
2009 No. 2297
Medicines
The Veterinary Medicines Regulations 2009  (revoked)
Made 12th August 2009
Laid before Parliament 27th August 2009
Coming into force 1st October 2009
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PART 1 Introduction
Title and commencement
1 
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Definition of “veterinary medicinal product”, interpretation and scope
2 
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Products to which these Regulations do not apply
3 
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PART 2 Authorised veterinary medicinal products
Placing a veterinary medicinal product on the market
4 
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Manufacture of veterinary medicinal products
5 
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The finished product
6 
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Classification, supply and possession of the product
7 
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Administration of the product
8 
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Importation of authorised veterinary medicinal products
9 
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Advertising the product
10 
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Advertising of prescription products and products containing psychotropic drugs or narcotics
11 
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Defence of publication in the course of business
12 
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Wholesale dealing
13 
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Feedingstuffs
14 
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Exemptions
15 
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Fees
16 
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PART 3 Records
Food-producing animals: proof of purchase of veterinary medicinal products
17 
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Food-producing animals: records of administration by a veterinary surgeon
18 
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Food-producing animals: records of acquisition and administration
19 
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Food-producing animals: retention of records
20 
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Records by a holder of a manufacturing authorisation
21 
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Records by a holder of a wholesale dealer’s authorisation
22 
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Records of the receipt or supply of prescription products
23 
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Records of products administered to a food-producing animal under the cascade
24 
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PART 4 Unauthorised veterinary medicinal products
Importation of an unauthorised veterinary medicinal product
25 
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Possession of an unauthorised veterinary medicinal product
26 
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Supply of an unauthorised veterinary medicinal product
27 
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PART 5 Miscellaneous provisions, enforcement and offences
The Veterinary Products Committee
28 
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Veterinary Products Committee appeals procedure
29 
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Appeals to an appointed person
30 
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Exports
31 
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Time limits
32 
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Appointment of inspectors
33 
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Powers of entry
34 
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Powers of an inspector
35 
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Inspection of pharmacies
36 
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Obstruction
37 
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Improvement notices
38 
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Appeals against improvement notices
39 
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Powers of a court on appeal
40 
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Seizure notices
41 
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Publication
42 
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Penalties
43 
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Northern Ireland
44 
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Revocation
45 
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SCHEDULE 1
Marketing authorisations
Regulation 4(3)
PART 1 Application for a marketing authorisation
Application for a marketing authorisation
1 
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Information with the application
2 
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Summary of product characteristics
3 
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Supply of a copy of the summary of product characteristics
4 
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Time limits for applications for products for use in food-producing animals
5 
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PART 2 Derogations from some of the requirements in Part 1
Scope
6 
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Bibliographic application
7 
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Application for a product using a new combination of active substances
8 
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Application using existing data
9 
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Application for a pharmacologically equivalent medicinal product
10 
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Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product
11 
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Extension of time limits
12 
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Parallel imports
13 
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Specific batch control scheme
14 
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Similar immunological products
15 
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Marketing a product authorised in another country
16 
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PART 3 Grant of a marketing authorisation
Time limits
17 
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Place of establishment of applicant
18 
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Procedure
19 
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Products authorised in another member State
20 
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Assessment reports
21 
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Grant of a marketing authorisation
22 
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Marketing authorisations for food-producing species
23 
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Refusal of a marketing authorisation
24 
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Publication following the grant of a marketing authorisation
25 
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Marketing authorisations in exceptional circumstances
26 
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Provisions of samples and expertise
27 
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Supply of information
28 
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Duties on the holder of a marketing authorisation relating to an immunological product
29 
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Control tests
30 
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Placing on the market
31 
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Duration and validity of a marketing authorisation
32 
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PART 4 Variations of marketing authorisations on the application of the holder
Variation of a marketing authorisation where the product is authorised using mutual recognition or the decentralised procedure
33 
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Variation of a marketing authorisation not authorised in another member State
34 
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Administrative variations
35 
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Changes after a marketing authorisation has been issued
36 
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Compulsory variation
37 
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PART 5 Suspension, etc. of a marketing authorisation
Suspension of a marketing authorisation: grounds
38 
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Suspension of a marketing authorisation: procedure
39 
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Revocation
40 
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Prohibiting the supply of veterinary medicinal products
41 
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PART 6 Mutual recognition and multiple applications
Application for a marketing authorisation where one already exists in another member State
42 
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Application in another member State
43 
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Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
44 
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PART 7 Labelling and package leaflets
Approval by the Secretary of State
45 
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Reference to being authorised
46 
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Language
47 
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Labelling with all the information on the immediate packaging
48 
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Products with immediate and outer packaging
49 
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Package leaflets
50 
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Ampoules
51 
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Small containers other than ampoules
52 
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Homeopathic remedies
53 
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Variations
54 
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PART 8 Pharmacovigilance
Qualified persons responsible for pharmacovigilance
55 
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Duties relating to the qualified person
56 
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Adverse reactions to a veterinary medicinal product administered in the United Kingdom
57 
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Adverse reactions to a veterinary medicinal product administered in a third country
58 
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Periodic safety update reports
59 
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Release of information by the marketing authorisation holder
60 
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Action taken on account of pharmacovigilance
61 
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PART 9 Homeopathic remedies
Meaning of “homeopathic remedy”
62 
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Placing a homeopathic remedy on the market in accordance with a registration
63 
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Application for registration
64 
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Procedure for registration
65 
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Products on the market before 1994
66 
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Classification
67 
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SCHEDULE 2
The manufacture of veterinary medicinal products
Regulation 5(2)
PART 1 Manufacturing authorisations
Application
1 
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Time limits
2 
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Granting the authorisation
3 
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The authorisation
4 
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Suspension, variation or revocation of the authorisation
5 
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Inspection of premises
6 
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Report following inspection
7 
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Duties on the holder of a manufacturing authorisation
8 
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Qualified persons for manufacture
9 
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Refusal or revocation of appointment
10 
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Duties on a qualified person
11 
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Register
12 
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Test sites
13 
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PART 2 Authorisation of manufacturers of autogenous vaccines
Authorisation to manufacture autogenous vaccines
14 
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Types of authorisation
15 
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Labelling
16 
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Records
17 
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Adverse reactions
18 
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Inspection of premises
19 
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PART 3 Authorisation of blood banks
Authorisation of blood banks
20 
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Supply and administration of blood from a blood bank
21 
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Labelling
22 
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Records
23 
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Inspection of premises
24 
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PART 4 Authorisation of manufacturers of products for administration under the cascade
Authorisation to manufacture products for administration under the cascade
25 
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Labelling
26 
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Records
27 
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Adverse reactions
28 
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Inspection of premises
29 
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PART 5 Authorisation of equine stem cell centres
Authorisation of stem cell centres
30 
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Supply and administration of stem cells
31 
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Labelling
32 
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Records
33 
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Inspection of premises
34 
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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
Classification of veterinary medicinal products
1 
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Wholesale supply of veterinary medicinal products
2 
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Retail supply of veterinary medicinal products
3 
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Prescriptions by a veterinary surgeon
4 
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Prescriptions
5 
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Written prescriptions
6 
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Duties when a product is prescribed or supplied
7 
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Supply by a veterinary surgeon from registered premises
8 
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Supply by a veterinary surgeon
9 
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Supply by a pharmacist
10 
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Supply of a veterinary medicinal product for incorporation into feedingstuffs
11 
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Labelling at the time of retail supply
12 
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Supply of veterinary medicinal products for use under the cascade
13 
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Supply by a suitably qualified person
14 
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Annual audit
15 
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PART 2 Requirements for a wholesale dealer’s authorisation
Application
16 
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Time limits
17 
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Granting the authorisation
18 
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The authorisation
19 
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Suspension, variation or revocation of the authorisation
20 
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Duties on the holder of a wholesale dealer’s authorisation
21 
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PART 3 Sheep dip
Supply of sheep dip
22 
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Use of sheep dip
23 
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SCHEDULE 4
Administration of a veterinary medicinal product outside the terms of a marketing authorisation
Regulation 8
Administration under the cascade
1 
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Withdrawal periods
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration to food-producing horses
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Immunological products for serious epizootic disease
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Immunological products for an imported or exported animal
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration by veterinary surgeons from other member States
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment in exceptional circumstances
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration of a homeopathic remedy
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration under an animal test certificate
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 5
Medicated feedingstuffs and specified feed additives
Regulation 14
Scope and interpretation
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Enforcement of Regulation (EC) No 178/2002
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Enforcement of Regulation (EC) No 1831/2003
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Enforcement of Regulation (EC) No 882/2004
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Enforcement of Regulation (EC) No 183/2005
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Incorporation of a veterinary medicinal product into a premixture
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Top dressing
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Incorporation of a veterinary medicinal product into feedingstuffs
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional record keeping requirements relating to veterinary medicinal products
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling a premixture containing a veterinary medicinal product
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling of feedingstuffs containing a specified feed additive
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling of feedingstuffs containing a veterinary medicinal product
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of specified feed additives
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of premixture
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of feedingstuffs containing a veterinary medicinal product
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prescriptions for feedingstuffs containing a veterinary medicinal product
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Writing the prescription
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Possession
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sampling and analysis
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Storage
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Packages and other containers
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transport
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Possession, placing on the market and use of feedingstuffs
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Imports from third countries
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trade between member States
26 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Import for incorporation into premixture or feedingstuffs for export
27 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Animals on domestic premises
28 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 6
Exemptions for small pet animals
Regulation 15(4)
Animals to which this Schedule applies
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Placing on the market, importing and administering the product
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacture
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Approval of the active substance
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The product
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pack size
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adverse reactions
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 7
Fees
Regulation 16
PART 1 Introduction
Interpretation
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payment of fees
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time of payment
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Multiple inspections
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expenses for inspections
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Translation
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 2 Fees relating to marketing authorisations
Fees for specified pharmaceutical applications
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Decentralised pharmaceutical application where the United Kingdom is the reference member State
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a marketing authorisation for an immunological product
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Decentralised immunological application where the United Kingdom is the reference member State
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a marketing authorisation using identical data
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for an exceptional marketing authorisation (pharmaceutical)
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees for an application for an exceptional marketing authorisation (immunological)
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fee for the conversion from an exceptional to a full marketing authorisation
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a marketing authorisation relating to a parallel import
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a variation obtained under a national procedure
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures: fees until 1st January 2010
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures: fees from 1st January 2010
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for an extension to a marketing authorisation
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Decentralised application for an extension where the United Kingdom is the reference member State
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision of information relating to the recognition of a United Kingdom marketing authorisation
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for the renewal of a national marketing authorisation
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Registration of a homeopathic remedy
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annual fees for marketing authorisations
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Auditor’s certificate
26 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Late payment of annual fees
27 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 Fees payable by manufacturers
Application for a manufacturing authorisation
28 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a variation of a manufacturing authorisation
29 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade
30 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annual fees
31 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Site inspections – type of site
32 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a site where immunological veterinary medicinal products are manufactured
33 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a site where sterile veterinary medicinal products are manufactured
34 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
35 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a site where veterinary medicinal products are assembled
36 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Test sites
37 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Animal blood bank or equine stem cell centre authorisations
38 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 4 Fees relating to a wholesale dealer’s authorisation
Application for a wholesale dealer’s authorisation
39 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Variation of a wholesale dealer’s authorisation
40 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annual fee for a wholesale dealer’s authorisation
41 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a wholesale dealer’s premises
42 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 Fees relating to feedingstuffs
Fees relating to feedingstuffs
43 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees relating to premises for supply by suitably qualified persons
44 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reduced fees
45 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 6 General
Testing samples
46 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Animal test certificates
47 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Importation of a veterinary medicinal product for treatment under the cascade
48 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 1986
49 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wholesale dealer’s import certificate
50 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Specific batch control
51 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Submission of control tests of an immunological product
52 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Export certificates
53 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates
54 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals to the Veterinary Products Committee: variations
55 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeal to the Veterinary Products Committee: suspensions
56 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeal to the Veterinary Products Committee: active substance under Schedule 6
57 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fee relating to an appointed person
58 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees relating to a veterinary surgeon’s practice premises
59 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Refund of fees relating to the Veterinary Products Committee or appointed persons
60 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees relating to an improvement notice
61 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-payment of fees
62 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Waiver or reduction of fees
63 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reduction of fees when an application is withdrawn
64 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .