UK Statutory Instrument
2006
United Kingdom
The Veterinary Medicines Regulations 2006
At a glance
Enforced by
What's here
86 compliance obligations
Penalty landscape
29 of 86 obligations carry a criminal penalty. 12 carry different penalties and 45 have no criminal penalty — flagged in the list below.
Who this Act binds
Plus 7 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Part 1
Browse 3 other sections in this Part — procedural / definitional / commencement
Definition of “veterinary medicinal product”, interpretation and scope
Products to which these Regulations do not apply
Part 2
Advertising of prescription products and products containing psychotropic drugs or narcotics
- Do not advertise prescription-only or psychotropic veterinary medicines to the public
Browse 12 other sections in this Part — procedural / definitional / commencement
Placing a veterinary medicinal product on the market
Manufacture of veterinary medicinal products
The finished product
Classification, supply and possession of the product
Administration of the product
Importation of authorised veterinary medicinal products
Advertising the product
Defence of publication in the course of business
Wholesale dealing
Feedingstuffs
Exemptions
Fees
Part 3
Browse 8 other sections in this Part — procedural / definitional / commencement
Food-producing animals: proof of purchase of veterinary medicinal products
Food-producing animals: records of administration by a veterinary surgeon
Food-producing animals: records of acquisition and administration
Food-producing animals: retention of records
Records by a holder of a manufacturing authorisation
Records by a holder of a wholesale dealer’s authorisation
Records of the receipt or supply of prescription products
Records of products administered to a food-producing animal under the cascade
Part 4
Browse 3 other sections in this Part — procedural / definitional / commencement
Importation of an unauthorised veterinary medicinal product
Possession of an unauthorised veterinary medicinal product
Supply of an unauthorised veterinary medicinal product
Part 5
Browse 17 other sections in this Part — procedural / definitional / commencement
The Veterinary Products Committee
Procedure for suspending,
Duties on the Secretary of State relating to exports
Time limits
Appointment of inspectors
Powers of entry
Powers of an inspector
Inspection of pharmacies
Obstruction
Improvement notices
Appeals against improvement notices
Powers of a court on appeal
Seizure notices
Publication of notices
Penalties
Northern Ireland
Revocations and amendments
Schedules
Time limits
Other duties (1) — Crown / regulator
- VMD must complete marketing authorisation procedure within 210 days Statutory regulator
Information with the application
- Submit a complete application for veterinary medicine marketing authorisation with all required information
Assessment reports
Other duties (1) — Crown / regulator
- Secretary of State must produce assessment reports for veterinary medicine applications Crown / Minister / Government department
Provisions of samples and expertise
- Fail to provide samples or expertise when required by Secretary of State
Supply of information
- Fail to supply information to the Secretary of State about veterinary medicine risks
Duties on the holder of a marketing authorisation relating to an immunological product
- Fail to submit batch test results before placing immunological product on market
Control tests
- Fail to provide evidence of control tests on demand
Placing on the market
- Notify VMD when you first place a veterinary medicine on the market and report sales data
Changes after a marketing authorisation has been issued
- Apply for marketing authorisation variation to reflect scientific progress
Compulsory variation
- Apply for compulsory marketing authorisation variation when directed
Suspension, etc. of a marketing authorisation of a product authorised in more than one member State
Other duties (1) — Crown / regulator
- Secretary of State must refer safety concerns to the Agency and comply with Commission decisions Crown / Minister / Government department
Supply of a copy of the summary of product characteristics
- Supply summary of product characteristics on request
Application for a marketing authorisation where one already exists in another member State
- Submit required documents for mutual recognition application
Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
- Apply for a veterinary medicine marketing authorisation using the decentralised procedure
Labelling with all the information on the immediate packaging
- Provide required labelling information on immediate packaging of veterinary medicines
Products with immediate and outer packaging
- Label immediate and outer packaging of veterinary medicinal products correctly
Package leaflets
- Supply approved package leaflet with veterinary medicine when needed
Ampoules
- Label ampoules correctly with specified information
Small containers other than ampoules
- Label small immediate packaging with batch number and expiry date
Qualified persons responsible for pharmacovigilance
Unlimited fine- Fail to have a qualified person for veterinary pharmacovigilance
Duties relating to the qualified person
- Ensure qualified person maintains pharmacovigilance and responds to requests
Adverse reactions to a veterinary medicinal product administered in a third country
- Fail to report adverse reactions from veterinary medicines used in third countries
Periodic safety update reports
- Fail to submit periodic safety update reports
Release of information by the marketing authorisation holder
- Notify the Secretary of State before publicising pharmacovigilance concerns
Action taken on account of pharmacovigilance
Other duties (1) — Crown / regulator
- Secretary of State must act on pharmacovigilance data: notify holders and take necessary regulatory action Crown / Minister / Government department
Placing a homeopathic remedy on the market in accordance with a registration
- Ensure homeopathic remedy meets conditions for registration
Duties on a qualified person
- Qualified person must ensure each batch of veterinary medicine is compliant and certified
Register
Other duties (1) — Crown / regulator
- Secretary of State must maintain register of manufacturers and qualified persons Crown / Minister / Government department
Authorisation to manufacture autogenous vaccines
- Manufacture autogenous vaccine without authorisation
Labelling
- Label autogenous vaccine containers with all required information
Records
Unlimited fine- Fail to keep veterinary vaccine supply records
Adverse reactions
- Notify Secretary of State of adverse reactions to autogenous vaccines within 15 days
Authorisation of blood banks
- Operate a blood bank without authorisation
Supply and administration of blood from a blood bank
- Supply or administer blood from a blood bank without complying with restrictions
Labelling
- Label blood containers with required information
Records
Unlimited fine- Fail to keep blood bank records for five years
Authorisation to manufacture products for administration under the cascade
Unlimited fine- Manufacture unauthorised veterinary product outside authorisation
Labelling
- Label containers of veterinary medicinal products before supply
Records
- Fail to keep records of veterinary medicinal product supply
Adverse reaction
- Notify VMD of adverse reactions to your products within 15 days
Inspection of premises
Other duties (1) — Crown / regulator
- VMD must inspect premises and issue certificates Crown / Minister / Government department
Report following inspection
Other duties (1) — Crown / regulator
- Secretary of State must inform manufacturers of inspection report findings Crown / Minister / Government department
Duties on the holder of a manufacturing authorisation
- Manufacture veterinary products in line with marketing authorisation and GMP
Supply of products for incorporation into feedingstuffs
- Supply veterinary medicines for feedingstuffs to unauthorised persons
Labelling at the time of retail supply
- Supply veterinary medicine with altered or unclear label
Supply of veterinary medicinal products for use under the cascade
Unlimited fine- Fail to label veterinary medicines supplied under the cascade
Supply by a suitably qualified person
- Supply POM-VPS/NFA-VPS medicines from approved premises with proper oversight
Annual audit
Unlimited fine- Fail to carry out annual audit of veterinary medicines
Wholesale supply of veterinary medicinal products
- Supply veterinary medicines wholesale without proper authorisation
Duties on the holder of a wholesale dealer’s authorisation
- Store, audit, and report as a veterinary wholesale dealer
Supply of sheep dip
Unlimited fine- Supply sheep dip without checking buyer’s certificate or keeping records
Use of sheep dip
Unlimited fine- Use sheep dip without a competent supervisor
Prescriptions by a veterinary surgeon
- Carry out clinical assessment before prescribing POM-V medicines
Prescriptions
- Supply POM-V and POM-VPS products only with a valid prescription
Duties when a product is prescribed or supplied
- Fail to comply with duties when prescribing or supplying veterinary medicines
Supply by a pharmacist
- Fail to comply with veterinary medicine supply rules for pharmacists
Supply by a veterinary surgeon when he is not present
Unlimited fine- Supply veterinary medicines without individual authorisation when vet not present
Withdrawal periods
- Specify withdrawal period for food-producing animals treated under the cascade
Administration by veterinary surgeons from other member States
- Veterinary surgeons from other member States: conditions and record-keeping for bringing in unauthorised medicines
Labelling a premixture containing a veterinary medicinal product
- Supply medicated premixture without proper labelling
Labelling of feedingstuffs containing a specified feed additive
- Supply feedingstuffs without required label
Labelling of feedingstuffs containing a veterinary medicinal product
- Supply incorrectly labelled medicated feedingstuffs
Supply of specified feed additives
Unlimited fine- Supply specified feed additives to unapproved persons
Supply of premixture
Unlimited fine- Supply premixture to unauthorised person
Supply of feedingstuffs containing a veterinary medicinal product
- Fail to comply with supply and record-keeping requirements for medicated feedingstuffs
Possession
- Possess veterinary medicines or feed additives without approval
Storage
- Fail to store veterinary medicinal products securely
Packages and other containers
- Use tamper-evident seals on medicated feedingstuffs packages
Enforcement of Regulation (EC)
- Contravene EU feed safety and traceability rules
Transport
- Fail to comply with transport requirements for medicated feedingstuffs
Possession, placing on the market and use of feedingstuffs
- Possess, market or use unauthorised feedingstuffs with veterinary medicines
Prescriptions for feedingstuffs containing a veterinary medicinal product
- Fail to comply with prescription requirements for medicated feedingstuffs
Imports from third countries
- Do not import animal feed containing veterinary medicines from outside the UK
Trade between member States
- Comply with conditions for importing medicated feedingstuffs from EU member states
Enforcement of Regulation (EC) No. 1831/2003
Unlimited fine- Possess unauthorised feed additives or breach EU feed rules
Enforcement of Regulation (EC) No. 183/2005
- Contravene feed hygiene requirements under EC Regulation 183/2005
Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products
- Operate without approval or fail to ensure even incorporation of veterinary medicinal product in feed
Incorporation of a veterinary medicinal product into a premixture
- Follow product rules and avoid duplicate active substances when mixing veterinary medicine into premixtures
Incorporation of a veterinary medicinal product into feedingstuffs
- Incorporate veterinary medicines into feed correctly and safely
Additional record keeping requirements relating to veterinary medicinal products
- Fail to keep required records for veterinary medicinal products in feed
Adverse reactions
- Notify VMD of serious adverse reactions within 15 days
Application for a variation to a marketing authorisation that has been issued in other member States
- Submit separate variation applications for each change and pay the fee
Late payment of annual fees
- Pay an additional fee if you pay your annual marketing authorisation fee late
Waiver or reduction of fees
- Provide written justification when requesting a fee waiver or reduction
In section 45 (offences under Part II)—
- Commit offences under medicines marketing or manufacturing rules
Browse 190 other Schedules — structural / supplementary
Application for a marketing authorisation
Application for a pharmacologically equivalent medicinal product
Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product
Extension of time limits
Parallel imports
Specific batch control scheme
Similar immunological products
Marketing in exceptional circumstances
Place of establishment of applicant
Procedure
Products authorised in another member State
Grant of a marketing authorisation
Marketing authorisations for food-producing species
Refusal of a marketing authorisation
Publication following the grant of a marketing authorisation
Provisional marketing authorisation
Summary of product characteristics
Duration and validity of a marketing authorisation
Variation of a marketing authorisation for a mutually recognised veterinary medicinal product
Variation of a marketing authorisation not authorised in another member State
Administrative variations
Suspension, etc. of a marketing authorisation
Prohibiting the supply of veterinary medicinal products
Application in another member State
Approval by the Secretary of State
Reference to being authorised
Language
Time limits for applications for products for use in food-producing animals
Homeopathic remedies
Variations
Adverse reactions to a veterinary medicinal product administered in the United Kingdom
Scope
Meaning of “homeopathic remedy”
Application for registration
Procedure for registration
Products on the market before 1994
Classification
Bibliographic application
Application for a product using a new combination of active substances
Application using existing data
Application
Qualified persons for manufacture
Refusal or revocation of appointment
Test sites
Types of authorisation
Time limits
Inspection of premises
Inspection of blood banks
Granting the authorisation
Inspection of premises
The authorisation
Suspension or revocation of the authorisation
Representation to the Secretary of State
Classification of veterinary medicinal products
Application
Time limits
Granting the authorisation
The authorisation
Suspension or revocation of the authorisation
Representations
Retail supply of veterinary medicinal products
Written prescriptions
Administration under the cascade
Immunological products for serious epizootic disease
Immunological products for an imported or exported animal
Treatment in exceptional circumstances
Administration of a homeopathic remedy
Scope and interpretation
Sampling and analysis
Enforcement of Regulation (EC) No. 882/2004
Animals to which this Schedule applies
Placing on the market, importing and administering the product
Manufacture
Approval of the active substance
The product
Labelling
Administration
Pack size
Interpretation of Schedule 7
Application for a marketing authorisation using identical data
Application for a provisional marketing authorisation
Application for a marketing authorisation relating to a parallel import
Application for a variation
Application for an extension to a marketing authorisation
Decentralised application for an extension where the United Kingdom is the reference member State
Provision of information relating to the recognition of a United Kingdom marketing authorisation
Application for the renewal of a national marketing authorisation
Application for the renewal of a marketing authorisation granted in more than one member State
Payment of fees
Registration of a homeopathic remedy
Annual fees for marketing authorisations
Auditor’s certificate
Application for a manufacturing authorisation
Application for a variation of a manufacturing authorisation
Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade
Annual fees
Site inspections—type of site
Inspection of a site where immunological veterinary medicinal products are manufactured
Time of payment
Inspection of a site where sterile veterinary medicinal products are manufactured
Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
Inspection of a site where veterinary medicinal products are assembled
Test sites
Animal blood bank authorisations
Expenses
Application for a wholesale dealer’s authorisation
Variation of a wholesale dealer’s authorisation
Annual fee for a wholesale dealer’s authorisation
Fees relating to feedingstuffs
Multiple inspections
Fees relating to distributors
Testing samples
Animal test certificates
Treatment under the cascade
Treatment in exceptional circumstances
Specific batch control
Submission of control tests of an immunological product
Export certificates
Fees relating to premises for supply by suitably qualified persons
Application to the Veterinary Products Committee
Translation
Non-payment of fees
Reduction of application fee
Fees for specified pharmaceutical applications
Decentralised pharmaceutical application where the United Kingdom is the reference member State
Application for a marketing authorisation for an immunological product
Decentralised immunological application where the United Kingdom is the reference member State
Sections 32 to 36 and 38 to 40 shall be...
In section 44 (provision of information to the licensing authority)—...
In section 46 (special defences under s45)—
In section 47 (standard provisions for licences or certificates)—
In section 48 (postponement of restrictions in relation to exports),...
In section 49 (special provisions in respect of exporting certain...
In section 51 (general sale lists)— (a) in subsection (1),...
In section 52 (sale or supply of medicinal products not...
In section 53 (sale or supply of medicinal products on...
In section 54 (sale of medicinal products from automatic machines),...
In section 55 (exemptions for doctors, dentists, veterinary surgeons and...
In section 56 (exemptions in respect of herbal remedies), in...
In section 57 (power to extend or modify exemptions)—
In section 58 (medicinal products on prescription only)—
In section 58A (requirement to specify certain products for human...
Section 58B (requirement to specify certain products for veterinary use...
In section 59 (special provisions in relation to new medicinal...
In section 60 (restricted sale, supply and administration of certain...
In section 61 (special restrictions on persons to be supplied...
In section 62 (prohibition of sale or supply, or importation,...
In section 65 (compliance with standards specified in monographs in...
In section 66 (further powers to regulate dealings with medicinal...
In section 72A (the responsible pharmacist)— (a) in subsection (2),...
In section 73 (power to extend or modify conditions)—
In section 76 (supplementary provisions as to registration of premises),...
In section 79 (provision for modifying or extending restrictions under...
In section 85 (labelling and marking of containers and packages),...
In section 86 (leaflets), in subsection (1), omit “appropriate”.
In section 87 (requirements as to containers), in subsection (1)—...
In section 88 (distinctive colours, shapes and markings of medicinal...
In section 89 (display of information on automatic machines), in...
Section 90 (provisions as to medicated animal feeding stuffs) shall...
In section 91 (offences under Part V, and supplementary provisions)—...
In section 95 (powers to regulate advertisements and representations)—
In section 99 (new editions of British Pharmacopoeia, and other...
In section 101 (other publications), in subsection (2)—
In section 102 (supplementary provisions)— (a) in subsection (2)—
In section 103 (construction of references to specified publications), in...
In section 104 (application of Act to certain articles and...
In section 105 (application of Act to certain other substances...
In section 108 (enforcement in England and Wales)—
In section 109 (enforcement in Scotland), in subsection (2), omit...
In section 110 (enforcement in Northern Ireland)—
In section 116 (liability to forfeiture under Customs and Excise...
Section 117 (special enforcement and sampling provisions relating to animal...
In section 121 (contravention due to default of other person),...
In section 122 (warranty as defence), in subsection (2), omit...
In section 125 (prosecutions), in subsection (4)—
In section 126 (presumptions)— (a) in subsection (1)—
In section 129 (orders and regulations)— (a) in subsection (2),...
In section 130 (meaning of “medicinal product” and related expressions)—...
In section 132 (general interpretation provisions)— (a) in subsection (1)—...
In Schedule 3 (sampling), in paragraph 17—
In Schedule 4 (provisions relating to Northern Ireland)—
The Medicines Act 1971
The Value Added Tax Act 1994
The Criminal Law (Consolidation) (Scotland) Act 1995
The Food Standards Act 1999
The Licensing Act 2003
The Animals (Scientific Procedures) Act 1986
The Consumer Protection Act 1987
The Environmental Protection Act 1990
The Sunday Trading Act 1994
Other sections — not classified into a Part
These sections exist in the Act but the contents-of-Parts walker did not place them under a Part. Likely amendments or sections inserted out of the original Part structure.
Browse 14 other unclassified sections
The Medicines Act 1968
In section 1 (Ministers responsible for administration of the Act)—...
In section 3 (functions of the Commission), in subsection (1),...
In section 4 (establishment of committees)— (a) in subsection (1),...
In section 5 (supplementary provisions as to Commission and committees)—...
In section 6 (the licensing authority)— (a) in subsection (1),...
In section 7 (general provisions as to dealing with medicinal...
In section 8 (provisions as to manufacture and wholesale dealing)—...
In section 9 (exemptions for doctors, dentists, veterinary surgeons and...
In section 10 (exemptions for pharmacists)— (a) in subsection (1),...
In section 15 (provision for extending or modifying exemptions)—
In section 18 (application for licence), omit subsection (3).
In section 23 (special provisions as to effect of manufacturer’s...
In section 28 (general power to suspend, revoke or vary...
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Veterinary Medicines Directorate
Executive agency of Defra. Regulates veterinary medicinal products in the UK. Authorises veterinary medicines, monitors safety, and enforces requirements for the manufacture, …
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