2011 No. 2159
Medicines
The Veterinary Medicines Regulations 2011 (revoked)
Regulations revoked (1.10.2013) by The Veterinary Medicines Regulations 2013 (S.I. 2013/2033), regs. 1, 47(a) (with reg. 3)
Made 25th August 2011
Laid before Parliament 7th September 2011
Coming into force 1st October 2011

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PART 1 Introduction

1 Title and commencement
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2 Definition of “veterinary medicinal product”, interpretation and scope
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3 Products to which these Regulations do not apply
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PART 2 Authorised veterinary medicinal products

4 Placing a veterinary medicinal product on the market
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5 Manufacture of veterinary medicinal products
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6 The finished product
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7 Classification, supply and possession of the product
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8 Administration of the product
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9 Importation of authorised veterinary medicinal products
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10 Advertising the product
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11 Advertising of prescription products and products containing psychotropic drugs or narcotics
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12 Defence of publication in the course of business
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13 Wholesale dealing
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14 Feedingstuffs
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15 Exemptions
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16 Fees
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PART 3 Records

17 Food-producing animals: proof of purchase of veterinary medicinal products
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18 Food-producing animals: records of administration by a veterinary surgeon
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19 Food-producing animals: records of acquisition and administration
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20 Food-producing animals: retention of records
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21 Records by a holder of a manufacturing authorisation
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22 Records by a holder of a wholesale dealer’s authorisation
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23 Records of the receipt or supply of prescription products
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24 Records of products administered to a food-producing animal under the cascade
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PART 4 Unauthorised veterinary medicinal products

25 Importation of an unauthorised veterinary medicinal product
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26 Possession of an unauthorised veterinary medicinal product
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27 Supply of an unauthorised veterinary medicinal product
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PART 5 Miscellaneous provisions, enforcement and offences

28 The Veterinary Products Committee
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29 Veterinary Products Committee appeals procedure
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30 Appeals to an appointed person
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31 Exports
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32 Time limits
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33 Appointment of inspectors
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34 Powers of entry
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35 Powers of an inspector
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36 Inspection of pharmacies
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37 Obstruction
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38 Improvement notices
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39 Appeals against improvement notices
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40 Powers of a court on appeal
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41 Seizure notices
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42 Publication
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43 Penalties
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44 Northern Ireland
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45 Review
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46 Revocations
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SCHEDULE 1 Marketing authorisations
Regulation 4(3)

PART 1 Application for a marketing authorisation

1 Application for a marketing authorisation
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2 Information with the application
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3 Summary of product characteristics
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4 Supply of a copy of the summary of product characteristics
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5 Time limits for applications for products for use in food-producing animals
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PART 2 Derogations from some of the requirements in Part 1

6 Scope
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7 Bibliographic application
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8 Application for a product using a new combination of active substances
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9 Application using existing data
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10 Application for a pharmacologically equivalent medicinal product
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11 Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product
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12 Extension of time limits
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13 Parallel imports
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14 Specific batch control scheme
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15 Similar immunological products
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16 Marketing a product authorised in another country
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PART 3 Grant of a marketing authorisation

17 Time limits
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18 Place of establishment of applicant
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19 Procedure
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20 Products authorised in another Member State
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21 Assessment reports
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22 Grant of a marketing authorisation
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23 Marketing authorisations for food-producing species
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24 Refusal of a marketing authorisation
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25 Publication following the grant of a marketing authorisation
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26 Marketing authorisations in exceptional circumstances
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27 Provisions of samples and expertise
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28 Supply of information
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29 Duties on the holder of a marketing authorisation relating to an immunological product
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30 Control tests
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31 Placing on the market
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32 Duration and validity of a marketing authorisation
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PART 4 Variations of marketing authorisations on the application of the holder

33 Variation of a marketing authorisation
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34 Refusal of a variation of a marketing authorisation
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35 Administrative variations
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36 Changes after a marketing authorisation has been issued
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37 Compulsory variation
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PART 5 Suspension, etc. of a marketing authorisation

38 Suspension of a marketing authorisation: grounds
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39 Suspension of a marketing authorisation: procedure
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40 Revocation
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41 Prohibiting the supply of veterinary medicinal products
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PART 6 Mutual recognition and multiple applications

42 Application for a marketing authorisation where one already exists in another member State
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43 Application in another Member State
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44 Application for a marketing authorisation in multiple Member States where a marketing authorisation does not exist in any member State
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PART 7 Labelling and package leaflets

45 Approval by the Secretary of State
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46 Reference to being authorised
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47 Language
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48 Labelling with all the information on the immediate packaging
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49 Products with immediate and outer packaging
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50 Package leaflets
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51 Ampoules
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52 Small containers other than ampoules
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53 Homeopathic remedies
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54 Variations
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PART 8 Pharmacovigilance

55 Qualified persons responsible for pharmacovigilance
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56 Duties relating to the qualified person
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57 Adverse reactions to a veterinary medicinal product administered in the United Kingdom
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58 Adverse reactions to a veterinary medicinal product administered in a third country
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59 Periodic safety update reports
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60 Release of information by the marketing authorisation holder
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61 Action taken on account of pharmacovigilance
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PART 9 Homeopathic remedies

62 Meaning of “homeopathic remedy”
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63 Placing a homeopathic remedy on the market in accordance with a registration
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64 Application for registration
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65 Procedure for registration
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66 Products on the market before 1994
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67 Classification
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SCHEDULE 2 The manufacture of veterinary medicinal products
Regulation 5(2)

PART 1 Manufacturing authorisations

1 Application
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2 Time limits
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3 Granting the authorisation
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4 The authorisation
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5 Suspension, variation or revocation of the authorisation
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6 Inspection of premises
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7 Report following inspection
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8 Duties on the holder of a manufacturing authorisation
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9 Qualified persons for manufacture
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10 Refusal or revocation of appointment
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11 Duties on a qualified person
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12 Register
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13 Test sites
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PART 2 Authorisation of manufacturers of autogenous vaccines

14 Authorisation to manufacture autogenous vaccines
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15 Types of authorisation
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16 Labelling
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17 Records
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18 Adverse reactions
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19 Inspection of premises
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PART 3 Authorisation of blood banks

20 Authorisation of blood banks
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21 Supply and administration of blood from a blood bank
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22 Labelling
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23 Records
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24 Inspection of premises
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PART 4 Authorisation of manufacturers of products for administration under the cascade

25 Authorisation to manufacture products for administration under the cascade
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26 Labelling
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27 Records
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28 Adverse reactions
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29 Inspection of premises
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PART 5 Authorisation of equine stem cell centres

30 Authorisation of stem cell centres
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31 Supply and administration of stem cells
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32 Labelling
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33 Records
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34 Inspection of premises
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SCHEDULE 3 Classification and supply, wholesale dealers and sheep dip
Regulation 7

PART 1 Classification and supply of authorised veterinary medicinal products

1 Classification of veterinary medicinal products
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2 Wholesale supply of veterinary medicinal products
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3 Retail supply of veterinary medicinal products
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4 Prescriptions by a veterinary surgeon
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5 Prescriptions
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6 Written prescriptions
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7 Duties when a product is prescribed or supplied
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8 Supply by a veterinary surgeon from registered premises
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9 Supply by a veterinary surgeon
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10 Supply by a pharmacist
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11 Supply of a veterinary medicinal product for incorporation into feedingstuffs
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12 Labelling at the time of retail supply
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13 Supply of veterinary medicinal products for use under the cascade
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14 Supply by a suitably qualified person
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15 Annual audit
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PART 2 Requirements for a wholesale dealer’s authorisation

16 Application
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17 Time limits
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18 Granting the authorisation
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19 The authorisation
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20 Suspension, variation or revocation of the authorisation
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21 Duties on the holder of a wholesale dealer’s authorisation
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PART 3 Sheep dip

22 Supply of sheep dip
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23 Use of sheep dip
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SCHEDULE 4 Administration of a veterinary medicinal product outside the terms of a marketing authorisation
Regulation 8

1 Administration under the cascade
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2 Withdrawal periods
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3 Administration to food-producing horses
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4 Immunological products for serious epizootic disease
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5 Immunological products for an imported or exported animal
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6 Administration by veterinary surgeons from other Member States
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7 Treatment in exceptional circumstances
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8 Administration of a homeopathic remedy
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9 Administration under an animal test certificate
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SCHEDULE 5 Medicated feedingstuffs and specified feed additives
Regulation 14

1 Scope and interpretation
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2 Enforcement of Regulation (EC) No 178/2002
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3 Enforcement of Regulation (EC) No 1831/2003
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4 Enforcement of Regulation (EC) No 882/2004
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5 Enforcement of Regulation (EC) No 183/2005
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6 Enforcement of Regulation (EC) No 767/2009
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7 Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products
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8 Incorporation of a veterinary medicinal product into a premixture
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9 Top dressing
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10 Incorporation of a veterinary medicinal product into feedingstuffs
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11 Additional record keeping requirements relating to veterinary medicinal products
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12 Labelling a premixture containing a veterinary medicinal product
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13 Labelling of feedingstuffs containing a specified feed additive
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14 Labelling of feedingstuffs containing a veterinary medicinal product
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15 Supply of specified feed additives
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16 Supply of premixture
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17 Supply of a complementary feedingstuff
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18 Supply of feedingstuffs containing a veterinary medicinal product
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19 Prescriptions for feedingstuffs containing a veterinary medicinal product
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20 Writing the prescription
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21 Possession
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22 Sampling and analysis
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23 Storage
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24 Packages and other containers
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25 Transport
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26 Possession, placing on the market and use of feedingstuffs
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27 Imports from third countries
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28 Trade between Member States
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29 Import for incorporation into premixture or feedingstuffs for export
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30 Animals on domestic premises
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SCHEDULE 6 Exemptions for small pet animals
Regulation 15(4)

1 Animals to which this Schedule applies
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2 Placing on the market, importing and administering the product
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3 Manufacture
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4 Approval of the active substance
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5 The product
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6 Labelling
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7 Administration
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8 Pack size
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9 Adverse reactions
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SCHEDULE 7 Fees
Regulation 16

PART 1 Introduction

1 Interpretation
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2 Payment of fees
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3 Time of payment
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4 Multiple inspections
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5 Expenses for inspections outside the United Kingdom
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6 Translation
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PART 2 Fees relating to marketing authorisations

7 Fees for specified pharmaceutical applications
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8 Decentralised pharmaceutical application where the United Kingdom is the reference Member State
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9 Application for a marketing authorisation for an immunological product
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10 Decentralised immunological application where the United Kingdom is the reference Member State
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11 Application for a marketing authorisation using identical data
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12 Application for an exceptional marketing authorisation (pharmaceutical)
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13 Fees for an application for an exceptional marketing authorisation (immunological)
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14 Fee for the conversion from an exceptional to a full marketing authorisation
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15 Application for a marketing authorisation relating to a parallel import
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16 Application to change the distribution category of a product authorised through the centralised procedure
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17 Application for a variation to a marketing authorisation dealt with under national or mutual recognition variation procedures.
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18 Application for a variation to a marketing authorisation dealt with under worksharing procedures
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19 Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference Member State
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20 Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension
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21 Exception for a variation relating to animal testing
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22 Application for the renewal of a national marketing authorisation
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23 Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure
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24 Registration of a homeopathic remedy
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25 Annual fees for marketing authorisations
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26 Auditor’s certificate
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PART 3 Fees payable by manufacturers

27 Application for a manufacturing authorisation
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28 Application for a variation of a manufacturing authorisation
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29 Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade
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30 Annual fees
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31 Site inspections – type of site
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32 Inspection of a site where immunological veterinary medicinal products are manufactured
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33 Inspection of a site where sterile veterinary medicinal products are manufactured
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34 Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
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35 Inspection of a site where veterinary medicinal products are assembled
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36 Test sites
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37 Animal blood bank or equine stem cell centre authorisations
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PART 4 Fees relating to a wholesale dealer’s authorisation

38 Application for a wholesale dealer’s authorisation
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39 Variation of a wholesale dealer’s authorisation
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40 Annual fee for a wholesale dealer’s authorisation
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41 Inspection of a wholesale dealer’s premises
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PART 5 Fees relating to feedingstuffs

42 Fees relating to feedingstuffs
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43 Fees relating to premises for supply by suitably qualified persons
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44 Reduced fees
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PART 6 General

45 Testing samples
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46 Animal test certificates
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47 Importation of a veterinary medicinal product for treatment under the cascade
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48 Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 1986
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49 Wholesale dealer’s import certificate
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50 Specific batch control
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51 Submission of control tests of an immunological product
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52 Export certificates
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53 Provision of advice
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54 Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates
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55 Appeals to the Veterinary Products Committee: variations
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56 Appeal to the Veterinary Products Committee: suspensions
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57 Appeal to the Veterinary Products Committee: active substance under Schedule 6
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58 Fee relating to an appointed person
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59 Fees relating to a veterinary surgeon’s practice premises
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60 Refund of fees relating to the Veterinary Products Committee or appointed persons
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61 Fees relating to an improvement notice
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62 Non-payment of fees
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63 Waiver or reduction of fees
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64 Reduction of fees when an application is withdrawn
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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”.