2008 No. 2297

Medicines

F1The Veterinary Medicines Regulations 2008

Made

Laid before Parliament

Coming into force

The Secretary of State is a Minister designated1 for the purposes of making Regulations under section 2(2) of the European Communities Act 19722 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 of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety3.

In accordance with section 56(1) of the Finance Act 19734, the Treasury consent to the making of these Regulations.

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:
Amendments (Textual)
F1

Regulations revoked (except reg. 45(2)) (1.10.2009) by The Veterinary Medicines Regulations 2009 (S.I. 2009/2297), regs. 1, 45 (with reg. 3)

F1PART 1Introduction

Title and commencementF11

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Definition of “veterinary medicinal product”, interpretation and scopeF12

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Products to which these Regulations do not applyF13

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F1PART 2Authorised veterinary medicinal products

Placing a veterinary medicinal product on the marketF14

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Manufacture of veterinary medicinal productsF15

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The finished productF16

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Classification, supply and possession of the productF17

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Administration of the productF18

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Importation of authorised veterinary medicinal productsF19

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Advertising the productF110

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Advertising of prescription products and products containing psychotropic drugs or narcoticsF111

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Defence of publication in the course of businessF112

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Wholesale dealingF113

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FeedingstuffsF114

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ExemptionsF115

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FeesF116

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F1PART 3Records

Food-producing animals: proof of purchase of veterinary medicinal productsF117

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Food-producing animals: records of administration by a veterinary surgeonF118

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Food-producing animals: records of acquisition and administrationF119

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Food-producing animals: retention of recordsF120

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Records by a holder of a manufacturing authorisationF121

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Records by a holder of a wholesale dealer’s authorisationF122

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Records of the receipt or supply of prescription productsF123

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Records of products administered to a food-producing animal under the cascadeF124

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F1PART 4Unauthorised veterinary medicinal products

Importation of an unauthorised veterinary medicinal productF125

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Possession of an unauthorised veterinary medicinal productF126

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Supply of an unauthorised veterinary medicinal productF127

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PART 5Miscellaneous provisions, enforcement and offences

The Veterinary Products CommitteeF128

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Veterinary Products Committee appeals procedureF129

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Appeals to an appointed personF130

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ExportsF131

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Time limitsF132

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Appointment of inspectorsF133

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Powers of entryF134

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Powers of an inspectorF135

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Inspection of pharmaciesF136

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ObstructionF137

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Improvement noticesF138

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Appeals against improvement noticesF139

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Powers of a court on appealF140

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Seizure noticesF141

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PublicationF142

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PenaltiesF143

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Northern IrelandF144

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Revocations and consequential amendment45

F11

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2

In section 1 of the Medicines Act 197122 (fees), in subsection (3), for “as amended by the Transfer of Functions (Wales) Order 1969 have the same meanings in this section as in that Act as so amended” substitute “(as amended) have the same meanings in this section as in that Act (as amended)”.

Jonathan ShawParliamentary Under Secretary of StateDepartment for Environment, Food and Rural Affairs
Dave WattsAlan CampbellTwo of the Lords Commissioners of Her Majesty’s Treasury

F1SCHEDULE 1Marketing authorisations

Regulation 4(3)

F1PART 1Application for a marketing authorisation

Application for a marketing authorisationF11

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Information with the applicationF12

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Summary of product characteristicsF13

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Supply of a copy of the summary of product characteristicsF14

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Time limits for applications for products for use in food-producing animalsF15

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F1PART 2Derogations from some of the requirements in Part 1

ScopeF16

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Bibliographic applicationF17

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Application for a product using a new combination of active substancesF18

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Application using existing dataF19

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Application for a pharmacologically equivalent medicinal productF110

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Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent productF111

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Extension of time limitsF112

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Parallel importsF113

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Specific batch control schemeF114

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Similar immunological productsF115

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Marketing in exceptional circumstancesF116

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F1PART 3Grant of a marketing authorisation

Time limitsF117

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Place of establishment of applicantF118

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ProcedureF119

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Products authorised in another member StateF120

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Assessment reportsF121

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Grant of a marketing authorisationF122

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Marketing authorisations for food-producing speciesF123

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Refusal of a marketing authorisationF124

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Publication following the grant of a marketing authorisationF125

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Provisional marketing authorisationF126

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Provisions of samples and expertiseF127

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Supply of informationF128

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Duties on the holder of a marketing authorisation relating to an immunological productF129

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Control testsF130

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Placing on the marketF131

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Duration and validity of a marketing authorisationF132

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F1PART 4Variations of marketing authorisations on the application of the holder

Variation of a marketing authorisation for a mutually recognised veterinary medicinal productF133

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Variation of a marketing authorisation not authorised in another member StateF134

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Administrative variationsF135

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Changes after a marketing authorisation has been issuedF136

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Compulsory variationF137

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F1PART 5Suspension, etc. of a marketing authorisation

Suspension of a marketing authorisation: groundsF138

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Suspension of a marketing authorisation: procedureF139

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RevocationF140

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Prohibiting the supply of veterinary medicinal productsF141

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F1PART 6Mutual recognition and multiple applications

Application for a marketing authorisation where one already exists in another member StateF142

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Application in another member StateF143

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Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member StateF144

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F1PART 7Labelling and package leaflets

Approval by the Secretary of StateF145

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Reference to being authorisedF146

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LanguageF147

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Labelling with all the information on the immediate packagingF148

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Products with immediate and outer packagingF149

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Package leafletsF150

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AmpoulesF151

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Small containers other than ampoulesF152

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Homeopathic remediesF153

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VariationsF154

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F1PART 8Pharmacovigilance

Qualified persons responsible for pharmacovigilanceF155

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Duties relating to the qualified personF156

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Adverse reactions to a veterinary medicinal product administered in the United KingdomF157

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Adverse reactions to a veterinary medicinal product administered in a third countryF158

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Periodic safety update reportsF159

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Release of information by the marketing authorisation holderF160

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Action taken on account of pharmacovigilanceF161

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F1PART 9Homeopathic remedies

Meaning of “homeopathic remedy”F162

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Placing a homeopathic remedy on the market in accordance with a registrationF163

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Application for registrationF164

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Procedure for registrationF165

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Products on the market before 1994F166

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ClassificationF167

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F1SCHEDULE 2The manufacture of veterinary medicinal products

Regulation 5(2)

F1PART 1Manufacturing authorisations

ApplicationF11

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Time limitsF12

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Granting the authorisationF13

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The authorisationF14

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Suspension, variation or revocation of the authorisationF15

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Inspection of premisesF16

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Report following inspectionF17

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Duties on the holder of a manufacturing authorisationF18

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Qualified persons for manufactureF19

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Refusal or revocation of appointmentF110

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Duties on a qualified personF111

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RegisterF112

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Test sitesF113

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F1PART 2Authorisation of manufacturers of autogenous vaccines

Authorisation to manufacture autogenous vaccinesF114

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Types of authorisationF115

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LabellingF116

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RecordsF117

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Adverse reactionsF118

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Inspection of premisesF119

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F1PART 3Authorisation of blood banks

Authorisation of blood banksF120

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Supply and administration of blood from a blood bankF121

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LabellingF122

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RecordsF123

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Inspection of blood banksF124

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F1PART 4Authorisation of manufacturers of products for administration under the cascade

Authorisation to manufacture products for administration under the cascadeF125

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LabellingF126

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RecordsF127

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Adverse reactionsF128

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Inspection of premisesF129

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F1PART 5Authorisation of equine stem cell centres

Authorisation of stem cell centresF130

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Supply and administration of stem cellsF131

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LabellingF132

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RecordsF133

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Inspection of equine stem cell centresF134

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F1SCHEDULE 3Classification and supply, wholesale dealers and sheep dip

Regulation 7

F1PART 1Classification and supply of authorised veterinary medicinal products

Classification of veterinary medicinal productsF11

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Wholesale supply of veterinary medicinal productsF12

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Retail supply of veterinary medicinal productsF13

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Prescriptions by a veterinary surgeonF14

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PrescriptionsF15

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Written prescriptionsF16

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Duties when a product is prescribed or suppliedF17

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Supply by a veterinary surgeon from registered practice premisesF18

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Supply by a veterinary surgeonF19

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Supply by a pharmacistF110

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Supply of a veterinary medicinal product for incorporation into feedingstuffsF111

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Labelling at the time of retail supplyF112

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Supply of veterinary medicinal products for use under the cascadeF113

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Supply by a suitably qualified personF114

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Annual auditF115

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F1PART 2Requirements for a wholesale dealer’s authorisation

ApplicationF116

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Time limitsF117

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Granting the authorisationF118

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The authorisationF119

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Suspension, variation or revocation of the authorisationF120

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Duties on the holder of a wholesale dealer’s authorisationF121

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F1PART 3Sheep dip

Supply of sheep dipF122

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Use of sheep dipF123

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

F1SCHEDULE 4Administration of a veterinary medicinal product outside the terms of a marketing authorisation

Regulation 8

Administration under the cascadeF11

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

Withdrawal periodsF12

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

Administration to food-producing horsesF13

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

Immunological products for serious epizootic diseaseF14

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

Immunological products for an imported or exported animalF15

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

Administration by veterinary surgeons from other member StatesF16

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

Treatment in exceptional circumstancesF17

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

Administration of a homeopathic remedyF18

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

Administration under an animal test certificateF19

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

F1SCHEDULE 5Medicated feedingstuffs and specified feed additives

Regulation 14

Scope and interpretationF11

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

Enforcement of Regulation (EC) No. 178/2002F12

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

Enforcement of Regulation (EC) No. 1831/2003F13

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

Enforcement of Regulation (EC) No. 882/2004F14

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

Enforcement of Regulation (EC) No. 183/2005F15

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

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal productsF16

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

Incorporation of a veterinary medicinal product into a premixtureF17

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

Incorporation of a veterinary medicinal product into feedingstuffsF18

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

Additional record keeping requirements relating to veterinary medicinal productsF19

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

Labelling a premixture containing a veterinary medicinal productF110

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

Labelling of feedingstuffs containing a specified feed additiveF111

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

Labelling of feedingstuffs containing a veterinary medicinal productF112

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

Supply of specified feed additivesF113

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

Supply of premixtureF114

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

Supply of feedingstuffs containing a veterinary medicinal productF115

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

Prescriptions for feedingstuffs containing a veterinary medicinal productF116

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

Writing the prescriptionF117

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

PossessionF118

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

Sampling and analysisF119

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

StorageF120

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

Packages and other containersF121

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

TransportF122

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

Possession, placing on the market and use of feedingstuffsF123

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

Imports from third countriesF124

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

Trade between member StatesF125

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

Import for incorporation into premixture or feedingstuffs for exportF126

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

Animals on domestic premisesF127

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

F1SCHEDULE 6Exemptions for small pet animals

Regulation 15(4)

Animals to which this Schedule appliesF11

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

Placing on the market, importing and administering the productF12

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

ManufactureF13

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

Approval of the active substanceF14

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

The productF15

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

LabellingF16

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

AdministrationF17

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

Pack sizeF18

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

Adverse reactionsF19

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

F1SCHEDULE 7Fees

Regulation 16

F1PART 1Introduction

InterpretationF11

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

Payment of feesF12

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

Time of paymentF13

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

Multiple inspectionsF14

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

Expenses for inspectionsF15

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

TranslationF16

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

F1PART 2Fees relating to marketing authorisations

Fees for specified pharmaceutical applicationsF17

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

Decentralised pharmaceutical application where the United Kingdom is the reference member StateF18

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

Application for a marketing authorisation for an immunological productF19

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

Decentralised immunological application where the United Kingdom is the reference member StateF110

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

Application for a marketing authorisation using identical dataF111

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

Application for a provisional marketing authorisation (pharmaceutical)F112

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

Fees for an application for a provisional marketing authorisation (immunological)F113

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

Fee for the conversion from a provisional to a full marketing authorisationF114

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

Application for a marketing authorisation relating to a parallel importF115

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

Application for a variationF116

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

Application for a variation to a marketing authorisation that has been issued in other member StatesF117

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

Application for an extension to a marketing authorisationF118

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

Decentralised application for an extension where the United Kingdom is the reference member StateF119

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

Provision of information relating to the recognition of a United Kingdom marketing authorisationF120

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

Application for the renewal of a national marketing authorisationF121

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

Application for the renewal of a marketing authorisation granted in more than one member StateF122

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

Registration of a homeopathic remedyF123

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

Annual fees for marketing authorisationsF124

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

Auditor’s certificateF125

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

Late payment of annual feesF126

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

F1PART 3Fees payable by manufacturers

Application for a manufacturing authorisationF127

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

Application for a variation of a manufacturing authorisationF128

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

Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascadeF129

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

Annual feesF130

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

Site inspections – type of siteF131

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

Inspection of a site where immunological veterinary medicinal products are manufacturedF132

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

Inspection of a site where sterile veterinary medicinal products are manufacturedF133

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

Inspection of a site where no immunological or sterile veterinary medicinal products are manufacturedF134

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

Inspection of a site where veterinary medicinal products are assembledF135

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

Test sitesF136

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

Animal blood bank or equine stem cell centre authorisationsF137

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

F1PART 4Fees relating to a wholesale dealer’s authorisation

Application for a wholesale dealer’s authorisationF138

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

Variation of a wholesale dealer’s authorisationF139

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

Annual fee for a wholesale dealer’s authorisationF140

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

Inspection of a wholesale dealer’s premisesF141

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

F1PART 5Fees relating to feedingstuffs

Fees relating to feedingstuffsF142

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

Fees relating to premises for supply by suitably qualified personsF143

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

Reduced feesF144

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

F1PART 6General

Testing samplesF145

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

Animal test certificatesF146

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

Treatment under the cascadeF147

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

Treatment under the Animals (Scientific Procedures) Act 1986F148

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

Treatment in exceptional circumstancesF149

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

Specific batch controlF150

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

Submission of control tests of an immunological productF151

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

Export certificatesF152

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

Appeals to the Veterinary Products Committee: marketing authorisations and ATCsF153

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

Appeals to the Veterinary Products Committee: variationsF154

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

Appeal to the Veterinary Products Committee: suspensionsF155

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

Appeal to the Veterinary Products Committee: active substance under Schedule 6F156

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

Fee relating to an appointed personF157

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

Fee for the inspection of a veterinary surgeon’s practice premisesF158

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

Fee for the registration of veterinary practice premises58A

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

Refund of fees relating to the Veterinary Products Committee or appointed personsF159

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

Fees relating to an improvement noticeF160

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

Non-payment of feesF161

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

Waiver or reduction of feesF162

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

Reduction of fees when an application is withdrawnF163

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

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2007.

Principal changes to the 2007 Regulations

The new Regulations introduce a fee for the registration of veterinary premises for the supply of veterinary medicinal products.

They provide comprehensive rights of appeal to an appointed person when applications for the authorisation or approval of manufacture or retail premises are refused.

They introduce new controls on the collection and supply of equine stem cells.

They introduce compulsory variations by the Secretary of State for manufacturers and wholesale dealers.

They allow suitably qualified persons to supply veterinary medicines to retail customers from pharmacies or registered veterinary premises without dual registration.

They introduce record-keeping requirements in relation to adverse reactions to products marketed under the small animals exemption scheme.

They update fees.

They have been changed so that the drafting is now gender-neutral.

They make an amendment to the Medicines Act 1971 arising from veterinary medicinal products no longer being licensed under the Medicines Act 1968.

The Regulations

The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products.

They implement Directive 2001/82/EC.

They enforce Regulations (EC) No. 178/2002, No. 1831/2003, No. 882/2004 No. 183/2005, in so far as they apply to veterinary medicinal products used in feedingstuffs, and to some specified feed additives used in feedingstuffs.

They implement Council Directive 90/167 so far it is not superseded by Regulation (EC) No. 183/2005.

They provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1).

They specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2).

They regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3).

They provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the rules of the “cascade” (regulation 8 and Schedule 4).

They control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12).

They control wholesale dealing (regulation 13 and Schedule 3).

They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5).

They provide for exemptions (regulation 15 and Schedule 6).

They provide for fees (regulation 16 and Schedule 7).

They require records to be kept (regulations 17 to 24).

They create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27).

They make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for an appeals procedure in the case of a refusal, etc., of a marketing authorisation (regulation 29).

They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41).

Under regulation 43 breach of the Regulations is an offence punishable—

a

on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or

b

on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.

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.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”.