- Enforced by
- VMD
- Status
- In Force
- Penalty ceiling
- Prosecution 30 of 90 obligations carry a criminal penalty. 12 carry different penalties and 48 have no criminal penalty — flagged in the list below.
Does it bind you?
Business-side roles with duties under this instrument.
Plus 7 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 2340 other Acts
Manufacturer — also bound by 502 other Acts
Applicant — also bound by 307 other Acts
Trader — also bound by 825 other Acts
Operator — also bound by 746 other Acts
Distributor — also bound by 182 other Acts
Employer — also bound by 682 other Acts
Farmer or Animal Keeper — also bound by 80 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.
3 other sections in this Part — procedural and definitional
- Do not advertise prescription-only or psychotropic veterinary medicines to the publicAny Person
12 other sections in this Part — procedural and definitional
- Keep records of veterinary medicine administration to food-producing animalsFarmer or Animal Keeper
- Keep batch records for each veterinary medicine and retain for 5 yearsManufacturer
- Keep detailed records of all wholesale veterinary medicine transactionsTrader
- Fail to keep required records for medicines given to food-producing animalsAny Person
4 other sections in this Part — procedural and definitional
3 other sections in this Part — procedural and definitional
17 other sections in this Part — procedural and definitional
Schedules
85 of 275 shownOther duties (1) — Crown / regulator
- VMD must complete marketing authorisation procedure within 210 daysStatutory regulator
- Submit a complete application for veterinary medicine marketing authorisation with all required informationApplicant
Other duties (1) — Crown / regulator
- Secretary of State must produce assessment reports for veterinary medicine applicationsCrown / Minister / Government department
- Fail to provide samples or expertise when required by Secretary of StateAny Person
- Fail to supply information to the Secretary of State about veterinary medicine risksAny Person
- Fail to submit batch test results before placing immunological product on marketAny Person
- Fail to provide evidence of control tests on demandAny Person
- Notify VMD when you first place a veterinary medicine on the market and report sales dataAny Person
- Apply for marketing authorisation variation to reflect scientific progressManufacturer
- Apply for compulsory marketing authorisation variation when directedManufacturer
Other duties (1) — Crown / regulator
- Secretary of State must refer safety concerns to the Agency and comply with Commission decisionsCrown / Minister / Government department
- Supply summary of product characteristics on requestManufacturer
- Submit required documents for mutual recognition applicationApplicant
- Apply for a veterinary medicine marketing authorisation using the decentralised procedureApplicant
- Provide required labelling information on immediate packaging of veterinary medicinesManufacturer
- Label immediate and outer packaging of veterinary medicinal products correctlyManufacturer
- Supply approved package leaflet with veterinary medicine when neededDistributor
- Label ampoules correctly with specified informationManufacturer
- Label small immediate packaging with batch number and expiry dateAny Person
- Fail to have a qualified person for veterinary pharmacovigilanceAny Person
Unlimited fine
- Ensure qualified person maintains pharmacovigilance and responds to requestsManufacturer
- Fail to report adverse reactions from veterinary medicines used in third countriesAny Person
- Fail to submit periodic safety update reportsAny Person
- Notify the Secretary of State before publicising pharmacovigilance concernsManufacturer
Other duties (1) — Crown / regulator
- Secretary of State must act on pharmacovigilance data: notify holders and take necessary regulatory actionCrown / Minister / Government department
- Ensure homeopathic remedy meets conditions for registrationAny Person
- Qualified person must ensure each batch of veterinary medicine is compliant and certifiedAny Person
Other duties (1) — Crown / regulator
- Secretary of State must maintain register of manufacturers and qualified personsCrown / Minister / Government department
- Manufacture autogenous vaccine without authorisationAny Person
- Label autogenous vaccine containers with all required informationOperator
- Fail to keep veterinary vaccine supply recordsAny Person
Unlimited fine
- Notify Secretary of State of adverse reactions to autogenous vaccines within 15 daysAny Person
- Operate a blood bank without authorisationAny Person
- Supply or administer blood from a blood bank without complying with restrictionsAny Person
- Label blood containers with required informationOperator
- Fail to keep blood bank records for five yearsAny Person
Unlimited fine
- Manufacture unauthorised veterinary product outside authorisationAny Person
Unlimited fine
- Label containers of veterinary medicinal products before supplyAny Person
- Fail to keep records of veterinary medicinal product supplyAny Person
- Notify VMD of adverse reactions to your products within 15 daysAny Person
Other duties (1) — Crown / regulator
- VMD must inspect premises and issue certificatesCrown / Minister / Government department
Other duties (1) — Crown / regulator
- Secretary of State must inform manufacturers of inspection report findingsCrown / Minister / Government department
- Manufacture veterinary products in line with marketing authorisation and GMPManufacturer
- Supply veterinary medicines for feedingstuffs to unauthorised personsAny Person
- Supply veterinary medicine with altered or unclear labelAny Person
- Fail to label veterinary medicines supplied under the cascadeAny Person
Unlimited fine
- Supply POM-VPS/NFA-VPS medicines from approved premises with proper oversightAny Person
- Fail to carry out annual audit of veterinary medicinesAny Person
Unlimited fine
- Supply veterinary medicines wholesale without proper authorisationAny Person
- Store, audit, and report as a veterinary wholesale dealerTrader
- Supply sheep dip without checking buyer’s certificate or keeping recordsAny Person
Unlimited fine
- Use sheep dip without a competent supervisorAny Person
Unlimited fine
- Carry out clinical assessment before prescribing POM-V medicinesAny Person
- Supply POM-V and POM-VPS products only with a valid prescriptionAny Person
- Fail to comply with duties when prescribing or supplying veterinary medicinesAny Person
- Fail to comply with veterinary medicine supply rules for pharmacistsAny Person
- Supply veterinary medicines without individual authorisation when vet not presentAny Person
Unlimited fine
- Specify withdrawal period for food-producing animals treated under the cascadeAny Person
- Veterinary surgeons from other member States: conditions and record-keeping for bringing in unauthorised medicinesAny Person
- Supply medicated premixture without proper labellingAny Person
- Supply feedingstuffs without required labelAny Person
- Supply incorrectly labelled medicated feedingstuffsAny Person
- Supply specified feed additives to unapproved personsManufacturer
Unlimited fine
- Supply premixture to unauthorised personManufacturer
Unlimited fine
- Fail to comply with supply and record-keeping requirements for medicated feedingstuffsManufacturer
- Possess veterinary medicines or feed additives without approvalAny Person
- Fail to store veterinary medicinal products securelyAny Person
- Use tamper-evident seals on medicated feedingstuffs packagesEmployer
- Contravene EU feed safety and traceability rulesAny Person
- Fail to comply with transport requirements for medicated feedingstuffsAny Person
- Possess, market or use unauthorised feedingstuffs with veterinary medicinesAny Person
- Fail to comply with prescription requirements for medicated feedingstuffsAny Person
- Do not import animal feed containing veterinary medicines from outside the UKAny Person
- Comply with conditions for importing medicated feedingstuffs from EU member statesAny Person
- Possess unauthorised feed additives or breach EU feed rulesAny Person
Unlimited fine
- Contravene feed hygiene requirements under EC Regulation 183/2005Manufacturer
- Operate without approval or fail to ensure even incorporation of veterinary medicinal product in feedAny Person
- Follow product rules and avoid duplicate active substances when mixing veterinary medicine into premixturesAny Person
- Incorporate veterinary medicines into feed correctly and safelyAny Person
- Fail to keep required records for veterinary medicinal products in feedManufacturer
- Notify VMD of serious adverse reactions within 15 daysManufacturer
- Submit separate variation applications for each change and pay the feeApplicant
- Pay an additional fee if you pay your annual marketing authorisation fee lateAny Person
- Provide written justification when requesting a fee waiver or reductionApplicant
- Commit offences under medicines marketing or manufacturing rulesAny Person
190 other schedules
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.