| Guvnor

Enforced by: VMD
Status: In Force
Penalty ceiling: Prosecution 26 of 78 obligations carry a criminal penalty. 7 carry different penalties and 45 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person49 Manufacturer14 Applicant4 Operator2

Plus 9 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

Human Medicines Regulations 2012 184 duties

Merchant Shipping Act 1995 144 duties

Insolvency (England and Wales) Rules 2016 104 duties

Communications Act 2003 92 duties

Road Traffic Act 1988 92 duties

Manufacturer — also bound by 502 other Acts

Pressure Equipment (Safety) Regulations 2016 93 duties

Measuring Instruments Regulations 2016 85 duties

Non-Automatic Weighing Instruments Regulations 2016 78 duties

Commission Delegated Regulation (EU) 2017/654 of 19 December 2016 supplementing Regulation (EU) 2016/1628 of the European Parliament and of the Council with regard to technical and general requirements relating to emission limits and type-approval for internal combustion engines for non-road mobile machinery 76 duties

Human Medicines Regulations 2012 75 duties

Applicant — also bound by 307 other Acts

Insolvency (England and Wales) Rules 2016 46 duties

Human Medicines Regulations 2012 42 duties

The Land Registration Rules 2003 25 duties

Regulation (EU) No 1178/2011 (Aircrew) 20 duties

Value Added Tax Regulations 1995 18 duties

Operator — also bound by 746 other Acts

Regulation (EU) No 965/2012 (Air Operations) 203 duties

Commission Implementing Regulation (EU) 2018/2066 of 19 December 2018 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council and amending Commission Regulation (EU) No 601/2012 (Text with EEA relevance) 121 duties

Commission Regulation (EU) No 601/2012 of 21 June 2012 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council (Text with EEA relevance) (repealed) 112 duties

Space Industry Regulations 2021 76 duties

Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (Text with EEA relevance) 66 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.

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

1 of 13 sections shown

s.005 Manufacture of veterinary medicinal products Regulated

Ensure manufacture is done by authorised manufacturerManufacturer

12 other sections in this Part — procedural and definitional

s.004 Placing a veterinary medicinal product on the market

s.006 The finished product

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 with 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

3 of 8 sections shown

s.018 Food-producing animals: records of administration by a veterinary surgeon Regulated

Record administration of veterinary medicine to food-producing animalsAny Person

s.021 Records by holders of a manufacturing authorisation Regulated

Keep batch records for veterinary medicines you manufacture or supplyManufacturer

s.024 Records of products administered to a food-producing animal under the cascade Regulated

Fail to keep cascade medicine recordsAny Person

5 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 purchase and administration

s.020 Food-producing animals: retention of records

s.022 Records by wholesale dealers

s.023 Records of products supplied on prescription

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 17 sections shown

17 other sections in this Part — procedural and definitional

s.028 The Veterinary Products Committee

s.029 Representations to the Veterinary Products Committee

s.030 Duties on the Secretary of State relating to exports

s.031 Time limits

s.032 Appointment of inspectors

s.033 Powers of entry

s.034 Powers of inspectors

s.035 Inspection of pharmacies

s.036 Obstruction

s.037 Improvement notices

s.038 Appeals against improvement notices

s.039 Powers of a court on appeal

s.040 Seizure notices

s.041 Publication of notices

s.042 Penalties

s.043 Northern Ireland

s.044 Revocations and amendments

Schedules

74 of 215 shown

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 Information with the application Regulated

Submit complete application for veterinary medicinal product marketing authorisationApplicant

s.sch001 Assessment reports Regulated

Other duties (1) — Crown / regulator

VMD must produce a formal assessment report for each medicine applicationCrown / Minister / Government department

s.sch001 Provisions of samples and expertise Regulated

Fail to provide samples or technical expertiseAny Person

s.sch001 Supply of information Regulated

Fail to supply information about veterinary medicinal productsAny Person

s.sch001 Duties on the holder of a marketing authorisation relating to an immunological product Regulated

Fail to submit batch test results for immunological productsAny Person

s.sch001 Control tests Regulated

Fail to provide control test evidence on demandAny Person

s.sch001 Placing on the market Regulated

Notify Secretary of State of market launches, withdrawals, and provide sales data on requestManufacturer

s.sch001 Administrative variations Regulated

Other duties (1) — Crown / regulator

Secretary of State must revoke wrongly granted administrative variations and require new applicationsCrown / Minister / Government department

s.sch001 Changes after a marketing authorisation has been issued Regulated

Keep manufacturing methods up to date and apply for authorisation variationsManufacturer

s.sch001 Suspension, etc., of a marketing authorisation of a product authorised in more than one member State Regulated

Other duties (1) — Crown / regulator

Secretary of State must refer product safety issues to European Medicines Agency and comply with decisionsCrown / Minister / Government department

s.sch001 Supply of a copy of the summary of product characteristics Regulated

Supply summary of product characteristics on demandManufacturer

s.sch001 Application for a marketing authorisation where one already exists in another member State Regulated

Submit identical dossier and identify reference Member State for mutual recognitionApplicant

s.sch001 Application in another member State Regulated

Other duties (1) — Crown / regulator

Secretary of State must process mutual recognition requests for veterinary medicines within deadlinesCrown / 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

Apply simultaneously for veterinary medicine authorisation in multiple EU statesApplicant

s.sch001 Labelling with all the information on the immediate packaging Regulated

Include all required labelling information on immediate packaging of veterinary medicinesManufacturer

s.sch001 Products with immediate and outer packaging Regulated

Label veterinary medicinal product packaging with required informationAny Person

s.sch001 Ampoules Regulated

Label ampoules and outer packaging 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 Prosecution

Fail to have a qualified person for pharmacovigilanceAny Person

Unlimited fine

s.sch001 Duties relating to the qualified person Regulated

Ensure qualified person maintains pharmacovigilance and responds to requestsManufacturer

s.sch001 Adverse reactions to a veterinary medicinal product administered in a third country Regulated

Fail to report adverse reactions to veterinary medicines in third countriesAny Person

s.sch001 Periodic safety update reports Regulated

Fail to submit periodic safety update reportsAny Person

s.sch001 Release of information by the marketing authorisation holder Regulated

Notify Secretary of State before releasing pharmacovigilance information to the publicManufacturer

s.sch001 Action taken on account of pharmacovigilance Regulated

Other duties (1) — Crown / regulator

Secretary of State must act on pharmacovigilance findings and notify affected partiesCrown / Minister / Government department

s.sch001 Registration of a homoeopathic veterinary medicinal product Regulated

Ensure homoeopathic veterinary product meets registration conditions before marketingAny Person

s.sch002 Duties on a qualified person Regulated

Qualified person must ensure each batch is compliant and certifiedAny Person

s.sch002 Register Regulated

Other duties (1) — Crown / regulator

Secretary of State must maintain and publish a register of authorised manufacturers and qualified personsCrown / Minister / Government department

s.sch002 Authorisation to manufacture autogenous vaccines Regulated

Manufacture autogenous vaccine without authorisationAny Person

s.sch002 Labelling Regulated

Label autogenous vaccine containers with required informationOperator

s.sch002 Records Regulated

Fail to keep records for autogenous vaccine manufacturingAny Person

s.sch002 Adverse reactions Regulated

Notify the Secretary of State of adverse reactions to autogenous vaccines within 15 daysAny Person

s.sch002 Authorisation of blood banks Prosecution

Operate an unauthorised animal blood bankAny Person

Unlimited fine

s.sch002 Supply and administration of blood from a blood bank Regulated

Supply or administer blood from a blood bank in breach of restrictionsAny Person

s.sch002 Labelling Regulated

Label blood containers with required informationOperator

s.sch002 Records Prosecution

Fail to keep blood bank recordsAny Person

Unlimited fine

s.sch002 Inspection of premises Regulated

Other duties (1) — Crown / regulator

VMD must inspect manufacturing premises regularlyCrown / Minister / Government department

s.sch002 Report following inspection Regulated

Other duties (1) — Crown / regulator

Secretary of State must inform manufacturer of inspection report findingsCrown / Minister / Government department

s.sch002 Duties on the holder of a manufacturing authorisation Regulated

Manufacture veterinary medicines correctly, keep a Qualified Person, and hold a GMP certificateManufacturer

s.sch003 Annual audit Prosecution

Fail to carry out annual veterinary medicine stock auditAny Person

Unlimited fine

s.sch003 Supply of sheep dip Regulated

Supply sheep dip without Certificate of Competence or required recordsAny Person

s.sch003 Duties on the holder of a wholesale dealer’s authorisation Regulated

Store, distribute and audit veterinary medicines correctlyAny Person

s.sch003 Wholesale supply of veterinary medicinal products Regulated

Supply veterinary medicines wholesale without authorisationAny Person

s.sch003 Prescriptions Regulated

Prescribe POM V without clinical assessment or prescribe excess amountAny Person

s.sch003 Form of prescription Regulated

Ensure written prescriptions meet legal content and validity requirementsAny Person

s.sch003 Supply of veterinary medicinal products for use under the cascade Regulated

Fail to comply with cascade prescribing and labelling rulesAny Person

s.sch003 Supply by a suitably qualified person Regulated

Supply POM-VPS and NFA-VPS products only from approved premises and be presentAny Person

s.sch004 Withdrawal periods Regulated

Specify appropriate withdrawal period for food-producing animals under cascadeAny Person

s.sch004 Administration by veterinary surgeons from other member States Regulated

Conditions for non-UK vets to bring and use unauthorised medicinesAny Person

s.sch005 Labelling of feedingstuffs containing specified feed additives Regulated

Supply feedingstuffs without required labellingAny Person

s.sch005 Labelling of feedingstuffs containing a veterinary medicinal product Regulated

Supply medicated feedingstuff without correct labellingAny Person

s.sch005 Supply of specified feed additives Regulated

Supply specified feed additives to unauthorised personsManufacturer

s.sch005 Supply of premixture Regulated

Supply premixture to an unauthorised personManufacturer

s.sch005 Supply of feedingstuffs containing a veterinary medicinal product Regulated

Supply medicated feedingstuffs without proper authorisationManufacturer

s.sch005 Possession Prosecution

Possess prohibited veterinary medicines or feed additives without approvalAny Person

Unlimited fine

s.sch005 Storage Regulated

Improper storage of veterinary medicinal productsAny Person

s.sch005 Packages and other containers Regulated

Ensure tamper-evident seals on feed containing veterinary medicinesAny Person

s.sch005 Transport Prosecution

Fail to comply with transport rules for medicated feedingstuffsAny Person

Unlimited fine

s.sch005 Enforcement of Regulation (EC) Regulated

Contravene EU feed safety requirementsAny Person

s.sch005 Possession, placing on the market and use of feedingstuffs Regulated

Possess, place on market, or feed animals with unauthorised medicated feedAny Person

s.sch005 Prescriptions for feedingstuffs containing a veterinary medicinal product Prosecution

Supply veterinary medicated feed without proper prescriptionAny Person

Unlimited fine

s.sch005 Imports from third countries Regulated

Do not import feedingstuffs containing veterinary medicines from third countriesAny Person

s.sch005 Trade between member States Regulated

Ensure imported medicated feedingstuffs meet EU manufacturing and UK authorisation rulesAny Person

s.sch005 Enforcement of Regulation (EC) No. 1831/2003 Regulated

Breach authorisation / labelling rules for animal feed additivesAny Person

s.sch005 Enforcement of Regulation (EC) No. 183/2005 Regulated

Contravene EU feed hygiene regulationsManufacturer

s.sch005 Incorporation of a veterinary medicinal product into premixtures Regulated

Follow product summary and avoid duplicate active substances in premixturesAny Person

s.sch005 Incorporation of a veterinary medicinal product into feedingstuffs Regulated

Incorporate veterinary medicines into feedingstuffs in compliance with all legal conditionsAny Person

s.sch005 Additional record keeping requirements relating to veterinary medicinal products Regulated

Fail to maintain records for veterinary medicinal products in feedAny Person

s.sch005 Additional labelling requirement for premixtures containing a veterinary medicinal product Regulated

Supply medicated premixture without required labellingAny Person

s.sch006 The product Regulated

Ensure veterinary medicinal product meets Schedule 6 product requirementsAny Person

s.sch006 Administration Regulated

Do not administer veterinary medicines by injection or into the inner earAny Person

s.sch006 Adverse reactions Regulated

Notify Secretary of State of adverse reactions within 15 daysManufacturer

s.sch007 Late payment of annual fees Regulated

Pay additional late fee for overdue annual marketing authorisation feesAny Person

s.sch007 Waiver or reduction of fees Regulated

Provide full written justification when requesting fee waiver or reductionApplicant

141 other schedules

s.sch001 Application for a marketing authorisation

s.sch001 Application for a pharmacologically equivalent medicinal product

s.sch001 Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product

s.sch001 Extension of time limits

s.sch001 Parallel imports

s.sch001 Specific batch control scheme

s.sch001 Similar immunological products

s.sch001 Marketing in exceptional circumstances

s.sch001 Place of establishment of applicant

s.sch001 Procedure

s.sch001 Products authorised in another member State

s.sch001 Grant of a marketing authorisation

s.sch001 Marketing authorisations for food-producing animals

s.sch001 Refusal of a marketing authorisation

s.sch001 Publication following the grant of a marketing authorisation

s.sch001 Provisional marketing authorisation

s.sch001 Summary of product characteristics

s.sch001 Duration and validity of a marketing authorisation

s.sch001 Variation of a marketing authorisation for a mutually recognised veterinary medicinal product

s.sch001 Variation of a marketing authorisation not authorised in another member State

s.sch001 Compulsory variation

s.sch001 Suspension,

s.sch001 Prohibiting the supply of veterinary medicinal products

s.sch001 Approval by the Secretary of State

s.sch001 Reference to being authorised

s.sch001 Language

s.sch001 Package leaflets

s.sch001 Time limits for applications for products for use in food-producing animals

s.sch001 Homoeopathic veterinary medicinal products

s.sch001 Variations

s.sch001 Adverse reactions to a veterinary medicinal product administered in the United Kingdom

s.sch001 Scope

s.sch001 Meaning of “homoeopathic veterinary medicinal product”

s.sch001 Application for registration

s.sch001 Procedure for registration

s.sch001 Products on the market before 1994

s.sch001 Administration

s.sch001 Bibliographic applications

s.sch001 Applications for products using a new combination of active substances

s.sch001 Applications using existing data

s.sch002 Application

s.sch002 Qualified persons for manufacture

s.sch002 Refusal or revocation of appointment

s.sch002 Test sites

s.sch002 Types of authorisation

s.sch002 Time limits

s.sch002 Inspection of premises

s.sch002 Inspection of blood banks

s.sch002 Granting the authorisation

s.sch002 The authorisation

s.sch002 Suspension or revocation of the authorisation

s.sch002 Representation to the Secretary of State

s.sch003 Classification of veterinary medicinal products

s.sch003 Application

s.sch003 Time limits

s.sch003 Granting the authorisation

s.sch003 The authorisation

s.sch003 Suspension or revocation of the authorisation

s.sch003 Representations

s.sch003 Retail supply of veterinary medicinal products

s.sch003 Supply of products for incorporation into feedingstuffs

s.sch003 Labelling at the time of retail supply

s.sch004 Administration

s.sch004 Administration under the cascade

s.sch004 Immunological products for serious epizootic disease

s.sch004 Immunological products for an imported or exported animal

s.sch004 Treatment in exceptional circumstances

s.sch005 Scope and interpretation

s.sch005 Sampling and analysis

s.sch005 Enforcement of Regulation (EC) No. 882/2004

s.sch006 Animals to which this Schedule applies

s.sch006 Placing on the market

s.sch006 Manufacture

s.sch006 The active substance

s.sch006 Labelling

s.sch006 Pack size

s.sch007 Payment of fees

s.sch007 Application for a provisional marketing authorisation

s.sch007 Application for a marketing authorisation relating to a parallel import

s.sch007 Application for a variation

s.sch007 Application for the renewal of a marketing authorisation

s.sch007 Registration of a homoeopathic veterinary medicinal product

s.sch007 Scope of Part 3

s.sch007 Provision of information relating to the recognition of United Kingdom marketing authorisation

s.sch007 Mutual recognition of a marketing authorisation already granted in another member State

s.sch007 Decentralised procedure where the United Kingdom is the reference member State

s.sch007 Decentralised procedure where the United Kingdom is not the reference member State

s.sch007 Time of payment

s.sch007 Application for a variation

s.sch007 Application for the renewal of a marketing authorisation

s.sch007 Application for a manufacturing authorisation

s.sch007 Application for a variation of a manufacturing authorisation

s.sch007 Application for an authorisation to manufacture an autogenous vaccine

s.sch007 Annual fees

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 Multiple inspections

s.sch007 Inspection of a site where veterinary medicinal products are assembled

s.sch007 Test sites

s.sch007 Animal blood bank authorisations

s.sch007 Expenses

s.sch007 Application for a wholesale dealer’s authorisation

s.sch007 Variation of a wholesale dealer’s authorisation

s.sch007 Annual fee for a wholesale dealer’s authorisation

s.sch007 Fees relating to feedingstuffs

s.sch007 Fees relating to distributors

s.sch007 Annual fees for marketing authorisations

s.sch007 Scope of Part 2

s.sch007 Auditor’s certificate

s.sch007 Submission of samples in connection with applications for marketing authorisations and animal test certificates

s.sch007 Animal Test Certificates

s.sch007 Treatment under the cascade

s.sch007 Treatment in exceptional circumstances

s.sch007 Specific batch control

s.sch007 Submission of control tests of an immunological product

s.sch007 Export Certificates

s.sch007 Fees relating to premises for supply by suitably qualified persons

s.sch007 Standard application for a marketing authorisation

s.sch007 Application to the Veterinary Products Committee

s.sch007 Non-payment of fees

s.sch007 Reduction of fees when an application is withdrawn

s.sch007 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

s.sch007 Application for a marketing authorisation involving other aspects not previously authorised in a veterinary medicinal product in the UK

s.sch007 Pharmacologically equivalent products

s.sch007 Application for a marketing authorisation using identical data

s.sch008 (1) The Medicines (Labelling) Regulations 1976 (S.I. 1976/1726) shall be...

s.sch008 In the Medicines (Manufacturer’s Undertakings for Imported Products) Regulations 1977...

s.sch008 In the Medicines (Certificates of Analysis) Regulations 1977 (S.I. 1977/1399)...

s.sch008 (1) In article 1(2) of the Medicines (Retail Sale or...

s.sch008 After article 1 of the Medicines (Prohibition of Non-medicinal Antimicrobial...

s.sch008 (1) In regulation 1(2) of the Medicines (Fluted Bottles) Regulations...

s.sch008 (1) In regulation 1(2)(a) of the Medicines (Sale or Supply)...

s.sch008 (1) In article 1(2) of the Medicines (Pharmacy and General...

s.sch008 After article 1 of the Medicines (Control of Substances for...

s.sch008 After rule 1 of The Medicines Act 1968 (Hearings by...

s.sch008 After rule 1 of the Medicines Act 1968 (Hearings by...

s.sch008 (1) In article 1(2) of the Medicines (Exemption from Licences)...

s.sch008 Article 2(1)(b) of the Medicines (Advisory Board on the Registration...

s.sch008 In the Medicines (Exemption from Licences) (Ingredients) Order 1974 (S.I....

11 other provisions

sch. 8 para. 3 sch. 8 para. 3

sch. 8 para. 5 sch. 8 para. 5

sch. 8 para. 6 sch. 8 para. 6

s.001 After regulation 1 of the Medicines (Standard Provisions for Licences...

s.002 After regulation 1 of the Medicines (Applications for Manufacturer’s and...

s.003 After article 1 of the Medicines (Control of Substances for...

s.004 After article 1 of the Medicines (Importation of Medicinal Products...

s.005 (1) In article 1(2) of the Medicines (Exemption from Licences)...

s.006 (1) In article 1(2) of the Medicines (Exemption from Licences)...

s.007 After article 1 of the Medicines (Extension to Antimicrobial Substances)...

s.008 After article 1 of the Medicines (Exemptions from Licences) (Emergency...

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

The Veterinary Medicines Regulations 2005

Does it bind you?

Other Acts binding the same actors

What it requires

Introduction

Authorised veterinary medicinal products

Records

Unauthorised veterinary medicinal products

Miscellaneous provisions, enforcement and offences

Schedules