The Veterinary Medicines Regulations 2006

1. Introductory Text

2. 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

3. 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

4. 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

5. 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

6. PART 5 Miscellaneous provisions, enforcement and offences

   1. 28. The Veterinary Products Committee

   2. 29. Procedure for suspending, etc. a marketing authorisation or animal test certificate

   3. 30. Duties on the Secretary of State relating to exports

   4. 31. Time limits

   5. 32. Appointment of inspectors

   6. 33. Powers of entry

   7. 34. Powers of an inspector

   8. 35. Inspection of pharmacies

   9. 36. Obstruction

   10. 37. Improvement notices

   11. 38. Appeals against improvement notices

   12. 39. Powers of a court on appeal

   13. 40. Seizure notices

   14. 41. Publication of notices

   15. 42. Penalties

   16. 43. Northern Ireland

   17. 44. Revocations and amendments

7. Signature

8. 1. SCHEDULE 1

      MARKETING AUTHORISATIONS

      1. PART 1 Application for a marketing authorisation

         1. 1. Application for a marketing authorisation

         2. 2. Information with the application

         3. 3. Summary of product characteristics

         4. 4. Supply of a copy of the summary of product characteristics

         5. 5. Time limits for applications for products for use in food-producing animals

      2. PART 2 Derogations from some of the requirements in Part 1

         1. 6. Scope

         2. 7. Bibliographic application

         3. 8. Application for a product using a new combination of active substances

         4. 9. Application using existing data

         5. 10. Application for a pharmacologically equivalent medicinal product

         6. 11. Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product

         7. 12. Extension of time limits

         8. 13. Parallel imports

         9. 14. Specific batch control scheme

         10. 15. Similar immunological products

         11. 16. Marketing in exceptional circumstances

      3. PART 3 Grant of a marketing authorisation

         1. 17. Time limits

         2. 18. Place of establishment of applicant

         3. 19. Procedure

         4. 20. Products authorised in another member State

         5. 21. Assessment reports

         6. 22. Grant of a marketing authorisation

         7. 23. Marketing authorisations for food-producing species

         8. 24. Refusal of a marketing authorisation

         9. 25. Publication following the grant of a marketing authorisation

         10. 26. Provisional marketing authorisation

         11. 27. Provisions of samples and expertise

         12. 28. Supply of information

         13. 29. Duties on the holder of a marketing authorisation relating to an immunological product

         14. 30. Control tests

         15. 31. Placing on the market

         16. 32. Duration and validity of a marketing authorisation

      4. PART 4 Variations of marketing authorisations on the application of the holder

         1. 33. Variation of a marketing authorisation for a mutually recognised veterinary medicinal product

         2. 34. Variation of a marketing authorisation not authorised in another member State

         3. 35. Administrative variations

         4. 36. Changes after a marketing authorisation has been issued

         5. 37. Compulsory variation

      5. PART 5 Suspension, etc. of a marketing authorisation

         1. 38. Suspension, etc. of a marketing authorisation

         2. 39. Suspension, etc. of a marketing authorisation of a product authorised in more than one member State

         3. 40. Prohibiting the supply of veterinary medicinal products

      6. PART 6 Mutual recognition and multiple applications

         1. 41. Application for a marketing authorisation where one already exists in another member State

         2. 42. Application in another member State

         3. 43. Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State

      7. PART 7 Labelling and package leaflets

         1. 44. Approval by the Secretary of State

         2. 45. Reference to being authorised

         3. 46. Language

         4. 47. Labelling with all the information on the immediate packaging

         5. 48. Products with immediate and outer packaging

         6. 49. Package leaflets

         7. 50. Ampoules

         8. 51. Small containers other than ampoules

         9. 52. Homeopathic remedies

         10. 53. Variations

      8. PART 8 Pharmacovigilance

         1. 54. Qualified persons responsible for pharmacovigilance

         2. 55. Duties relating to the qualified person

         3. 56. Adverse reactions to a veterinary medicinal product administered in the United Kingdom

         4. 57. Adverse reactions to a veterinary medicinal product administered in a third country

         5. 58. Periodic safety update reports

         6. 59. Release of information by the marketing authorisation holder

         7. 60. Action taken on account of pharmacovigilance

      9. PART 9 Homeopathic remedies

         1. 61. Meaning of “homeopathic remedy”

         2. 62. Placing a homeopathic remedy on the market in accordance with a registration

         3. 63. Application for registration

         4. 64. Procedure for registration

         5. 65. Products on the market before 1994

         6. 66. Classification

   2. SCHEDULE 2

      THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS

      1. PART 1 Manufacturing authorisation

         1. 1. Application

         2. 2. Time limits

         3. 3. Granting the authorisation

         4. 4. The authorisation

         5. 5. Suspension or revocation of the authorisation

         6. 6. Representation to the Secretary of State

         7. 7. Inspection of premises

         8. 8. Report following inspection

         9. 9. Duties on the holder of a manufacturing authorisation

         10. 10. Qualified persons for manufacture

         11. 11. Refusal or revocation of appointment

         12. 12. Duties on a qualified person

         13. 13. Register

         14. 14. Test sites

      2. PART 2 Authorisation of manufacturers of autogenous vaccines

         1. 15. Authorisation to manufacture autogenous vaccines

         2. 16. Types of authorisation

         3. 17. Labelling

         4. 18. Records

         5. 19. Adverse reactions

         6. 20. Inspection of premises

      3. PART 3 Authorisation of blood banks

         1. 21. Authorisation of blood banks

         2. 22. Supply and administration of blood from a blood bank

         3. 23. Labelling

         4. 24. Records

         5. 25. Inspection of blood banks

      4. PART 4 Authorisation of manufacturers of products for administration under the cascade

         1. 26. Authorisation to manufacture products for administration under the cascade

         2. 27. Labelling

         3. 28. Records

         4. 29. Adverse reaction

         5. 30. Inspection of premises

   3. SCHEDULE 3

      CLASSIFICATION AND SUPPLY, WHOLESALE DEALERS AND SHEEP DIP

      1. PART 1 Classification and supply of authorised veterinary medicinal products

         1. 1. Classification of veterinary medicinal products

         2. 2. Wholesale supply of veterinary medicinal products

         3. 3. Retail supply of veterinary medicinal products

         4. 4. Prescriptions by a veterinary surgeon

         5. 5. Prescriptions

         6. 6. Written prescriptions

         7. 7. Duties when a product is prescribed or supplied

         8. 8. Supply by a pharmacist

         9. 9. Supply by a veterinary surgeon when he is not present

         10. 10. Supply of products for incorporation into feedingstuffs

         11. 11. Labelling at the time of retail supply

         12. 12. Supply of veterinary medicinal products for use under the cascade

         13. 13. Supply by a suitably qualified person

         14. 14. Annual audit

      2. PART 2 Requirements for a wholesale dealer’s authorisation

         1. 15. Application

         2. 16. Time limits

         3. 17. Granting the authorisation

         4. 18. The authorisation

         5. 19. Suspension or revocation of the authorisation

         6. 20. Representations

         7. 21. Duties on the holder of a wholesale dealer’s authorisation

      3. PART 3 Sheep dip

         1. 22. Supply of sheep dip

         2. 23. Use of sheep dip

   4. SCHEDULE 4

      ADMINISTRATION OF A VETERINARY MEDICINAL PRODUCT OUTSIDE THE TERMS OF A MARKETING AUTHORISATION

      1. 1. Administration under the cascade

      2. 2. Withdrawal periods

      3. 3. Immunological products for serious epizootic disease

      4. 4. Immunological products for an imported or exported animal

      5. 5. Administration by veterinary surgeons from other member States

      6. 6. Treatment in exceptional circumstances

      7. 7. Administration of a homeopathic remedy

   5. SCHEDULE 5

      MEDICATED FEEDINGSTUFFS AND SPECIFIED FEED ADDITIVES

      1. 1. Scope and interpretation

      2. 2. Enforcement of Regulation (EC) No. 178/2002

      3. 3. Enforcement of Regulation (EC) No. 1831/2003

      4. 4. Enforcement of Regulation (EC) No. 882/2004

      5. 5. Enforcement of Regulation (EC) No. 183/2005

      6. 6. Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

      7. 7. Incorporation of a veterinary medicinal product into a premixture

      8. 8. Incorporation of a veterinary medicinal product into feedingstuffs

      9. 9. Additional record keeping requirements relating to veterinary medicinal products

      10. 10. Labelling a premixture containing a veterinary medicinal product

      11. 11. Labelling of feedingstuffs containing a specified feed additive

      12. 12. Labelling of feedingstuffs containing a veterinary medicinal product

      13. 13. Supply of specified feed additives

      14. 14. Supply of premixture

      15. 15. Supply of feedingstuffs containing a veterinary medicinal product

      16. 16. Possession

      17. 17. Sampling and analysis

      18. 18. Storage

      19. 19. Packages and other containers

      20. 20. Transport

      21. 21. Possession, placing on the market and use of feedingstuffs

      22. 22. Prescriptions for feedingstuffs containing a veterinary medicinal product

      23. 23. Imports from third countries

      24. 24. Trade between member States

   6. SCHEDULE 6

      EXEMPTIONS FOR SMALL PET ANIMALS

      1. 1. Animals to which this Schedule applies

      2. 2. Placing on the market, importing and administering the product

      3. 3. Manufacture

      4. 4. Approval of the active substance

      5. 5. The product

      6. 6. Labelling

      7. 7. Administration

      8. 8. Pack size

      9. 9. Adverse reactions

   7. SCHEDULE 7

      FEES

      1. PART 1 Introduction

         1. 1. Interpretation of Schedule 7

         2. 2. Payment of fees

         3. 3. Time of payment

         4. 4. Multiple inspections

         5. 5. Translation

      2. PART 2 Fees relating to marketing authorisations

         1. 6. Fees for specified pharmaceutical applications

         2. 7. Decentralised pharmaceutical application where the United Kingdom is the reference member State

         3. 8. Application for a marketing authorisation for an immunological product

         4. 9. Decentralised immunological application where the United Kingdom is the reference member State

         5. 10. Application for a marketing authorisation using identical data

         6. 11. Application for a provisional marketing authorisation

         7. 12. Application for a marketing authorisation relating to a parallel import

         8. 13. Application for a variation

         9. 14. Application for a variation to a marketing authorisation that has been issued in other member States

         10. 15. Application for an extension to a marketing authorisation

         11. 16. Decentralised application for an extension where the United Kingdom is the reference member State

         12. 17. Provision of information relating to the recognition of a United Kingdom marketing authorisation

         13. 18. Application for the renewal of a national marketing authorisation

         14. 19. Application for the renewal of a marketing authorisation granted in more than one member State

         15. 20. Registration of a homeopathic remedy

         16. 21. Annual fees for marketing authorisations

         17. 22. Auditor’s certificate

         18. 23. Late payment of annual fees

      3. PART 3 Fees payable by manufacturers

         1. 24. Application for a manufacturing authorisation

         2. 25. Application for a variation of a manufacturing authorisation

         3. 26. Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade

         4. 27. Annual fees

         5. 28. Site inspections—type of site

         6. 29. Inspection of a site where immunological veterinary medicinal products are manufactured

         7. 30. Inspection of a site where sterile veterinary medicinal products are manufactured

         8. 31. Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured

         9. 32. Inspection of a site where veterinary medicinal products are assembled

         10. 33. Test sites

         11. 34. Animal blood bank authorisations

         12. 35. Expenses

      4. PART 4 Fees relating to a wholesale dealer’s authorisation

         1. 36. Application for a wholesale dealer’s authorisation

         2. 37. Variation of a wholesale dealer’s authorisation

         3. 38. Annual fee for a wholesale dealer’s authorisation

      5. PART 5 Fees relating to feedingstuffs

         1. 39. Fees relating to feedingstuffs

         2. 40. Fees relating to distributors

      6. PART 6 General

         1. 41. Testing samples

         2. 42. Animal test certificates

         3. 43. Treatment under the cascade

         4. 44. Treatment in exceptional circumstances

         5. 45. Specific batch control

         6. 46. Submission of control tests of an immunological product

         7. 47. Export certificates

         8. 48. Fees relating to premises for supply by suitably qualified persons

         9. 49. Application to the Veterinary Products Committee

         10. 50. Non-payment of fees

         11. 51. Waiver or reduction of fees

         12. 52. Reduction of application fee

   8. SCHEDULE 8

      AMENDMENTS TO THE MEDICINES ACTS ETC.

      1. PART 1 Consequential amendments to the Medicines Acts 1968 and 1971

         1. 1. The Medicines Act 1968

         2. 2. In section 1 (Ministers responsible for administration of the Act)—...

         3. 3. In section 3 (functions of the Commission), in subsection (1),...

         4. 4. In section 4 (establishment of committees)— (a) in subsection (1),...

         5. 5. In section 5 (supplementary provisions as to Commission and committees)—...

         6. 6. In section 6 (the licensing authority)— (a) in subsection (1),...

         7. 7. In section 7 (general provisions as to dealing with medicinal...

         8. 8. In section 8 (provisions as to manufacture and wholesale dealing)—...

         9. 9. In section 9 (exemptions for doctors, dentists, veterinary surgeons and...

         10. 10. In section 10 (exemptions for pharmacists)— (a) in subsection (1),...

         11. 11. In section 15 (provision for extending or modifying exemptions)—

         12. 12. In section 18 (application for licence), omit subsection (3).

         13. 13. In section 23 (special provisions as to effect of manufacturer’s...

         14. 14. In section 28 (general power to suspend, revoke or vary...

         15. 15. Sections 32 to 36 and 38 to 40 shall be...

         16. 16. In section 44 (provision of information to the licensing authority)—...

         17. 17. In section 45 (offences under Part II)—

         18. 18. In section 46 (special defences under s45)—

         19. 19. In section 47 (standard provisions for licences or certificates)—

         20. 20. In section 48 (postponement of restrictions in relation to exports),...

         21. 21. In section 49 (special provisions in respect of exporting certain...

         22. 22. In section 51 (general sale lists)— (a) in subsection (1),...

         23. 23. In section 52 (sale or supply of medicinal products not...

         24. 24. In section 53 (sale or supply of medicinal products on...

         25. 25. In section 54 (sale of medicinal products from automatic machines),...

         26. 26. In section 55 (exemptions for doctors, dentists, veterinary surgeons and...

         27. 27. In section 56 (exemptions in respect of herbal remedies), in...

         28. 28. In section 57 (power to extend or modify exemptions)—

         29. 29. In section 58 (medicinal products on prescription only)—

         30. 30. In section 58A (requirement to specify certain products for human...

         31. 31. Section 58B (requirement to specify certain products for veterinary use...

         32. 32. In section 59 (special provisions in relation to new medicinal...

         33. 33. In section 60 (restricted sale, supply and administration of certain...

         34. 34. In section 61 (special restrictions on persons to be supplied...

         35. 35. In section 62 (prohibition of sale or supply, or importation,...

         36. 36. In section 65 (compliance with standards specified in monographs in...

         37. 37. In section 66 (further powers to regulate dealings with medicinal...

         38. 38. In section 72A (the responsible pharmacist)— (a) in subsection (2),...

         39. 39. In section 73 (power to extend or modify conditions)—

         40. 40. In section 76 (supplementary provisions as to registration of premises),...

         41. 41. In section 79 (provision for modifying or extending restrictions under...

         42. 42. In section 85 (labelling and marking of containers and packages),...

         43. 43. In section 86 (leaflets), in subsection (1), omit “appropriate”.

         44. 44. In section 87 (requirements as to containers), in subsection (1)—...

         45. 45. In section 88 (distinctive colours, shapes and markings of medicinal...

         46. 46. In section 89 (display of information on automatic machines), in...

         47. 47. Section 90 (provisions as to medicated animal feeding stuffs) shall...

         48. 48. In section 91 (offences under Part V, and supplementary provisions)—...

         49. 49. In section 95 (powers to regulate advertisements and representations)—

         50. 50. In section 99 (new editions of British Pharmacopoeia, and other...

         51. 51. In section 101 (other publications), in subsection (2)—

         52. 52. In section 102 (supplementary provisions)— (a) in subsection (2)—

         53. 53. In section 103 (construction of references to specified publications), in...

         54. 54. In section 104 (application of Act to certain articles and...

         55. 55. In section 105 (application of Act to certain other substances...

         56. 56. In section 108 (enforcement in England and Wales)—

         57. 57. In section 109 (enforcement in Scotland), in subsection (2), omit...

         58. 58. In section 110 (enforcement in Northern Ireland)—

         59. 59. In section 116 (liability to forfeiture under Customs and Excise...

         60. 60. Section 117 (special enforcement and sampling provisions relating to animal...

         61. 61. In section 121 (contravention due to default of other person),...

         62. 62. In section 122 (warranty as defence), in subsection (2), omit...

         63. 63. In section 125 (prosecutions), in subsection (4)—

         64. 64. In section 126 (presumptions)— (a) in subsection (1)—

         65. 65. In section 129 (orders and regulations)— (a) in subsection (2),...

         66. 66. In section 130 (meaning of “medicinal product” and related expressions)—...

         67. 67. In section 132 (general interpretation provisions)— (a) in subsection (1)—...

         68. 68. In Schedule 3 (sampling), in paragraph 17—

         69. 69. In Schedule 4 (provisions relating to Northern Ireland)—

         70. 70. The Medicines Act 1971

      2. PART 2 Consequential amendments to secondary legislation

         1. 1. The Medicines (Surgical Materials) Order 1971

         2. 2. The Medicines (Specified Articles and Substances) Order 1976

         3. 3. The Medicines (Radioactive Substances) Order 1978

         4. 4. The Medicines (Administration of Radioactive Substances) Regulations 1978

         5. 5. The Medicines (Cyanogenetic Substances) Order 1984

         6. 6. The Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986

         7. 7. The Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992

         8. 8. The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

         9. 9. The Medicines (Advertising) Regulations 1994

         10. 10. The Medicines (Monitoring of Advertising) Regulations 1994

         11. 11. The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

         12. 12. The Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003

         13. 13. The Herbal Medicines Advisory Committee Order 2005

         14. 14. The Medicines (Advisory Bodies) (No. 2) Regulations 2005

   9. SCHEDULE 9

      OTHER CONSEQUENTIAL AMENDMENTS

      1. PART 1 Consequential amendments to primary legislation

         1. 1. The Pharmacy Act 1954

         2. 2. The Trade Descriptions Act 1968

         3. 3. The Poisons Act 1972

         4. 4. The City of London (Various Powers) Act 1977

         5. 5. The Sporting Events (Control of Alcohol etc.) Act 1985

         6. 6. The Animals (Scientific Procedures) Act 1986

         7. 7. The Consumer Protection Act 1987

         8. 8. The Environmental Protection Act 1990

         9. 9. The Sunday Trading Act 1994

         10. 10. The Value Added Tax Act 1994

         11. 11. The Criminal Law (Consolidation) (Scotland) Act 1995

         12. 12. The Food Standards Act 1999

         13. 13. The Licensing Act 2003

      2. PART 2 Consequential revocations of and amendments to secondary legislation

         1. 1. Revocations

         2. 2. Importation of Animal Pathogens Order 1980

         3. 3. The Warble Fly (England and Wales) Order 1982

         4. 4. The Environmental Protection (Prescribed Processes and Substances) Regulations 1991

         5. 5. The Products of Animal Origin (Import and Export) Regulations 1996

9. Explanatory Note