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The Veterinary Medicines Regulations 2005

S.I. 2005/2745 · Made 6 October 2005

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 6th October 2005

Laid before Parliament 7th October 2005

Coming into force

Except for regulation 14 and Schedule 5 30th October 2005

Regulation 14 and Schedule 5 1st January 2006

The Secretary of State is a Minister designated f1 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;

She 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 consents to the making of these Regulations;

The Secretary of State makes these Regulations in exercise of the powers conferred on her 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 with 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 purchase and administration
  23. 20Food-producing animals: retention of records
  24. 21Records by holders of a manufacturing authorisation
  25. 22Records by wholesale dealers
  26. 23Records of products supplied on prescription
  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. 29Representations to the Veterinary Products Committee
  35. 30Duties on the Secretary of State relating to exports
  36. 31Time limits
  37. 32Appointment of inspectors
  38. 33Powers of entry
  39. 34Powers of inspectors
  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 applications
  61. 8Applications for products using a new combination of active substances
  62. 9Applications 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 animals
  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 and revocation 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. 52Homoeopathic veterinary medicinal products
  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: Homoeopathic veterinary medicinal products
  121. 61Meaning of “homoeopathic veterinary medicinal product”
  122. 62Registration of a homoeopathic veterinary medicinal product
  123. 63Application for registration
  124. 64Procedure for registration
  125. 65Products on the market before 1994
  126. 66Administration
  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. Schedule 3: Classification and supply and wholesale dealers
  157. Part 1: Classification and supply of authorised veterinary medicinal products
  158. 1Classification of veterinary medicinal products
  159. 2Wholesale supply of veterinary medicinal products
  160. 3Retail supply of veterinary medicinal products
  161. 4Supply of products for incorporation into feedingstuffs
  162. 5Prescriptions
  163. 6Form of prescription
  164. 7Labelling at the time of retail supply
  165. 8Supply of veterinary medicinal products for use under the cascade
  166. 9Supply by a suitably qualified person
  167. 10Annual audit
  168. 11Supply of sheep dip
  169. Part 2: Requirements for a wholesale dealer’s authorisation
  170. 12Application
  171. 13Time limits
  172. 14Granting the authorisation
  173. 15The authorisation
  174. 16Suspension or revocation of the authorisation
  175. 17Representations
  176. 18Duties on the holder of a wholesale dealer’s authorisation
  177. Schedule 4: Administration of a veterinary medicinal product outside the terms of a marketing authorisation
  178. 1Administration
  179. 2Administration under the cascade
  180. 3Withdrawal periods
  181. 4Immunological products for serious epizootic disease
  182. 5Immunological products for an imported or exported animal
  183. 6Administration by veterinary surgeons from other member States
  184. 7Treatment in exceptional circumstances
  185. Schedule 5: Medicated feedingstuffs and specified feed additives
  186. 1Scope and interpretation
  187. 2Enforcement of Regulation (EC) No. 178/2002
  188. 3Enforcement of Regulation (EC) No. 1831/2003
  189. 4Enforcement of Regulation (EC) No. 882/2004
  190. 5Enforcement of Regulation (EC) No. 183/2005
  191. 6Incorporation of a veterinary medicinal product into premixtures
  192. 7Incorporation of a veterinary medicinal product into feedingstuffs
  193. 8Additional record keeping requirements relating to veterinary medicinal products
  194. 9Additional labelling requirement for premixtures containing a veterinary medicinal product
  195. 10Labelling of feedingstuffs containing specified feed additives
  196. 11Labelling of feedingstuffs containing a veterinary medicinal product
  197. 12Supply of specified feed additives
  198. 13Supply of premixture
  199. 14Supply of feedingstuffs containing a veterinary medicinal product
  200. 15Possession
  201. 16Sampling and analysis
  202. 17Storage
  203. 18Packages and other containers
  204. 19Transport
  205. 20Possession, placing on the market and use of feedingstuffs
  206. 21Prescriptions for feedingstuffs containing a veterinary medicinal product
  207. 22Imports from third countries
  208. 23Trade between member States
  209. Schedule 6: Exemptions for small pet animals
  210. 1Animals to which this Schedule applies
  211. 2Placing on the market
  212. 3Manufacture
  213. 4The active substance
  214. 5The product
  215. 6Labelling
  216. 7Administration
  217. 8Pack size
  218. 9Adverse reactions
  219. Schedule 7: Fees
  220. Part 1: Introduction
  221. 1Payment of fees
  222. 2Time of payment
  223. 3Multiple inspections
  224. Part 2: Fees relating to national marketing authorisations
  225. 4Scope of Part 2
  226. 5Standard application for a marketing authorisation
  227. 6Application for a marketing authorisation for a product with an active substance not contained in a veterinary medicinal product previously authorised in the United Kingdom
  228. 7Application for a marketing authorisation involving other aspects not previously authorised in a veterinary medicinal product in the UK
  229. 8Pharmacologically equivalent products
  230. 9Application for a marketing authorisation using identical data
  231. 10Application for a provisional marketing authorisation
  232. 11Application for a marketing authorisation relating to a parallel import
  233. 12Application for a variation
  234. 13Application for the renewal of a marketing authorisation
  235. 14Registration of a homoeopathic veterinary medicinal product
  236. Part 3: Fees relating to decentralised and mutual recognition procedures
  237. 15Scope of Part 3
  238. 16Provision of information relating to the recognition of United Kingdom marketing authorisation
  239. 17Mutual recognition of a marketing authorisation already granted in another member State
  240. 18Decentralised procedure where the United Kingdom is the reference member State
  241. 19Decentralised procedure where the United Kingdom is not the reference member State
  242. 20Application for a variation
  243. 21Application for the renewal of a marketing authorisation
  244. Part 4: Fees payable by manufacturers
  245. 22Application for a manufacturing authorisation
  246. 23Application for a variation of a manufacturing authorisation
  247. 24Application for an authorisation to manufacture an autogenous vaccine
  248. 25Annual fees
  249. 26Site inspections – type of site
  250. 27Inspection of a site where immunological veterinary medicinal products are manufactured
  251. 28Inspection of a site where sterile veterinary medicinal products are manufactured
  252. 29Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
  253. 30Inspection of a site where veterinary medicinal products are assembled
  254. 31Test sites
  255. 32Animal blood bank authorisations
  256. 33Expenses
  257. Part 5: Fees relating to a wholesale dealer’s authorisation
  258. 34Application for a wholesale dealer’s authorisation
  259. 35Variation of a wholesale dealer’s authorisation
  260. 36Annual fee for a wholesale dealer’s authorisation
  261. Part 6: Fees relating to feedingstuffs
  262. 37Fees relating to feedingstuffs
  263. 38Fees relating to distributors
  264. Part 7: General
  265. 39Annual fees for marketing authorisations
  266. 40Auditor’s certificate
  267. 41Late payment of annual fees
  268. 42Submission of samples in connection with applications for marketing authorisations and animal test certificates
  269. 43Animal Test Certificates
  270. 44Treatment under the cascade
  271. 45Treatment in exceptional circumstances
  272. 46Specific batch control
  273. 47Submission of control tests of an immunological product
  274. 48Export Certificates
  275. 49Fees relating to premises for supply by suitably qualified persons
  276. 50Application to the Veterinary Products Committee
  277. 51Non-payment of fees
  278. 52Waiver or reduction of fees
  279. 53Reduction of fees when an application is withdrawn
  280. Schedule 8: Revocations and amendments.
  281. 1Part 1
  282. 2Instruments revoked on 1st January 2006
  283. 3Consequential amendments
  284. The Medicines (Standard Provisions for Licences and Certificates) Regulations 1971
  285. 1Paragraph 1
  286. The Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971
  287. 2Paragraph 2
  288. The Medicines (Control of Substances for Manufacture) Order 1971
  289. 3Paragraph 3
  290. The Medicines (Importation of Medicinal Products for Re-exportation) Order 1971
  291. 4Paragraph 4
  292. The Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971
  293. 5Paragraph 5
  294. The Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972
  295. 6Paragraph 6
  296. The Medicines (Extension to Antimicrobial Substances) Order 1973
  297. 7Paragraph 7
  298. The Medicines (Exemptions from Licences) (Emergency Importation) Order 1974
  299. 8Paragraph 8
  300. The Medicines (Exemption from Licences) (Ingredients) Order 1974
  301. 9Paragraph 9
  302. The Medicines (Labelling) Regulations 1976
  303. 10Paragraph 10
  304. The Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977
  305. 11Paragraph 11
  306. The Medicines (Certificates of Analysis) Regulations 1977
  307. 12Paragraph 12
  308. The Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977
  309. 13Paragraph 13
  310. The Medicines (Prohibition of Non-medicinal Antimicrobial Substances) Order 1977
  311. 14Paragraph 14
  312. The Medicines (Fluted Bottles) Regulations 1978
  313. 15Paragraph 15
  314. The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980
  315. 16Paragraph 16
  316. The Medicines (Pharmacy and General Sale – Exemption) Order 1980
  317. 17Paragraph 17
  318. The Medicines (Control of Substances for Manufacture) Order 1985
  319. 18Paragraph 18
  320. The Medicines Act 1968 (Hearings by Persons Appointed)(Scotland) Rules 1986
  321. 19Paragraph 19
  322. The Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986
  323. 20Paragraph 20
  324. The Medicines (Exemption from Licences) (Wholesale Dealing) Order 1990
  325. 21Paragraph 21
  326. The Medicines (Advisory Board On The Registration Of Homoeopathic Products) Order 1995
  327. 22Paragraph 22
  328. Part 4: Transitional provisions
  329. 1Conversions of authorisations, etc.
  330. 2Suitably qualified persons
  331. 3Existing applications
  332. 4Existing procedures
  333. 5Records
  334. 6Labels
  335. 7Fees
  336. 8References to “coming into force”
  337. Explanatory note