The Veterinary Medicines Regulations 2009

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. 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. Revocation

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 a product authorised in another country

      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. Marketing authorisations in exceptional circumstances

         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 where the product is authorised using mutual recognition or the decentralised procedure

         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 of a marketing authorisation: grounds

         2. 39. Suspension of a marketing authorisation: procedure

         3. 40. Revocation

         4. 41. Prohibiting the supply of veterinary medicinal products

      6. PART 6 Mutual recognition and multiple applications

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

         2. 43. Application in another member State

         3. 44. 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. 45. Approval by the Secretary of State

         2. 46. Reference to being authorised

         3. 47. Language

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

         5. 49. Products with immediate and outer packaging

         6. 50. Package leaflets

         7. 51. Ampoules

         8. 52. Small containers other than ampoules

         9. 53. Homeopathic remedies

         10. 54. Variations

      8. PART 8 Pharmacovigilance

         1. 55. Qualified persons responsible for pharmacovigilance

         2. 56. Duties relating to the qualified person

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

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

         5. 59. Periodic safety update reports

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

         7. 61. Action taken on account of pharmacovigilance

      9. PART 9 Homeopathic remedies

         1. 62. Meaning of “homeopathic remedy”

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

         3. 64. Application for registration

         4. 65. Procedure for registration

         5. 66. Products on the market before 1994

         6. 67. Classification

   2. SCHEDULE 2

      The manufacture of veterinary medicinal products

      1. PART 1 Manufacturing authorisations

         1. 1. Application

         2. 2. Time limits

         3. 3. Granting the authorisation

         4. 4. The authorisation

         5. 5. Suspension, variation or revocation of the authorisation

         6. 6. Inspection of premises

         7. 7. Report following inspection

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

         9. 9. Qualified persons for manufacture

         10. 10. Refusal or revocation of appointment

         11. 11. Duties on a qualified person

         12. 12. Register

         13. 13. Test sites

      2. PART 2 Authorisation of manufacturers of autogenous vaccines

         1. 14. Authorisation to manufacture autogenous vaccines

         2. 15. Types of authorisation

         3. 16. Labelling

         4. 17. Records

         5. 18. Adverse reactions

         6. 19. Inspection of premises

      3. PART 3 Authorisation of blood banks

         1. 20. Authorisation of blood banks

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

         3. 22. Labelling

         4. 23. Records

         5. 24. Inspection of premises

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

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

         2. 26. Labelling

         3. 27. Records

         4. 28. Adverse reactions

         5. 29. Inspection of premises

      5. PART 5 Authorisation of equine stem cell centres

         1. 30. Authorisation of stem cell centres

         2. 31. Supply and administration of stem cells

         3. 32. Labelling

         4. 33. Records

         5. 34. 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 veterinary surgeon from registered premises

         9. 9. Supply by a veterinary surgeon

         10. 10. Supply by a pharmacist

         11. 11. Supply of a veterinary medicinal product for incorporation into feedingstuffs

         12. 12. Labelling at the time of retail supply

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

         14. 14. Supply by a suitably qualified person

         15. 15. Annual audit

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

         1. 16. Application

         2. 17. Time limits

         3. 18. Granting the authorisation

         4. 19. The authorisation

         5. 20. Suspension, variation or revocation of the authorisation

         6. 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. Administration to food-producing horses

      4. 4. Immunological products for serious epizootic disease

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

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

      7. 7. Treatment in exceptional circumstances

      8. 8. Administration of a homeopathic remedy

      9. 9. Administration under an animal test certificate

   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. Top dressing

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

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

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

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

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

      14. 14. Supply of specified feed additives

      15. 15. Supply of premixture

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

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

      18. 18. Writing the prescription

      19. 19. Possession

      20. 20. Sampling and analysis

      21. 21. Storage

      22. 22. Packages and other containers

      23. 23. Transport

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

      25. 25. Imports from third countries

      26. 26. Trade between member States

      27. 27. Import for incorporation into premixture or feedingstuffs for export

      28. 28. Animals on domestic premises

   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

         2. 2. Payment of fees

         3. 3. Time of payment

         4. 4. Multiple inspections

         5. 5. Expenses for inspections

         6. 6. Translation

      2. PART 2 Fees relating to marketing authorisations

         1. 7. Fees for specified pharmaceutical applications

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

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

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

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

         6. 12. Application for an exceptional marketing authorisation (pharmaceutical)

         7. 13. Fees for an application for an exceptional marketing authorisation (immunological)

         8. 14. Fee for the conversion from an exceptional to a full marketing authorisation

         9. 15. Application for a marketing authorisation relating to a parallel import

         10. 16. Application for a variation obtained under a national procedure

         11. 17. Application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures: fees until 1st January 2010

         12. 18. Application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures: fees from 1st January 2010

         13. 19. Application for an extension to a marketing authorisation

         14. 20. Decentralised application for an extension where the United Kingdom is the reference member State

         15. 21. Provision of information relating to the recognition of a United Kingdom marketing authorisation

         16. 22. Application for the renewal of a national marketing authorisation

         17. 23. Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure

         18. 24. Registration of a homeopathic remedy

         19. 25. Annual fees for marketing authorisations

         20. 26. Auditor’s certificate

         21. 27. Late payment of annual fees

      3. PART 3 Fees payable by manufacturers

         1. 28. Application for a manufacturing authorisation

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

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

         4. 31. Annual fees

         5. 32. Site inspections – type of site

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

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

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

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

         10. 37. Test sites

         11. 38. Animal blood bank or equine stem cell centre authorisations

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

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

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

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

         4. 42. Inspection of a wholesale dealer’s premises

      5. PART 5 Fees relating to feedingstuffs

         1. 43. Fees relating to feedingstuffs

         2. 44. Fees relating to premises for supply by suitably qualified persons

         3. 45. Reduced fees

      6. PART 6 General

         1. 46. Testing samples

         2. 47. Animal test certificates

         3. 48. Importation of a veterinary medicinal product for treatment under the cascade

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

         5. 50. Wholesale dealer’s import certificate

         6. 51. Specific batch control

         7. 52. Submission of control tests of an immunological product

         8. 53. Export certificates

         9. 54. Appeals to the Veterinary Products Committee: marketing authorisations and animal test certificates

         10. 55. Appeals to the Veterinary Products Committee: variations

         11. 56. Appeal to the Veterinary Products Committee: suspensions

         12. 57. Appeal to the Veterinary Products Committee: active substance under Schedule 6

         13. 58. Fee relating to an appointed person

         14. 59. Fees relating to a veterinary surgeon’s practice premises

         15. 60. Refund of fees relating to the Veterinary Products Committee or appointed persons

         16. 61. Fees relating to an improvement notice

         17. 62. Non-payment of fees

         18. 63. Waiver or reduction of fees

         19. 64. Reduction of fees when an application is withdrawn

9. Explanatory Note