The Veterinary Medicines Regulations 2005

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 with 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 purchase and administration

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

   5. 21. Records by holders of a manufacturing authorisation

   6. 22. Records by wholesale dealers

   7. 23. Records of products supplied on prescription

   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. Representations to the Veterinary Products Committee

   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 inspectors

   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 applications

         3. 8. Applications for products using a new combination of active substances

         4. 9. Applications 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 animals

         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 and revocation 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. Homoeopathic veterinary medicinal products

         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 Homoeopathic veterinary medicinal products

         1. 61. Meaning of “homoeopathic veterinary medicinal product”

         2. 62. Registration of a homoeopathic veterinary medicinal product

         3. 63. Application for registration

         4. 64. Procedure for registration

         5. 65. Products on the market before 1994

         6. 66. Administration

   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

   3. SCHEDULE 3

      Classification and supply and wholesale dealers

      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. Supply of products for incorporation into feedingstuffs

         5. 5. Prescriptions

         6. 6. Form of prescription

         7. 7. Labelling at the time of retail supply

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

         9. 9. Supply by a suitably qualified person

         10. 10. Annual audit

         11. 11. Supply of sheep dip

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

         1. 12. Application

         2. 13. Time limits

         3. 14. Granting the authorisation

         4. 15. The authorisation

         5. 16. Suspension or revocation of the authorisation

         6. 17. Representations

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

   4. SCHEDULE 4

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

      1. 1. Administration

      2. 2. Administration under the cascade

      3. 3. Withdrawal periods

      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

   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. Incorporation of a veterinary medicinal product into premixtures

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

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

      9. 9. Additional labelling requirement for premixtures containing a veterinary medicinal product

      10. 10. Labelling of feedingstuffs containing specified feed additives

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

      12. 12. Supply of specified feed additives

      13. 13. Supply of premixture

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

      15. 15. Possession

      16. 16. Sampling and analysis

      17. 17. Storage

      18. 18. Packages and other containers

      19. 19. Transport

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

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

      22. 22. Imports from third countries

      23. 23. 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

      3. 3. Manufacture

      4. 4. 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. Payment of fees

         2. 2. Time of payment

         3. 3. Multiple inspections

      2. PART 2 Fees relating to national marketing authorisations

         1. 4. Scope of Part 2

         2. 5. Standard application for a marketing authorisation

         3. 6. Application for a marketing authorisation for a product with an active substance not contained in a veterinary medicinal product previously authorised in the United Kingdom

         4. 7. Application for a marketing authorisation involving other aspects not previously authorised in a veterinary medicinal product in the UK

         5. 8. Pharmacologically equivalent products

         6. 9. Application for a marketing authorisation using identical data

         7. 10. Application for a provisional marketing authorisation

         8. 11. Application for a marketing authorisation relating to a parallel import

         9. 12. Application for a variation

         10. 13. Application for the renewal of a marketing authorisation

         11. 14. Registration of a homoeopathic veterinary medicinal product

      3. PART 3 Fees relating to decentralised and mutual recognition procedures

         1. 15. Scope of Part 3

         2. 16. Provision of information relating to the recognition of United Kingdom marketing authorisation

         3. 17. Mutual recognition of a marketing authorisation already granted in another member State

         4. 18. Decentralised procedure where the United Kingdom is the reference member State

         5. 19. Decentralised procedure where the United Kingdom is not the reference member State

         6. 20. Application for a variation

         7. 21. Application for the renewal of a marketing authorisation

      4. PART 4 Fees payable by manufacturers

         1. 22. Application for a manufacturing authorisation

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

         3. 24. Application for an authorisation to manufacture an autogenous vaccine

         4. 25. Annual fees

         5. 26. Site inspections – type of site

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

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

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

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

         10. 31. Test sites

         11. 32. Animal blood bank authorisations

         12. 33. Expenses

      5. PART 5 Fees relating to a wholesale dealer’s authorisation

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

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

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

      6. PART 6 Fees relating to feedingstuffs

         1. 37. Fees relating to feedingstuffs

         2. 38. Fees relating to distributors

      7. PART 7 General

         1. 39. Annual fees for marketing authorisations

         2. 40. Auditor’s certificate

         3. 41. Late payment of annual fees

         4. 42. Submission of samples in connection with applications for marketing authorisations and animal test certificates

         5. 43. Animal Test Certificates

         6. 44. Treatment under the cascade

         7. 45. Treatment in exceptional circumstances

         8. 46. Specific batch control

         9. 47. Submission of control tests of an immunological product

         10. 48. Export Certificates

         11. 49. Fees relating to premises for supply by suitably qualified persons

         12. 50. Application to the Veterinary Products Committee

         13. 51. Non-payment of fees

         14. 52. Waiver or reduction of fees

         15. 53. Reduction of fees when an application is withdrawn

   8. SCHEDULE 8

      Revocations and amendments.

      1. PART 1

      2. PART 2 Instruments revoked on 1st January 2006

      3. PART 3 Consequential amendments

         1. The Medicines (Standard Provisions for Licences and Certificates) Regulations 1971

            1. 1. After regulation 1 of the Medicines (Standard Provisions for Licences...

         2. The Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971

            1. 2. After regulation 1 of the Medicines (Applications for Manufacturer’s and...

         3. The Medicines (Control of Substances for Manufacture) Order 1971

            1. 3. After article 1 of the Medicines (Control of Substances for...

         4. The Medicines (Importation of Medicinal Products for Re-exportation) Order 1971

            1. 4. After article 1 of the Medicines (Importation of Medicinal Products...

         5. The Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971

            1. 5. (1) In article 1(2) of the Medicines (Exemption from Licences)...

         6. The Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972

            1. 6. (1) In article 1(2) of the Medicines (Exemption from Licences)...

         7. The Medicines (Extension to Antimicrobial Substances) Order 1973

            1. 7. After article 1 of the Medicines (Extension to Antimicrobial Substances)...

         8. The Medicines (Exemptions from Licences) (Emergency Importation) Order 1974

            1. 8. After article 1 of the Medicines (Exemptions from Licences) (Emergency...

         9. The Medicines (Exemption from Licences) (Ingredients) Order 1974

            1. 9. In the Medicines (Exemption from Licences) (Ingredients) Order 1974 (S.I....

         10. The Medicines (Labelling) Regulations 1976

             1. 10. (1) The Medicines (Labelling) Regulations 1976 (S.I. 1976/1726) shall be...

         11. The Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977

             1. 11. In the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977...

         12. The Medicines (Certificates of Analysis) Regulations 1977

             1. 12. In the Medicines (Certificates of Analysis) Regulations 1977 (S.I. 1977/1399)...

         13. The Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977

             1. 13. (1) In article 1(2) of the Medicines (Retail Sale or...

         14. The Medicines (Prohibition of Non-medicinal Antimicrobial Substances) Order 1977

             1. 14. After article 1 of the Medicines (Prohibition of Non-medicinal Antimicrobial...

         15. The Medicines (Fluted Bottles) Regulations 1978

             1. 15. (1) In regulation 1(2) of the Medicines (Fluted Bottles) Regulations...

         16. The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980

             1. 16. (1) In regulation 1(2)(a) of the Medicines (Sale or Supply)...

         17. The Medicines (Pharmacy and General Sale – Exemption) Order 1980

             1. 17. (1) In article 1(2) of the Medicines (Pharmacy and General...

         18. The Medicines (Control of Substances for Manufacture) Order 1985

             1. 18. After article 1 of the Medicines (Control of Substances for...

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

             1. 19. After rule 1 of The Medicines Act 1968 (Hearings by...

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

             1. 20. After rule 1 of the Medicines Act 1968 (Hearings by...

         21. The Medicines (Exemption from Licences) (Wholesale Dealing) Order 1990

             1. 21. (1) In article 1(2) of the Medicines (Exemption from Licences)...

         22. The Medicines (Advisory Board On The Registration Of Homoeopathic Products) Order 1995

             1. 22. Article 2(1)(b) of the Medicines (Advisory Board on the Registration...

      4. PART 4 Transitional provisions

         1. 1. Conversions of authorisations, etc.

         2. 2. Suitably qualified persons

         3. 3. Existing applications

         4. 4. Existing procedures

         5. 5. Records

         6. 6. Labels

         7. 7. Fees

         8. 8. References to “coming into force”

9. Explanatory Note