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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 (Text with EEA relevance)- Recitals
CHAPTER I — SUBJECT MATTER, SCOPE AND DEFINITIONS- CHAPTER II — MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS
- Section 1 — General provisions
- Section 2 — Dossier requirements
- Section 3 — 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
- 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
- CHAPTER III — PROCEDURES FOR MARKETING AUTHORISATIONS
- Section 1 — Marketing authorisations valid throughout the Union (centralised marketing authorisations)
- Section 2 — Marketing authorisations valid in a single Member State (national marketing authorisations)
- Section 3 — Marketing authorisations valid in several Member States (decentralised marketing authorisations)
- Section 4 — Mutual recognition of national marketing authorisations
- Section 5 — Subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures
- Section 6 — Review procedure
- CHAPTER IV — POST-MARKETING AUTHORISATION MEASURES
- Section 1 — Union product database
- Section 2 — Collection of data by Member States and responsibilities of marketing authorisation holders
- 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
- CHAPTER V — 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
- Section 2 — Retail
- 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
- 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
- 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
- Final
- ANNEX I — INFORMATION REFERRED TO IN POINT (A) OF ARTICLE 8(1)
- ANNEX II — REQUIREMENTS REFERRED TO IN ARTICLE 8(1), POINT (B)
- ANNEX III — LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 136(1)
- ANNEX IV