The Veterinary Medicines Regulations 2011

Made: 25th August 2011

Laid before Parliament: 7th September 2011

Coming into force: 1st October 2011

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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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Review

45

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Revocations

46

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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

33

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Refusal of a variation of a marketing authorisation

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