The Veterinary Medicines Regulations 2013

1. Introductory Text

2. PART 1

   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

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

   2. 5. Manufacture of veterinary medicinal products

   3. 6. Marketing of products not in accordance with a marketing authorisation

   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

   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

   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

   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. Offence

   17. 44. Penalties

   18. 45. Northern Ireland

   19. 46. Review

   20. 47. Revocations

7. Signature

8. 1. SCHEDULE 1

      Marketing authorisations

      1. PART 1

         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

         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

         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

         1. 33. Variation of a marketing authorisation

         2. 34. Refusal of a variation of a marketing authorisation

         3. 35. Administrative variations

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

         5. 37. Compulsory variation

      5. PART 5 etc.

         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

         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

         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

         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

         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

         7. 68. Offences

   2. SCHEDULE 2

      The manufacture of veterinary medicinal products

      1. PART 1

         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

         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

         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

         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

         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

         6. 35. Offences

   3. SCHEDULE 3

      Classification and supply, wholesale dealers and sheep dip

      1. PART 1

         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

         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

         1. 22. Supply of sheep dip

         2. 23. Use of sheep dip

         3. 24. Offences

   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

      10. 10. Offences

   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. Enforcement of Regulation (EC) No 767/2009

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

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

      9. 9. Top dressing

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

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

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

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

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

      15. 15. Supply of specified feed additives

      16. 16. Supply of premixture

      17. 17. Supply of a complementary feedingstuff

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

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

      20. 20. Writing the prescription

      21. 21. Possession

      22. 22. Sampling and analysis

      23. 23. Storage

      24. 24. Packages and other containers

      25. 25. Transport

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

      27. 27. Imports from third countries

      28. 28. Trade between member States

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

      30. 30. Animals on domestic premises

      31. 31. Offences

   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

         1. 1. Interpretation

         2. 2. Payment of fees

         3. 3. Time of payment

         4. 4. Multiple inspections

         5. 5. Expenses for inspections outside the United Kingdom

         6. 6. Translation

      2. PART 2

         1. 7. 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 or biosimilar product

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

         5. 11. Applications for a marketing authorisation using data already assessed

         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 to change the distribution category of a product authorised through the centralised procedure

         11. 17. Application for a variation to a marketing authorisation dealt with under national or mutual recognition variation procedures.

         12. 18. Application for a variation to a marketing authorisation dealt with under worksharing procedures

         13. 19. Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member State

         14. 20. Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension

         15. 21. Exception for a variation relating to animal testing

         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. Renewal of a homeopathic remedy

         20. 26. Annual fees for marketing authorisations

         21. 27. Auditor’s certificate

      3. PART 3

         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

         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

         1. 43. Fees for approvals and annual fees relating to feedingstuffs in Great Britain

         2. 44. Inspection fees relating to feedingstuffs in Great Britain

         3. 45. Fees payable in relation to feedingstuffs in Northern Ireland

         4. 46. Fees relating to premises for supply by suitably qualified persons

      6. PART 6

         1. 47. Testing samples

         2. 48. Animal test certificates

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

         4. 50. Wholesale dealer’s import certificate

         5. 51. Specific batch control

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

         7. 53. Export certificates

         8. 54. Provision of advice

         9. 55. Appeals to the Veterinary Products Committee

         10. 56. Fee relating to an appointed person

         11. 57. Fees relating to a veterinary surgeon’s practice premises

         12. 58. Refund of fees relating to the Veterinary Products Committee or appointed persons

         13. 59. Fees relating to an improvement notice

         14. 60. Non-payment of fees

         15. 61. Waiver or reduction of fees

         16. 62. Reduction of fees when an application is withdrawn

9. Explanatory Note