Retained EU Law
2019
United Kingdom
Regulation (EU) 2019/6 on veterinary medicinal products (as assimilated)
At a glance
Enforced by
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Browse 161 other sections — procedural / definitional / commencement
Subject matter
Scope
Conflict of laws
Definitions
Marketing authorisations
Submission of applications for marketing authorisations
Languages
Data to be submitted with the application
Clinical trials
Labelling of the immediate packaging of veterinary medicinal products
Labelling of the outer packaging of veterinary medicinal products
Labelling of small immediate packaging units of veterinary medicinal products
Additional information on the immediate packaging or outer packaging of veterinary medicinal products
Package leaflet of veterinary medicinal products
General requirement regarding product information
Package leaflet of registered homeopathic veterinary medicinal products
Implementing powers with respect to this Section
Generic veterinary medicinal products
Hybrid veterinary medicinal products
Combination veterinary medicinal products
Application based on informed consent
Application based on bibliographic data
Applications for limited markets
Validity of a marketing authorisation for a limited market and procedure for its re-examination
Applications in exceptional circumstances
Terms of the marketing authorisation in exceptional circumstances
Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination
Examination of applications
Requests to laboratories in the course of the examination of applications
Information on manufacturers in third countries
Additional information from the applicant
Withdrawal of applications
Outcome of the assessment
Classification of veterinary medicinal products
Summary of the product characteristics
Decisions granting marketing authorisations
Decisions refusing marketing authorisations
Protection of technical documentation
Periods of the protection of technical documentation
Prolongation and additional periods of the protection of technical documentation
Patent-related rights
Scope of the centralised marketing authorisation procedure
Application for centralised marketing authorisation
Procedure for centralised marketing authorisation
Re-examination of the opinion of the Agency
Scope of national marketing authorisation
Procedure for national marketing authorisation
Scope of decentralised marketing authorisation
Procedure for decentralised marketing authorisation
Request by the applicant for re-examination of the assessment report
Scope of mutual recognition of national marketing authorisations
Procedure for mutual recognition of national marketing authorisations
Subsequent recognition of marketing authorisations by additional Member States concerned
Review procedure
Union database on veterinary medicinal products
Access to the product database
Collection of data on antimicrobial medicinal products used in animals
Responsibilities of the marketing authorisation holders
Small and medium-sized enterprises
Variations
Variations that do not require assessment
Application for variations requiring assessment
Consequential changes to product information
Groups of variations
Work-sharing procedure
Procedure for variations requiring assessment
Measures to close the procedure for variations requiring assessment
Implementation of variations requiring assessment
Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product
Procedure for harmonisation of summaries of product characteristics for the reference veterinary medicinal products
Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products
Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products
Union pharmacovigilance system
Union pharmacovigilance database
Access to the pharmacovigilance database
Reporting and recording of suspected adverse events
Pharmacovigilance responsibilities of the marketing authorisation holder
Qualified person responsible for pharmacovigilance
Pharmacovigilance responsibilities of the competent authorities and the Agency
Delegation of tasks by competent authority
Signal management process
Scope of the Union interest referral
Union interest referral procedure
Decision following the Union interest referral
Homeopathic veterinary medicinal products
Registration of homeopathic veterinary medicinal products
Application and procedure for registration of homeopathic veterinary medicinal products
Manufacturing authorisations
Application for manufacturing authorisation
Procedure for granting of manufacturing authorisations
Database on manufacturing and wholesale distribution
Changes to manufacturing authorisations on request
Obligations of the holder of a manufacturing authorisation
Certificates of good manufacturing practice
Importers, manufacturers and distributors of active substances established in the Union
Record keeping
Qualified person responsible for manufacturing and batch release
Certificates of veterinary medicinal products
Wholesale distribution authorisations
Application and procedures for wholesale distribution authorisations
Obligations of wholesale distributors
Parallel trade in veterinary medicinal products
Retail of veterinary medicinal products and record keeping
Retail of veterinary medicinal products at a distance
Veterinary prescriptions
Use of medicinal products
Use of antimicrobial medicinal products
Record-keeping by owners and keepers of food-producing animals
Record-keeping obligations for equine animals
Use of immunological veterinary medicinal products
Use of veterinary medicinal products by veterinarians providing services in other Member States
Use of medicinal products outside the terms of the marketing authorisation in non-food-producing animal species
Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species
Use of medicinal products for food-producing aquatic species
Withdrawal period for medicinal products used outside the terms of the marketing authorisation in food-producing animal species
Health situation
Collection and disposal of waste of veterinary medicinal products
Animals or products of animal origin imported into the Union
Advertising of veterinary medicinal products
Advertising of veterinary medicinal products subject to veterinary prescription
Promotion of medicinal products used in animals
Implementation of advertising provisions
Controls
Audits by the Commission
Certificate of suitability
Specific rules on pharmacovigilance inspections
Proof of the product quality for veterinary medicinal products
Proof of the product quality specific for immunological veterinary medicinal products
Temporary safety restrictions
Suspending, revoking, or varying the terms, of marketing authorisations
Suspending or revoking a wholesale distribution authorisation
Removal of importers, manufacturers and distributors of active substance from the manufacturing and wholesale distribution database
Suspending or revoking manufacturing authorisations
Prohibiting the supply of veterinary medicinal products
Penalties imposed by Member States
Financial penalties imposed by the Commission on holders of marketing authorisation for centrally authorised veterinary medicinal products
Competent authorities
Scientific opinion for international organisations for animal health
Committee for Veterinary Medicinal Products
Members of the Committee
Tasks of the Committee
Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products
Members of the coordination group
Tasks of the coordination group
Standing Committee on Veterinary Medicinal Products
Amendments to Annex II
Exercise of the delegation
Data protection
Repeal
Relation with other Union acts
Prior applications
Existing veterinary medicinal products, marketing authorisations and registrations
Transitional provisions regarding delegated and implementing acts
Establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database
Initial input to the product database by competent authorities
Review of rules for environmental risk assessment
Commission report on traditional herbal products used to treat animals
Review of measures regarding animals of the equine species
Transitional provisions regarding certain certificates of good manufacturing practice
Entry into force and application
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Veterinary Medicines Directorate
Executive agency of Defra. Regulates veterinary medicinal products in the UK. Authorises veterinary medicines, monitors safety, and enforces requirements for the manufacture, …
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