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Statutory Instruments

2008 No. 2297

Medicines

The Veterinary Medicines Regulations 2008

Made

26th August 2008

Laid before Parliament

1st September 2008

Coming into force

1st October 2008

Contents

Go to Preamble

  1. PART 1

    Introduction

    1. 1. Title and commencement

    2. 2. Definition of “veterinary medicinal product”, interpretation and scope

    3. 3. Products to which these Regulations do not apply

  2. PART 2

    Authorised veterinary medicinal products

    1. 4. Placing a veterinary medicinal product on the market

    2. 5. Manufacture of veterinary medicinal products

    3. 6. The finished product

    4. 7. Classification, supply and possession of the product

    5. 8. Administration of the product

    6. 9. Importation of authorised veterinary medicinal products

    7. 10. Advertising the product

    8. 11. Advertising of prescription products and products containing psychotropic drugs or narcotics

    9. 12. Defence of publication in the course of business

    10. 13. Wholesale dealing

    11. 14. Feedingstuffs

    12. 15. Exemptions

    13. 16. Fees

  3. PART 3

    Records

    1. 17. Food-producing animals: proof of purchase of veterinary medicinal products

    2. 18. Food-producing animals: records of administration by a veterinary surgeon

    3. 19. Food-producing animals: records of acquisition and administration

    4. 20. Food-producing animals: retention of records

    5. 21. Records by a holder of a manufacturing authorisation

    6. 22. Records by a holder of a wholesale dealer’s authorisation

    7. 23. Records of the receipt or supply of prescription products

    8. 24. Records of products administered to a food-producing animal under the cascade

  4. PART 4

    Unauthorised veterinary medicinal products

    1. 25. Importation of an unauthorised veterinary medicinal product

    2. 26. Possession of an unauthorised veterinary medicinal product

    3. 27. Supply of an unauthorised veterinary medicinal product

  5. PART 5

    Miscellaneous provisions, enforcement and offences

    1. 28. The Veterinary Products Committee

    2. 29. Veterinary Products Committee appeals procedure

    3. 30. Appeals to an appointed person

    4. 31. Exports

    5. 32. Time limits

    6. 33. Appointment of inspectors

    7. 34. Powers of entry

    8. 35. Powers of an inspector

    9. 36. Inspection of pharmacies

    10. 37. Obstruction

    11. 38. Improvement notices

    12. 39. Appeals against improvement notices

    13. 40. Powers of a court on appeal

    14. 41. Seizure notices

    15. 42. Publication

    16. 43. Penalties

    17. 44. Northern Ireland

    18. 45. Revocations and consequential amendment

    1. SCHEDULE 1

      Marketing authorisations

      1. PART 1

        Application for a marketing authorisation

      2. PART 2

        Derogations from some of the requirements in Part 1

      3. PART 3

        Grant of a marketing authorisation

      4. PART 4

        Variations of marketing authorisations on the application of the holder

      5. PART 5

        Suspension, etc. of a marketing authorisation

      6. PART 6

        Mutual recognition and multiple applications

      7. PART 7

        Labelling and package leaflets

      8. PART 8

        Pharmacovigilance

      9. PART 9

        Homeopathic remedies

    2. SCHEDULE 2

      The manufacture of veterinary medicinal products

      1. PART 1

        Manufacturing authorisations

      2. PART 2

        Authorisation of manufacturers of autogenous vaccines

      3. PART 3

        Authorisation of blood banks

      4. PART 4

        Authorisation of manufacturers of products for administration under the cascade

      5. PART 5

        Authorisation of equine stem cell centres

    3. SCHEDULE 3

      Classification and supply, wholesale dealers and sheep dip

      1. PART 1

        Classification and supply of authorised veterinary medicinal products

      2. PART 2

        Requirements for a wholesale dealer’s authorisation

      3. PART 3

        Sheep dip

    4. SCHEDULE 4

      Administration of a veterinary medicinal product outside the terms of a marketing authorisation

    5. SCHEDULE 5

      Medicated feedingstuffs and specified feed additives

    6. SCHEDULE 6

      Exemptions for small pet animals

    7. SCHEDULE 7

      Fees

      1. PART 1

        Introduction

      2. PART 2

        Fees relating to marketing authorisations

      3. PART 3

        Fees payable by manufacturers

      4. PART 4

        Fees relating to a wholesale dealer’s authorisation

      5. PART 5

        Fees relating to feedingstuffs

      6. PART 6

        General

Go to Explanatory Note

The Secretary of State is a Minister designated(1) for the purposes of making Regulations under section 2(2) of the European Communities Act 1972(2) in relation to measures in the veterinary and phytosanitary fields for the protection of public health.

The Secretary of State has carried out the consultation required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(3).

In accordance with section 56(1) of the Finance Act 1973(4), the Treasury consent to the making of these Regulations.

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973.

(3)

OJ No. L31, 1.2.2002, p. 1. Back [3]

(4)

1973 c.51. Back [4]

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