UK Statutory Instrument
2013
United Kingdom
Veterinary Medicines Regulations 2013
At a glance
Enforced by
What's here
88 compliance obligations, 3 practical guides across 2 topics
Penalty landscape
7 of 88 obligations carry a criminal penalty. 81 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.
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Supporting — topic alignment
3 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.
Part 1 — Introduction
Browse 3 other sections in this Part — procedural / definitional / commencement
Title and commencement
Definition of “veterinary medicinal product”, interpretation and scope
Products to which these Regulations do not apply
Part 2 — Authorised veterinary medicinal products
Browse 14 other sections in this Part — procedural / definitional / commencement
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
Part 3 — Records
Browse 9 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
Reporting of sales and usage data in relation to antibiotics
Part 4 — Unauthorised veterinary medicinal products
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 — Miscellaneous provisions, enforcement and offences
Browse 20 other sections in this Part — procedural / definitional / commencement
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
Schedules
Hybrid veterinary medicinal products
- Provide study results for hybrid veterinary medicinal products
Time limits for marketing authorisations granted under the procedure for a generic veterinary medicinal product
- Wait before placing generic veterinary medicines on the market
Time limits
Other duties (1) — Crown / regulator
- Secretary of State must complete veterinary medicine authorisation within 210 days Crown / Minister / Government department
Marketing authorisations for food-producing species
Other duties (1) — Crown / regulator
- Secretary of State must not grant marketing authorisation unless MRLs established and substances in Table 1 Crown / Minister / Government department
Refusal of a marketing authorisation
Other duties (1) — Crown / regulator
- VMD must refuse marketing authorisation if conditions not met Crown / Minister / Government department
Provisions of samples and expertise
- Provide samples and technical expertise when requested by the VMD
Records and supply of information
- Report safety concerns and retain clinical trial records for veterinary medicines
Duties on the holder of a marketing authorisation relating to an immunological product
- Get written approval before marketing immunological veterinary medicines
Information with the application: animal testing
- Disclose animal test conditions when applying for veterinary medicine authorisation
Control tests
- Provide evidence of control tests on demand
Placing on the market
- Notify VMD of market changes and provide sales data on request
Variation procedure
- Submit marketing authorisation variation applications electronically
Changes after a marketing authorisation has been issued
- Keep marketing authorisation up to date with scientific progress
Suspension of a marketing authorisation: procedure
Other duties (1) — Crown / regulator
- Secretary of State must notify marketing authorisation holder immediately upon suspension Crown / Minister / Government department
Supply of a copy of the summary of product characteristics
- Provide copy of product characteristics summary on request
Application for a marketing authorisation where one already exists in a member State
- Apply for mutual recognition of your veterinary medicine marketing authorisation
Application in a member State
Other duties (1) — Crown / regulator
- VMD must prepare and share assessment report within 90 days Crown / Minister / Government department
Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
- Submit identical dossiers and nominate a reference member state for decentralised marketing authorisation
Labelling of immediate packaging of veterinary medicinal products
- Label immediate packaging of veterinary medicinal products with required information
Duties of marketing authorisation holder in relation to pharmacovigilance
- Monitor and manage pharmacovigilance for your veterinary medicinal products
Duties of marketing authorisation holder in relation to signal management process
- Carry out signal management process for veterinary medicines
Duties of qualified person (pharmacovigilance)
- Establish and maintain a pharmacovigilance system for veterinary products
Adverse events following administration of a veterinary medicinal product
- Record and report adverse events from your veterinary medicines
Annual benefit-risk reports
- Submit annual benefit-risk reports to the Veterinary Medicines Directorate
Release of information by the marketing authorisation holder
- Do not publicise pharmacovigilance concerns without notifying the Secretary of State
Action taken on account of pharmacovigilance
Other duties (1) — Crown / regulator
- Secretary of State may suspend, revoke or vary veterinary medicine authorisations on pharmacovigilance grounds Crown / Minister / Government department
Procedure for registration
Other duties (1) — Crown / regulator
- VMD must process homeopathic remedy registration within 210 days Statutory regulator
Offences
- Fail to comply with veterinary medicines regulatory requirements
Application for a product using a new combination of active substances
- Provide scientific justification for a new combination of active substances
The condition is that the person who holds a marketing...
- Provide information for Northern Ireland marketing authorisation
The QNIG certificate holder must provide to the Secretary of...
- Keep your QNIG certificate information up to date with the Secretary of State
Duties on a qualified person
- Qualified person must certify each batch meets marketing authorisation before release
Personnel
- Appoint a qualified person to supervise autogenous vaccine manufacture and label containers
Labelling
- Label veterinary medicines and blood products correctly
Records
- Keep detailed records of certain veterinary products supplied
Adverse events
- Notify the VMD of adverse events within 30 days
Good manufacturing or distribution practice
- Comply with good manufacturing/distribution practice and report adverse reactions
Offences
- Label equine stem cell containers with required information and avoid therapeutic claims
Offences
- Fail to comply with Schedule 2 requirements (veterinary medicines)
The authorisation
- Notify VMD before making material changes to premises or operations
Application for variation to the authorisation
- Notify VMD before changing your site or key staff
Good manufacturing practice certificates and inspection of sites
- Ensure manufacturer has valid GMP certificate before importing veterinary medicines
Duties on the holder of a manufacturing authorisation
- Manufacture veterinary medicines in line with authorisation and GMP
Good manufacturing practice
- Implement and maintain a pharmaceutical quality system for manufacturing veterinary medicines
Recalled and counterfeit products
- Handle recalled and counterfeit veterinary medicines properly
Supply by a pharmacist
- Pharmacists must supply veterinary medicines only from registered premises
Labelling at the time of retail supply
- Ensure your veterinary medicine packaging is clearly labelled when supplied
Supply by a suitably qualified person
- Supply veterinary medicines only from authorised premises and follow handover rules
Audit
- Carry out annual stock audit of prescription-only veterinary medicines
Periodic inspections and suspension etc. for lack of use
- Notify VMD before making material changes to your wholesale premises or operations
Application for variation to the authorisation
- Notify VMD before making material changes to your premises, operations or qualified person
Duties on the holder of a wholesale dealer’s authorisation
- Store veterinary medicines correctly, follow GDP, audit stock annually, and supply information on demand
Documentation accompanying veterinary medicinal products supplied wholesale
- Provide documentation and keep records for wholesale supplies of veterinary medicines
Recalled, counterfeit or returned products
- Handle recalled, counterfeit or returned veterinary products correctly
Audit
- Conduct an annual stock audit for wholesale veterinary medicines
Contractual arrangements between holders of wholesale dealer’s authorisations
- Record written contract when outsourcing wholesale dealing
Self-inspection programme
- Run an annual self-inspection programme and keep records for 5 years
Supply of sheep dip
- Supply sheep dip safely and provide safety notices and gloves
Offences
- Fail to comply with veterinary medicines supply and use rules
Retail storage of veterinary medicinal products
- Store veterinary medicines according to label instructions and product characteristics
Prescriptions by a veterinary surgeon
- Carry out clinical assessment before prescribing POM-V or cascade medicines
Prescriptions
- Supply prescription-only veterinary medicines under valid prescriptions and keep records
Duties when a product is prescribed or supplied
- Check user competence, advise on safe use, and prescribe only minimum amount
Duties in relation to prescribing of antibiotic veterinary medicinal products
- Restrict prophylactic antibiotic prescribing and retain records
Supply by a veterinary surgeon
- Oversee handover of veterinary medicines to customers
Administration under the cascade
- Follow the cascade when prescribing unauthorised veterinary medicines
Offences
- Fail to comply with veterinary medicines regulations (withdrawal periods, administration, supply)
Withdrawal periods
- Specify a minimum withdrawal period when using the cascade on food-producing animals
Administration to food-producing horses
- Record equine medicine details in the horse passport
Administration by veterinary surgeons from other countries
- Comply with conditions when bringing unapproved veterinary medicines into the UK
Misuse of the cascade
- Do not promote or facilitate misuse of the veterinary cascade
Incorporation of a medicinal premix into feedingstuffs
- Incorporate medicinal premixes into feed correctly
Additional record keeping requirements relating to medicinal premixes
- Keep daily records of medicated feed and premix transactions
Supply of feedingstuffs containing a medicinal premix
- Supply medicated feedingstuffs only to authorised persons, with a prescription, and keep records for 5 years
Medicated feedingstuff prescriptions for feedingstuffs containing a medicinal premix
- Ensure medicated feedingstuff prescriptions are complete and valid
Enforcement of Regulation (EC) No 178/2002
- You must comply with feed safety and traceability rules
Sampling for cross-contamination
- Manage and monitor cross-contamination of non-target feeds
Transport
- Transport feedingstuffs with proper labelling, cleaning and driver instructions
Possession, placing on the market and use of feedingstuffs
- Safely manage medicated feedingstuffs for animals
Offences
- Fail to comply with veterinary medicines requirements
Enforcement of Regulation (EC) No 183/2005
- Comply with EU feed hygiene and safety rules for medicated feedingstuffs
Authorisation of manufacturers and distributors of feedingstuffs containing medicinal premixes
- Obtain authorisation to make or distribute medicated animal feed
Incorporation of a medicinal premix into an intermediate feedingstuff
- Follow product specifications when mixing medicinal premixes into feed
Offences
- Fail to comply with veterinary medicines regulatory requirements (Schedule 6 paras 3A, 3B, 9)
Persons registered in accordance with paragraph 3A: annual return
- Submit annual return for small pet animal veterinary products
The product
- Ensure your veterinary product meets approval and prohibition requirements
Adverse events
- Fail to report serious adverse events or keep records for veterinary medicines
Annual fees for marketing authorisations
- Provide annual turnover statement for marketing authorisation fees
Browse 208 other Schedules — structural / supplementary
Application for a marketing authorisation
Application 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
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
Publication following the grant , refusal, suspension, variation or revocation of a marketing authorisation
Marketing authorisations in exceptional circumstances
Information with the application: format
Information with the application: POM-VPS, NFA-VPS and AVM-GSL
Summary of product characteristics
Duration and validity of marketing authorisation
Variation of a marketing authorisation
Refusal of a variation of a marketing authorisation
Administrative variations
Compulsory variation
Suspension , revocation, etc of a marketing authorisation: grounds
Revocation
Prohibiting the supply of veterinary medicinal products
Temporary restrictions
Restrictions in relation to immunological veterinary medicines
Approval by the Secretary of State
Reference to being authorised
Language
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
Signal management process
Adverse reactions to a veterinary medicinal product administered in another country
Scope
Pharmacovigilance inspections by Secretary of State
Powers of Secretary of State in relation to signal management process
Meaning of “homeopathic remedy”
Placing a homeopathic remedy on the market in accordance with a registration
Application for registration
Products on the market before 1994
Classification
Bibliographic application
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...
A QNIG certificate has effect as if it were a...
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
Register
Test sites
Authorisation to manufacture specific veterinary medicinal products
Prohibition
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
Inspection of sites
Prohibition on manufacture, importation or distribution of active substances unless registered
Application for registration
Supply of information
Procedure for grant of authorisations and time limits
Inspection of sites
Report following inspection
Records
Inspection of premises
Suspension, revocation etc of the authorisation
Report following inspection
Qualified persons for manufacture
Classification of veterinary medicinal products
Supply of a medicinal premix
Supply of veterinary medicinal products for use under the cascade
Wholesale dealer’s authorisation
Application for authorisation
Procedure and time limits for authorisations
Wholesale supply of veterinary medicinal products
Suspension, variation or revocation of the authorisation
Register of authorised wholesale dealers
Use of sheep dip
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
Written prescriptions
Supply by a veterinary surgeon from registered premises
Immunological products for serious epizootic disease or emerging disease
Immunological products for an imported or exported animal
Administration of autogenous vaccines
Treatment in exceptional circumstances
Administration of a homeopathic remedy
Administration under an animal test certificate
Scope and interpretation
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
Writing the medicated feedingstuff prescription
Possession
Sampling and analysis
Storage
Packages and other containers
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
Enforcement of Regulation (EU) 2017/625
Enforcement of Regulation (EC) No 767/2009
Top dressing
Animals to which this Schedule applies
Placing on the market, importing and administering the product
Manufacture
Register of persons placing veterinary medicinal products on the market (small pet animals)
Approval of the active substance
Labelling
Administration
Pack size
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
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
Official guidance
Authoritative sources published by regulators or government explaining this legislation.
- Guidance for trials using feed additives not authorised - GOV.UK (opens in a new tab) from FSA Detailed Guidance
- Guidance for trials using feed additives not authorised | Food Standards Scotland (opens in a new tab) from Food Standards Scotland Detailed Guidance
- UK REACH Authorisation Overview (opens in a new tab) from HSE Detailed Guidance
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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