UK Statutory Instrument
2005
United Kingdom
The Veterinary Medicines Regulations 2005
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 215 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 animals
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,
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
Homoeopathic veterinary medicinal products
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 “homoeopathic veterinary medicinal product”
Registration of a 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
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
Granting the authorisation
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
Annual audit
Supply of sheep dip
Application
Time limits
Granting the authorisation
The authorisation
Suspension or revocation of the authorisation
Representations
Duties on the holder of a wholesale dealer’s authorisation
Wholesale supply of veterinary medicinal products
Retail supply of veterinary medicinal products
Supply of products for incorporation into feedingstuffs
Prescriptions
Form of prescription
Labelling at the time of retail supply
Supply of veterinary medicinal products for use under the cascade
Supply by a suitably qualified person
Administration
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
Scope and interpretation
Labelling of feedingstuffs containing specified feed additives
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
Transport
Enforcement of Regulation (EC)
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
Incorporation of a veterinary medicinal product into premixtures
Incorporation of a veterinary medicinal product into feedingstuffs
Additional record keeping requirements relating to veterinary medicinal products
Additional labelling requirement for premixtures containing a veterinary medicinal product
Animals to which this Schedule applies
Placing on the market
Manufacture
The active substance
The product
Labelling
Administration
Pack size
Adverse reactions
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
Late payment of annual fees
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
Waiver or reduction 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....
Browse 52 other sections — procedural / definitional / commencement
Title and commencement
After regulation 1 of the Medicines (Standard Provisions for Licences...
Definition of “veterinary medicinal product”, interpretation and scope
After regulation 1 of the Medicines (Applications for Manufacturer’s and...
Products to which these Regulations do not apply
After article 1 of the Medicines (Control of Substances for...
Placing a veterinary medicinal product on the market
After article 1 of the Medicines (Importation of Medicinal Products...
Manufacture of veterinary medicinal products
(1) In article 1(2) of the Medicines (Exemption from Licences)...
The finished product
(1) In article 1(2) of the Medicines (Exemption from Licences)...
Classification, supply and possession of the product
After article 1 of the Medicines (Extension to Antimicrobial Substances)...
Administration of the product
After article 1 of the Medicines (Exemptions from Licences) (Emergency...
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
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
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
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
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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