Retained EU Law SI 2019 United Kingdom

Regulation (EU) 2019/6 on veterinary medicinal products (as assimilated)

Read it on legislation.gov.uk (opens in a new tab)
Enforced by
VMD
Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer23 Any Person13 Applicant6 Distributor5 Trader1 Operator1 Landlord1

Plus 49 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.

Manufacturer — also bound by 551 other Acts
Any Person — also bound by 2684 other Acts
Applicant — also bound by 325 other Acts
Distributor — also bound by 201 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
Landlord — also bound by 238 other Acts
Housing Act 1985 55 duties
Housing Act 1996 30 duties

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.

s.annex iii para.1 the obligation, as an applicant, to provide accurate information and... Regulated
  • Comply with obligations for veterinary medicine marketing authorisationsApplicant
s.art006 Submission of applications for marketing authorisations Regulated
  • Submit accurate veterinary medicine marketing authorisation applications electronicallyApplicant
s.art009 Clinical trials Regulated
Other duties (1) — Crown / regulator
  • VMD must decide veterinary clinical trial applications within 60 daysStatutory regulator
s.art010 Labelling of the immediate packaging of veterinary medicinal products Regulated
  • Label veterinary medicine immediate packaging correctlyManufacturer
s.art011 Labelling of the outer packaging of veterinary medicinal products Regulated
  • Label veterinary medicine outer packaging with required warnings and detailsManufacturer
s.art012 Labelling of small immediate packaging units of veterinary medicinal products Regulated
  • Label small veterinary medicine packs with specified details onlyAny Person
s.art014 Package leaflet of veterinary medicinal products Regulated
  • Make a package leaflet available for each veterinary medicinal productManufacturer
s.art016 Package leaflet of registered homeopathic veterinary medicinal products Regulated
  • Include all required information in your homeopathic vet product leafletTrader
s.art017 Implementing powers with respect to this Section Regulated
Other duties (1) — Crown / regulator
  • Commission must adopt veterinary medicine labelling and packaging rulesCrown / Minister / Government department
s.art018 Generic veterinary medicinal products Regulated
Other duties (1) — Crown / regulator
  • Competent authority must transmit reference product information within 30 daysStatutory regulator
s.art019 Hybrid veterinary medicinal products Regulated
  • Provide study/trial results for hybrid veterinary medicinesApplicant
s.art024 Validity of a marketing authorisation for a limited market and procedure for its re-examination Regulated
  • Re-apply for limited-market veterinary medicine authorisation before expiryAny Person
s.art026 Terms of the marketing authorisation in exceptional circumstances Regulated
  • Comply with exceptional-authorisation safety conditions and product monitoringManufacturer
s.art027 Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination Regulated
  • Apply for re-examination of your exceptional-authorisation veterinary medicine annuallyAny Person
s.art028 Examination of applications Regulated
Other duties (1) — Crown / regulator
  • Competent authority must examine and assess veterinary medicine applicationsStatutory regulator
s.art030 Information on manufacturers in third countries Regulated
Other duties (1) — Crown / regulator
  • VMD must verify third-country manufacturers can produce or test veterinary medicinesStatutory regulator
s.art031 Additional information from the applicant Regulated
Other duties (1) — Crown / regulator
  • Regulator must request missing info and pause review clockStatutory regulator
s.art032 Withdrawal of applications Regulated
Other duties (1) — Crown / regulator
  • Regulator must publish withdrawn veterinary medicine applications and any reportStatutory regulator
s.art033 Outcome of the assessment Regulated
Other duties (1) — Crown / regulator
  • Regulator must issue assessment report with outcome and reasonsStatutory regulator
s.art034 Classification of veterinary medicinal products Regulated
Other duties (1) — Crown / regulator
  • VMD/Commission must classify specified veterinary medicines as prescription-onlyStatutory regulator
s.art037 Decisions refusing marketing authorisations Regulated
Other duties (1) — Crown / regulator
  • VMD must refuse marketing authorisations on specified grounds and give reasonsStatutory regulator
s.art038 Protection of technical documentation Regulated
  • Don't use another applicant's protected veterinary medicine data without permissionApplicant
s.art044 Procedure for centralised marketing authorisation Regulated
Other duties (1) — Crown / regulator
  • Agency must assess applications and issue opinion within 210 daysStatutory regulator
s.art045 Re-examination of the opinion of the Agency Regulated
Other duties (1) — Crown / regulator
  • Agency must re-examine opinions and notify applicant within 90/15 daysStatutory regulator
s.art047 Procedure for national marketing authorisation Regulated
Other duties (1) — Crown / regulator
  • Competent authority must meet 210-day deadline and publish assessment reportStatutory regulator
s.art049 Procedure for decentralised marketing authorisation Regulated
Other duties (1) — Crown / regulator
  • Competent authority must decide decentralised marketing authorisation applicationsStatutory regulator
s.art050 Request by the applicant for re-examination of the assessment report Regulated
Other duties (1) — Crown / regulator
  • Coordination group must re-examine assessment report within 60 daysStatutory regulator
s.art052 Procedure for mutual recognition of national marketing authorisations Regulated
  • Apply for mutual recognition of a national marketing authorisationApplicant
s.art053 Subsequent recognition of marketing authorisations by additional Member States concerned Regulated
Other duties (1) — Crown / regulator
  • Competent authorities must grant subsequent veterinary marketing authorisations within 60 daysStatutory regulator
s.art055 Union database on veterinary medicinal products Regulated
Other duties (1) — Crown / regulator
  • Agency must establish and maintain the veterinary medicines product databaseStatutory regulator
s.art057 Collection of data on antimicrobial medicinal products used in animals Regulated
Other duties (1) — Crown / regulator
  • Member States must collect and report antimicrobial veterinary medicine dataCrown / Minister / Government department
s.art058 Responsibilities of the marketing authorisation holders Regulated
  • Meet all veterinary medicines marketing authorisation holder responsibilitiesManufacturer
s.art059 Small and medium-sized enterprises Regulated
Other duties (1) — Crown / regulator
  • UK must advise small and medium-sized enterprises on veterinary medicines complianceCrown / Minister / Government department
s.art060 Variations Regulated
Other duties (1) — Crown / regulator
  • Commission must establish list of veterinary variations not requiring assessmentCrown / Minister / Government department
s.art061 Variations that do not require assessment Regulated
  • Record approved variations in the product database within 30 daysManufacturer
s.art062 Application for variations requiring assessment Regulated
  • Submit application for variations not on the pre-approved listManufacturer
s.art066 Procedure for variations requiring assessment Regulated
Other duties (1) — Crown / regulator
  • Regulators must process variation applications within statutory deadlinesStatutory regulator
s.art067 Measures to close the procedure for variations requiring assessment Regulated
Other duties (1) — Crown / regulator
  • Regulator must finalise variation applications within 30 days and notify the holderStatutory regulator
s.art068 Implementation of variations requiring assessment Regulated
  • Implement vet medicine variations only after approval; supply requested informationManufacturer
s.art070 Procedure for harmonisation of summaries of product characteristics for the reference veterinary medicinal products Regulated
  • Submit translated product information to national medicines authoritiesManufacturer
s.art071 Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products Regulated
  • Apply to harmonise your generic veterinary SmPC within 60 daysManufacturer
s.art072 Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products Regulated
Other duties (1) — Crown / regulator
  • Competent authority must require MAHs to update environmental safety docsStatutory regulator
s.art073 Union pharmacovigilance system Regulated
  • Operate pharmacovigilance system and encourage adverse event reportingManufacturer
s.art074 Union pharmacovigilance database Regulated
Other duties (1) — Crown / regulator
  • Agency must establish and maintain the pharmacovigilance databaseStatutory regulator
s.art076 Reporting and recording of suspected adverse events Regulated
  • Record suspected adverse events for your veterinary medicines within 30 daysManufacturer
s.art077 Pharmacovigilance responsibilities of the marketing authorisation holder Regulated
  • Set up and maintain a pharmacovigilance system for your veterinary medicinesManufacturer
s.art078 Qualified person responsible for pharmacovigilance Regulated
  • Qualified person must manage pharmacovigilance and act as contact pointAny Person
s.art079 Pharmacovigilance responsibilities of the competent authorities and the Agency Regulated
  • Submit pharmacovigilance system master file to regulator on requestAny Person
s.art081 Signal management process Regulated
  • Monitor and report safety signals for your veterinary medicinesManufacturer
s.art082 Scope of the Union interest referral Regulated
  • Provide all available information to the Agency during a Union interest referralManufacturer
s.art083 Union interest referral procedure Regulated
Other duties (1) — Crown / regulator
  • Agency must manage Union interest referral procedure on set timescalesStatutory regulator
s.art084 Decision following the Union interest referral Regulated
  • Marketing authorisation holders must comply with Commission decisionsAny Person
s.art088 Manufacturing authorisations Regulated
  • Obtain authorisation to manufacture, process or import veterinary medicinesAny Person
s.art090 Procedure for granting of manufacturing authorisations Regulated
Other duties (1) — Crown / regulator
  • Competent authority must inspect manufacturing site before grantStatutory regulator
s.art091 Database on manufacturing and wholesale distribution Regulated
Other duties (1) — Crown / regulator
  • Agency must establish and maintain the manufacturing and wholesale databaseStatutory regulator
s.art092 Changes to manufacturing authorisations on request Regulated
Other duties (1) — Crown / regulator
  • Competent authority must process manufacturing authorisation changes within 30 daysStatutory regulator
s.art093 Obligations of the holder of a manufacturing authorisation Regulated
  • Meet veterinary medicine manufacturing authorisation obligationsManufacturer
s.art094 Certificates of good manufacturing practice Regulated
  • Check overseas veterinary-medicine makers hold a GMP certificate before supplyingManufacturer
s.art095 Importers, manufacturers and distributors of active substances established in the Union Regulated
  • Register your veterinary medicine active substance business with the VMDManufacturer
s.art096 Record keeping Regulated
  • Keep records of all veterinary medicines you supplyManufacturer
s.art097 Qualified person responsible for manufacturing and batch release Regulated
  • Appoint a qualified person for veterinary medicine manufacturing and batch releaseManufacturer
s.art098 Certificates of veterinary medicinal products Regulated
Other duties (1) — Crown / regulator
  • Competent authority or Agency must issue requested veterinary product certificatesStatutory regulator
s.art099 Wholesale distribution authorisations Regulated
  • Obtain a wholesale distribution authorisation to supply veterinary medicinesDistributor
s.art100 Application and procedures for wholesale distribution authorisations Regulated
  • Apply for a wholesale distribution authorisation with evidence of complianceApplicant
s.art101 Obligations of wholesale distributors Regulated
  • You must meet wholesale distribution obligations for veterinary medicinesDistributor
s.art102 Parallel trade in veterinary medicinal products Regulated
  • Verify parallel-traded veterinary medicines are equivalent and notify regulatorsDistributor
s.art103 Retail of veterinary medicinal products and record keeping Regulated
  • Buy only from authorised wholesalers, keep transaction records and audit stock annuallyDistributor
s.art104 Retail of veterinary medicinal products at a distance Regulated
  • Meet online distance-selling information requirements for veterinary medicinesDistributor
s.art105 Veterinary prescriptions Regulated
  • Vets must assess animals and issue prescriptions with required contentAny Person
s.art106 Use of medicinal products Regulated
  • Use veterinary medicines only in line with their authorisationAny Person
s.art107 Use of antimicrobial medicinal products Regulated
  • Don't use antibiotics routinely, for growth, or preventively without justificationAny Person
s.art108 Record-keeping by owners and keepers of food-producing animals Regulated
  • Keep records of veterinary medicines used in food-producing animalsLandlord
s.art109 Record-keeping obligations for equine animals Regulated
Other duties (1) — Crown / regulator
  • Commission must set standard forms and content for equine medicine recordsCrown / Minister / Government department
s.art115 Withdrawal period for medicinal products used outside the terms of the marketing authorisation in food-producing animal species Regulated
  • Vets must set withdrawal periods for off-label medicines in food-producing animalsAny Person
s.art117 Collection and disposal of waste of veterinary medicinal products Regulated
Other duties (1) — Crown / regulator
  • Member States must ensure systems for collecting and disposing of veterinary medicine wasteCrown / Minister / Government department
s.art118 Animals or products of animal origin imported into the Union Regulated
  • You must not use designated antimicrobials on export animals or productsOperator
s.art119 Advertising of veterinary medicinal products Regulated
  • Ensure your veterinary medicine advertising complies with all legal requirementsAny Person
s.art121 Promotion of medicinal products used in animals Regulated
  • Do not offer gifts or inducements to veterinary prescribers or suppliersAny Person
s.art123 Controls Regulated
Other duties (1) — Crown / regulator
  • Competent authorities must carry out risk-based controlsStatutory regulator
s.art124 Audits by the Commission Regulated
Other duties (1) — Crown / regulator
  • Commission must draft and publish audit reports after auditsCrown / Minister / Government department
s.art126 Specific rules on pharmacovigilance inspections Regulated
Other duties (1) — Crown / regulator
  • Regulators must regularly inspect veterinary pharmacovigilance systems and master filesStatutory regulator
s.art127 Proof of the product quality for veterinary medicinal products Regulated
  • Keep quality control test results for veterinary medicines availableManufacturer
s.art128 Proof of the product quality specific for immunological veterinary medicinal products Regulated
  • Keep batch samples and provide them to VMD on requestManufacturer
s.art129 Temporary safety restrictions Regulated
  • Apply to vary your marketing authorisation after temporary safety restrictionsManufacturer
s.art130 Suspending, revoking, or varying the terms, of marketing authorisations Regulated
Other duties (1) — Crown / regulator
  • VMD must suspend/revoke/vary veterinary medicine licences if safety or compliance failsStatutory regulator
s.art131 Suspending or revoking a wholesale distribution authorisation Regulated
Other duties (1) — Crown / regulator
  • VMD must suspend or revoke distribution authorisations for serious non-complianceStatutory regulator
s.art132 Removal of importers, manufacturers and distributors of active substance from the manufacturing and wholesale distribution database Regulated
Other duties (1) — Crown / regulator
  • VMD must remove non-compliant active substance firms from databaseStatutory regulator
s.art133 Suspending or revoking manufacturing authorisations Regulated
Other duties (1) — Crown / regulator
  • VMD must suspend or revoke manufacturing authorisations for Article 93 non-complianceStatutory regulator
s.art134 Prohibiting the supply of veterinary medicinal products Regulated
Other duties (1) — Crown / regulator
  • Competent authority must prohibit supply and order recall of unsafe veterinary medicinesStatutory regulator
s.art135 Penalties imposed by Member States Regulated
Other duties (1) — Crown / regulator
  • Publish details of financial penalties imposed under veterinary medicines rulesStatutory regulator
s.art137 Competent authorities Regulated
Other duties (1) — Crown / regulator
  • Competent authorities must share records with other regulators on requestStatutory regulator
s.art138 Scientific opinion for international organisations for animal health Regulated
Other duties (1) — Crown / regulator
  • Agency must establish procedural rules for international scientific opinionsStatutory regulator
s.art141 Tasks of the Committee Regulated
Other duties (1) — Crown / regulator
  • Veterinary medicines committee must deliver scientific opinions and adviceStatutory regulator
s.art144 Tasks of the coordination group Regulated
Other duties (1) — Crown / regulator
  • Coordination group must review veterinary medicines issues and publish annual listStatutory regulator
s.art154 Establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database Regulated
Other duties (1) — Crown / regulator
  • Agency must set up veterinary medicine safety and supply-chain databasesStatutory regulator
s.art155 Initial input to the product database by competent authorities Regulated
Other duties (1) — Crown / regulator
  • Competent authorities must submit authorised veterinary medicine data to Agency by 28 Jan 2022Statutory regulator
s.art156 Review of rules for environmental risk assessment Regulated
Other duties (1) — Crown / regulator
  • Commission must report on veterinary medicines environmental risk by 28 Jan 2022Crown / Minister / Government department
s.art157 Commission report on traditional herbal products used to treat animals Regulated
Other duties (1) — Crown / regulator
  • Commission must report on traditional herbal products by 29 January 2027Crown / Minister / Government department
s.art158 Review of measures regarding animals of the equine species Regulated
Other duties (1) — Crown / regulator
  • Commission must report on equine medicines and food-chain exclusionCrown / Minister / Government department
62 other provisions — procedural and definitional
s.art001 Subject matter
s.art002 Scope
s.art003 Conflict of laws
s.art004 Definitions
s.art005 Marketing authorisations
s.art007 Languages
s.art008 Data to be submitted with the application
s.art013 Additional information on the immediate packaging or outer packaging of veterinary medicinal products
s.art015 General requirement regarding product information
s.art020 Combination veterinary medicinal products
s.art021 Application based on informed consent
s.art022 Application based on bibliographic data
s.art023 Applications for limited markets
s.art025 Applications in exceptional circumstances
s.art029 Requests to laboratories in the course of the examination of applications
s.art035 Summary of the product characteristics
s.art036 Decisions granting marketing authorisations
s.art039 Periods of the protection of technical documentation
s.art040 Prolongation and additional periods of the protection of technical documentation
s.art041 Patent-related rights
s.art042 Scope of the centralised marketing authorisation procedure
s.art043 Application for centralised marketing authorisation
s.art046 Scope of national marketing authorisation
s.art048 Scope of decentralised marketing authorisation
s.art051 Scope of mutual recognition of national marketing authorisations
s.art054 Review procedure
s.art056 Access to the product database
s.art063 Consequential changes to product information
s.art064 Groups of variations
s.art065 Work-sharing procedure
s.art069 Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product
s.art075 Access to the pharmacovigilance database
s.art080 Delegation of tasks by competent authority
s.art085 Homeopathic veterinary medicinal products
s.art086 Registration of homeopathic veterinary medicinal products
s.art087 Application and procedure for registration of homeopathic veterinary medicinal products
s.art089 Application for manufacturing authorisation
s.art110 Use of immunological veterinary medicinal products
s.art111 Use of veterinary medicinal products by veterinarians providing services in other Member States
s.art112 Use of medicinal products outside the terms of the marketing authorisation in non-food-producing animal species
s.art113 Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species
s.art114 Use of medicinal products for food-producing aquatic species
s.art116 Health situation
s.art120 Advertising of veterinary medicinal products subject to veterinary prescription
s.art122 Implementation of advertising provisions
s.art125 Certificate of suitability
s.art136 Financial penalties imposed by the Commission on holders of marketing authorisation for centrally authorised veterinary medicinal products
s.art139 Committee for Veterinary Medicinal Products
s.art140 Members of the Committee
s.art142 Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products
s.art143 Members of the coordination group
s.art145 Standing Committee on Veterinary Medicinal Products
s.art146 Amendments to Annex II
s.art147 Exercise of the delegation
s.art148 Data protection
s.art149 Repeal
s.art150 Relation with other Union acts
s.art151 Prior applications
s.art152 Existing veterinary medicinal products, marketing authorisations and registrations
s.art153 Transitional provisions regarding delegated and implementing acts
s.art159 Transitional provisions regarding certain certificates of good manufacturing practice
s.art160 Entry into force and application

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.