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The Veterinary Medicines Regulations 2013

S.I. 2013/2033 · Made 6 August 2013 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 17 May 2024.

Medicines

Made 6th August 2013

Laid before Parliament 20th August 2013

Coming into force 1st October 2013

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 and requirements 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.C1C2

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

Modifications

C1

Regulations: power to amend conferred (11.4.2021) by Medicines and Medical Devices Act 2021 (c. 3), ss. 10(1), 50(2)(c)

C2

Regulations applied in part (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(a), Sch. 1 (with regs. 7, 8)

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. 6Marketing of products not in accordance with a marketing authorisation
  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. 10AInducements and hospitality
  14. 11Advertising of prescription products and products containing psychotropic drugs or narcotics
  15. 12Defence of publication in the course of business
  16. 13Wholesale dealing
  17. 14Feedingstuffs
  18. 15Exemptions
  19. 16Fees
  20. Part 3: Records
  21. 17Food-producing animals: proof of purchase of veterinary medicinal products
  22. 18Food-producing animals: records of administration by a veterinary surgeon
  23. 19Food-producing animals: records of acquisition and administration
  24. 20Food-producing animals: retention of records
  25. 21Records by a holder of a manufacturing authorisation
  26. 22Records by a holder of a wholesale dealer’s authorisation
  27. 23Records of the receipt or supply of prescription products
  28. 24Records of products administered to a food-producing animal under the cascade
  29. 24AReporting of sales and usage data in relation to antibiotics
  30. Part 4: Unauthorised veterinary medicinal products
  31. 25Importation of an unauthorised veterinary medicinal product
  32. 26Possession of an unauthorised veterinary medicinal product
  33. 27Supply of an unauthorised veterinary medicinal product
  34. Part 5: Miscellaneous provisions, enforcement and offences
  35. 28The Veterinary Products Committee
  36. 29Veterinary Products Committee appeals procedure
  37. 30Appeals to an appointed person
  38. 31Exports
  39. 32Time limits
  40. 33Appointment of inspectors
  41. 34Powers of entry
  42. 35Powers of an inspector
  43. 36Inspection of pharmacies
  44. 37Obstruction
  45. 38Improvement notices
  46. 39Appeals against improvement notices
  47. 40Powers of a court on appeal
  48. 41Seizure notices
  49. 42Publication
  50. 43Offence
  51. 44Penalties
  52. 45Northern Ireland Repealed
  53. 46Review
  54. 47Revocations
  55. Signature
  56. Schedule 1: Marketing authorisations in Great Britain in Northern Ireland
  57. Part 1: Application for a marketing authorisation
  58. 1Application for a marketing authorisation
  59. 2Information with the application: general
  60. 2AInformation with the application: format
  61. 2BInformation with the application: animal testing
  62. 2CInformation with the application: POM-VPS, NFA-VPS and AVM-GSL
  63. 3Summary of product characteristics
  64. 4Supply of a copy of the summary of product characteristics
  65. 5Time limits for applications for products for use in food-producing animals Repealed
  66. Part 2: Derogations from some of the requirements in Part 1
  67. 6Scope
  68. 7Bibliographic application
  69. 8Application for a product using a new combination of active substances
  70. 9Application using existing data
  71. 10Application for a generic veterinary medicinal product
  72. 10AHybrid veterinary medicinal products
  73. 11Time limits for marketing authorisations granted under the procedure for a generic veterinary medicinal product
  74. 12Extension of time limits
  75. 12ATime limits – supplementary
  76. 13Parallel imports Repealed
  77. 14Specific batch control scheme
  78. 15Similar immunological products
  79. 16Marketing a product authorised in another country
  80. Part 3: Grant of a marketing authorisation
  81. 17Time limits
  82. 18Place of establishment of applicant
  83. 19Procedure
  84. 20Products authorised in another member State Repealed
  85. 21Assessment reports
  86. 22Grant of a marketing authorisation
  87. 22AWithdrawal of application for marketing authorisation
  88. 23Marketing authorisations for food-producing species
  89. 24Refusal of a marketing authorisation
  90. 25Publication following the grant , refusal, suspension, variation or revocation of a marketing authorisation
  91. 26Marketing authorisations in exceptional circumstances
  92. 27Provisions of samples and expertise
  93. 28Records and supply of information
  94. 29Duties on the holder of a marketing authorisation relating to an immunological product
  95. 30Control tests
  96. 31Placing on the market
  97. 32Duration and validity of marketing authorisation
  98. Part 4: Variations of marketing authorisations on the application of the holder
  99. 33Variation of a marketing authorisation
  100. 33AVariation procedure
  101. 34Refusal of a variation of a marketing authorisation
  102. 35Administrative variations
  103. 36Changes after a marketing authorisation has been issued
  104. 37Compulsory variation
  105. Part 5: Suspension, etc. of a marketing authorisation
  106. 38Suspension , revocation, etc of a marketing authorisation: grounds
  107. 39Suspension of a marketing authorisation: procedure
  108. 40Revocation
  109. 41Prohibiting the supply of veterinary medicinal products
  110. 41ATemporary restrictions
  111. 41BRestrictions in relation to immunological veterinary medicines
  112. Part 6: Mutual recognition and multiple applications
  113. 42Application for a marketing authorisation where one already exists in a member State
  114. 43Application in a member State
  115. 44Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
  116. Part 7: Labelling and package leaflets
  117. 45Approval by the Secretary of State
  118. 46Reference to being authorised
  119. 47Language
  120. 48Labelling of immediate packaging of veterinary medicinal products
  121. 49Labelling of the outer packaging of veterinary medicinal products
  122. 50Labelling of small immediate packaging units of veterinary medicinal products
  123. 51Package leaflet of veterinary medicinal products
  124. 52Small containers other than ampoules
  125. 53Homeopathic remedies
  126. 54Variations
  127. Part 8: Pharmacovigilance
  128. 55Qualified persons responsible for pharmacovigilance Repealed
  129. 56Duties of marketing authorisation holder in relation to pharmacovigilance
  130. 56ADuties of marketing authorisation holder in relation to signal management process
  131. 56BDuties of qualified person (pharmacovigilance)
  132. 56CSignal management process
  133. 57Adverse events following administration of a veterinary medicinal product
  134. 58Adverse reactions to a veterinary medicinal product administered in another country Repealed
  135. 59Annual benefit-risk reports
  136. 60Release of information by the marketing authorisation holder
  137. 60APharmacovigilance inspections by Secretary of State
  138. 60BPowers of Secretary of State in relation to signal management process
  139. 61Action taken on account of pharmacovigilance
  140. Part 9: Homeopathic remedies
  141. 62Meaning of “homeopathic remedy”
  142. 63Placing a homeopathic remedy on the market in accordance with a registration
  143. 64Application for registration
  144. 65Procedure for registration
  145. 66Products on the market before 1994
  146. 67Classification
  147. 68Offences
  148. Schedule 1A: Converted EU marketing authorisations
  149. 1Paragraph 1
  150. 2Paragraph 2
  151. 3Paragraph 3
  152. 4Paragraph 4
  153. Schedule 1B: Qualifying Northern Ireland good (QNIG) certificates
  154. 1Paragraph 1
  155. 2Paragraph 2
  156. 3Paragraph 3
  157. 4Paragraph 4
  158. 5Paragraph 5
  159. 6Paragraph 6
  160. 7Paragraph 7
  161. 8Paragraph 8
  162. 9Paragraph 9
  163. Schedule 2: The manufacture of veterinary medicinal products
  164. Part 1: Manufacturing authorisations
  165. 1Manufacturing authorisation
  166. 2Application for authorisation
  167. 3Procedure for grant of authorisations and time limits
  168. 4The authorisation
  169. 4AApplication for variation to the authorisation
  170. 5Suspension, revocation etc of the authorisation
  171. 6Good manufacturing practice certificates and inspection of sites
  172. 7Report following inspection
  173. 8Duties on the holder of a manufacturing authorisation
  174. 8AGood manufacturing practice
  175. 8BRecalled and counterfeit products
  176. 9Qualified persons for manufacture
  177. 10Refusal, revocation, suspension or variation of appointment
  178. 11Duties on a qualified person
  179. 12Register
  180. 13Test sites
  181. Part 2: Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade
  182. 14Authorisation to manufacture specific veterinary medicinal products
  183. 15Prohibition
  184. 16Personnel
  185. 17Process of authorisation
  186. 18Authorisation in relation to blood banks
  187. 19Authorisation in relation to stem cells
  188. 20Authorisation in relation to products for administration under the cascade
  189. 21Suspension, compulsory variation or revocation of authorisation
  190. 22Labelling
  191. 23Records
  192. 24Adverse events
  193. 25Inspection of sites
  194. Part 2A: Active Substances
  195. 26Prohibition on manufacture, importation or distribution of active substances unless registered
  196. 27Application for registration
  197. 28Good manufacturing or distribution practice
  198. 29Supply of information
  199. 30Inspection of sites
  200. 31Report following inspection
  201. Part 2B: Schedule 2 Offences
  202. 32Offences
  203. 33Records Repealed
  204. 34Inspection of premises Repealed
  205. 35Offences Repealed
  206. Schedule 3: Classification and supply, wholesale dealers and sheep dip
  207. Part 1: Classification and supply of authorised veterinary medicinal products
  208. 1Classification of veterinary medicinal products
  209. 2Wholesale supply of veterinary medicinal products
  210. 3Retail supply of veterinary medicinal products
  211. 3ASupply of samples
  212. 3BRegister of online suppliers of veterinary medicinal products
  213. 3CApplication for registration
  214. 3DDuties in relation to online supply
  215. 3ERetail storage of veterinary medicinal products
  216. 4Prescriptions by a veterinary surgeon
  217. 5Prescriptions
  218. 6Written prescriptions
  219. 7Duties when a product is prescribed or supplied
  220. 7ADuties in relation to prescribing of antibiotic veterinary medicinal products
  221. 8Supply by a veterinary surgeon from registered premises
  222. 9Supply by a veterinary surgeon
  223. 10Supply by a pharmacist
  224. 11Supply of a medicinal premix
  225. 12Labelling at the time of retail supply
  226. 13Supply of veterinary medicinal products for use under the cascade
  227. 14Supply by a suitably qualified person
  228. 15Audit
  229. Part 2: Requirements for a wholesale dealer’s authorisation
  230. 16Wholesale dealer’s authorisation
  231. 17Application for authorisation
  232. 18Procedure and time limits for authorisations
  233. 19Periodic inspections and suspension etc. for lack of use
  234. 19AApplication for variation to the authorisation
  235. 20Suspension, variation or revocation of the authorisation
  236. 21Duties on the holder of a wholesale dealer’s authorisation
  237. 21ARegister of authorised wholesale dealers
  238. 21BDocumentation accompanying veterinary medicinal products supplied wholesale
  239. 21CRecalled, counterfeit or returned products
  240. 21DAudit
  241. 21EContractual arrangements between holders of wholesale dealer’s authorisations
  242. 21FSelf-inspection programme
  243. Part 3: Sheep dip
  244. 22Supply of sheep dip
  245. 23Use of sheep dip
  246. 24Offences
  247. Schedule 4: Administration of a veterinary medicinal product outside the terms of a marketing authorisation
  248. 1Administration under the cascade
  249. 2Withdrawal periods
  250. 3Administration to food-producing horses
  251. 4Immunological products for serious epizootic disease or emerging disease
  252. 5Immunological products for an imported or exported animal
  253. 6Administration by veterinary surgeons from other countries
  254. 6AAdministration of autogenous vaccines
  255. 7Treatment in exceptional circumstances
  256. 8Administration of a homeopathic remedy
  257. 9Administration under an animal test certificate
  258. 9AMisuse of the cascade
  259. 10Offences
  260. Schedule 5: Medicated feedingstuffs and specified feed additives
  261. 1Scope and interpretation
  262. 2Enforcement of Regulation (EC) No 178/2002
  263. 3Enforcement of Regulation (EC) No 1831/2003
  264. 4Enforcement of Regulation (EU) 2017/625
  265. 5Enforcement of Regulation (EC) No 183/2005
  266. 6Enforcement of Regulation (EC) No 767/2009
  267. 7Authorisation of manufacturers and distributors of feedingstuffs containing medicinal premixes
  268. 8Incorporation of a medicinal premix into an intermediate feedingstuff
  269. 9Top dressing
  270. 10Incorporation of a medicinal premix into feedingstuffs
  271. 11Additional record keeping requirements relating to medicinal premixes
  272. 12Labelling an intermediate feedingstuff containing a medicinal premix
  273. 13Labelling of feedingstuffs containing a specified feed additive
  274. 14Labelling of feedingstuffs containing a medicinal premix
  275. 15Supply of specified feed additives
  276. 16Supply of intermediate feedingstuff or specified feed additive
  277. 17Supply of a complementary feedingstuff
  278. 18Supply of feedingstuffs containing a medicinal premix
  279. 19Medicated feedingstuff prescriptions for feedingstuffs containing a medicinal premix
  280. 20Writing the medicated feedingstuff prescription
  281. 21Possession
  282. 22Sampling and analysis
  283. 22ASampling for cross-contamination
  284. 23Storage
  285. 24Packages and other containers
  286. 25Transport
  287. 26Possession, placing on the market and use of feedingstuffs
  288. 26AUnused and expired medicated feedingstuffs
  289. 27Imports from third countries Repealed
  290. 28Trade between countries
  291. 29Import for incorporation into intermediate feedingstuffs or feedingstuffs for export
  292. 30Animals on domestic premises
  293. 31Offences
  294. Schedule 6: Exemptions for small pet animals
  295. 1Animals to which this Schedule applies
  296. 2Placing on the market, importing and administering the product
  297. 3Manufacture
  298. 3ARegister of persons placing veterinary medicinal products on the market (small pet animals)
  299. 3BPersons registered in accordance with paragraph 3A: annual return
  300. 4Approval of the active substance
  301. 5The product
  302. 6Labelling
  303. 7Administration
  304. 8Pack size
  305. 9Adverse events
  306. 10Offences
  307. Schedule 7: Fees
  308. Part 1: Introduction
  309. 1Interpretation
  310. 2Payment of fees
  311. 3Time of payment
  312. 4Multiple inspections
  313. 5Expenses for inspections outside the United Kingdom
  314. 6Translation
  315. Part 2: Fees relating to marketing authorisations
  316. 7Application for a marketing authorisation for a pharmaceutical , immunological or biological that is not immunological veterinary medicinal product
  317. 7AApplication for a marketing authorisation for specific applications
  318. 8Decentralised pharmaceutical application where the United Kingdom is the reference member State Repealed
  319. 9Application for a marketing authorisation for an immunological or biosimilar product Repealed
  320. 10Decentralised immunological application where the United Kingdom is the reference member State Repealed
  321. 11Application for a marketing authorisation based on informed consent
  322. 12Application for an exceptional marketing authorisation (pharmaceutical)
  323. 13Fees for an application for an exceptional marketing authorisation (immunological or biological non-immunological)
  324. 14Fee for the conversion from an exceptional to a full marketing authorisation
  325. 15Application for a marketing authorisation relating to a parallel import Repealed
  326. 15AFee for a generic marketing authorisation
  327. 16Application to change the distribution category of a product authorised through the centralised procedure Repealed
  328. 17Application for a variation to a marketing authorisation ....
  329. 18Application for a variation to a marketing authorisation dealt with under worksharing procedures Repealed
  330. 19Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member State Repealed
  331. 20Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension Repealed
  332. 21Exception for a variation relating to animal testing
  333. 22Application for a reassessment of an exceptional marketing authorisation
  334. 23Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure Repealed
  335. 24Registration of a homeopathic remedy
  336. 25Renewal of a homeopathic remedy
  337. 26Annual fees for marketing authorisations
  338. 27Auditor’s certificate
  339. Part 3: Fees payable by manufacturers
  340. 28Application for a manufacturing authorisation
  341. 29Application for a variation of a manufacturing authorisation
  342. 30Inspection of sites authorised to manufacture a product for administration under the cascade
  343. 30AAutogenous vaccines
  344. 30BAssessment of a variation of an authorisation to manufacture an autogenous vaccine
  345. 31Annual fee (manufacturing authorisations)
  346. 32Site inspections – type of site
  347. 33Inspection of a site where immunological veterinary medicinal products are manufactured
  348. 34Inspection of a site where sterile veterinary medicinal products are manufactured
  349. 35Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
  350. 36Inspection of a site where veterinary medicinal products are assembled
  351. 37Test sites
  352. 38Animal blood bank or non-food animal stem cell centre authorisations
  353. Part 4: Fees relating to a wholesale dealer’s authorisation
  354. 39Application for a wholesale dealer’s authorisation
  355. 40Variation of a wholesale dealer’s authorisation
  356. 41Annual fee for a wholesale dealer’s authorisation
  357. 42Inspection of a wholesale dealer’s sites
  358. Part 5: Fees relating to feedingstuffs
  359. 43Fees for applications for authorisation and annual fees relating to feedingstuffs in Great Britain
  360. 44Inspection fees relating to feedingstuffs in Great Britain
  361. 45Fees payable in relation to feedingstuffs in Northern Ireland Repealed
  362. 46Fees relating to premises for supply by suitably qualified persons
  363. Part 6: General
  364. 47Testing samples
  365. 48Animal test certificates
  366. 49Importation of a veterinary medicinal product for treatment under the cascade
  367. 50Wholesale dealer’s import certificate
  368. 51Specific batch control
  369. 52Submission of control tests of an immunological product
  370. 53Export certificates
  371. 54Provision of advice
  372. 54AProvision of scientific advice
  373. 55Appeals to the Veterinary Products Committee
  374. 56Fee relating to an appointed person
  375. 57Fees relating to a veterinary ... practice premises
  376. 57AFee in relation to verifying destruction of controlled drug
  377. 57BPharmacovigilance inspections
  378. 58Refund of fees relating to the Veterinary Products Committee or appointed persons
  379. 59Fees relating to an improvement notice
  380. 60Non-payment of fees
  381. 61Waiver or reduction of fees
  382. 62Reduction of fees when an application is withdrawn
  383. Explanatory note