UK Statutory Instrument
2006
United Kingdom
The Veterinary Medicines Regulations 2006
At a glance
Enforced by
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.
Schedules
Browse 275 other Schedules — structural / supplementary
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
Time limits
Place of establishment of applicant
Procedure
Information with the application
Products authorised in another member State
Assessment reports
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
Provisions of samples and expertise
Supply of information
Duties on the holder of a marketing authorisation relating to an immunological product
Summary of product characteristics
Control tests
Placing on the market
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
Changes after a marketing authorisation has been issued
Compulsory variation
Suspension, etc. of a marketing authorisation
Suspension, etc. of a marketing authorisation of a product authorised in more than one member State
Supply of a copy of the summary of product characteristics
Prohibiting the supply of veterinary medicinal products
Application for a marketing authorisation where one already exists in another member State
Application in another member State
Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
Approval by the Secretary of State
Reference to being authorised
Language
Labelling with all the information on the immediate packaging
Products with immediate and outer packaging
Package leaflets
Time limits for applications for products for use in food-producing animals
Ampoules
Small containers other than ampoules
Homeopathic remedies
Variations
Qualified persons responsible for pharmacovigilance
Duties relating to the qualified person
Adverse reactions to a veterinary medicinal product administered in the United Kingdom
Adverse reactions to a veterinary medicinal product administered in a third country
Periodic safety update reports
Release of information by the marketing authorisation holder
Scope
Action taken on account of pharmacovigilance
Meaning of “homeopathic remedy”
Placing a homeopathic remedy on the market in accordance with a registration
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
Duties on a qualified person
Register
Test sites
Authorisation to manufacture autogenous vaccines
Types of authorisation
Labelling
Records
Adverse reactions
Time limits
Inspection of premises
Authorisation of blood banks
Supply and administration of blood from a blood bank
Labelling
Records
Inspection of blood banks
Authorisation to manufacture products for administration under the cascade
Labelling
Records
Adverse reaction
Granting the authorisation
Inspection of premises
The authorisation
Suspension or revocation of the authorisation
Representation to the Secretary of State
Inspection of premises
Report following inspection
Duties on the holder of a manufacturing authorisation
Classification of veterinary medicinal products
Supply of products for incorporation into feedingstuffs
Labelling at the time of retail supply
Supply of veterinary medicinal products for use under the cascade
Supply by a suitably qualified person
Annual audit
Application
Time limits
Granting the authorisation
The authorisation
Suspension or revocation of the authorisation
Wholesale supply of veterinary medicinal products
Representations
Duties on the holder of a wholesale dealer’s authorisation
Supply of sheep dip
Use of sheep dip
Retail supply of veterinary medicinal products
Prescriptions by a veterinary surgeon
Prescriptions
Written prescriptions
Duties when a product is prescribed or supplied
Supply by a pharmacist
Supply by a veterinary surgeon when he is not present
Administration under the cascade
Withdrawal periods
Immunological products for serious epizootic disease
Immunological products for an imported or exported animal
Administration by veterinary surgeons from other member States
Treatment in exceptional circumstances
Administration of a homeopathic remedy
Scope and interpretation
Labelling a premixture containing a veterinary medicinal product
Labelling of feedingstuffs containing a specified feed additive
Labelling of feedingstuffs containing a veterinary medicinal product
Supply of specified feed additives
Supply of premixture
Supply of feedingstuffs containing a veterinary medicinal product
Possession
Sampling and analysis
Storage
Packages and other containers
Enforcement of Regulation (EC)
Transport
Possession, placing on the market and use of feedingstuffs
Prescriptions for feedingstuffs containing a veterinary medicinal product
Imports from third countries
Trade between member States
Enforcement of Regulation (EC) No. 1831/2003
Enforcement of Regulation (EC) No. 882/2004
Enforcement of Regulation (EC) No. 183/2005
Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products
Incorporation of a veterinary medicinal product into a premixture
Incorporation of a veterinary medicinal product into feedingstuffs
Additional record keeping requirements relating to veterinary medicinal products
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
Adverse reactions
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 a variation to a marketing authorisation that has been issued in other member States
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
Late payment of annual fees
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
Waiver or reduction 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 45 (offences under Part II)—
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
Browse 58 other sections — procedural / definitional / commencement
Title and commencement
The Medicines Act 1968
Definition of “veterinary medicinal product”, interpretation and scope
In section 1 (Ministers responsible for administration of the Act)—...
Products to which these Regulations do not apply
In section 3 (functions of the Commission), in subsection (1),...
Placing a veterinary medicinal product on the market
In section 4 (establishment of committees)— (a) in subsection (1),...
Manufacture of veterinary medicinal products
In section 5 (supplementary provisions as to Commission and committees)—...
The finished product
In section 6 (the licensing authority)— (a) in subsection (1),...
Classification, supply and possession of the product
In section 7 (general provisions as to dealing with medicinal...
Administration of the product
In section 8 (provisions as to manufacture and wholesale dealing)—...
Importation of authorised veterinary medicinal products
In section 9 (exemptions for doctors, dentists, veterinary surgeons and...
Advertising the product
In section 10 (exemptions for pharmacists)— (a) in subsection (1),...
Advertising of prescription products and products containing psychotropic drugs or narcotics
In section 15 (provision for extending or modifying exemptions)—
Defence of publication in the course of business
In section 18 (application for licence), omit subsection (3).
Wholesale dealing
In section 23 (special provisions as to effect of manufacturer’s...
Feedingstuffs
In section 28 (general power to suspend, revoke or vary...
Exemptions
Fees
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
Importation of an unauthorised veterinary medicinal product
Possession of an unauthorised veterinary medicinal product
Supply of an unauthorised veterinary medicinal product
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
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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