UK Statutory Instrument
2005
United Kingdom
The Veterinary Medicines Regulations 2005
At a glance
Enforced by
What's here
75 compliance obligations
Penalty landscape
25 of 75 obligations carry a criminal penalty. 7 carry different penalties and 43 have no criminal penalty — flagged in the list below.
Who this Act binds
Plus 9 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 — Introduction
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 — Authorised veterinary medicinal products
Manufacture of veterinary medicinal products
- Ensure manufacture is done by authorised manufacturer
Browse 12 other sections in this Part — procedural / definitional / commencement
Placing a veterinary medicinal product on the market
The finished product
Classification, supply and possession of the product
Administration of the product
Importation of authorised veterinary medicinal products
Advertising the product
Advertising of prescription products and products with psychotropic drugs or narcotics
Defence of publication in the course of business
Wholesale dealing
Feedingstuffs
Exemptions
Fees
Part 3 — Records
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 purchase and administration
Food-producing animals: retention of records
Records by holders of a manufacturing authorisation
Records by wholesale dealers
Records of products supplied on prescription
Records of products administered to a food-producing animal under the cascade
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 17 other sections in this Part — procedural / definitional / commencement
The Veterinary Products Committee
Representations to the Veterinary Products Committee
Duties on the Secretary of State relating to exports
Time limits
Appointment of inspectors
Powers of entry
Powers of inspectors
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
- Secretary of State must complete veterinary medicine authorisation within 210 days Crown / Minister / Government department
Information with the application
- Submit complete application for veterinary medicinal product marketing authorisation
Assessment reports
Other duties (1) — Crown / regulator
- VMD must produce a formal assessment report for each medicine application Crown / Minister / Government department
Provisions of samples and expertise
- Fail to provide samples or technical expertise
Supply of information
- Fail to supply information about veterinary medicinal products
Duties on the holder of a marketing authorisation relating to an immunological product
- Fail to submit batch test results for immunological products
Control tests
- Fail to provide control test evidence on demand
Placing on the market
- Notify Secretary of State of market launches, withdrawals, and provide sales data on request
Administrative variations
Other duties (1) — Crown / regulator
- Secretary of State must revoke wrongly granted administrative variations and require new applications Crown / Minister / Government department
Changes after a marketing authorisation has been issued
- Keep manufacturing methods up to date and apply for authorisation variations
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 product safety issues to European Medicines Agency and comply with decisions Crown / Minister / Government department
Supply of a copy of the summary of product characteristics
- Supply summary of product characteristics on demand
Application for a marketing authorisation where one already exists in another member State
- Submit identical dossier and identify reference Member State for mutual recognition
Application in another member State
Other duties (1) — Crown / regulator
- Secretary of State must process mutual recognition requests for veterinary medicines within deadlines Crown / Minister / Government department
Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State
- Apply simultaneously for veterinary medicine authorisation in multiple EU states
Labelling with all the information on the immediate packaging
- Include all required labelling information on immediate packaging of veterinary medicines
Products with immediate and outer packaging
- Label veterinary medicinal product packaging with required information
Ampoules
- Label ampoules and outer packaging with required information
Small containers other than ampoules
- Label small single-dose containers with batch number and expiry date
Qualified persons responsible for pharmacovigilance
Unlimited fine- Fail to have a qualified person for 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 to veterinary medicines in third countries
Periodic safety update reports
- Fail to submit periodic safety update reports
Release of information by the marketing authorisation holder
- Notify Secretary of State before releasing pharmacovigilance information to the public
Action taken on account of pharmacovigilance
Other duties (1) — Crown / regulator
- Secretary of State must act on pharmacovigilance findings and notify affected parties Crown / Minister / Government department
Registration of a homoeopathic veterinary medicinal product
- Ensure homoeopathic veterinary product meets registration conditions before marketing
Duties on a qualified person
- Qualified person must ensure each batch is compliant and certified
Register
Other duties (1) — Crown / regulator
- Secretary of State must maintain and publish a register of authorised manufacturers and qualified persons Crown / Minister / Government department
Authorisation to manufacture autogenous vaccines
- Manufacture autogenous vaccine without authorisation
Labelling
- Label autogenous vaccine containers with required information
Records
- Fail to keep records for autogenous vaccine manufacturing
Adverse reactions
- Notify the Secretary of State of adverse reactions to autogenous vaccines within 15 days
Authorisation of blood banks
Unlimited fine- Operate an unauthorised animal blood bank
Supply and administration of blood from a blood bank
- Supply or administer blood from a blood bank in breach of restrictions
Labelling
- Label blood containers with required information
Records
Unlimited fine- Fail to keep blood bank records
Inspection of premises
Other duties (1) — Crown / regulator
- VMD must inspect manufacturing premises regularly Crown / Minister / Government department
Report following inspection
Other duties (1) — Crown / regulator
- Secretary of State must inform manufacturer of inspection report findings Crown / Minister / Government department
Duties on the holder of a manufacturing authorisation
- Manufacture veterinary medicines correctly, keep a Qualified Person, and hold a GMP certificate
Annual audit
Unlimited fine- Fail to carry out annual veterinary medicine stock audit
Supply of sheep dip
- Supply sheep dip without Certificate of Competence or required records
Duties on the holder of a wholesale dealer’s authorisation
- Store, distribute and audit veterinary medicines correctly
Wholesale supply of veterinary medicinal products
- Supply veterinary medicines wholesale without authorisation
Prescriptions
- Prescribe POM V without clinical assessment or prescribe excess amount
Form of prescription
- Ensure written prescriptions meet legal content and validity requirements
Supply of veterinary medicinal products for use under the cascade
- Fail to comply with cascade prescribing and labelling rules
Supply by a suitably qualified person
- Supply POM-VPS and NFA-VPS products only from approved premises and be present
Withdrawal periods
- Specify appropriate withdrawal period for food-producing animals under cascade
Administration by veterinary surgeons from other member States
- Conditions for non-UK vets to bring and use unauthorised medicines
Labelling of feedingstuffs containing specified feed additives
- Supply feedingstuffs without required labelling
Labelling of feedingstuffs containing a veterinary medicinal product
- Supply medicated feedingstuff without correct labelling
Supply of specified feed additives
- Supply specified feed additives to unauthorised persons
Supply of premixture
- Supply premixture to an unauthorised person
Supply of feedingstuffs containing a veterinary medicinal product
- Supply medicated feedingstuffs without proper authorisation
Possession
Unlimited fine- Possess prohibited veterinary medicines or feed additives without approval
Storage
- Improper storage of veterinary medicinal products
Packages and other containers
- Ensure tamper-evident seals on feed containing veterinary medicines
Transport
Unlimited fine- Fail to comply with transport rules for medicated feedingstuffs
Enforcement of Regulation (EC)
- Contravene EU feed safety requirements
Possession, placing on the market and use of feedingstuffs
- Possess, place on market, or feed animals with unauthorised medicated feed
Prescriptions for feedingstuffs containing a veterinary medicinal product
Unlimited fine- Supply veterinary medicated feed without proper prescription
Imports from third countries
- Do not import feedingstuffs containing veterinary medicines from third countries
Trade between member States
- Ensure imported medicated feedingstuffs meet EU manufacturing and UK authorisation rules
Enforcement of Regulation (EC) No. 1831/2003
- Breach authorisation / labelling rules for animal feed additives
Enforcement of Regulation (EC) No. 183/2005
- Contravene EU feed hygiene regulations
Incorporation of a veterinary medicinal product into premixtures
- Follow product summary and avoid duplicate active substances in premixtures
Incorporation of a veterinary medicinal product into feedingstuffs
- Incorporate veterinary medicines into feedingstuffs in compliance with all legal conditions
Additional record keeping requirements relating to veterinary medicinal products
- Fail to maintain records for veterinary medicinal products in feed
Additional labelling requirement for premixtures containing a veterinary medicinal product
- Supply medicated premixture without required labelling
The product
- Ensure veterinary medicinal product meets Schedule 6 product requirements
Administration
- Do not administer veterinary medicines by injection or into the inner ear
Adverse reactions
- Notify Secretary of State of adverse reactions within 15 days
Late payment of annual fees
- Pay additional late fee for overdue annual marketing authorisation fees
Waiver or reduction of fees
- Provide full written justification when requesting fee waiver or reduction
Browse 141 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 animals
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
Compulsory variation
Suspension,
Prohibiting the supply of veterinary medicinal products
Approval by the Secretary of State
Reference to being authorised
Language
Package leaflets
Time limits for applications for products for use in food-producing animals
Homoeopathic veterinary medicinal products
Variations
Adverse reactions to a veterinary medicinal product administered in the United Kingdom
Scope
Meaning of “homoeopathic veterinary medicinal product”
Application for registration
Procedure for registration
Products on the market before 1994
Administration
Bibliographic applications
Applications for products using a new combination of active substances
Applications 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
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
Supply of products for incorporation into feedingstuffs
Labelling at the time of retail supply
Administration
Administration under the cascade
Immunological products for serious epizootic disease
Immunological products for an imported or exported animal
Treatment in exceptional circumstances
Scope and interpretation
Sampling and analysis
Enforcement of Regulation (EC) No. 882/2004
Animals to which this Schedule applies
Placing on the market
Manufacture
The active substance
Labelling
Pack size
Payment of fees
Application for a provisional marketing authorisation
Application for a marketing authorisation relating to a parallel import
Application for a variation
Application for the renewal of a marketing authorisation
Registration of a homoeopathic veterinary medicinal product
Scope of Part 3
Provision of information relating to the recognition of United Kingdom marketing authorisation
Mutual recognition of a marketing authorisation already granted in another member State
Decentralised procedure where the United Kingdom is the reference member State
Decentralised procedure where the United Kingdom is not the reference member State
Time of payment
Application for a variation
Application for the renewal of a marketing authorisation
Application for a manufacturing authorisation
Application for a variation of a manufacturing authorisation
Application for an authorisation to manufacture an autogenous vaccine
Annual fees
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
Multiple inspections
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
Fees relating to distributors
Annual fees for marketing authorisations
Scope of Part 2
Auditor’s certificate
Submission of samples in connection with applications for marketing authorisations and animal test certificates
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
Standard application for a marketing authorisation
Application to the Veterinary Products Committee
Non-payment of fees
Reduction of fees when an application is withdrawn
Application for a marketing authorisation for a product with an active substance not contained in a veterinary medicinal product previously authorised in the United Kingdom
Application for a marketing authorisation involving other aspects not previously authorised in a veterinary medicinal product in the UK
Pharmacologically equivalent products
Application for a marketing authorisation using identical data
(1) The Medicines (Labelling) Regulations 1976 (S.I. 1976/1726) shall be...
In the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977...
In the Medicines (Certificates of Analysis) Regulations 1977 (S.I. 1977/1399)...
(1) In article 1(2) of the Medicines (Retail Sale or...
After article 1 of the Medicines (Prohibition of Non-medicinal Antimicrobial...
(1) In regulation 1(2) of the Medicines (Fluted Bottles) Regulations...
(1) In regulation 1(2)(a) of the Medicines (Sale or Supply)...
(1) In article 1(2) of the Medicines (Pharmacy and General...
After article 1 of the Medicines (Control of Substances for...
After rule 1 of The Medicines Act 1968 (Hearings by...
After rule 1 of the Medicines Act 1968 (Hearings by...
(1) In article 1(2) of the Medicines (Exemption from Licences)...
Article 2(1)(b) of the Medicines (Advisory Board on the Registration...
In the Medicines (Exemption from Licences) (Ingredients) Order 1974 (S.I....
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 8 other unclassified sections
After regulation 1 of the Medicines (Standard Provisions for Licences...
After regulation 1 of the Medicines (Applications for Manufacturer’s and...
After article 1 of the Medicines (Control of Substances for...
After article 1 of the Medicines (Importation of Medicinal Products...
(1) In article 1(2) of the Medicines (Exemption from Licences)...
(1) In article 1(2) of the Medicines (Exemption from Licences)...
After article 1 of the Medicines (Extension to Antimicrobial Substances)...
After article 1 of the Medicines (Exemptions from Licences) (Emergency...
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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Regulators
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