
2008 No. 2297
Medicines
The Veterinary Medicines Regulations 2008
Made 26th August 2008
Laid before Parliament 1st September 2008
Coming into force 1st October 2008

The Secretary of State is a Minister designated for the purposes of making Regulations under section 2(2) of the European Communities Act 1972 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 safety.
In accordance with section 56(1) of the Finance Act 1973, 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.
PART 1 Introduction
Title and commencement
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Definition of “veterinary medicinal product”, interpretation and scope
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Products to which these Regulations do not apply
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 2 Authorised veterinary medicinal products
Placing a veterinary medicinal product on the market
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacture of veterinary medicinal products
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The finished product
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Classification, supply and possession of the product
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration of the product
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Importation of authorised veterinary medicinal products
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advertising the product
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advertising of prescription products and products containing psychotropic drugs or narcotics
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Defence of publication in the course of business
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wholesale dealing
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Feedingstuffs
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exemptions
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 Records
Food-producing animals: proof of purchase of veterinary medicinal products
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: records of administration by a veterinary surgeon
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: records of acquisition and administration
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: retention of records
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records by a holder of a manufacturing authorisation
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records by a holder of a wholesale dealer’s authorisation
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of the receipt or supply of prescription products
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of products administered to a food-producing animal under the cascade
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 4 Unauthorised veterinary medicinal products
Importation of an unauthorised veterinary medicinal product
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Possession of an unauthorised veterinary medicinal product
26 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of an unauthorised veterinary medicinal product
27 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 Miscellaneous provisions, enforcement and offences
The Veterinary Products Committee
28 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Veterinary Products Committee appeals procedure
29 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals to an appointed person
30 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exports
31 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time limits
32 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appointment of inspectors
33 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of entry
34 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of an inspector
35 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of pharmacies
36 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Obstruction
37 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Improvement notices
38 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals against improvement notices
39 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of a court on appeal
40 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Seizure notices
41 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Publication
42 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Penalties
43 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Northern Ireland
44 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocations and consequential amendment
45 

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(2) In section 1 of the Medicines Act 1971 (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 Shaw
Parliamentary Under Secretary of State
Department for Environment, Food and Rural Affairs

Dave Watts
Alan Campbell
Two of the Lords Commissioners of Her Majesty’s Treasury

SCHEDULE 1
Marketing authorisations
Regulation 4(3)
PART 1 Application for a marketing authorisation
Application for a marketing authorisation
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Information with the application
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Summary of product characteristics
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of a copy of the summary of product characteristics
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time limits for applications for products for use in food-producing animals
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 2 Derogations from some of the requirements in Part 1
Scope
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bibliographic application
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a product using a new combination of active substances
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application using existing data
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a pharmacologically equivalent medicinal product
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extension of time limits
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Parallel imports
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Specific batch control scheme
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Similar immunological products
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Marketing in exceptional circumstances
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 Grant of a marketing authorisation
Time limits
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Place of establishment of applicant
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedure
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Products authorised in another member State
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Assessment reports
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Grant of a marketing authorisation
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Marketing authorisations for food-producing species
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Refusal of a marketing authorisation
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Publication following the grant of a marketing authorisation
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provisional marketing authorisation
26 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provisions of samples and expertise
27 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of information
28 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duties on the holder of a marketing authorisation relating to an immunological product
29 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Control tests
30 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Placing on the market
31 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duration and validity of a marketing authorisation
32 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 4 Variations of marketing authorisations on the application of the holder
Variation of a marketing authorisation for a mutually recognised veterinary medicinal product
33 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Variation of a marketing authorisation not authorised in another member State
34 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administrative variations
35 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes after a marketing authorisation has been issued
36 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Compulsory variation
37 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 Suspension, etc. of a marketing authorisation
Suspension of a marketing authorisation: grounds
38 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Suspension of a marketing authorisation: procedure
39 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocation
40 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prohibiting the supply of veterinary medicinal products
41 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 6 Mutual recognition and multiple applications
Application for a marketing authorisation where one already exists in another member State
42 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application in another member State
43 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
44 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 7 Labelling and package leaflets
Approval by the Secretary of State
45 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reference to being authorised
46 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Language
47 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling with all the information on the immediate packaging
48 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Products with immediate and outer packaging
49 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Package leaflets
50 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ampoules
51 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Small containers other than ampoules
52 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Homeopathic remedies
53 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Variations
54 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 8 Pharmacovigilance
Qualified persons responsible for pharmacovigilance
55 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duties relating to the qualified person
56 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adverse reactions to a veterinary medicinal product administered in the United Kingdom
57 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adverse reactions to a veterinary medicinal product administered in a third country
58 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Periodic safety update reports
59 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Release of information by the marketing authorisation holder
60 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Action taken on account of pharmacovigilance
61 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 9 Homeopathic remedies
Meaning of “homeopathic remedy”
62 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Placing a homeopathic remedy on the market in accordance with a registration
63 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for registration
64 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedure for registration
65 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Products on the market before 1994
66 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Classification
67 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 2
The manufacture of veterinary medicinal products
Regulation 5(2)
PART 1 Manufacturing authorisations
Application
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time limits
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Granting the authorisation
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The authorisation
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Suspension, variation or revocation of the authorisation
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of premises
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Report following inspection
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duties on the holder of a manufacturing authorisation
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Qualified persons for manufacture
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Refusal or revocation of appointment
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duties on a qualified person
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Register
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Test sites
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 2 Authorisation of manufacturers of autogenous vaccines
Authorisation to manufacture autogenous vaccines
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Types of authorisation
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adverse reactions
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of premises
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 Authorisation of blood banks
Authorisation of blood banks
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply and administration of blood from a blood bank
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of blood banks
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 4 Authorisation of manufacturers of products for administration under the cascade
Authorisation to manufacture products for administration under the cascade
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling
26 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records
27 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adverse reactions
28 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of premises
29 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 Authorisation of equine stem cell centres
Authorisation of stem cell centres
30 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply and administration of stem cells
31 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling
32 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records
33 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of equine stem cell centres
34 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wholesale supply of veterinary medicinal products
2 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Retail supply of veterinary medicinal products
3 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prescriptions by a veterinary surgeon
4 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prescriptions
5 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Written prescriptions
6 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duties when a product is prescribed or supplied
7 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply by a veterinary surgeon from registered practice premises
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply by a veterinary surgeon
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply by a pharmacist
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of a veterinary medicinal product for incorporation into feedingstuffs
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling at the time of retail supply
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of veterinary medicinal products for use under the cascade
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply by a suitably qualified person
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annual audit
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 2 Requirements for a wholesale dealer’s authorisation
Application
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time limits
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Granting the authorisation
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The authorisation
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Suspension, variation or revocation of the authorisation
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Duties on the holder of a wholesale dealer’s authorisation
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 Sheep dip
Supply of sheep dip
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Use of sheep dip
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SCHEDULE 4
Administration of a veterinary medicinal product outside the terms of a marketing authorisation
Regulation 8
Administration under the cascade
1 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Incorporation of a veterinary medicinal product into feedingstuffs
8 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional record keeping requirements relating to veterinary medicinal products
9 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling a premixture containing a veterinary medicinal product
10 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling of feedingstuffs containing a specified feed additive
11 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labelling of feedingstuffs containing a veterinary medicinal product
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of specified feed additives
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of premixture
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of feedingstuffs containing a veterinary medicinal product
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prescriptions for feedingstuffs containing a veterinary medicinal product
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Writing the prescription
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Possession
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sampling and analysis
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Storage
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Packages and other containers
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transport
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Possession, placing on the market and use of feedingstuffs
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Imports from third countries
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trade between member States
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Import for incorporation into premixture or feedingstuffs for export
26 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Animals on domestic premises
27 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 a provisional marketing authorisation (pharmaceutical)
12 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees for an application for a provisional marketing authorisation (immunological)
13 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fee for the conversion from a provisional to a full marketing authorisation
14 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a marketing authorisation relating to a parallel import
15 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a variation
16 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a variation to a marketing authorisation that has been issued in other member States
17 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for an extension to a marketing authorisation
18 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Decentralised application for an extension where the United Kingdom is the reference member State
19 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision of information relating to the recognition of a United Kingdom marketing authorisation
20 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for the renewal of a national marketing authorisation
21 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for the renewal of a marketing authorisation granted in more than one member State
22 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Registration of a homeopathic remedy
23 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annual fees for marketing authorisations
24 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Auditor’s certificate
25 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Late payment of annual fees
26 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 Fees payable by manufacturers
Application for a manufacturing authorisation
27 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for a variation of a manufacturing authorisation
28 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade
29 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annual fees
30 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Site inspections – type of site
31 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a site where immunological veterinary medicinal products are manufactured
32 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a site where sterile veterinary medicinal products are manufactured
33 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
34 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a site where veterinary medicinal products are assembled
35 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Test sites
36 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Animal blood bank or equine stem cell centre authorisations
37 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 4 Fees relating to a wholesale dealer’s authorisation
Application for a wholesale dealer’s authorisation
38 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Variation of a wholesale dealer’s authorisation
39 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annual fee for a wholesale dealer’s authorisation
40 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of a wholesale dealer’s premises
41 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 Fees relating to feedingstuffs
Fees relating to feedingstuffs
42 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees relating to premises for supply by suitably qualified persons
43 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reduced fees
44 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 6 General
Testing samples
45 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Animal test certificates
46 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment under the cascade
47 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment under the Animals (Scientific Procedures) Act 1986
48 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment in exceptional circumstances
49 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Specific batch control
50 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Submission of control tests of an immunological product
51 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Export certificates
52 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals to the Veterinary Products Committee: marketing authorisations and ATCs
53 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals to the Veterinary Products Committee: variations
54 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeal to the Veterinary Products Committee: suspensions
55 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeal to the Veterinary Products Committee: active substance under Schedule 6
56 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fee relating to an appointed person
57 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fee for the inspection of a veterinary surgeon’s practice premises
58 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fee for the registration of veterinary practice premises
58A. 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Refund of fees relating to the Veterinary Products Committee or appointed persons
59 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees relating to an improvement notice
60 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-payment of fees
61 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Waiver or reduction of fees
62 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reduction of fees when an application is withdrawn
63 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .