The Veterinary Medicines Regulations 2011

Made: 25th August 2011

Laid before Parliament: 7th September 2011

Coming into force: 1st October 2011

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

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

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

Review

45

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

Revocations

46

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

SCHEDULE 1 — Marketing authorisations

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 a product authorised in another country

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

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

Marketing authorisations in exceptional circumstances

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

33

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

Refusal of a variation of a marketing authorisation

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

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 premises

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 premises

34

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

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

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

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 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

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

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

Enforcement of Regulation (EC) No 767/2009

6

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

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

7

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

Incorporation of a veterinary medicinal product into a premixture

8

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

Top dressing

9

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

Incorporation of a veterinary medicinal product into feedingstuffs

10

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

Additional record keeping requirements relating to veterinary medicinal products

11

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

Labelling a premixture containing a veterinary medicinal product

12

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

Labelling of feedingstuffs containing a specified feed additive

13

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

Labelling of feedingstuffs containing a veterinary medicinal product

14

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

Supply of specified feed additives

15

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

Supply of premixture

16

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

Supply of a complementary feedingstuff

17

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

Supply of feedingstuffs containing a veterinary medicinal product

18

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

Prescriptions for feedingstuffs containing a veterinary medicinal product

19

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

Writing the prescription

20

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

Possession

21

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

Sampling and analysis

22

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

Storage

23

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

Packages and other containers

24

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

Transport

25

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

Possession, placing on the market and use of feedingstuffs

26

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

Imports from third countries

27

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

Trade between Member States

28

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

Import for incorporation into premixture or feedingstuffs for export

29

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

Animals on domestic premises

30

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

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 outside the United Kingdom

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 to change the distribution category of a product authorised through the centralised procedure

16

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

Application for a variation to a marketing authorisation dealt with under national or mutual recognition variation procedures.

17

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

Application for a variation to a marketing authorisation dealt with under worksharing procedures

18

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

Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference Member State

19

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

Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension

20

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

Exception for a variation relating to animal testing

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

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

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

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

Importation of a veterinary medicinal product for treatment under the cascade

47

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

Importation of a veterinary medicinal product for administration under the Animals (Scientific Procedures) Act 1986

48

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

Wholesale dealer’s import certificate

49

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

Specific batch control

50

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

Submission of control tests of an immunological product

51

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

Export certificates

52

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

Provision of advice

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

Henley — Parliamentary Under Secretary of State — Department for Environment, Food and Rural Affairs — 2011-08-20

We consent

James Duddridge — Angela Watkinson — Two of the Lords Commissioners of Her Majesty’s Treasury — 2011-08-25

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2009.

Principal changes to the 2009 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.defra.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 L334, 12.12.2008, p.7.

[^f00007]: OJ No L 15, 20.1.2010, p. 1.

[^f00008]: OJ No L 149, 7.6.2008, p. 3.

[^f00009]: OJ No L152, 16.6.2009, p. 11.

[^f00010]: OJ No L229, 1.9.2009, p. 1. Regulation (EC) No 767 2009 was last amended by Regulation (EC) 939/2010 (OJ No L277, 20.10. 2010, p. 4).

[^f00011]: 1986 c. 14.

[^f00012]: For provisions on breaking open packages see regulation 7(3).

[^f00013]: Published by the World Health Organization at: www.who.int/medicines/en.

[^f00014]: 1981 c. 22.

[^f00015]: 1980 c. 43; sections 51 and 52 have been substituted by the Courts Act 2003 (c.39), section 47.

[^f00016]: OJ No L31, 1.2.2002, p. 1; last amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council (OJ L188, 18.7.2009, p. 14).

[^f00017]: OJ No L268, 18.10.2003, p. 29; last amended by Regulation (EC) No 767/2009 of the European Parliament and of the Council (OJ L229, 1.9.2009, p.1).

[^f00018]: Corrected version at OJ No L191, 28.5.2004, p. 1.

[^f00019]: OJ No L35, 8.2.2005, p. 1; last amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ L87, 31, 3.2009, p.109).

[^f00020]: S.I. 1981/1675 (N.I. 26).

[^f00021]: OJ L92, 7.4.1990, p. 42.

[^f00022]: OJ 228, 17.8.1991, p. 70.

[^f00023]: OJ L311, 28.11.2001, p. 1; last amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council (OJ L188, 18.7.2009, p. 14).

[^f00024]: OJ L334, 12.12.2008, p. 7.

[^f00025]: OJ L152, 16.6.2009, p. 11.

[^f00026]: OJ L229, 1.9.2009, p. 1, last amended by Commission Regulation (EU) No 939/2010 (OJ L277, 21.10.2010, p. 14).

[^f00027]: OJ L293, 11.11.2010, p.72; corrected at OJ L293, 11.11.2010, p. 72.

[^f00028]: S.I. 2009/2297, amended by S.I. 2010/231 and 2011/1116.

[^f00029]: S.I. 2011/1116.

[^f00030]: S.I. 2010/231.

[^f00031]: 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).

[^f00032]: OJ No L334, 12.12.2008, p. 7.

[^f00033]: ISBN 9287145873.

[^f00034]: OJ No L 228, 17.8.91, p. 70.

[^f00035]: S. I. 2001/3998; relevant amending instruments are S. I. 2003/1432 and 2005/1653

[^f00036]: Published at: http://www.vmd.gov.uk/Industry/QPAS/SQPs/htm.

[^f00037]: OJ No C 63, 1.3.94, p. 4.

[^f00038]: The number of days of the withdrawal period is calculated by dividing 500 by the mean temperature of the water in degrees Celsius.

[^f00039]: OJ No L367, 22.12.2006, p. 33.

[^f00040]: Published at www.rcvs.org.uk/PrintFullArticle.asp?NodeID=89642.

[^f00041]: OJ No L 31, 1.2.2002, p. 1.

[^f00042]: OJ No L268, 18.10.2003, p. 29.

[^f00043]: Corrected version at OJ No L191, 28.5.2004, p. 1.

[^f00044]: OJ No L35, 8.2.2005, p. 1

[^f00045]: OJ No L86, 6.4.1979, p. 30.

[^f00046]: OJ No L268, 18.10.2003, p. 29. Regulation (EC) no 1831/2003 was last amended by Article 29 of Regulation (EC) No 767/2009 (OJ No L229, 1.9.2009, p. 1.)

[^f00048]: OJ No L 92, 7.4.90, p. 42.

Editorial notes

[^key-f7d07e050938f4c588a67c6643bc345c]: Regulations revoked (1.10.2013) by The Veterinary Medicines Regulations 2013 (S.I. 2013/2033), regs. 1, 47(a) (with reg. 3)

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