UK Statutory Instrument SI 2007/2539 United Kingdom

The Veterinary Medicines Regulations 2007

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Regulated 4 of 35 obligations carry a criminal penalty. 31 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer17 Any Person12 Distributor2 Trader1 Applicant1 Operator1

Plus 1 duty on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Manufacturer — also bound by 502 other Acts
Any Person — also bound by 2340 other Acts
Distributor — also bound by 182 other Acts
Trader — also bound by 825 other Acts
Companies Act 2006 243 duties
Companies Act 1985 85 duties
Applicant — also bound by 307 other Acts
Operator — also bound by 746 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

sch. 4 Administration under the cascade Regulated
  • Veterinary surgeon must use the cascade to choose a suitable medicine for animalsAny Person
sch. 5 Scope and interpretation Regulated
  • Obtain approval to make or sell medicated feed or premixturesDistributor
sch. 6 Animals to which this Schedule applies Regulated
  • Notify Secretary of State of serious adverse reactions to veterinary medicines within 15 daysManufacturer
s.005 Manufacture of veterinary medicinal products Regulated
  • Ensure veterinary medicines are manufactured by the authorised manufacturerAny Person
s.018 Food-producing animals: records of administration by a veterinary surgeon Regulated
  • Record veterinary medicine administration to food-producing animalsAny Person
s.021 Records by a holder of a manufacturing authorisation Regulated
  • Keep records of each veterinary medicinal product batch and retain for 5 yearsManufacturer
s.022 Records by a holder of a wholesale dealer’s authorisation Regulated
  • Record all veterinary medicine transactions as a wholesale dealerAny Person
s.024 Records of products administered to a food-producing animal under the cascade Regulated
  • Fail to keep cascade administration records for food-producing animalsAny Person
39 other provisions — procedural and definitional
s.001 Title and commencement
s.002 Definition of “veterinary medicinal product”, interpretation and scope
s.003 Products to which these Regulations do not apply
s.004 Placing a veterinary medicinal product on the market
s.006 The finished product
s.007 Classification, supply and possession of the product
s.008 Administration of the product
s.009 Importation of authorised veterinary medicinal products
s.010 Advertising the product
s.011 Advertising of prescription products and products containing psychotropic drugs or narcotics
s.012 Defence of publication in the course of business
s.013 Wholesale dealing
s.014 Feedingstuffs
s.015 Exemptions
s.016 Fees
s.017 Food-producing animals: proof of purchase of veterinary medicinal products
s.019 Food-producing animals: records of acquisition and administration
s.020 Food-producing animals: retention of records
s.023 Records of the receipt or supply of prescription products
s.025 Importation of an unauthorised veterinary medicinal product
s.026 Possession of an unauthorised veterinary medicinal product
s.027 Supply of an unauthorised veterinary medicinal product
s.028 The Veterinary Products Committee
s.029 Veterinary Products Committee appeals procedure
s.030 Exports
s.031 Time limits
s.032 Appointment of inspectors
s.033 Powers of entry
s.034 Powers of an inspector
s.035 Inspection of pharmacies
s.036 Obstruction
s.037 Improvement notices
s.038 Appeals against improvement notices
s.039 Powers of a court on appeal
s.040 Seizure notices
s.041 Publication
s.042 Penalties
s.043 Northern Ireland
s.044 Revocation
Schedules

Schedules

27 of 226 shown
s.sch001 Provisions of samples and expertise Regulated
  • Provide samples and technical expertise to the Secretary of State on requestManufacturer
s.sch001 Supply of information Regulated
  • Notify Secretary of State of new risk-benefit info or foreign restrictionsManufacturer
s.sch001 Duties on the holder of a marketing authorisation relating to an immunological product Regulated
  • Obtain written approval before marketing immunological veterinary productsManufacturer
s.sch001 Control tests Regulated
  • Provide control test evidence on demand to the Secretary of StateManufacturer
s.sch001 Placing on the market Regulated
  • Notify MHRA when you first sell or remove a veterinary medicine from the UK marketManufacturer
s.sch001 Changes after a marketing authorisation has been issued Regulated
  • Apply for marketing authorisation variations when scientific methods changeManufacturer
s.sch001 Compulsory variation Regulated
  • Apply for compulsory variation within the time limit specified by the Secretary of StateManufacturer
s.sch001 Suspension of a marketing authorisation: procedure Regulated
Other duties (1) — Crown / regulator
  • Marketing authorisation suspension: Secretary of State must notify and refer to AgencyCrown / Minister / Government department
s.sch001 Supply of a copy of the summary of product characteristics Regulated
  • Supply summary of product characteristics on demandManufacturer
s.sch001 Qualified persons responsible for pharmacovigilance Regulated
  • Appoint a qualified person for pharmacovigilance (drug safety)Manufacturer
s.sch001 Duties relating to the qualified person Regulated
  • Set up a system to collect and report suspected adverse reactionsManufacturer
s.sch001 Adverse reactions to a veterinary medicinal product administered in the United Kingdom Regulated
  • Report serious adverse reactions to veterinary medicines within 15 daysManufacturer
s.sch001 Adverse reactions to a veterinary medicinal product administered in a third country Regulated
  • Fail to report adverse reactions to veterinary medicine used abroadAny Person
s.sch001 Periodic safety update reports Regulated
  • Submit periodic safety update reports to the Secretary of StateManufacturer
s.sch001 Release of information by the marketing authorisation holder Regulated
  • Notify Secretary of State before releasing pharmacovigilance information to the publicManufacturer
s.sch002 Duties on a qualified person Regulated
  • Qualified person must certify each batch of veterinary medicineAny Person
s.sch002 Labelling Regulated
  • Label autogenous vaccine containers with required informationOperator
s.sch002 Authorisation of blood banks Regulated
  • Operate a blood bank without authorisationAny Person
s.sch002 Duties on the holder of a manufacturing authorisation Regulated
  • Manufacture veterinary medicines in line with marketing authorisation and maintain required systemsManufacturer
s.sch003 Supply by a suitably qualified person Regulated
  • Supply POM-VPS and NFA-VPS medicines from approved premises onlyAny Person
s.sch003 Wholesale supply of veterinary medicinal products Regulated
  • Fail to comply with wholesale supply rules for veterinary medicinesAny Person
s.sch003 Duties on the holder of a wholesale dealer’s authorisation Regulated
  • Comply with wholesale dealer duties for veterinary medicinesTrader
s.sch003 Supply of sheep dip Regulated
  • Supply sheep dip only to certificate holders with record-keeping and safety equipmentDistributor
s.sch003 Prescriptions by a veterinary surgeon Regulated
  • Carry out clinical assessment before prescribing POM-V medicinesAny Person
s.sch003 Supply by a veterinary surgeon Regulated
  • Be present or authorise each transaction and verify competency for supplyAny Person
s.sch007 Annual fees for marketing authorisations Regulated
  • Pay annual fee and provide turnover statement when requestedManufacturer
s.sch007 Waiver or reduction of fees Regulated
  • Provide full written justification when requesting a fee waiver or reductionApplicant
199 other schedules
s.sch001 Application for a marketing authorisation
s.sch001 Application for a pharmacologically equivalent medicinal product
s.sch001 Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product
s.sch001 Extension of time limits
s.sch001 Parallel imports
s.sch001 Specific batch control scheme
s.sch001 Similar immunological products
s.sch001 Marketing in exceptional circumstances
s.sch001 Time limits
s.sch001 Place of establishment of applicant
s.sch001 Procedure
s.sch001 Information with the application
s.sch001 Products authorised in another member State
s.sch001 Assessment reports
s.sch001 Grant of a marketing authorisation
s.sch001 Marketing authorisations for food-producing species
s.sch001 Refusal of a marketing authorisation
s.sch001 Publication following the grant of a marketing authorisation
s.sch001 Provisional marketing authorisation
s.sch001 Summary of product characteristics
s.sch001 Duration and validity of a marketing authorisation
s.sch001 Variation of a marketing authorisation for a mutually recognised veterinary medicinal product
s.sch001 Variation of a marketing authorisation not authorised in another member State
s.sch001 Administrative variations
s.sch001 Suspension of a marketing authorisation: grounds
s.sch001 Revocation
s.sch001 Prohibiting the supply of veterinary medicinal products
s.sch001 Application for a marketing authorisation where one already exists in another member State
s.sch001 Application in another member State
s.sch001 Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
s.sch001 Approval by the Secretary of State
s.sch001 Reference to being authorised
s.sch001 Language
s.sch001 Labelling with all the information on the immediate packaging
s.sch001 Products with immediate and outer packaging
s.sch001 Time limits for applications for products for use in food-producing animals
s.sch001 Package leaflets
s.sch001 Ampoules
s.sch001 Small containers other than ampoules
s.sch001 Homeopathic remedies
s.sch001 Variations
s.sch001 Scope
s.sch001 Action taken on account of pharmacovigilance
s.sch001 Meaning of “homeopathic remedy”
s.sch001 Placing a homeopathic remedy on the market in accordance with a registration
s.sch001 Application for registration
s.sch001 Procedure for registration
s.sch001 Products on the market before 1994
s.sch001 Classification
s.sch001 Bibliographic application
s.sch001 Application for a product using a new combination of active substances
s.sch001 Application using existing data
s.sch002 Application
s.sch002 Qualified persons for manufacture
s.sch002 Refusal or revocation of appointment
s.sch002 Register
s.sch002 Test sites
s.sch002 Authorisation to manufacture autogenous vaccines
s.sch002 Types of authorisation
s.sch002 Records
s.sch002 Adverse reactions
s.sch002 Time limits
s.sch002 Inspection of premises
s.sch002 Supply and administration of blood from a blood bank
s.sch002 Labelling
s.sch002 Records
s.sch002 Inspection of blood banks
s.sch002 Authorisation to manufacture products for administration under the cascade
s.sch002 Labelling
s.sch002 Records
s.sch002 Adverse reactions
s.sch002 Granting the authorisation
s.sch002 Inspection of premises
s.sch002 The authorisation
s.sch002 Suspension or revocation of the authorisation
s.sch002 Appeal to an appointed person
s.sch002 Inspection of premises
s.sch002 Report following inspection
s.sch003 Classification of veterinary medicinal products
s.sch003 Supply by a pharmacist
s.sch003 Supply of a veterinary medicinal product for incorporation into feedingstuffs
s.sch003 Labelling at the time of retail supply
s.sch003 Supply of veterinary medicinal products for use under the cascade
s.sch003 Annual audit
s.sch003 Application
s.sch003 Time limits
s.sch003 Granting the authorisation
s.sch003 The authorisation
s.sch003 Suspension or revocation of the authorisation
s.sch003 Appeals
s.sch003 Use of sheep dip
s.sch003 Retail supply of veterinary medicinal products
s.sch003 Prescriptions
s.sch003 Written prescriptions
s.sch003 Duties when a product is prescribed or supplied
s.sch003 Supply by a veterinary surgeon from registered premises
s.sch004 Administration under the cascade
s.sch004 Withdrawal periods
s.sch004 Administration to food-producing horses
s.sch004 Immunological products for serious epizootic disease
s.sch004 Immunological products for an imported or exported animal
s.sch004 Administration by veterinary surgeons from other member States
s.sch004 Treatment in exceptional circumstances
s.sch004 Administration of a homeopathic remedy
s.sch004 Administration under an animal test certificate
s.sch005 Scope and interpretation
s.sch005 Labelling a premixture containing a veterinary medicinal product
s.sch005 Labelling of feedingstuffs containing a specified feed additive
s.sch005 Labelling of feedingstuffs containing a veterinary medicinal product
s.sch005 Supply of specified feed additives
s.sch005 Supply of premixture
s.sch005 Supply of feedingstuffs containing a veterinary medicinal product
s.sch005 Prescriptions for feedingstuffs containing a veterinary medicinal product
s.sch005 Writing the prescription
s.sch005 Possession
s.sch005 Sampling and analysis
s.sch005 Enforcement of Regulation (EC)
s.sch005 Storage
s.sch005 Packages and other containers
s.sch005 Transport
s.sch005 Possession, placing on the market and use of feedingstuffs
s.sch005 Imports from third countries
s.sch005 Trade between member States
s.sch005 Enforcement of Regulation (EC) No. 1831/2003
s.sch005 Enforcement of Regulation (EC) No. 882/2004
s.sch005 Enforcement of Regulation (EC) No. 183/2005
s.sch005 Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products
s.sch005 Incorporation of a veterinary medicinal product into a premixture
s.sch005 Incorporation of a veterinary medicinal product into feedingstuffs
s.sch005 Additional record keeping requirements relating to veterinary medicinal products
s.sch006 Animals to which this Schedule applies
s.sch006 Placing on the market, importing and administering the product
s.sch006 Manufacture
s.sch006 Approval of the active substance
s.sch006 The product
s.sch006 Labelling
s.sch006 Administration
s.sch006 Pack size
s.sch006 Adverse reactions
s.sch007 Interpretation of Schedule 7
s.sch007 Decentralised immunological application where the United Kingdom is the reference member State
s.sch007 Application for a marketing authorisation using identical data
s.sch007 Application for a provisional marketing authorisation (pharmaceutical)
s.sch007 Fees for an application for a provisional marketing authorisation (immunological)
s.sch007 Fee for the conversion from a provisional to a full marketing authorisation
s.sch007 Application for a marketing authorisation relating to a parallel import
s.sch007 Application for a variation
s.sch007 Application for a variation to a marketing authorisation that has been issued in other member States
s.sch007 Application for an extension to a marketing authorisation
s.sch007 Decentralised application for an extension where the United Kingdom is the reference member State
s.sch007 Payment of fees
s.sch007 Provision of information relating to the recognition of a United Kingdom marketing authorisation
s.sch007 Application for the renewal of a national marketing authorisation
s.sch007 Application for the renewal of a marketing authorisation granted in more than one member State
s.sch007 Registration of a homeopathic remedy
s.sch007 Auditor’s certificate
s.sch007 Late payment of annual fees
s.sch007 Application for a manufacturing authorisation
s.sch007 Application for a variation of a manufacturing authorisation
s.sch007 Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade
s.sch007 Time of payment
s.sch007 Annual fees
s.sch007 Site inspections—type of site
s.sch007 Inspection of a site where immunological veterinary medicinal products are manufactured
s.sch007 Inspection of a site where sterile veterinary medicinal products are manufactured
s.sch007 Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
s.sch007 Inspection of a site where veterinary medicinal products are assembled
s.sch007 Test sites
s.sch007 Animal blood bank authorisations
s.sch007 Application for a wholesale dealer’s authorisation
s.sch007 Variation of a wholesale dealer’s authorisation
s.sch007 Multiple inspections
s.sch007 Annual fee for a wholesale dealer’s authorisation
s.sch007 Inspection of a wholesale dealer’s premises
s.sch007 Fees relating to feedingstuffs
s.sch007 Fees relating to premises for supply by suitably qualified persons
s.sch007 Reduced fees
s.sch007 Testing samples
s.sch007 Animal test certificates
s.sch007 Treatment under the cascade
s.sch007 Treatment under the Animals (Scientific Procedures) Act 1986
s.sch007 Treatment in exceptional circumstances
s.sch007 Expenses for inspections
s.sch007 Specific batch control
s.sch007 Submission of control tests of an immunological product
s.sch007 Export certificates
s.sch007 Appeals to the Veterinary Products Committee: marketing authorisations and ATCs
s.sch007 Appeals to the Veterinary Products Committee: variations
s.sch007 Appeal to the Veterinary Products Committee: suspensions
s.sch007 Appeal to the Veterinary Products Committee: active substance under Schedule 6
s.sch007 Fees relating to an appointed person
s.sch007 Refund of fees relating to the Veterinary Products Committee or appointed persons
s.sch007 Fees relating to an improvement notice
s.sch007 Translation
s.sch007 Non-payment of fees
s.sch007 Reduction of fees when an application is withdrawn
s.sch007 Fees for specified pharmaceutical applications
s.sch007 Decentralised pharmaceutical application where the United Kingdom is the reference member State
s.sch007 Application for a marketing authorisation for an immunological product

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.