting the supply of veterinary medicinal products
  97. Part 6: Mutual recognition and multiple applications
  98. 41Application for a marketing authorisation where one already exists in another member State
  99. 42Application in another member State
  100. 43Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
  101. Part 7: Labelling and package leaflets
  102. 44Approval by the Secretary of State
  103. 45Reference to being authorised
  104. 46Language
  105. 47Labelling with all the information on the immediate packaging
  106. 48Products with immediate and outer packaging
  107. 49Package leaflets
  108. 50Ampoules
  109. 51Small containers other than ampoules
  110. 52Homeopathic remedies
  111. 53Variations
  112. Part 8: Pharmacovigilance
  113. 54Qualified persons responsible for pharmacovigilance
  114. 55Duties relating to the qualified person
  115. 56Adverse reactions to a veterinary medicinal product administered in the United Kingdom
  116. 57Adverse reactions to a veterinary medicinal product administered in a third country
  117. 58Periodic safety update reports
  118. 59Release of information by the marketing authorisation holder
  119. 60Action taken on account of pharmacovigilance
  120. Part 9: Homeopathic remedies
  121. 61Meaning of “homeopathic remedy”
  122. 62Placing a homeopathic remedy on the market in accordance with a registration
  123. 63Application for registration
  124. 64Procedure for registration
  125. 65Products on the market before 1994
  126. 66Classification
  127. Schedule 2: THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS
  128. Part 1: Manufacturing authorisation
  129. 1Application
  130. 2Time limits
  131. 3Granting the authorisation
  132. 4The authorisation
  133. 5Suspension or revocation of the authorisation
  134. 6Representation to the Secretary of State
  135. 7Inspection of premises
  136. 8Report following inspection
  137. 9Duties on the holder of a manufacturing authorisation
  138. 10Qualified persons for manufacture
  139. 11Refusal or revocation of appointment
  140. 12Duties on a qualified person
  141. 13Register
  142. 14Test sites
  143. Part 2: Authorisation of manufacturers of autogenous vaccines
  144. 15Authorisation to manufacture autogenous vaccines
  145. 16Types of authorisation
  146. 17Labelling
  147. 18Records
  148. 19Adverse reactions
  149. 20Inspection of premises
  150. Part 3: Authorisation of blood banks
  151. 21Authorisation of blood banks
  152. 22Supply and administration of blood from a blood bank
  153. 23Labelling
  154. 24Records
  155. 25Inspection of blood banks
  156. Part 4: Authorisation of manufacturers of products for administration under the cascade
  157. 26Authorisation to manufacture products for administration under the cascade
  158. 27Labelling
  159. 28Records
  160. 29Adverse reaction
  161. 30Inspection of premises
  162. Schedule 3: CLASSIFICATION AND SUPPLY, WHOLESALE DEALERS AND SHEEP DIP
  163. Part 1: Classification and supply of authorised veterinary medicinal products
  164. 1Classification of veterinary medicinal products
  165. 2Wholesale supply of veterinary medicinal products
  166. 3Retail supply of veterinary medicinal products
  167. 4Prescriptions by a veterinary surgeon
  168. 5Prescriptions
  169. 6Written prescriptions
  170. 7Duties when a product is prescribed or supplied
  171. 8Supply by a pharmacist
  172. 9Supply by a veterinary surgeon when he is not present
  173. 10Supply of products for incorporation into feedingstuffs
  174. 11Labelling at the time of retail supply
  175. 12Supply of veterinary medicinal products for use under the cascade
  176. 13Supply by a suitably qualified person
  177. 14Annual audit
  178. Part 2: Requirements for a wholesale dealer’s authorisation
  179. 15Application
  180. 16Time limits
  181. 17Granting the authorisation
  182. 18The authorisation
  183. 19Suspension or revocation of the authorisation
  184. 20Representations
  185. 21Duties on the holder of a wholesale dealer’s authorisation
  186. Part 3: Sheep dip
  187. 22Supply of sheep dip
  188. 23Use of sheep dip
  189. Schedule 4: ADMINISTRATION OF A VETERINARY MEDICINAL PRODUCT OUTSIDE THE TERMS OF A MARKETING AUTHORISATION
  190. 1Administration under the cascade
  191. 2Withdrawal periods
  192. 3Immunological products for serious epizootic disease
  193. 4Immunological products for an imported or exported animal
  194. 5Administration by veterinary surgeons from other member States
  195. 6Treatment in exceptional circumstances
  196. 7Administration of a homeopathic remedy
  197. Schedule 5: MEDICATED FEEDINGSTUFFS AND SPECIFIED FEED ADDITIVES
  198. 1Scope and interpretation
  199. 2Enforcement of Regulation (EC) No. 178/2002
  200. 3Enforcement of Regulation (EC) No. 1831/2003
  201. 4Enforcement of Regulation (EC) No. 882/2004
  202. 5Enforcement of Regulation (EC) No. 183/2005
  203. 6Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products
  204. 7Incorporation of a veterinary medicinal product into a premixture
  205. 8Incorporation of a veterinary medicinal product into feedingstuffs
  206. 9Additional record keeping requirements relating to veterinary medicinal products
  207. 10Labelling a premixture containing a veterinary medicinal product
  208. 11Labelling of feedingstuffs containing a specified feed additive
  209. 12Labelling of feedingstuffs containing a veterinary medicinal product
  210. 13Supply of specified feed additives
  211. 14Supply of premixture
  212. 15Supply of feedingstuffs containing a veterinary medicinal product
  213. 16Possession
  214. 17Sampling and analysis
  215. 18Storage
  216. 19Packages and other containers
  217. 20Transport
  218. 21Possession, placing on the market and use of feedingstuffs
  219. 22Prescriptions for feedingstuffs containing a veterinary medicinal product
  220. 23Imports from third countries
  221. 24Trade between member States
  222. Schedule 6: EXEMPTIONS FOR SMALL PET ANIMALS
  223. 1Animals to which this Schedule applies
  224. 2Placing on the market, importing and administering the product
  225. 3Manufacture
  226. 4Approval of the active substance
  227. 5The product
  228. 6Labelling
  229. 7Administration
  230. 8Pack size
  231. 9Adverse reactions
  232. Schedule 7: FEES
  233. Part 1: Introduction
  234. 1Interpretation of Schedule 7
  235. 2Payment of fees
  236. 3Time of payment
  237. 4Multiple inspections
  238. 5Translation
  239. Part 2: Fees relating to marketing authorisations
  240. 6Fees for specified pharmaceutical applications
  241. 7Decentralised pharmaceutical application where the United Kingdom is the reference member State
  242. 8Application for a marketing authorisation for an immunological product
  243. 9Decentralised immunological application where the United Kingdom is the reference member State
  244. 10Application for a marketing authorisation using identical data
  245. 11Application for a provisional marketing authorisation
  246. 12Application for a marketing authorisation relating to a parallel import
  247. 13Application for a variation
  248. 14Application for a variation to a marketing authorisation that has been issued in other member States
  249. 15Application for an extension to a marketing authorisation
  250. 16Decentralised application for an extension where the United Kingdom is the reference member State
  251. 17Provision of information relating to the recognition of a United Kingdom marketing authorisation
  252. 18Application for the renewal of a national marketing authorisation
  253. 19Application for the renewal of a marketing authorisation granted in more than one member State
  254. 20Registration of a homeopathic remedy
  255. 21Annual fees for marketing authorisations
  256. 22Auditor’s certificate
  257. 23Late payment of annual fees
  258. Part 3: Fees payable by manufacturers
  259. 24Application for a manufacturing authorisation
  260. 25Application for a variation of a manufacturing authorisation
  261. 26Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade
  262. 27Annual fees
  263. 28Site inspections—type of site
  264. 29Inspection of a site where immunological veterinary medicinal products are manufactured
  265. 30Inspection of a site where sterile veterinary medicinal products are manufactured
  266. 31Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
  267. 32Inspection of a site where veterinary medicinal products are assembled
  268. 33Test sites
  269. 34Animal blood bank authorisations
  270. 35Expenses
  271. Part 4: Fees relating to a wholesale dealer’s authorisation
  272. 36Application for a wholesale dealer’s authorisation
  273. 37Variation of a wholesale dealer’s authorisation
  274. 38Annual fee for a wholesale dealer’s authorisation
  275. Part 5: Fees relating to feedingstuffs
  276. 39Fees relating to feedingstuffs
  277. 40Fees relating to distributors
  278. Part 6: General
  279. 41Testing samples
  280. 42Animal test certificates
  281. 43Treatment under the cascade
  282. 44Treatment in exceptional circumstances
  283. 45Specific batch control
  284. 46Submission of control tests of an immunological product
  285. 47Export certificates
  286. 48Fees relating to premises for supply by suitably qualified persons
  287. 49Application to the Veterinary Products Committee
  288. 50Non-payment of fees
  289. 51Waiver or reduction of fees
  290. 52Reduction of application fee
  291. Schedule 8: AMENDMENTS TO THE MEDICINES ACTS ETC.
  292. Part 1: Consequential amendments to the Medicines Acts 1968 and 1971
  293. 1The Medicines Act 1968
  294. 2The Medicines Act 1968
  295. 3The Medicines Act 1968
  296. 4The Medicines Act 1968
  297. 5The Medicines Act 1968
  298. 6The Medicines Act 1968
  299. 7The Medicines Act 1968
  300. 8The Medicines Act 1968
  301. 9The Medicines Act 1968
  302. 10The Medicines Act 1968
  303. 11The Medicines Act 1968
  304. 12The Medicines Act 1968
  305. 13The Medicines Act 1968
  306. 14The Medicines Act 1968
  307. 15The Medicines Act 1968
  308. 16The Medicines Act 1968
  309. 17The Medicines Act 1968
  310. 18The Medicines Act 1968
  311. 19The Medicines Act 1968
  312. 20The Medicines Act 1968
  313. 21The Medicines Act 1968
  314. 22The Medicines Act 1968
  315. 23The Medicines Act 1968
  316. 24The Medicines Act 1968
  317. 25The Medicines Act 1968
  318. 26The Medicines Act 1968
  319. 27The Medicines Act 1968
  320. 28The Medicines Act 1968
  321. 29The Medicines Act 1968
  322. 30The Medicines Act 1968
  323. 31The Medicines Act 1968
  324. 32The Medicines Act 1968
  325. 33The Medicines Act 1968
  326. 34The Medicines Act 1968
  327. 35The Medicines Act 1968
  328. 36The Medicines Act 1968
  329. 37The Medicines Act 1968
  330. 38The Medicines Act 1968
  331. 39The Medicines Act 1968
  332. 40The Medicines Act 1968
  333. 41The Medicines Act 1968
  334. 42The Medicines Act 1968
  335. 43The Medicines Act 1968
  336. 44The Medicines Act 1968
  337. 45The Medicines Act 1968
  338. 46The Medicines Act 1968
  339. 47The Medicines Act 1968
  340. 48The Medicines Act 1968
  341. 49The Medicines Act 1968
  342. 50The Medicines Act 1968
  343. 51The Medicines Act 1968
  344. 52The Medicines Act 1968
  345. 53The Medicines Act 1968
  346. 54The Medicines Act 1968
  347. 55The Medicines Act 1968
  348. 56The Medicines Act 1968
  349. 57The Medicines Act 1968
  350. 58The Medicines Act 1968
  351. 59The Medicines Act 1968
  352. 60The Medicines Act 1968
  353. 61The Medicines Act 1968
  354. 62The Medicines Act 1968
  355. 63The Medicines Act 1968
  356. 64The Medicines Act 1968
  357. 65The Medicines Act 1968
  358. 66The Medicines Act 1968
  359. 67The Medicines Act 1968
  360. 68The Medicines Act 1968
  361. 69The Medicines Act 1968
  362. 70The Medicines Act 1971
  363. Part 2: Consequential amendments to secondary legislation
  364. 1The Medicines (Surgical Materials) Order 1971
  365. 2The Medicines (Specified Articles and Substances) Order 1976
  366. 3The Medicines (Radioactive Substances) Order 1978
  367. 4The Medicines (Administration of Radioactive Substances) Regulations 1978
  368. 5The Medicines (Cyanogenetic Substances) Order 1984
  369. 6The Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986
  370. 7The Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992
  371. 8The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994
  372. 9The Medicines (Advertising) Regulations 1994
  373. 10The Medicines (Monitoring of Advertising) Regulations 1994
  374. 11The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
  375. 12The Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003 Repealed
  376. 13The Herbal Medicines Advisory Committee Order 2005
  377. 14The Medicines (Advisory Bodies) (No. 2) Regulations 2005
  378. Schedule 9: OTHER CONSEQUENTIAL AMENDMENTS
  379. Part 1: Consequential amendments to primary legislation
  380. 1The Pharmacy Act 1954
  381. 2The Trade Descriptions Act 1968
  382. 3The Poisons Act 1972
  383. 4The City of London (Various Powers) Act 1977
  384. 5The Sporting Events (Control of Alcohol etc.) Act 1985
  385. 6... Repealed
  386. 7The Consumer Protection Act 1987
  387. 8The Environmental Protection Act 1990
  388. 9The Sunday Trading Act 1994
  389. 10The Value Added Tax Act 1994
  390. 11The Criminal Law (Consolidation) (Scotland) Act 1995
  391. 12The Food Standards Act 1999
  392. 13The Licensing Act 2003
  393. Part 2: Consequential revocations of and amendments to secondary legislation
  394. 1Revocations
  395. 2Importation of Animal Pathogens Order 1980
  396. 3The Warble Fly (England and Wales) Order 1982
  397. 4The Environmental Protection (Prescribed Processes and Substances) Regulations 1991
  398. 5The Products of Animal Origin (Import and Export) Regulations 1996
  399. Explanatory note