The Veterinary Medicines Regulations 2013

  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.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. 10A.Inducements and hospitality

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

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

    11. 13.Wholesale dealing

    12. 14.Feedingstuffs

    13. 15.Exemptions

    14. 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

    9. 24A.Reporting of sales and usage data in relation to antibiotics

  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.Offence

    17. 44.Penalties

    18. 45.Northern Ireland

    19. 46.Review

    20. 47.Revocations

  7. Signature

    1. SCHEDULE 1

      Marketing authorisations in Great Britain in Northern Ireland

      1. PART 1 Application for a marketing authorisation

        1. 1.Application for a marketing authorisation

        2. 2.Information with the application: general

        3. 2A.Information with the application: format

        4. 2B.Information with the application: animal testing

        5. 2C.Information with the application: POM-VPS, NFA-VPS and AVM-GSL

        6. 3.Summary of product characteristics

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

        8. 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 generic veterinary medicinal product

        6. 10A.Hybrid veterinary medicinal products

        7. 11.Time limits for marketing authorisations granted under the procedure for a generic veterinary medicinal product

        8. 12.Extension of time limits

        9. 12A.Time limits – supplementary

        10. 13.Parallel imports

        11. 14.Specific batch control scheme

        12. 15.Similar immunological products

        13. 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. 22A.Withdrawal of application for marketing authorisation

        8. 23.Marketing authorisations for food-producing species

        9. 24.Refusal of a marketing authorisation

        10. 25.Publication following the grant , refusal, suspension, variation or revocation of a marketing authorisation

        11. 26.Marketing authorisations in exceptional circumstances

        12. 27.Provisions of samples and expertise

        13. 28.Records and supply of information

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

        15. 30.Control tests

        16. 31.Placing on the market

        17. 32.Duration and validity of marketing authorisation

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

        1. 33.Variation of a marketing authorisation

        2. 33A.Variation procedure

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

        4. 35.Administrative variations

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

        6. 37.Compulsory variation

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

        1. 38.Suspension , revocation, etc 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

        5. 41A.Temporary restrictions

        6. 41B.Restrictions in relation to immunological veterinary medicines

      6. PART 6 Mutual recognition and multiple applications

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

        2. 43.Application in a 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 of immediate packaging of veterinary medicinal products

        5. 49.Labelling of the outer packaging of veterinary medicinal products

        6. 50.Labelling of small immediate packaging units of veterinary medicinal products

        7. 51.Package leaflet of veterinary medicinal products

        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 of marketing authorisation holder in relation to pharmacovigilance

        3. 56A.Duties of marketing authorisation holder in relation to signal management process

        4. 56B.Duties of qualified person (pharmacovigilance)

        5. 56C.Signal management process

        6. 57.Adverse events following administration of a veterinary medicinal product

        7. 58.Adverse reactions to a veterinary medicinal product administered in another country

        8. 59.Annual benefit-risk reports

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

        10. 60A.Pharmacovigilance inspections by Secretary of State

        11. 60B.Powers of Secretary of State in relation to signal management process

        12. 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

        7. 68.Offences

    2. SCHEDULE 1A

      Converted EU marketing authorisations

      1. 1.In this Schedule— “ converted EU marketing authorisation ” means...

      2. 2.This paragraph applies to an EU marketing authorisation which—

      3. 3.A converted EU marketing authorisation has effect on and after...

      4. 4.Without prejudice to the generality of paragraph 3—

    3. SCHEDULE 1B

      Qualifying Northern Ireland good (QNIG) certificates

      1. 1.In this Schedule— “QNIG certificate” means a certificate issued under...

      2. 2.This Schedule applies to a veterinary medicinal product which is—...

      3. 3.If the condition in paragraph 4 is met in respect...

      4. 4.The condition is that the person who holds a marketing...

      5. 5.A QNIG certificate has effect as if it were a...

      6. 6.The QNIG certificate holder must provide to the Secretary of...

      7. 7.Without prejudice to any other power to suspend a marketing...

      8. 8.The Secretary of State must publish any notice given under...

      9. 9.Paragraphs 39 and 40 of Schedule 1 apply to the...

    4. SCHEDULE 2

      The manufacture of veterinary medicinal products

      1. PART 1 Manufacturing authorisations

        1. 1.Manufacturing authorisation

        2. 2.Application for authorisation

        3. 3.Procedure for grant of authorisations and time limits

        4. 4.The authorisation

        5. 4A.Application for variation to the authorisation

        6. 5.Suspension, revocation etc of the authorisation

        7. 6.Good manufacturing practice certificates and inspection of sites

        8. 7.Report following inspection

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

        10. 8A.Good manufacturing practice

        11. 8B.Recalled and counterfeit products

        12. 9.Qualified persons for manufacture

        13. 10.Refusal, revocation, suspension or variation of appointment

        14. 11.Duties on a qualified person

        15. 12.Register

        16. 13.Test sites

      2. PART 2 Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade

        1. 14.Authorisation to manufacture specific veterinary medicinal products

        2. 15.Prohibition

        3. 16.Personnel

        4. 17.Process of authorisation

        5. 18.Authorisation in relation to blood banks

        6. 19.Authorisation in relation to stem cells

        7. 20.Authorisation in relation to products for administration under the cascade

        8. 21.Suspension, compulsory variation or revocation of authorisation

        9. 22.Labelling

        10. 23.Records

        11. 24.Adverse events

        12. 25.Inspection of sites

      3. PART 2A Active Substances

        1. 26.Prohibition on manufacture, importation or distribution of active substances unless registered

        2. 27.Application for registration

        3. 28.Good manufacturing or distribution practice

        4. 29.Supply of information

        5. 30.Inspection of sites

        6. 31.Report following inspection

      4. PART 2B Schedule 2 Offences

        1. 32.Offences

        2. 33.Records

        3. 34.Inspection of premises

        4. 35.Offences

    5. 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. 3A.Supply of samples

        5. 3B.Register of online suppliers of veterinary medicinal products

        6. 3C.Application for registration

        7. 3D.Duties in relation to online supply

        8. 3E.Retail storage of veterinary medicinal products

        9. 4.Prescriptions by a veterinary surgeon

        10. 5.Prescriptions

        11. 6.Written prescriptions

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

        13. 7A.Duties in relation to prescribing of antibiotic veterinary medicinal products

        14. 8.Supply by a veterinary surgeon from registered premises

        15. 9.Supply by a veterinary surgeon

        16. 10.Supply by a pharmacist

        17. 11.Supply of a medicinal premix

        18. 12.Labelling at the time of retail supply

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

        20. 14.Supply by a suitably qualified person

        21. 15.Audit

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

        1. 16.Wholesale dealer’s authorisation

        2. 17.Application for authorisation

        3. 18.Procedure and time limits for authorisations

        4. 19.Periodic inspections and suspension etc. for lack of use

        5. 19A.Application for variation to the authorisation

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

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

        8. 21A.Register of authorised wholesale dealers

        9. 21B.Documentation accompanying veterinary medicinal products supplied wholesale

        10. 21C.Recalled, counterfeit or returned products

        11. 21D.Audit

        12. 21E.Contractual arrangements between holders of wholesale dealer’s authorisations

        13. 21F.Self-inspection programme

      3. PART 3 Sheep dip

        1. 22.Supply of sheep dip

        2. 23.Use of sheep dip

        3. 24.Offences

    6. 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 or emerging disease

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

      6. 6.Administration by veterinary surgeons from other countries

      7. 6A.Administration of autogenous vaccines

      8. 7.Treatment in exceptional circumstances

      9. 8.Administration of a homeopathic remedy

      10. 9.Administration under an animal test certificate

      11. 9A.Misuse of the cascade

      12. 10.Offences

    7. 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 (EU) 2017/625

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

      6. 6.Enforcement of Regulation (EC) No 767/2009

      7. 7.Authorisation of manufacturers and distributors of feedingstuffs containing medicinal premixes

      8. 8.Incorporation of a medicinal premix into an intermediate feedingstuff

      9. 9.Top dressing

      10. 10.Incorporation of a medicinal premix into feedingstuffs

      11. 11.Additional record keeping requirements relating to medicinal premixes

      12. 12.Labelling an intermediate feedingstuff containing a medicinal premix

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

      14. 14.Labelling of feedingstuffs containing a medicinal premix

      15. 15.Supply of specified feed additives

      16. 16.Supply of intermediate feedingstuff or specified feed additive

      17. 17.Supply of a complementary feedingstuff

      18. 18.Supply of feedingstuffs containing a medicinal premix

      19. 19.Medicated feedingstuff prescriptions for feedingstuffs containing a medicinal premix

      20. 20.Writing the medicated feedingstuff prescription

      21. 21.Possession

      22. 22.Sampling and analysis

      23. 22A.Sampling for cross-contamination

      24. 23.Storage

      25. 24.Packages and other containers

      26. 25.Transport

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

      28. 26A.Unused and expired medicated feedingstuffs

      29. 27.Imports from third countries

      30. 28.Trade between countries

      31. 29.Import for incorporation into intermediate feedingstuffs or feedingstuffs for export

      32. 30.Animals on domestic premises

      33. 31.Offences

    8. 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. 3A.Register of persons placing veterinary medicinal products on the market (small pet animals)

      5. 3B.Persons registered in accordance with paragraph 3A: annual return

      6. 4.Approval of the active substance

      7. 5.The product

      8. 6.Labelling

      9. 7.Administration

      10. 8.Pack size

      11. 9.Adverse events

      12. 10.Offences

    9. 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 outside the United Kingdom

        6. 6.Translation

      2. PART 2 Fees relating to marketing authorisations

        1. 7.Application for a marketing authorisation for a pharmaceutical , immunological or biological that is not immunological veterinary medicinal product

        2. 7A.Application for a marketing authorisation for specific applications

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

        4. 9.Application for a marketing authorisation for an immunological or biosimilar product

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

        6. 11.Application for a marketing authorisation based on informed consent

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

        8. 13.Fees for an application for an exceptional marketing authorisation (immunological or biological non-immunological)

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

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

        11. 15A.Fee for a generic marketing authorisation

        12. 16.Application to change the distribution category of a product authorised through the centralised procedure

        13. 17.Application for a variation to a marketing authorisation ....

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

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

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

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

        18. 22.Application for a reassessment of an exceptional marketing authorisation

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

        20. 24.Registration of a homeopathic remedy

        21. 25.Renewal of a homeopathic remedy

        22. 26.Annual fees for marketing authorisations

        23. 27.Auditor’s certificate

      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.Inspection of sites authorised to manufacture a product for administration under the cascade

        4. 30A.Autogenous vaccines

        5. 30B.Assessment of a variation of an authorisation to manufacture an autogenous vaccine

        6. 31.Annual fee (manufacturing authorisations)

        7. 32.Site inspections – type of site

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

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

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

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

        12. 37.Test sites

        13. 38.Animal blood bank or non-food animal 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 sites

      5. PART 5 Fees relating to feedingstuffs

        1. 43.Fees for applications for authorisation 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 General

        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. 54A.Provision of scientific advice

        10. 55.Appeals to the Veterinary Products Committee

        11. 56.Fee relating to an appointed person

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

        13. 57A.Fee in relation to verifying destruction of controlled drug

        14. 57B.Pharmacovigilance inspections

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

        16. 59.Fees relating to an improvement notice

        17. 60.Non-payment of fees

        18. 61.Waiver or reduction of fees

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

  9. Explanatory Note