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

http://www.legislation.gov.uk/uksi/2011/2159The Veterinary Medicines Regulations 2011 (revoked)MedicinesEuropean ParliamentEuropean UnionAnimal healthAnimal experimentationenMEDICINESStatute Law DatabaseExpert Participation2024-05-20Expert Participation2013-10-01These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2009.Statutory Instruments2011 No. 2159MedicinesThe Veterinary Medicines Regulations 2011 (revoked)Made25th August 2011Laid before Parliament7th September 2011Coming into force1st October 2011

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PART 1IntroductionTitle and commencement1.

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Definition of “veterinary medicinal product”, interpretation and scope2.

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Products to which these Regulations do not apply3.

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PART 2Authorised veterinary medicinal productsPlacing a veterinary medicinal product on the market4.

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Manufacture of veterinary medicinal products5.

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The finished product6.

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Classification, supply and possession of the product7.

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Administration of the product8.

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Importation of authorised veterinary medicinal products9.

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Advertising the product10.

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Advertising of prescription products and products containing psychotropic drugs or narcotics11.

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Defence of publication in the course of business12.

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Wholesale dealing13.

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Feedingstuffs14.

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Exemptions15.

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Fees16.

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PART 3RecordsFood-producing animals: proof of purchase of veterinary medicinal products17.

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Food-producing animals: records of administration by a veterinary surgeon18.

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Food-producing animals: records of acquisition and administration19.

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Food-producing animals: retention of records20.

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Records by a holder of a manufacturing authorisation21.

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Records by a holder of a wholesale dealer’s authorisation22.

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Records of the receipt or supply of prescription products23.

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Records of products administered to a food-producing animal under the cascade24.

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PART 4Unauthorised veterinary medicinal productsImportation of an unauthorised veterinary medicinal product25.

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Possession of an unauthorised veterinary medicinal product26.

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Supply of an unauthorised veterinary medicinal product27.

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PART 5Miscellaneous provisions, enforcement and offencesThe Veterinary Products Committee28.

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Veterinary Products Committee appeals procedure29.

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Appeals to an appointed person30.

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Exports31.

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Time limits32.

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Appointment of inspectors33.

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Powers of entry34.

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Powers of an inspector35.

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Inspection of pharmacies36.

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Obstruction37.

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Improvement notices38.

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Appeals against improvement notices39.

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Powers of a court on appeal40.

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Seizure notices41.

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Publication42.

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Penalties43.

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Northern Ireland44.

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Review45.

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Revocations46.

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SCHEDULE 1

Regulation 4(3)

Marketing authorisationsPART 1Application for a marketing authorisationApplication for a marketing authorisation1.

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Information with the application2.

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Summary of product characteristics3.

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Supply of a copy of the summary of product characteristics4.

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Time limits for applications for products for use in food-producing animals5.

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PART 2Derogations from some of the requirements in Part 1Scope6.

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Bibliographic application7.

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Application for a product using a new combination of active substances8.

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Application using existing data9.

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Application for a pharmacologically equivalent medicinal product10.

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Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product11.

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Extension of time limits12.

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Parallel imports13.

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Specific batch control scheme14.

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Similar immunological products15.

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Marketing a product authorised in another country16.

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PART 3Grant of a marketing authorisationTime limits17.

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Place of establishment of applicant18.

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Procedure19.

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Products authorised in another Member State20.

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Assessment reports21.

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Grant of a marketing authorisation22.

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Marketing authorisations for food-producing species23.

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Refusal of a marketing authorisation24.

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Publication following the grant of a marketing authorisation25.

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Marketing authorisations in exceptional circumstances26.

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Provisions of samples and expertise27.

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Supply of information28.

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Duties on the holder of a marketing authorisation relating to an immunological product29.

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Control tests30.

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Placing on the market31.

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Duration and validity of a marketing authorisation32.

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PART 4Variations of marketing authorisations on the application of the holderVariation of a marketing authorisation33.

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Refusal of a variation of a marketing authorisation34.

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Administrative variations35.

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Changes after a marketing authorisation has been issued36.

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Compulsory variation37.

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PART 5Suspension, etc. of a marketing authorisationSuspension of a marketing authorisation: grounds38.

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Suspension of a marketing authorisation: procedure39.

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Revocation40.

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Prohibiting the supply of veterinary medicinal products41.

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PART 6Mutual recognition and multiple applicationsApplication for a marketing authorisation where one already exists in another member State42.

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Application in another Member State43.

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Application for a marketing authorisation in multiple Member States where a marketing authorisation does not exist in any member State44.

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PART 7Labelling and package leafletsApproval by the Secretary of State45.

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Reference to being authorised46.

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Language47.

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Labelling with all the information on the immediate packaging48.

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Products with immediate and outer packaging49.

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Package leaflets50.

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Ampoules51.

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Small containers other than ampoules52.

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Homeopathic remedies53.

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Variations54.

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PART 8PharmacovigilanceQualified persons responsible for pharmacovigilance55.

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Duties relating to the qualified person56.

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Adverse reactions to a veterinary medicinal product administered in the United Kingdom57.

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Adverse reactions to a veterinary medicinal product administered in a third country58.

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Periodic safety update reports59.

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Release of information by the marketing authorisation holder60.

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Action taken on account of pharmacovigilance61.

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PART 9Homeopathic remediesMeaning of “homeopathic remedy”62.

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Placing a homeopathic remedy on the market in accordance with a registration63.

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Application for registration64.

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Procedure for registration65.

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Products on the market before 199466.

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Classification67.

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SCHEDULE 2

Regulation 5(2)

The manufacture of veterinary medicinal productsPART 1Manufacturing authorisationsApplication1.

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Time limits2.

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Granting the authorisation3.

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The authorisation4.

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Suspension, variation or revocation of the authorisation5.

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Inspection of premises6.

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Report following inspection7.

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Duties on the holder of a manufacturing authorisation8.

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Qualified persons for manufacture9.

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Refusal or revocation of appointment10.

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Duties on a qualified person11.

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Register12.

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Test sites13.

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PART 2Authorisation of manufacturers of autogenous vaccinesAuthorisation to manufacture autogenous vaccines14.

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Types of authorisation15.

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Labelling16.

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Records17.

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Adverse reactions18.

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Inspection of premises19.

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PART 3Authorisation of blood banksAuthorisation of blood banks20.

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Supply and administration of blood from a blood bank21.

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Labelling22.

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Records23.

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Inspection of premises24.

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PART 4Authorisation of manufacturers of products for administration under the cascadeAuthorisation to manufacture products for administration under the cascade25.

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Labelling26.

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Records27.

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Adverse reactions28.

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Inspection of premises29.

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PART 5Authorisation of equine stem cell centresAuthorisation of stem cell centres30.

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Supply and administration of stem cells31.

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Labelling32.

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Records33.

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Inspection of premises34.

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SCHEDULE 3

Regulation 7

Classification and supply, wholesale dealers and sheep dipPART 1Classification and supply of authorised veterinary medicinal productsClassification of veterinary medicinal products1.

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Wholesale supply of veterinary medicinal products2.

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Retail supply of veterinary medicinal products3.

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Prescriptions by a veterinary surgeon4.

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Prescriptions5.

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Written prescriptions6.

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Duties when a product is prescribed or supplied7.

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Supply by a veterinary surgeon from registered premises8.

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Supply by a veterinary surgeon9.

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Supply by a pharmacist10.

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Supply of a veterinary medicinal product for incorporation into feedingstuffs11.

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Labelling at the time of retail supply12.

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Supply of veterinary medicinal products for use under the cascade13.

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Supply by a suitably qualified person14.

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Annual audit15.

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PART 2Requirements for a wholesale dealer’s authorisationApplication16.

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Time limits17.

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Granting the authorisation18.

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The authorisation19.

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Suspension, variation or revocation of the authorisation20.

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Duties on the holder of a wholesale dealer’s authorisation21.

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PART 3Sheep dipSupply of sheep dip22.

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Use of sheep dip23.

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SCHEDULE 4

Regulation 8

Administration of a veterinary medicinal product outside the terms of a marketing authorisationAdministration under the cascade1.

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Withdrawal periods2.

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Administration to food-producing horses3.

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Immunological products for serious epizootic disease4.

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Immunological products for an imported or exported animal5.

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Administration by veterinary surgeons from other Member States6.

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Treatment in exceptional circumstances7.

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Administration of a homeopathic remedy8.

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Administration under an animal test certificate9.

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SCHEDULE 5

Regulation 14

Medicated feedingstuffs and specified feed additivesScope and interpretation1.

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Enforcement of Regulation (EC) No 178/20022.

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Enforcement of Regulation (EC) No 1831/20033.

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Enforcement of Regulation (EC) No 882/20044.

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Enforcement of Regulation (EC) No 183/20055.

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Enforcement of Regulation (EC) No 767/20096.

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Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products7.

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Incorporation of a veterinary medicinal product into a premixture8.

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Top dressing9.

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Incorporation of a veterinary medicinal product into feedingstuffs10.

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Additional record keeping requirements relating to veterinary medicinal products11.

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Labelling a premixture containing a veterinary medicinal product12.

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Labelling of feedingstuffs containing a specified feed additive13.

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Labelling of feedingstuffs containing a veterinary medicinal product14.

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Supply of specified feed additives15.

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Supply of premixture16.

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Supply of a complementary feedingstuff17.

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Supply of feedingstuffs containing a veterinary medicinal product18.

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Prescriptions for feedingstuffs containing a veterinary medicinal product19.

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Writing the prescription20.

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Possession21.

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Sampling and analysis22.

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Storage23.

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Packages and other containers24.

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Transport25.

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Possession, placing on the market and use of feedingstuffs26.

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Imports from third countries27.

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Trade between Member States28.

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Import for incorporation into premixture or feedingstuffs for export29.

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Animals on domestic premises30.

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SCHEDULE 6

Regulation 15(4)

Exemptions for small pet animalsAnimals to which this Schedule applies1.

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Placing on the market, importing and administering the product2.

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Manufacture3.

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Approval of the active substance4.

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The product5.

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Labelling6.

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Administration7.

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Pack size8.

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Adverse reactions9.

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SCHEDULE 7

Regulation 16

FeesPART 1IntroductionInterpretation1.

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Payment of fees2.

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Time of payment3.

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Multiple inspections4.

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Expenses for inspections outside the United Kingdom5.

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Translation6.

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PART 2Fees relating to marketing authorisationsFees for specified pharmaceutical applications7.

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Decentralised pharmaceutical application where the United Kingdom is the reference Member State8.

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Application for a marketing authorisation for an immunological product9.

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Decentralised immunological application where the United Kingdom is the reference Member State10.

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Application for a marketing authorisation using identical data11.

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Application for an exceptional marketing authorisation (pharmaceutical)12.

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Fees for an application for an exceptional marketing authorisation (immunological)13.

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Fee for the conversion from an exceptional to a full marketing authorisation14.

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Application for a marketing authorisation relating to a parallel import15.

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Application to change the distribution category of a product authorised through the centralised procedure16.

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Application for a variation to a marketing authorisation dealt with under national or mutual recognition variation procedures.17.

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Application for a variation to a marketing authorisation dealt with under worksharing procedures18.

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Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference Member State19.

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Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension20.

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Exception for a variation relating to animal testing21.

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Application for the renewal of a national marketing authorisation22.

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Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure23.

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Registration of a homeopathic remedy24.

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Annual fees for marketing authorisations25.

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Auditor’s certificate26.

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PART 3Fees payable by manufacturersApplication for a manufacturing authorisation27.

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Application for a variation of a manufacturing authorisation28.

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Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade29.

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Annual fees30.

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Site inspections – type of site31.

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Inspection of a site where immunological veterinary medicinal products are manufactured32.

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Inspection of a site where sterile veterinary medicinal products are manufactured33.

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Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured34.

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Inspection of a site where veterinary medicinal products are assembled35.

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Test sites36.

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Animal blood bank or equine stem cell centre authorisations37.

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PART 4Fees relating to a wholesale dealer’s authorisationApplication for a wholesale dealer’s authorisation38.

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Variation of a wholesale dealer’s authorisation39.

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Annual fee for a wholesale dealer’s authorisation40.

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Inspection of a wholesale dealer’s premises41.

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PART 5Fees relating to feedingstuffsFees relating to feedingstuffs42.

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Fees relating to premises for supply by suitably qualified persons43.

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Reduced fees44.

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PART 6GeneralTesting samples45.

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Animal test certificates46.

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Importation of a veterinary medicinal product for treatment under the cascade47.

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Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 198648.

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Wholesale dealer’s import certificate49.

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Specific batch control50.

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Submission of control tests of an immunological product51.

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Export certificates52.

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Provision of advice53.

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Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates54.

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Appeals to the Veterinary Products Committee: variations55.

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Appeal to the Veterinary Products Committee: suspensions56.

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Appeal to the Veterinary Products Committee: active substance under Schedule 657.

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Fee relating to an appointed person58.

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Fees relating to a veterinary surgeon’s practice premises59.

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Refund of fees relating to the Veterinary Products Committee or appointed persons60.

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Fees relating to an improvement notice61.

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Non-payment of fees62.

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Waiver or reduction of fees63.

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Reduction of fees when an application is withdrawn64.

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EXPLANATORY NOTE(This note is not part of the Regulations)

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

Principal changes to the 2009 Regulations:

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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”.