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Veterinary Medicinal Products Regulation In force since 28 January 2022

Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
32019R0006 · official text on EUR-Lex

This English text is a careful, terminology-researched translation prepared by eucite.com — not an official government translation. The German original linked above is the legally authoritative text.

Articles

Chapter I SUBJECT MATTER, SCOPE AND DEFINITIONS

• Article 1 — Subject matter
• Article 2 — Scope
• Article 3 — Conflict of laws
• Article 4 — Definitions

Chapter II MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS

Section 1 General provisions

• Article 5 — Marketing authorisations
• Article 6 — Submission of applications for marketing authorisations
• Article 7 — Languages

Section 2 Dossier requirements

• Article 8 — Data to be submitted with the application

Section 3 Clinical trials

• Article 9 — Clinical trials

Section 4 Labelling and package leaflet

• Article 10 — Labelling of the immediate packaging of veterinary medicinal products
• Article 11 — Labelling of the outer packaging of veterinary medicinal products
• Article 12 — Labelling of small immediate packaging units of veterinary medicinal products
• Article 13 — Additional information on the immediate packaging or outer packaging of veterinary medicinal products
• Article 14 — Package leaflet of veterinary medicinal products
• Article 15 — General requirement regarding product information
• Article 16 — Package leaflet of registered homeopathic veterinary medicinal products
• Article 17 — Implementing powers with respect to this Section

Section 5 Specific requirements for generic, hybrid and combination veterinary medicinal products and for applications based on informed consent and bibliographic data

• Article 18 — Generic veterinary medicinal products
• Article 19 — Hybrid veterinary medicinal products
• Article 20 — Combination veterinary medicinal products
• Article 21 — Application based on informed consent
• Article 22 — Application based on bibliographic data

Section 6 Marketing authorisations for limited market and in exceptional circumstances

• Article 23 — Applications for limited markets
• Article 24 — Validity of a marketing authorisation for a limited market and procedure for its re-examination
• Article 25 — Applications in exceptional circumstances
• Article 26 — Terms of the marketing authorisation in exceptional circumstances
• Article 27 — Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination

Section 7 Examination of applications and basis for granting marketing authorisations

• Article 28 — Examination of applications
• Article 29 — Requests to laboratories in the course of the examination of applications
• Article 30 — Information on manufacturers in third countries
• Article 31 — Additional information from the applicant
• Article 32 — Withdrawal of applications
• Article 33 — Outcome of the assessment
• Article 34 — Classification of veterinary medicinal products
• Article 35 — Summary of the product characteristics
• Article 36 — Decisions granting marketing authorisations
• Article 37 — Decisions refusing marketing authorisations

Section 8 Protection of technical documentation

• Article 38 — Protection of technical documentation
• Article 39 — Periods of the protection of technical documentation
• Article 40 — Prolongation and additional periods of the protection of technical documentation
• Article 41 — Patent-related rights

Chapter III PROCEDURES FOR MARKETING AUTHORISATIONS

Section 1 Marketing authorisations valid throughout the Union (‘centralised marketing authorisations’)

• Article 42 — Scope of the centralised marketing authorisation procedure
• Article 43 — Application for centralised marketing authorisation
• Article 44 — Procedure for centralised marketing authorisation
• Article 45 — Re-examination of the opinion of the Agency

Section 2 Marketing authorisations valid in a single Member State (‘national marketing authorisations’)

• Article 46 — Scope of national marketing authorisation
• Article 47 — Procedure for national marketing authorisation

Section 3 Marketing authorisations valid in several Member States (‘decentralised marketing authorisations’)

• Article 48 — Scope of decentralised marketing authorisation
• Article 49 — Procedure for decentralised marketing authorisation
• Article 50 — Request by the applicant for re-examination of the assessment report

Section 4 Mutual recognition of national marketing authorisations

• Article 51 — Scope of mutual recognition of national marketing authorisations
• Article 52 — Procedure for mutual recognition of national marketing authorisations

Section 5 Subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures

• Article 53 — Subsequent recognition of marketing authorisations by additional Member States concerned

Section 6 Review procedure

• Article 54 — Review procedure

Chapter IV POST-MARKETING AUTHORISATION MEASURES

Section 1 Union product database

• Article 55 — Union database on veterinary medicinal products
• Article 56 — Access to the product database

Section 2 Collection of data by Member States and responsibilities of marketing authorisation holders

• Article 57 — Collection of data on antimicrobial medicinal products used in animals
• Article 58 — Responsibilities of the marketing authorisation holders
• Article 59 — Small and medium-sized enterprises

Section 3 Changes to the terms of the marketing authorisations

• Article 60 — Variations
• Article 61 — Variations that do not require assessment
• Article 62 — Application for variations requiring assessment
• Article 63 — Consequential changes to product information
• Article 64 — Groups of variations
• Article 65 — Work-sharing procedure
• Article 66 — Procedure for variations requiring assessment
• Article 67 — Measures to close the procedure for variations requiring assessment
• Article 68 — Implementation of variations requiring assessment

Section 4 Harmonisation of the summaries of product characteristics for nationally authorised products

• Article 69 — Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product
• Article 70 — Procedure for harmonisation of summaries of product characteristics for the reference veterinary medicinal products
• Article 71 — Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products
• Article 72 — Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products

Section 5 Pharmacovigilance

• Article 73 — Union pharmacovigilance system
• Article 74 — Union pharmacovigilance database
• Article 75 — Access to the pharmacovigilance database
• Article 76 — Reporting and recording of suspected adverse events
• Article 77 — Pharmacovigilance responsibilities of the marketing authorisation holder
• Article 78 — Qualified person responsible for pharmacovigilance
• Article 79 — Pharmacovigilance responsibilities of the competent authorities and the Agency
• Article 80 — Delegation of tasks by competent authority
• Article 81 — Signal management process

Section 6 Union interest referral

• Article 82 — Scope of the Union interest referral
• Article 83 — Union interest referral procedure
• Article 84 — Decision following the Union interest referral

Chapter V HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS

• Article 85 — Homeopathic veterinary medicinal products
• Article 86 — Registration of homeopathic veterinary medicinal products
• Article 87 — Application and procedure for registration of homeopathic veterinary medicinal products

Chapter VI MANUFACTURING, IMPORT AND EXPORT

• Article 88 — Manufacturing authorisations
• Article 89 — Application for manufacturing authorisation
• Article 90 — Procedure for granting of manufacturing authorisations
• Article 91 — Database on manufacturing and wholesale distribution
• Article 92 — Changes to manufacturing authorisations on request
• Article 93 — Obligations of the holder of a manufacturing authorisation
• Article 94 — Certificates of good manufacturing practice
• Article 95 — Importers, manufacturers and distributors of active substances established in the Union
• Article 96 — Record keeping
• Article 97 — Qualified person responsible for manufacturing and batch release
• Article 98 — Certificates of veterinary medicinal products

Chapter VII SUPPLY AND USE

Section 1 Wholesale distribution

• Article 99 — Wholesale distribution authorisations
• Article 100 — Application and procedures for wholesale distribution authorisations
• Article 101 — Obligations of wholesale distributors
• Article 102 — Parallel trade in veterinary medicinal products

Section 2 Retail

• Article 103 — Retail of veterinary medicinal products and record keeping
• Article 104 — Retail of veterinary medicinal products at a distance
• Article 105 — Veterinary prescriptions

Section 3 Use

• Article 106 — Use of medicinal products
• Article 107 — Use of antimicrobial medicinal products
• Article 108 — Record-keeping by owners and keepers of food-producing animals
• Article 109 — Record-keeping obligations for equine animals
• Article 110 — Use of immunological veterinary medicinal products
• Article 111 — Use of veterinary medicinal products by veterinarians providing services in other Member States
• Article 112 — Use of medicinal products outside the terms of the marketing authorisation in non-food-producing animal species
• Article 113 — Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species
• Article 114 — Use of medicinal products for food-producing aquatic species
• Article 115 — Withdrawal period for medicinal products used outside the terms of the marketing authorisation in food-producing animal species
• Article 116 — Health situation
• Article 117 — Collection and disposal of waste of veterinary medicinal products
• Article 118 — Animals or products of animal origin imported into the Union

Section 4 Advertising

• Article 119 — Advertising of veterinary medicinal products
• Article 120 — Advertising of veterinary medicinal products subject to veterinary prescription
• Article 121 — Promotion of medicinal products used in animals
• Article 122 — Implementation of advertising provisions

Chapter VIII INSPECTIONS AND CONTROLS

• Article 123 — Controls
• Article 124 — Audits by the Commission
• Article 125 — Certificate of suitability
• Article 126 — Specific rules on pharmacovigilance inspections
• Article 127 — Proof of the product quality for veterinary medicinal products
• Article 128 — Proof of the product quality specific for immunological veterinary medicinal products

Chapter IX RESTRICTIONS AND PENALTIES

• Article 129 — Temporary safety restrictions
• Article 130 — Suspending, revoking, or varying the terms, of marketing authorisations
• Article 131 — Suspending or revoking a wholesale distribution authorisation
• Article 132 — Removal of importers, manufacturers and distributors of active substance from the manufacturing and wholesale distribution database
• Article 133 — Suspending or revoking manufacturing authorisations
• Article 134 — Prohibiting the supply of veterinary medicinal products
• Article 135 — Penalties imposed by Member States
• Article 136 — Financial penalties imposed by the Commission on holders of marketing authorisation for centrally authorised veterinary medicinal products

Chapter X REGULATORY NETWORK

• Article 137 — Competent authorities
• Article 138 — Scientific opinion for international organisations for animal health
• Article 139 — Committee for Veterinary Medicinal Products
• Article 140 — Members of the Committee
• Article 141 — Tasks of the Committee
• Article 142 — Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products
• Article 143 — Members of the coordination group
• Article 144 — Tasks of the coordination group

Chapter XI COMMON AND PROCEDURAL PROVISIONS

• Article 145 — Standing Committee on Veterinary Medicinal Products
• Article 146 — Amendments to Annex II
• Article 147 — Exercise of the delegation
• Article 148 — Data protection

Chapter XII TRANSITIONAL AND FINAL PROVISIONS

• Article 149 — Repeal
• Article 150 — Relation with other Union acts
• Article 151 — Prior applications
• Article 152 — Existing veterinary medicinal products, marketing authorisations and registrations
• Article 153 — Transitional provisions regarding delegated and implementing acts
• Article 154 — Establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database
• Article 155 — Initial input to the product database by competent authorities
• Article 156 — Review of rules for environmental risk assessment
• Article 157 — Commission report on traditional herbal products used to treat animals
• Article 158 — Review of measures regarding animals of the equine species
• Article 159 — Transitional provisions regarding certain certificates of good manufacturing practice
• Article 160 — Entry into force and application