Provisions of samples and expertise
- Provide samples and technical expertise to the Secretary of State on request
UK Statutory Instrument
2007
United Kingdom
The Veterinary Medicines Regulations 2007
At a glance
What's here
31 compliance obligations
Who this Act binds
Plus 1 non-business duty 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.
Schedules
Supply of information
- Notify Secretary of State of new risk-benefit info or foreign restrictions
Duties on the holder of a marketing authorisation relating to an immunological product
- Obtain written approval before marketing immunological veterinary products
Control tests
- Provide control test evidence on demand to the Secretary of State
Placing on the market
- Notify MHRA when you first sell or remove a veterinary medicine from the UK market
Changes after a marketing authorisation has been issued
- Apply for marketing authorisation variations when scientific methods change
Compulsory variation
- Apply for compulsory variation within the time limit specified by the Secretary of State
Suspension of a marketing authorisation: procedure
Other duties (1) — Crown / regulator
- Marketing authorisation suspension: Secretary of State must notify and refer to Agency Crown / Minister / Government department
Supply of a copy of the summary of product characteristics
- Supply summary of product characteristics on demand
Qualified persons responsible for pharmacovigilance
- Appoint a qualified person for pharmacovigilance (drug safety)
Duties relating to the qualified person
- Set up a system to collect and report suspected adverse reactions
Adverse reactions to a veterinary medicinal product administered in the United Kingdom
- Report serious adverse reactions to veterinary medicines within 15 days
Periodic safety update reports
- Submit periodic safety update reports to the Secretary of State
Release of information by the marketing authorisation holder
- Notify Secretary of State before releasing pharmacovigilance information to the public
Duties on a qualified person
- Qualified person must certify each batch of veterinary medicine
Labelling
- Label autogenous vaccine containers with required information
Duties on the holder of a manufacturing authorisation
- Manufacture veterinary medicines in line with marketing authorisation and maintain required systems
Supply by a suitably qualified person
- Supply POM-VPS and NFA-VPS medicines from approved premises only
Duties on the holder of a wholesale dealer’s authorisation
- Comply with wholesale dealer duties for veterinary medicines
Supply of sheep dip
- Supply sheep dip only to certificate holders with record-keeping and safety equipment
Prescriptions by a veterinary surgeon
- Carry out clinical assessment before prescribing POM-V medicines
Supply by a veterinary surgeon
- Be present or authorise each transaction and verify competency for supply
Annual fees for marketing authorisations
- Pay annual fee and provide turnover statement when requested
Waiver or reduction of fees
- Provide full written justification when requesting a fee waiver or reduction
Browse 202 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
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
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
Administrative variations
Suspension of a marketing authorisation: grounds
Revocation
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
Time limits for applications for products for use in food-producing animals
Package leaflets
Ampoules
Small containers other than ampoules
Homeopathic remedies
Variations
Adverse reactions to a veterinary medicinal product administered in a third country
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
Register
Test sites
Authorisation to manufacture autogenous vaccines
Types of authorisation
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 reactions
Granting the authorisation
Inspection of premises
The authorisation
Suspension or revocation of the authorisation
Appeal to an appointed person
Inspection of premises
Report following inspection
Classification of veterinary medicinal products
Supply by a pharmacist
Supply of a veterinary medicinal product for incorporation into feedingstuffs
Labelling at the time of retail supply
Supply of veterinary medicinal products for use under the cascade
Annual audit
Application
Time limits
Granting the authorisation
The authorisation
Wholesale supply of veterinary medicinal products
Suspension or revocation of the authorisation
Appeals
Use of sheep dip
Retail supply of veterinary medicinal products
Prescriptions
Written prescriptions
Duties when a product is prescribed or supplied
Supply by a veterinary surgeon from registered premises
Administration under the cascade
Withdrawal periods
Administration to food-producing horses
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
Administration under an animal test certificate
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
Prescriptions for feedingstuffs containing a veterinary medicinal product
Writing the prescription
Possession
Sampling and analysis
Enforcement of Regulation (EC)
Storage
Packages and other containers
Transport
Possession, placing on the market and use of feedingstuffs
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
Decentralised immunological application where the United Kingdom is the reference member State
Application for a marketing authorisation using identical data
Application for a provisional marketing authorisation (pharmaceutical)
Fees for an application for a provisional marketing authorisation (immunological)
Fee for the conversion from a provisional to a full 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
Payment of fees
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
Registration of a homeopathic remedy
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
Time of payment
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
Inspection of a site where veterinary medicinal products are assembled
Test sites
Animal blood bank authorisations
Application for a wholesale dealer’s authorisation
Variation of a wholesale dealer’s authorisation
Multiple inspections
Annual fee for a wholesale dealer’s authorisation
Inspection of a wholesale dealer’s premises
Fees relating to feedingstuffs
Fees relating to premises for supply by suitably qualified persons
Reduced fees
Testing samples
Animal test certificates
Treatment under the cascade
Treatment under the Animals (Scientific Procedures) Act 1986
Treatment in exceptional circumstances
Expenses for inspections
Specific batch control
Submission of control tests of an immunological product
Export certificates
Appeals to the Veterinary Products Committee: marketing authorisations and ATCs
Appeals to the Veterinary Products Committee: variations
Appeal to the Veterinary Products Committee: suspensions
Appeal to the Veterinary Products Committee: active substance under Schedule 6
Fees relating to an appointed person
Refund of fees relating to the Veterinary Products Committee or appointed persons
Fees relating to an improvement notice
Translation
Non-payment of fees
Reduction of fees when an application is withdrawn
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
Administration under the cascade
- Veterinary surgeon must use the cascade to choose a suitable medicine for animals
Scope and interpretation
- Obtain approval to make or sell medicated feed or premixtures
Animals to which this Schedule applies
- Notify Secretary of State of serious adverse reactions to veterinary medicines within 15 days
Manufacture of veterinary medicinal products
- Ensure veterinary medicines are manufactured by the authorised manufacturer
Food-producing animals: records of administration by a veterinary surgeon
- Record veterinary medicine administration to food-producing animals
Records by a holder of a manufacturing authorisation
- Keep records of each veterinary medicinal product batch and retain for 5 years
Records by a holder of a wholesale dealer’s authorisation
- Record all veterinary medicine transactions as a wholesale dealer
Browse 40 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
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 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 acquisition and administration
Food-producing animals: retention of records
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
Veterinary Products Committee appeals procedure
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
Penalties
Northern Ireland
Revocation
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