UK Statutory Instrument
2013
United Kingdom
Veterinary Medicines Regulations 2013
At a glance
Enforced by
What's here
2 practical guides
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Supporting — topic alignment
2 guidesWhat 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 296 other Schedules — structural / supplementary
Application for a marketing authorisation
Application for a generic veterinary medicinal product
Hybrid veterinary medicinal products
Time limits for marketing authorisations granted under the procedure for a generic veterinary medicinal product
Extension of time limits
Time limits – supplementary
Parallel imports
Specific batch control scheme
Similar immunological products
Marketing a product authorised in another country
Time limits
Place of establishment of applicant
Procedure
Information with the application: general
Products authorised in another member State
Assessment reports
Grant of a marketing authorisation
Withdrawal of application for marketing authorisation
Marketing authorisations for food-producing species
Refusal of a marketing authorisation
Publication following the grant , refusal, suspension, variation or revocation of a marketing authorisation
Marketing authorisations in exceptional circumstances
Provisions of samples and expertise
Records and supply of information
Duties on the holder of a marketing authorisation relating to an immunological product
Information with the application: format
Information with the application: animal testing
Information with the application: POM-VPS, NFA-VPS and AVM-GSL
Summary of product characteristics
Control tests
Placing on the market
Duration and validity of marketing authorisation
Variation of a marketing authorisation
Variation procedure
Refusal of a variation of a marketing authorisation
Administrative variations
Changes after a marketing authorisation has been issued
Compulsory variation
Suspension , revocation, etc of a marketing authorisation: grounds
Suspension of a marketing authorisation: procedure
Supply of a copy of the summary of product characteristics
Revocation
Prohibiting the supply of veterinary medicinal products
Temporary restrictions
Restrictions in relation to immunological veterinary medicines
Application for a marketing authorisation where one already exists in a member State
Application in a 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 of immediate packaging of veterinary medicinal products
Labelling of the outer packaging of veterinary medicinal products
Time limits for applications for products for use in food-producing animals
Labelling of small immediate packaging units of veterinary medicinal products
Package leaflet of veterinary medicinal products
Small containers other than ampoules
Homeopathic remedies
Variations
Qualified persons responsible for pharmacovigilance
Duties of marketing authorisation holder in relation to pharmacovigilance
Duties of marketing authorisation holder in relation to signal management process
Duties of qualified person (pharmacovigilance)
Signal management process
Adverse events following administration of a veterinary medicinal product
Adverse reactions to a veterinary medicinal product administered in another country
Annual benefit-risk reports
Scope
Release of information by the marketing authorisation holder
Pharmacovigilance inspections by Secretary of State
Powers of Secretary of State in relation to signal management process
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
Offences
Bibliographic application
Application for a product using a new combination of active substances
Application using existing data
In this Schedule— “ converted EU marketing authorisation ” means...
This paragraph applies to an EU marketing authorisation which—
A converted EU marketing authorisation has effect on and after...
Without prejudice to the generality of paragraph 3—
In this Schedule— “QNIG certificate” means a certificate issued under...
This Schedule applies to a veterinary medicinal product which is—...
If the condition in paragraph 4 is met in respect...
The condition is that the person who holds a marketing...
A QNIG certificate has effect as if it were a...
The QNIG certificate holder must provide to the Secretary of...
Without prejudice to any other power to suspend a marketing...
The Secretary of State must publish any notice given under...
Paragraphs 39 and 40 of Schedule 1 apply to the...
Manufacturing authorisation
Refusal, revocation, suspension or variation of appointment
Duties on a qualified person
Register
Test sites
Authorisation to manufacture specific veterinary medicinal products
Prohibition
Personnel
Process of authorisation
Authorisation in relation to blood banks
Authorisation in relation to stem cells
Application for authorisation
Authorisation in relation to products for administration under the cascade
Suspension, compulsory variation or revocation of authorisation
Labelling
Records
Adverse events
Inspection of sites
Prohibition on manufacture, importation or distribution of active substances unless registered
Application for registration
Good manufacturing or distribution practice
Supply of information
Procedure for grant of authorisations and time limits
Inspection of sites
Report following inspection
Offences
Records
Inspection of premises
Offences
The authorisation
Application for variation to the authorisation
Suspension, revocation etc of the authorisation
Good manufacturing practice certificates and inspection of sites
Report following inspection
Duties on the holder of a manufacturing authorisation
Good manufacturing practice
Recalled and counterfeit products
Qualified persons for manufacture
Classification of veterinary medicinal products
Supply by a pharmacist
Supply of a medicinal premix
Labelling at the time of retail supply
Supply of veterinary medicinal products for use under the cascade
Supply by a suitably qualified person
Audit
Wholesale dealer’s authorisation
Application for authorisation
Procedure and time limits for authorisations
Periodic inspections and suspension etc. for lack of use
Application for variation to the authorisation
Wholesale supply of veterinary medicinal products
Suspension, variation or revocation of the authorisation
Duties on the holder of a wholesale dealer’s authorisation
Register of authorised wholesale dealers
Documentation accompanying veterinary medicinal products supplied wholesale
Recalled, counterfeit or returned products
Audit
Contractual arrangements between holders of wholesale dealer’s authorisations
Self-inspection programme
Supply of sheep dip
Use of sheep dip
Offences
Retail supply of veterinary medicinal products
Supply of samples
Register of online suppliers of veterinary medicinal products
Application for registration
Duties in relation to online supply
Retail storage of veterinary medicinal products
Prescriptions by a veterinary surgeon
Prescriptions
Written prescriptions
Duties when a product is prescribed or supplied
Duties in relation to prescribing of antibiotic veterinary medicinal products
Supply by a veterinary surgeon from registered premises
Supply by a veterinary surgeon
Administration under the cascade
Offences
Withdrawal periods
Administration to food-producing horses
Immunological products for serious epizootic disease or emerging disease
Immunological products for an imported or exported animal
Administration by veterinary surgeons from other countries
Administration of autogenous vaccines
Treatment in exceptional circumstances
Administration of a homeopathic remedy
Administration under an animal test certificate
Misuse of the cascade
Scope and interpretation
Incorporation of a medicinal premix into feedingstuffs
Additional record keeping requirements relating to medicinal premixes
Labelling an intermediate feedingstuff containing a medicinal premix
Labelling of feedingstuffs containing a specified feed additive
Labelling of feedingstuffs containing a medicinal premix
Supply of specified feed additives
Supply of intermediate feedingstuff or specified feed additive
Supply of a complementary feedingstuff
Supply of feedingstuffs containing a medicinal premix
Medicated feedingstuff prescriptions for feedingstuffs containing a medicinal premix
Enforcement of Regulation (EC) No 178/2002
Writing the medicated feedingstuff prescription
Possession
Sampling and analysis
Sampling for cross-contamination
Storage
Packages and other containers
Transport
Possession, placing on the market and use of feedingstuffs
Unused and expired medicated feedingstuffs
Imports from third countries
Trade between countries
Import for incorporation into intermediate feedingstuffs or feedingstuffs for export
Enforcement of Regulation (EC) No 1831/2003
Animals on domestic premises
Offences
Enforcement of Regulation (EU) 2017/625
Enforcement of Regulation (EC) No 183/2005
Enforcement of Regulation (EC) No 767/2009
Authorisation of manufacturers and distributors of feedingstuffs containing medicinal premixes
Incorporation of a medicinal premix into an intermediate feedingstuff
Top dressing
Animals to which this Schedule applies
Offences
Placing on the market, importing and administering the product
Manufacture
Register of persons placing veterinary medicinal products on the market (small pet animals)
Persons registered in accordance with paragraph 3A: annual return
Approval of the active substance
The product
Labelling
Administration
Pack size
Adverse events
Interpretation
Decentralised immunological application where the United Kingdom is the reference member State
Application for a marketing authorisation based on informed consent
Application for an exceptional marketing authorisation (pharmaceutical)
Fees for an application for an exceptional marketing authorisation (immunological or biological non-immunological)
Fee for the conversion from an exceptional to a full marketing authorisation
Application for a marketing authorisation relating to a parallel import
Fee for a generic marketing authorisation
Application to change the distribution category of a product authorised through the centralised procedure
Application for a variation to a marketing authorisation ....
Application for a variation to a marketing authorisation dealt with under worksharing procedures
Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member State
Payment of fees
Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension
Exception for a variation relating to animal testing
Application for a reassessment of an exceptional marketing authorisation
Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure
Registration of a homeopathic remedy
Renewal 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
Time of payment
Inspection of sites authorised to manufacture a product for administration under the cascade
Autogenous vaccines
Assessment of a variation of an authorisation to manufacture an autogenous vaccine
Annual fee (manufacturing authorisations)
Site inspections – type of site
Inspection of a site where immunological veterinary medicinal products are manufactured
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 or non-food animal stem cell centre authorisations
Application for a wholesale dealer’s authorisation
Multiple inspections
Variation of a wholesale dealer’s authorisation
Annual fee for a wholesale dealer’s authorisation
Inspection of a wholesale dealer’s sites
Fees for applications for authorisation and annual fees relating to feedingstuffs in Great Britain
Inspection fees relating to feedingstuffs in Great Britain
Fees payable in relation to feedingstuffs in Northern Ireland
Fees relating to premises for supply by suitably qualified persons
Testing samples
Animal test certificates
Importation of a veterinary medicinal product for treatment under the cascade
Expenses for inspections outside the United Kingdom
Wholesale dealer’s import certificate
Specific batch control
Submission of control tests of an immunological product
Export certificates
Provision of advice
Provision of scientific advice
Appeals to the Veterinary Products Committee
Fee relating to an appointed person
Fees relating to a veterinary surgeon’s practice premises
Fee in relation to verifying destruction of controlled drug
Pharmacovigilance inspections
Refund of fees relating to the Veterinary Products Committee or appointed persons
Fees relating to an improvement notice
Translation
Non-payment of fees
Waiver or reduction of fees
Reduction of fees when an application is withdrawn
Application for a marketing authorisation for a pharmaceutical , immunological or biological that is not immunological veterinary medicinal product
Application for a marketing authorisation for specific applications
Decentralised pharmaceutical application where the United Kingdom is the reference member State
Application for a marketing authorisation for an immunological or biosimilar product
Browse 49 other sections — procedural / definitional / commencement
Title and commencement
Definition of “veterinary medicinal product”, interpretation and scope
Products to which these Regulations do not apply
Placing a veterinary medicinal product on the market
Manufacture of veterinary medicinal products
Marketing of products not in accordance with a marketing authorisation
Classification, supply and possession of the product
Administration of the product
Importation of authorised veterinary medicinal products
Advertising the product
Inducements and hospitality
Advertising of prescription products and products containing psychotropic drugs or narcotics
Defence of publication in the course of business
Wholesale dealing
Feedingstuffs
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
Reporting of sales and usage data in relation to antibiotics
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
Veterinary Products Committee appeals procedure
Appeals to an appointed person
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
Offence
Penalties
Northern Ireland
Review
Revocations
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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