The Veterinary Medicines Regulations 2008

Type Statutory-Instrument
Publication 2008-08-26
Last updated 2009-10-01
State In force
Department King's Printer of Acts of Parliament
PDF Download
articles Not indexed
Reform history JSON API

Made: 26th August 2008

Laid before Parliament: 1st September 2008

Coming into force: 1st October 2008

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

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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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Revocations and consequential amendment

45

  • (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  • (2) In section 1 of the Medicines Act 1971[^f00022] (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)”.

SCHEDULE 1 — Marketing authorisations

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 in exceptional circumstances

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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Provisional marketing authorisation

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 for a mutually recognised veterinary medicinal product

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

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 blood banks

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 equine stem cell centres

34

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SCHEDULE 3 — Classification and supply, wholesale dealers and sheep dip

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 practice 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

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

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

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

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

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

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

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

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

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

Signed

Jonathan Shaw — Parliamentary Under Secretary of State — Department for Environment, Food and Rural Affairs — 2008-08-26

Dave Watts — Alan Campbell — Two of the Lords Commissioners of Her Majesty’s Treasury — 2008-08-22

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

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

Principal changes to the 2007 Regulations The new Regulations introduce a fee for the registration of veterinary premises for the supply of veterinary medicinal products. They provide comprehensive rights of appeal to an appointed person when applications for the authorisation or approval of manufacture or retail premises are refused. They introduce new controls on the collection and supply of equine stem cells. They introduce compulsory variations by the Secretary of State for manufacturers and wholesale dealers. They allow suitably qualified persons to supply veterinary medicines to retail customers from pharmacies or registered veterinary premises without dual registration. They introduce record-keeping requirements in relation to adverse reactions to products marketed under the small animals exemption scheme. They update fees. They have been changed so that the drafting is now gender-neutral. They make an amendment to the Medicines Act 1971 arising from veterinary medicinal products no longer being licensed under the Medicines Act 1968.

The Regulations The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products. They implement Directive 2001/82/EC. They enforce Regulations (EC) No. 178/2002, No. 1831/2003, No. 882/2004 No. 183/2005, in so far as they apply to veterinary medicinal products used in feedingstuffs, and to some specified feed additives used in feedingstuffs. They implement Council Directive 90/167 so far it is not superseded by Regulation (EC) No. 183/2005. They provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1). They specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2). They regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3). They provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the rules of the “cascade” (regulation 8 and Schedule 4). They control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12). They control wholesale dealing (regulation 13 and Schedule 3). They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5). They provide for exemptions (regulation 15 and Schedule6). They provide for fees (regulation 16 and Schedule 7). They require records to be kept (regulations 17 to 24). They create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27). They make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for an appeals procedure in the case of a refusal, etc., of a marketing authorisation (regulation 29). They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41). Under regulation 43 breach of the Regulations is an offence punishable— a on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or b on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.

A full impact assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available, together with a transposition note and a table showing fee changes, on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”.

Footnotes

[^f00001]: S.I. 1999/2027.

[^f00002]: 1972 c. 68.

[^f00003]: OJ No. L31, 1.2.2002, p. 1.

[^f00004]: 1973 c.51.

[^f00022]: 1971 c.69, as amended by section 21 of the Health and Medicines Act 1988 (c. 49) and S.I. 1994/3144, 2004/1031, 2005/2750 and 2006/2407.

Fee for the registration of veterinary practice premises

58A

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

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

Fees relating to an improvement notice

Non-payment of fees

Waiver or reduction of fees

Reduction of fees when an application is withdrawn

Editorial notes

[^key-c0458e053c8163c87ad0cb6da7d5ed5d]: Regulations revoked (except reg. 45(2)) (1.10.2009) by The Veterinary Medicines Regulations 2009 (S.I. 2009/2297), regs. 1, 45 (with reg. 3)

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