The Veterinary Medicines Regulations 2009

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

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

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

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

Administration under the cascade

1

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Withdrawal periods

2

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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

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

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

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 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

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

Signed

Jim Fitzpatrick — Minister of State — Department for Environment, Food and Rural Affairs — 2009-08-10

We consent

Dave Watts — Steve McCabe — Two of the Lords Commissioners of Her Majesty’s Treasury — 2009-08-12

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2008.

Principal changes to the 2008 Regulations: implementation of European obligations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Regulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.

[^f00005]: OJ No. L136, 30.4.2004, p. 1.

[^f00006]: OJ No L 149, 7.6.2008, p. 3.

[^f00007]: 1986 c. 14.

[^f00008]: For provisions on breaking open packages see regulation 7(3).

[^f00009]: Published by the World Health Organization at: www.who.int/medicines/en.

[^f00010]: 1981 c. 22.

[^f00011]: 1980 c.43; sections 51 and 52 have been substituted by the Courts Act 2003 (c.39), section 47.

[^f00012]: OJ No. L 31, 1.2.2002, p. 1.

[^f00013]: OJ No. L268, 18.10.2003, p. 29.

[^f00014]: Corrected version at OJ No. L191, 28.5.2004, p. 1.

[^f00015]: OJ No. L35, 8.2.2005, p. 1.

[^f00016]: S. I. 1981/1675 (N.I. 26).

[^f00017]: S. I. 2008/2297.

[^f00018]: 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.

[^f00019]: OJ No L 211, 28.11.2001, p. 1 as last amended by Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ No L152, 16.6.2009, p. 11. Annex I was inserted by Commission Directive 2009/9/EC (OJ No L 44, 14.2.2009, p. 10).

[^f00020]: OJ No L224, 18.8.1990, p. 1 This Regulation has been replaced by Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, (OJ No L 152, 16.6.2009, p. 11) but by virtue of Article 29 of that Regulation the Annexes to Regulation 2377/90 continue in force until the adoption of a Commission Regulation replacing them.

[^f00021]: OJ No L 159, 27.6.2003, p. 1.

[^f00022]: OJ No L334, 12.12.2008, P.7.

[^f00023]: ISBN 9287145873.

[^f00024]: OJ No L 228, 17.8.91, p. 70.

[^f00025]: S. I. 2001/3998; relevant amending instruments are S. I. 2003/1432 and 2005/1653.

[^f00026]: Published at: http://www.vmd.gov.uk/Industry/QPAS/SQPs/htm.

[^f00027]: OJ No C 63, 1.3.94, p. 4.

[^f00028]: The number of days of the withdrawal period is calculated by dividing 500 by the mean temperature of the water in degrees Celsius.

[^f00029]: OJ No L367, 22.12.2006, p. 33.

[^f00030]: Published at www.rcvs.org.uk/PrintFullArticle.asp?NodeID=89642.

[^f00031]: OJ No L 31, 1.2.2002, p. 1.

[^f00032]: OJ No L268, 18.10.2003, p. 29.

[^f00033]: Corrected version at OJ No L191, 28.5.2004, p. 1.

[^f00034]: OJ No L35, 8.2.2005, p. 1.

[^f00035]: OJ No L86, 6.4.1979, p. 30.

[^f00036]: OJ No L102, 15.4.76, p. 1.

[^f00037]: OJ No L 92, 7.4.90, p. 42.

[^f00038]: On 1st January 2010 this Regulation is superseded by Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ No L 334, 12.12.2008, p. 7) but for the purposes of variations to marketing authorisations granted under the national procedure the classifications in Commission Regulation (EC) No 1084/2003 continue to be used.

[^f00039]: The Committee was established by Article 30 of Regulation (EC) No 762/2004 of the European Parliament `and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ No L136, 30.4.2004, p. 1).

[^f00040]: OJ No L334, 12.12.2008, p. 7. This Regulation supersedes Regulation (EC) No 1084/2003 on 1st January 2010.

Editorial notes

[^key-9f3eb49940157ce4e55ebf70ddde0ca8]: Regulations revoked (1.10.2011) by The Veterinary Medicines Regulations 2011 (S.I. 2011/2159), regs. 1, 46(1)

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