UK Statutory Instrument SI 2013 United Kingdom

Veterinary Medicines Regulations 2013

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2011 (S.I. 2011/2159).

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
VMD
Status
Amended (in force with amendments)
Penalty ceiling
Regulated 7 of 116 obligations carry a criminal penalty. 109 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person46 Manufacturer28 Applicant10 Trader6 Operator4 Distributor4 Farmer or Animal Keeper2 Self-Employed Person2

Plus 14 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Any Person — also bound by 2684 other Acts
Manufacturer — also bound by 551 other Acts
Applicant — also bound by 325 other Acts
Trader — also bound by 864 other Acts
Companies Act 2006 244 duties
Companies Act 1985 85 duties
Operator — also bound by 803 other Acts
Distributor — also bound by 201 other Acts
Farmer or Animal Keeper — also bound by 86 other Acts
Self-Employed Person — also bound by 78 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

Part 1

Introduction

0 of 3 sections shown
3 other sections in this Part — procedural and definitional
s.001 Title and commencement
s.002 Definition of “veterinary medicinal product”, interpretation and scope
s.003 Products to which these Regulations do not apply
Part 2

Authorised veterinary medicinal products

2 of 14 sections shown
s.005 Manufacture of veterinary medicinal products Regulated
  • Use only the authorised manufacturer for each production stageManufacturer
s.010 Inducements and hospitality Regulated
  • Do not offer prohibited gifts or hospitality when promoting veterinary medicinesAny Person
12 other sections in this Part — procedural and definitional
s.004 Placing a veterinary medicinal product on the market
s.006 Marketing of products not in accordance with a marketing authorisation
s.007 Classification, supply and possession of the product
s.008 Administration of the product
s.009 Importation of authorised veterinary medicinal products
s.010 Advertising the product
s.011 Advertising of prescription products and products containing psychotropic drugs or narcotics
s.012 Defence of publication in the course of business
s.013 Wholesale dealing
s.014 Feedingstuffs
s.015 Exemptions
s.016 Fees
Part 3

Records

5 of 9 sections shown
s.018 Food-producing animals: records of administration by a veterinary surgeon Regulated
  • Record administration of veterinary medicine to food-producing animalsSelf-Employed Person
s.021 Records by a holder of a manufacturing authorisation Regulated
  • Keep batch records for veterinary medicines you manufacture or supplyManufacturer
s.022 Records by a holder of a wholesale dealer’s authorisation Regulated
  • Record wholesale veterinary medicine transactions and keep recordsTrader
s.024 Records of products administered to a food-producing animal under the cascade Regulated
  • Record cascade treatments for food-producing animals and keep records for 5 yearsAny Person
s.024 Reporting of sales and usage data in relation to antibiotics Regulated
  • Provide antibiotic sales and usage data when requested by the Secretary of StateManufacturer
4 other sections in this Part — procedural and definitional
s.017 Food-producing animals: proof of purchase of veterinary medicinal products
s.019 Food-producing animals: records of acquisition and administration
s.020 Food-producing animals: retention of records
s.023 Records of the receipt or supply of prescription products
Part 4

Unauthorised veterinary medicinal products

0 of 3 sections shown
3 other sections in this Part — procedural and definitional
s.025 Importation of an unauthorised veterinary medicinal product
s.026 Possession of an unauthorised veterinary medicinal product
s.027 Supply of an unauthorised veterinary medicinal product
Part 5

Miscellaneous provisions, enforcement and offences

0 of 20 sections shown
20 other sections in this Part — procedural and definitional
s.028 The Veterinary Products Committee
s.029 Veterinary Products Committee appeals procedure
s.030 Appeals to an appointed person
s.031 Exports
s.032 Time limits
s.033 Appointment of inspectors
s.034 Powers of entry
s.035 Powers of an inspector
s.036 Inspection of pharmacies
s.037 Obstruction
s.038 Improvement notices
s.039 Appeals against improvement notices
s.040 Powers of a court on appeal
s.041 Seizure notices
s.042 Publication
s.043 Offence
s.044 Penalties
s.045 Northern Ireland
s.046 Review
s.047 Revocations
Schedules

Schedules

109 of 296 shown
s.sch001 Hybrid veterinary medicinal products Regulated
  • Provide study results for hybrid veterinary medicinal productsApplicant
s.sch001 Time limits for marketing authorisations granted under the procedure for a generic veterinary medicinal product Regulated
  • Wait before placing generic veterinary medicines on the marketApplicant
s.sch001 Similar immunological products Regulated
  • Provide pre-clinical or clinical trial results for similar immunological productsApplicant
s.sch001 Time limits Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must complete veterinary medicine authorisation within 210 daysCrown / Minister / Government department
s.sch001 Products authorised in another member State Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must reject conflicting veterinary medicine authorisation applicationsCrown / Minister / Government department
s.sch001 Assessment reports Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must assess veterinary medicine dossiersCrown / Minister / Government department
s.sch001 Marketing authorisations for food-producing species Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must not grant marketing authorisation unless MRLs established and substances in Table 1Crown / Minister / Government department
s.sch001 Refusal of a marketing authorisation Regulated
Other duties (1) — Crown / regulator
  • VMD must refuse marketing authorisation if conditions not metCrown / Minister / Government department
s.sch001 Provisions of samples and expertise Regulated
  • Provide samples and technical expertise when requested by the VMDManufacturer
s.sch001 Records and supply of information Regulated
  • Report safety concerns and retain clinical trial records for veterinary medicinesManufacturer
s.sch001 Duties on the holder of a marketing authorisation relating to an immunological product Regulated
  • Get written approval before marketing immunological veterinary medicinesManufacturer
s.sch001 Information with the application: animal testing Regulated
  • Disclose animal test conditions when applying for veterinary medicine authorisationApplicant
s.sch001 Control tests Regulated
  • Provide evidence of control tests on demandManufacturer
s.sch001 Placing on the market Regulated
  • Notify VMD of market changes and provide sales data on requestManufacturer
s.sch001 Variation procedure Regulated
  • Submit marketing authorisation variation applications electronicallyApplicant
s.sch001 Changes after a marketing authorisation has been issued Regulated
  • Keep marketing authorisation up to date with scientific progressManufacturer
s.sch001 Suspension of a marketing authorisation: procedure Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must notify marketing authorisation holder immediately upon suspensionCrown / Minister / Government department
s.sch001 Supply of a copy of the summary of product characteristics Regulated
  • Provide copy of product characteristics summary on requestManufacturer
s.sch001 Application for a marketing authorisation where one already exists in a member State Regulated
  • Apply for mutual recognition of your veterinary medicine marketing authorisationApplicant
s.sch001 Application in a member State Regulated
Other duties (1) — Crown / regulator
  • VMD must prepare and share assessment report within 90 daysCrown / Minister / Government department
s.sch001 Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State Regulated
  • Submit identical dossiers and nominate a reference member state for decentralised marketing authorisationApplicant
s.sch001 Approval by the Secretary of State Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must approve containers, packaging, labels and leaflets for marketing authorisationCrown / Minister / Government department
s.sch001 Labelling of immediate packaging of veterinary medicinal products Regulated
  • Label immediate packaging of veterinary medicinal products with required informationAny Person
s.sch001 Small containers other than ampoules Regulated
  • Label small single-dose containers with batch number and expiry dateAny Person
s.sch001 Qualified persons responsible for pharmacovigilance Regulated
  • Appoint and retain a qualified pharmacovigilance personManufacturer
s.sch001 Duties of marketing authorisation holder in relation to pharmacovigilance Regulated
  • Monitor and manage pharmacovigilance for your veterinary medicinal productsManufacturer
s.sch001 Duties of marketing authorisation holder in relation to signal management process Regulated
  • Carry out signal management process for veterinary medicinesManufacturer
s.sch001 Duties of qualified person (pharmacovigilance) Regulated
  • Establish and maintain a pharmacovigilance system for veterinary productsAny Person
s.sch001 Adverse events following administration of a veterinary medicinal product Regulated
  • Record and report adverse events from your veterinary medicinesManufacturer
s.sch001 Annual benefit-risk reports Regulated
  • Submit annual benefit-risk reports to the Veterinary Medicines DirectorateManufacturer
s.sch001 Release of information by the marketing authorisation holder Regulated
  • Do not publicise pharmacovigilance concerns without notifying the Secretary of StateManufacturer
s.sch001 Action taken on account of pharmacovigilance Regulated
Other duties (1) — Crown / regulator
  • Secretary of State may suspend, revoke or vary veterinary medicine authorisations on pharmacovigilance groundsCrown / Minister / Government department
s.sch001 Procedure for registration Regulated
Other duties (1) — Crown / regulator
  • VMD must process homeopathic remedy registration within 210 daysStatutory regulator
s.sch001 Classification Regulated
  • Specify the classification of homeopathic remedies in registrationAny Person
s.sch001 Offences Regulated
  • Fail to comply with veterinary medicines regulatory requirementsAny Person
s.sch001 Application for a product using a new combination of active substances Regulated
  • Provide scientific justification for a new combination of active substancesApplicant
s.sch001b If the condition in paragraph 4 is met in respect... Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must issue QNIG certificate to eligible marketing authorisation holdersCrown / Minister / Government department
s.sch001b The condition is that the person who holds a marketing... Regulated
  • Provide information for Northern Ireland marketing authorisationAny Person
s.sch001b The QNIG certificate holder must provide to the Secretary of... Regulated
  • Keep your QNIG certificate information up to date with the Secretary of StateAny Person
s.sch001b The Secretary of State must publish any notice given under... Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must publish paragraph 7 noticesCrown / Minister / Government department
s.sch002 Duties on a qualified person Regulated
  • Qualified person must certify each batch meets marketing authorisation before releaseAny Person
s.sch002 Personnel Regulated
  • Appoint a qualified person to supervise autogenous vaccine manufacture and label containersOperator
s.sch002 Labelling Regulated
  • Label veterinary medicines and blood products correctlyManufacturer
s.sch002 Records Regulated
  • Keep detailed records of certain veterinary products suppliedOperator
s.sch002 Adverse events Regulated
  • Notify the VMD of adverse events within 30 daysManufacturer
s.sch002 Application for registration Regulated
  • Apply to register before starting active substance activitiesApplicant
s.sch002 Good manufacturing or distribution practice Regulated
  • Comply with good manufacturing/distribution practice and report adverse reactionsManufacturer
s.sch002 Offences Regulated
  • Label equine stem cell containers with required information and avoid therapeutic claimsOperator
s.sch002 Inspection of premises Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must inspect authorised premises based on riskCrown / Minister / Government department
s.sch002 Offences Regulated
  • Fail to comply with Schedule 2 requirements (veterinary medicines)Any Person
s.sch002 The authorisation Regulated
  • Notify VMD before making material changes to premises or operationsManufacturer
s.sch002 Application for variation to the authorisation Regulated
  • Notify VMD before changing your site or key staffManufacturer
s.sch002 Good manufacturing practice certificates and inspection of sites Regulated
  • Ensure manufacturer has valid GMP certificate before importing veterinary medicinesManufacturer
s.sch002 Duties on the holder of a manufacturing authorisation Regulated
  • Manufacture veterinary medicines in line with authorisation and GMPManufacturer
s.sch002 Good manufacturing practice Regulated
  • Implement and maintain a pharmaceutical quality system for manufacturing veterinary medicinesManufacturer
s.sch002 Recalled and counterfeit products Regulated
  • Handle recalled and counterfeit veterinary medicines properlyManufacturer
s.sch003 Supply by a pharmacist Regulated
  • Pharmacists must supply veterinary medicines only from registered premisesAny Person
s.sch003 Labelling at the time of retail supply Regulated
  • Ensure your veterinary medicine packaging is clearly labelled when suppliedAny Person
s.sch003 Supply by a suitably qualified person Regulated
  • Supply veterinary medicines only from authorised premises and follow handover rulesAny Person
s.sch003 Audit Regulated
  • Carry out annual stock audit of prescription-only veterinary medicinesDistributor
s.sch003 Wholesale dealer’s authorisation Regulated
  • Obtain a wholesale dealer’s authorisation before selling veterinary medicinesAny Person
s.sch003 Periodic inspections and suspension etc. for lack of use Regulated
  • Notify VMD before making material changes to your wholesale premises or operationsAny Person
s.sch003 Application for variation to the authorisation Regulated
  • Notify VMD before making material changes to your premises, operations or qualified personAny Person
s.sch003 Duties on the holder of a wholesale dealer’s authorisation Regulated
  • Store veterinary medicines correctly, follow GDP, audit stock annually, and supply information on demandTrader
s.sch003 Register of authorised wholesale dealers Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must maintain and publish register of authorised wholesale dealersCrown / Minister / Government department
s.sch003 Documentation accompanying veterinary medicinal products supplied wholesale Regulated
  • Provide documentation and keep records for wholesale supplies of veterinary medicinesTrader
s.sch003 Recalled, counterfeit or returned products Regulated
  • Handle recalled, counterfeit or returned veterinary products correctlyTrader
s.sch003 Audit Regulated
  • Conduct an annual stock audit for wholesale veterinary medicinesTrader
s.sch003 Contractual arrangements between holders of wholesale dealer’s authorisations Regulated
  • Record written contract when outsourcing wholesale dealingAny Person
s.sch003 Self-inspection programme Regulated
  • Run an annual self-inspection programme and keep records for 5 yearsTrader
s.sch003 Supply of sheep dip Regulated
  • Supply sheep dip safely and provide safety notices and glovesAny Person
s.sch003 Offences Regulated
  • Fail to comply with veterinary medicines supply and use rulesAny Person
s.sch003 Application for registration Regulated
  • Register with VMD before supplying veterinary medicines onlineApplicant
s.sch003 Duties in relation to online supply Regulated
  • Display required online retailer details on your veterinary medicine websiteAny Person
s.sch003 Retail storage of veterinary medicinal products Regulated
  • Store veterinary medicines according to label instructions and product characteristicsDistributor
s.sch003 Prescriptions by a veterinary surgeon Regulated
  • Carry out clinical assessment before prescribing POM-V or cascade medicinesAny Person
s.sch003 Prescriptions Regulated
  • Supply prescription-only veterinary medicines under valid prescriptions and keep recordsAny Person
s.sch003 Duties when a product is prescribed or supplied Regulated
  • Check user competence, advise on safe use, and prescribe only minimum amountAny Person
s.sch003 Duties in relation to prescribing of antibiotic veterinary medicinal products Regulated
  • Restrict prophylactic antibiotic prescribing and retain recordsSelf-Employed Person
s.sch003 Supply by a veterinary surgeon Regulated
  • Oversee handover of veterinary medicines to customersAny Person
s.sch004 Administration under the cascade Regulated
  • Follow the cascade when prescribing unauthorised veterinary medicinesAny Person
s.sch004 Offences Regulated
  • Fail to comply with veterinary medicines regulations (withdrawal periods, administration, supply)Any Person
s.sch004 Withdrawal periods Regulated
  • Specify a minimum withdrawal period when using the cascade on food-producing animalsAny Person
s.sch004 Administration to food-producing horses Regulated
  • Record equine medicine details in the horse passportAny Person
s.sch004 Administration by veterinary surgeons from other countries Regulated
  • Comply with conditions when bringing unapproved veterinary medicines into the UKAny Person
s.sch004 Treatment in exceptional circumstances Regulated
  • Obtain import certificate before using foreign veterinary medicinesAny Person
s.sch004 Misuse of the cascade Regulated
  • Do not promote or facilitate misuse of the veterinary cascadeAny Person
s.sch005 Incorporation of a medicinal premix into feedingstuffs Regulated
  • Incorporate medicinal premixes into feed correctlyAny Person
s.sch005 Additional record keeping requirements relating to medicinal premixes Regulated
  • Keep daily records of medicated feed and premix transactionsManufacturer
s.sch005 Supply of feedingstuffs containing a medicinal premix Regulated
  • Supply medicated feedingstuffs only to authorised persons, with a prescription, and keep records for 5 yearsDistributor
s.sch005 Medicated feedingstuff prescriptions for feedingstuffs containing a medicinal premix Regulated
  • Ensure medicated feedingstuff prescriptions are complete and validFarmer or Animal Keeper
s.sch005 Enforcement of Regulation (EC) No 178/2002 Regulated
  • You must comply with feed safety and traceability rulesAny Person
s.sch005 Sampling for cross-contamination Regulated
  • Manage and monitor cross-contamination of non-target feedsOperator
s.sch005 Storage Regulated
  • Store medicated feed products only in locked areas or sealed containersAny Person
s.sch005 Packages and other containers Regulated
  • Use tamper-evident seals for feedingstuffs with veterinary medicinesAny Person
s.sch005 Transport Regulated
  • Transport feedingstuffs with proper labelling, cleaning and driver instructionsAny Person
s.sch005 Possession, placing on the market and use of feedingstuffs Regulated
  • Safely manage medicated feedingstuffs for animalsFarmer or Animal Keeper
s.sch005 Imports from third countries Regulated
  • Do not import feedingstuffs containing veterinary medicines from third countriesAny Person
s.sch005 Trade between countries Regulated
  • Do not import medicated feedingstuffs unless they meet UK composition standardsAny Person
s.sch005 Offences Regulated
  • Fail to comply with veterinary medicines requirementsAny Person
s.sch005 Enforcement of Regulation (EC) No 183/2005 Regulated
  • Comply with EU feed hygiene and safety rules for medicated feedingstuffsAny Person
s.sch005 Authorisation of manufacturers and distributors of feedingstuffs containing medicinal premixes Regulated
  • Obtain authorisation to make or distribute medicated animal feedDistributor
s.sch005 Incorporation of a medicinal premix into an intermediate feedingstuff Regulated
  • Follow product specifications when mixing medicinal premixes into feedAny Person
s.sch006 Offences Regulated
  • Fail to comply with veterinary medicines regulatory requirements (Schedule 6 paras 3A, 3B, 9)Any Person
s.sch006 Register of persons placing veterinary medicinal products on the market (small pet animals) Regulated
  • Register with VMD before placing small-pet veterinary medicines on the marketAny Person
s.sch006 Persons registered in accordance with paragraph 3A: annual return Regulated
  • Submit annual return for small pet animal veterinary productsAny Person
s.sch006 The product Regulated
  • Ensure your veterinary product meets approval and prohibition requirementsAny Person
s.sch006 Adverse events Regulated
  • Fail to report serious adverse events or keep records for veterinary medicinesManufacturer
s.sch007 Annual fees for marketing authorisations Regulated
  • Provide annual turnover statement for marketing authorisation feesManufacturer
187 other schedules
s.sch001 Application for a marketing authorisation
s.sch001 Application for a generic veterinary medicinal product
s.sch001 Extension of time limits
s.sch001 Time limits – supplementary
s.sch001 Parallel imports
s.sch001 Specific batch control scheme
s.sch001 Marketing a product authorised in another country
s.sch001 Place of establishment of applicant
s.sch001 Procedure
s.sch001 Information with the application: general
s.sch001 Grant of a marketing authorisation
s.sch001 Withdrawal of application for marketing authorisation
s.sch001 Publication following the grant , refusal, suspension, variation or revocation of a marketing authorisation
s.sch001 Marketing authorisations in exceptional circumstances
s.sch001 Information with the application: format
s.sch001 Information with the application: POM-VPS, NFA-VPS and AVM-GSL
s.sch001 Summary of product characteristics
s.sch001 Duration and validity of marketing authorisation
s.sch001 Variation of a marketing authorisation
s.sch001 Refusal of a variation of a marketing authorisation
s.sch001 Administrative variations
s.sch001 Compulsory variation
s.sch001 Suspension , revocation, etc of a marketing authorisation: grounds
s.sch001 Revocation
s.sch001 Prohibiting the supply of veterinary medicinal products
s.sch001 Temporary restrictions
s.sch001 Restrictions in relation to immunological veterinary medicines
s.sch001 Reference to being authorised
s.sch001 Language
s.sch001 Labelling of the outer packaging of veterinary medicinal products
s.sch001 Time limits for applications for products for use in food-producing animals
s.sch001 Labelling of small immediate packaging units of veterinary medicinal products
s.sch001 Package leaflet of veterinary medicinal products
s.sch001 Homeopathic remedies
s.sch001 Variations
s.sch001 Signal management process
s.sch001 Adverse reactions to a veterinary medicinal product administered in another country
s.sch001 Scope
s.sch001 Pharmacovigilance inspections by Secretary of State
s.sch001 Powers of Secretary of State in relation to signal management process
s.sch001 Meaning of “homeopathic remedy”
s.sch001 Placing a homeopathic remedy on the market in accordance with a registration
s.sch001 Application for registration
s.sch001 Products on the market before 1994
s.sch001 Bibliographic application
s.sch001 Application using existing data
s.sch001a In this Schedule— “ converted EU marketing authorisation ” means...
s.sch001a This paragraph applies to an EU marketing authorisation which—
s.sch001a A converted EU marketing authorisation has effect on and after...
s.sch001a Without prejudice to the generality of paragraph 3—
s.sch001b In this Schedule— “QNIG certificate” means a certificate issued under...
s.sch001b This Schedule applies to a veterinary medicinal product which is—...
s.sch001b A QNIG certificate has effect as if it were a...
s.sch001b Without prejudice to any other power to suspend a marketing...
s.sch001b Paragraphs 39 and 40 of Schedule 1 apply to the...
s.sch002 Manufacturing authorisation
s.sch002 Refusal, revocation, suspension or variation of appointment
s.sch002 Register
s.sch002 Test sites
s.sch002 Authorisation to manufacture specific veterinary medicinal products
s.sch002 Prohibition
s.sch002 Process of authorisation
s.sch002 Authorisation in relation to blood banks
s.sch002 Authorisation in relation to stem cells
s.sch002 Application for authorisation
s.sch002 Authorisation in relation to products for administration under the cascade
s.sch002 Suspension, compulsory variation or revocation of authorisation
s.sch002 Inspection of sites
s.sch002 Prohibition on manufacture, importation or distribution of active substances unless registered
s.sch002 Supply of information
s.sch002 Procedure for grant of authorisations and time limits
s.sch002 Inspection of sites
s.sch002 Report following inspection
s.sch002 Records
s.sch002 Suspension, revocation etc of the authorisation
s.sch002 Report following inspection
s.sch002 Qualified persons for manufacture
s.sch003 Classification of veterinary medicinal products
s.sch003 Supply of a medicinal premix
s.sch003 Supply of veterinary medicinal products for use under the cascade
s.sch003 Application for authorisation
s.sch003 Procedure and time limits for authorisations
s.sch003 Wholesale supply of veterinary medicinal products
s.sch003 Suspension, variation or revocation of the authorisation
s.sch003 Use of sheep dip
s.sch003 Retail supply of veterinary medicinal products
s.sch003 Supply of samples
s.sch003 Register of online suppliers of veterinary medicinal products
s.sch003 Written prescriptions
s.sch003 Supply by a veterinary surgeon from registered premises
s.sch004 Immunological products for serious epizootic disease or emerging disease
s.sch004 Immunological products for an imported or exported animal
s.sch004 Administration of autogenous vaccines
s.sch004 Administration of a homeopathic remedy
s.sch004 Administration under an animal test certificate
s.sch005 Scope and interpretation
s.sch005 Labelling an intermediate feedingstuff containing a medicinal premix
s.sch005 Labelling of feedingstuffs containing a specified feed additive
s.sch005 Labelling of feedingstuffs containing a medicinal premix
s.sch005 Supply of specified feed additives
s.sch005 Supply of intermediate feedingstuff or specified feed additive
s.sch005 Supply of a complementary feedingstuff
s.sch005 Writing the medicated feedingstuff prescription
s.sch005 Possession
s.sch005 Sampling and analysis
s.sch005 Unused and expired medicated feedingstuffs
s.sch005 Import for incorporation into intermediate feedingstuffs or feedingstuffs for export
s.sch005 Enforcement of Regulation (EC) No 1831/2003
s.sch005 Animals on domestic premises
s.sch005 Enforcement of Regulation (EU) 2017/625
s.sch005 Enforcement of Regulation (EC) No 767/2009
s.sch005 Top dressing
s.sch006 Animals to which this Schedule applies
s.sch006 Placing on the market, importing and administering the product
s.sch006 Manufacture
s.sch006 Approval of the active substance
s.sch006 Labelling
s.sch006 Administration
s.sch006 Pack size
s.sch007 Interpretation
s.sch007 Decentralised immunological application where the United Kingdom is the reference member State
s.sch007 Application for a marketing authorisation based on informed consent
s.sch007 Application for an exceptional marketing authorisation (pharmaceutical)
s.sch007 Fees for an application for an exceptional marketing authorisation (immunological or biological non-immunological)
s.sch007 Fee for the conversion from an exceptional to a full marketing authorisation
s.sch007 Application for a marketing authorisation relating to a parallel import
s.sch007 Fee for a generic marketing authorisation
s.sch007 Application to change the distribution category of a product authorised through the centralised procedure
s.sch007 Application for a variation to a marketing authorisation ....
s.sch007 Application for a variation to a marketing authorisation dealt with under worksharing procedures
s.sch007 Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member State
s.sch007 Payment of fees
s.sch007 Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension
s.sch007 Exception for a variation relating to animal testing
s.sch007 Application for a reassessment of an exceptional marketing authorisation
s.sch007 Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure
s.sch007 Registration of a homeopathic remedy
s.sch007 Renewal of a homeopathic remedy
s.sch007 Auditor’s certificate
s.sch007 Application for a manufacturing authorisation
s.sch007 Application for a variation of a manufacturing authorisation
s.sch007 Time of payment
s.sch007 Inspection of sites authorised to manufacture a product for administration under the cascade
s.sch007 Autogenous vaccines
s.sch007 Assessment of a variation of an authorisation to manufacture an autogenous vaccine
s.sch007 Annual fee (manufacturing authorisations)
s.sch007 Site inspections – type of site
s.sch007 Inspection of a site where immunological veterinary medicinal products are manufactured
s.sch007 Inspection of a site where sterile veterinary medicinal products are manufactured
s.sch007 Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured
s.sch007 Inspection of a site where veterinary medicinal products are assembled
s.sch007 Test sites
s.sch007 Animal blood bank or non-food animal stem cell centre authorisations
s.sch007 Application for a wholesale dealer’s authorisation
s.sch007 Multiple inspections
s.sch007 Variation of a wholesale dealer’s authorisation
s.sch007 Annual fee for a wholesale dealer’s authorisation
s.sch007 Inspection of a wholesale dealer’s sites
s.sch007 Fees for applications for authorisation and annual fees relating to feedingstuffs in Great Britain
s.sch007 Inspection fees relating to feedingstuffs in Great Britain
s.sch007 Fees payable in relation to feedingstuffs in Northern Ireland
s.sch007 Fees relating to premises for supply by suitably qualified persons
s.sch007 Testing samples
s.sch007 Animal test certificates
s.sch007 Importation of a veterinary medicinal product for treatment under the cascade
s.sch007 Expenses for inspections outside the United Kingdom
s.sch007 Wholesale dealer’s import certificate
s.sch007 Specific batch control
s.sch007 Submission of control tests of an immunological product
s.sch007 Export certificates
s.sch007 Provision of advice
s.sch007 Provision of scientific advice
s.sch007 Appeals to the Veterinary Products Committee
s.sch007 Fee relating to an appointed person
s.sch007 Fees relating to a veterinary surgeon’s practice premises
s.sch007 Fee in relation to verifying destruction of controlled drug
s.sch007 Pharmacovigilance inspections
s.sch007 Refund of fees relating to the Veterinary Products Committee or appointed persons
s.sch007 Fees relating to an improvement notice
s.sch007 Translation
s.sch007 Non-payment of fees
s.sch007 Waiver or reduction of fees
s.sch007 Reduction of fees when an application is withdrawn
s.sch007 Application for a marketing authorisation for a pharmaceutical , immunological or biological that is not immunological veterinary medicinal product
s.sch007 Application for a marketing authorisation for specific applications
s.sch007 Decentralised pharmaceutical application where the United Kingdom is the reference member State
s.sch007 Application for a marketing authorisation for an immunological or biosimilar product

Help complying

Guvnor’s practical routes through this instrument.

Set up a veterinary practice

Follow this path to meet every regulatory obligation for your veterinary practice — from workplace health and safety and COSHH controls through …

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Meet your veterinary practice regulatory duties Veterinary practice compliance checklist Wholesale licences for controlled and excise goods

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