http://www.legislation.gov.uk/uksi/2011/2159The Veterinary Medicines Regulations 2011 (revoked)MedicinesEuropean ParliamentEuropean UnionAnimal healthAnimal experimentationenMEDICINESStatute Law DatabaseExpert Participation2024-05-20Expert Participation2013-10-01 These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2009. 2011 No. 2159MedicinesThe Veterinary Medicines Regulations 2011 (revoked)<CommentaryRef Ref="key-f7d07e050938f4c588a67c6643bc345c"/>Made25th August 2011Laid before Parliament7th September 2011Coming into force1st October 2011. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 1IntroductionTitle and commencement1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Definition of “veterinary medicinal product”, interpretation and scope2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Products to which these Regulations do not apply3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 2Authorised veterinary medicinal productsPlacing a veterinary medicinal product on the market4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Manufacture of veterinary medicinal products5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .The finished product6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Classification, supply and possession of the product7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administration of the product8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Importation of authorised veterinary medicinal products9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Advertising the product10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Advertising of prescription products and products containing psychotropic drugs or narcotics11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Defence of publication in the course of business12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Wholesale dealing13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Feedingstuffs14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Exemptions15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Fees16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 3RecordsFood-producing animals: proof of purchase of veterinary medicinal products17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Food-producing animals: records of administration by a veterinary surgeon18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Food-producing animals: records of acquisition and administration19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Food-producing animals: retention of records20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Records by a holder of a manufacturing authorisation21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Records by a holder of a wholesale dealer’s authorisation22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Records of the receipt or supply of prescription products23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Records of products administered to a food-producing animal under the cascade24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 4Unauthorised veterinary medicinal productsImportation of an unauthorised veterinary medicinal product25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Possession of an unauthorised veterinary medicinal product26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of an unauthorised veterinary medicinal product27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 5Miscellaneous provisions, enforcement and offencesThe Veterinary Products Committee28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Veterinary Products Committee appeals procedure29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Appeals to an appointed person30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Exports31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Time limits32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Appointment of inspectors33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Powers of entry34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Powers of an inspector35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of pharmacies36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Obstruction37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Improvement notices38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Appeals against improvement notices39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Powers of a court on appeal40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Seizure notices41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Publication42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Penalties43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Northern Ireland44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Review45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Revocations46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 SCHEDULE 1Marketing authorisationsRegulation 4(3)PART 1Application for a marketing authorisationApplication for a marketing authorisation1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Information with the application2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Summary of product characteristics3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of a copy of the summary of product characteristics4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Time limits for applications for products for use in food-producing animals5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 2Derogations from some of the requirements in Part 1Scope6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Bibliographic application7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a product using a new combination of active substances8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application using existing data9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a pharmacologically equivalent medicinal product10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Extension of time limits12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Parallel imports13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Specific batch control scheme14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Similar immunological products15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Marketing a product authorised in another country16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 3Grant of a marketing authorisationTime limits17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Place of establishment of applicant18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Procedure19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Products authorised in another Member State20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Assessment reports21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Grant of a marketing authorisation22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Marketing authorisations for food-producing species23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Refusal of a marketing authorisation24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Publication following the grant of a marketing authorisation25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Marketing authorisations in exceptional circumstances26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Provisions of samples and expertise27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of information28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Duties on the holder of a marketing authorisation relating to an immunological product29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Control tests30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Placing on the market31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Duration and validity of a marketing authorisation32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 4Variations of marketing authorisations on the application of the holderVariation of a marketing authorisation33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Refusal of a variation of a marketing authorisation34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administrative variations35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Changes after a marketing authorisation has been issued36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Compulsory variation37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 5Suspension, <Abbreviation Expansion="et cetera" xml:lang="la">etc.</Abbreviation> of a marketing authorisationSuspension of a marketing authorisation: grounds38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Suspension of a marketing authorisation: procedure39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Revocation40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Prohibiting the supply of veterinary medicinal products41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 6Mutual recognition and multiple applicationsApplication for a marketing authorisation where one already exists in another member State42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application in another Member State43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a marketing authorisation in multiple Member States where a marketing authorisation does not exist in any member State44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 7Labelling and package leafletsApproval by the Secretary of State45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Reference to being authorised46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Language47. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling with all the information on the immediate packaging48. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Products with immediate and outer packaging49. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Package leaflets50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Ampoules51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Small containers other than ampoules52. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Homeopathic remedies53. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Variations54. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 8PharmacovigilanceQualified persons responsible for pharmacovigilance55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Duties relating to the qualified person56. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Adverse reactions to a veterinary medicinal product administered in the United Kingdom57. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Adverse reactions to a veterinary medicinal product administered in a third country58. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Periodic safety update reports59. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Release of information by the marketing authorisation holder60. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Action taken on account of pharmacovigilance61. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 9Homeopathic remediesMeaning of “homeopathic remedy”62. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Placing a homeopathic remedy on the market in accordance with a registration63. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for registration64. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Procedure for registration65. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Products on the market before 199466. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Classification67. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SCHEDULE 2The manufacture of veterinary medicinal productsRegulation 5(2)PART 1Manufacturing authorisationsApplication1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Time limits2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Granting the authorisation3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .The authorisation4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Suspension, variation or revocation of the authorisation5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of premises6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Report following inspection7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Duties on the holder of a manufacturing authorisation8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Qualified persons for manufacture9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Refusal or revocation of appointment10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Duties on a qualified person11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Register12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Test sites13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 2Authorisation of manufacturers of autogenous vaccinesAuthorisation to manufacture autogenous vaccines14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Types of authorisation15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Records17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Adverse reactions18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of premises19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 3Authorisation of blood banksAuthorisation of blood banks20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply and administration of blood from a blood bank21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Records23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of premises24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 4Authorisation of manufacturers of products for administration under the cascadeAuthorisation to manufacture products for administration under the cascade25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Records27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Adverse reactions28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of premises29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 5Authorisation of equine stem cell centresAuthorisation of stem cell centres30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply and administration of stem cells31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Records33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of premises34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SCHEDULE 3Classification and supply, wholesale dealers and sheep dipRegulation 7PART 1Classification and supply of authorised veterinary medicinal productsClassification of veterinary medicinal products1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Wholesale supply of veterinary medicinal products2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Retail supply of veterinary medicinal products3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Prescriptions by a veterinary surgeon4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Prescriptions5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Written prescriptions6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Duties when a product is prescribed or supplied7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply by a veterinary surgeon from registered premises8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply by a veterinary surgeon9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply by a pharmacist10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of a veterinary medicinal product for incorporation into feedingstuffs11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling at the time of retail supply12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of veterinary medicinal products for use under the cascade13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply by a suitably qualified person14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Annual audit15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 2Requirements for a wholesale dealer’s authorisationApplication16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Time limits17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Granting the authorisation18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .The authorisation19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Suspension, variation or revocation of the authorisation20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Duties on the holder of a wholesale dealer’s authorisation21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 3Sheep dipSupply of sheep dip22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Use of sheep dip23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SCHEDULE 4Administration of a veterinary medicinal product outside the terms of a marketing authorisationRegulation 8Administration under the cascade1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Withdrawal periods2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administration to food-producing horses3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Immunological products for serious epizootic disease4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Immunological products for an imported or exported animal5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administration by veterinary surgeons from other Member States6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Treatment in exceptional circumstances7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administration of a homeopathic remedy8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administration under an animal test certificate9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SCHEDULE 5Medicated feedingstuffs and specified feed additivesRegulation 14Scope and interpretation1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Enforcement of Regulation <Citation URI="http://www.legislation.gov.uk/european/regulation/2002/0178" id="c00052" Year="2002" Number="0178" Class="EuropeanUnionRegulation">(EC) No 178/2002</Citation>2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Enforcement of Regulation <Citation URI="http://www.legislation.gov.uk/european/regulation/2003/1831" id="c00054" Year="2003" Number="1831" Class="EuropeanUnionRegulation">(EC) No 1831/2003</Citation>3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Enforcement of Regulation <Citation URI="http://www.legislation.gov.uk/european/regulation/2004/0882" id="c00057" Year="2004" Number="0882" Class="EuropeanUnionRegulation">(EC) No 882/2004</Citation>4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Enforcement of Regulation <Citation URI="http://www.legislation.gov.uk/european/regulation/2005/0183" id="c00059" Year="2005" Number="0183" Class="EuropeanUnionRegulation">(EC) No 183/2005</Citation>5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Enforcement of Regulation <Citation URI="http://www.legislation.gov.uk/european/regulation/2009/0767" id="c00061" Year="2009" Number="0767" Class="EuropeanUnionRegulation">(EC) No 767/2009</Citation>6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Incorporation of a veterinary medicinal product into a premixture8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Top dressing9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Incorporation of a veterinary medicinal product into feedingstuffs10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Additional record keeping requirements relating to veterinary medicinal products11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling a premixture containing a veterinary medicinal product12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling of feedingstuffs containing a specified feed additive13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling of feedingstuffs containing a veterinary medicinal product14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of specified feed additives15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of premixture16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of a complementary feedingstuff17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Supply of feedingstuffs containing a veterinary medicinal product18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Prescriptions for feedingstuffs containing a veterinary medicinal product19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Writing the prescription20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Possession21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Sampling and analysis22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Storage23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Packages and other containers24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Transport25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Possession, placing on the market and use of feedingstuffs26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Imports from third countries27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Trade between Member States28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Import for incorporation into premixture or feedingstuffs for export29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Animals on domestic premises30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SCHEDULE 6Exemptions for small pet animalsRegulation 15(4)Animals to which this Schedule applies1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Placing on the market, importing and administering the product2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Manufacture3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Approval of the active substance4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .The product5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Labelling6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Administration7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pack size8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Adverse reactions9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SCHEDULE 7FeesRegulation 16PART 1IntroductionInterpretation1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Payment of fees2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Time of payment3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Multiple inspections4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Expenses for inspections outside the United Kingdom5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Translation6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 2Fees relating to marketing authorisationsFees for specified pharmaceutical applications7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Decentralised pharmaceutical application where the United Kingdom is the reference Member State8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a marketing authorisation for an immunological product9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Decentralised immunological application where the United Kingdom is the reference Member State10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a marketing authorisation using identical data11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for an exceptional marketing authorisation (pharmaceutical)12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Fees for an application for an exceptional marketing authorisation (immunological)13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Fee for the conversion from an exceptional to a full marketing authorisation14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a marketing authorisation relating to a parallel import15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application to change the distribution category of a product authorised through the centralised procedure16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a variation to a marketing authorisation dealt with under national or mutual recognition variation procedures.17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a variation to a marketing authorisation dealt with under worksharing procedures18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference Member State19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Exception for a variation relating to animal testing21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for the renewal of a national marketing authorisation22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Registration of a homeopathic remedy24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Annual fees for marketing authorisations25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Auditor’s certificate26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 3Fees payable by manufacturersApplication for a manufacturing authorisation27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for a variation of a manufacturing authorisation28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Annual fees30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Site inspections – type of site31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of a site where immunological veterinary medicinal products are manufactured32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of a site where sterile veterinary medicinal products are manufactured33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of a site where veterinary medicinal products are assembled35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Test sites36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Animal blood bank or equine stem cell centre authorisations37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 4Fees relating to a wholesale dealer’s authorisationApplication for a wholesale dealer’s authorisation38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Variation of a wholesale dealer’s authorisation39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Annual fee for a wholesale dealer’s authorisation40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Inspection of a wholesale dealer’s premises41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 5Fees relating to feedingstuffsFees relating to feedingstuffs42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Fees relating to premises for supply by suitably qualified persons43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Reduced fees44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PART 6GeneralTesting samples45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Animal test certificates46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Importation of a veterinary medicinal product for treatment under the cascade47. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 198648. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Wholesale dealer’s import certificate49. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Specific batch control50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Submission of control tests of an immunological product51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Export certificates52. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Provision of advice53. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates54. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Appeals to the Veterinary Products Committee: variations55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Appeal to the Veterinary Products Committee: suspensions56. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Appeal to the Veterinary Products Committee: active substance under Schedule 657. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Fee relating to an appointed person58. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Fees relating to a veterinary surgeon’s practice premises59. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Refund of fees relating to the Veterinary Products Committee or appointed persons60. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Fees relating to an improvement notice61. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Non-payment of fees62. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Waiver or reduction of fees63. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Reduction of fees when an application is withdrawn64. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . <CommentaryRef Ref="key-f7d07e050938f4c588a67c6643bc345c"/>EXPLANATORY NOTE(This note is not part of the Regulations)

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2009.

<CommentaryRef Ref="key-f7d07e050938f4c588a67c6643bc345c"/>Principal changes to the 2009 Regulations:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A full impact assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available, together with a transposition note and a table showing fee changes, on www.vmd.defra.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”.

 Regulations revoked (1.10.2013) by The Veterinary Medicines Regulations 2013 (S.I. 2013/2033), regs. 1, 47(a) (with reg. 3)