Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 Decemb... (32019R0006)
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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)
- 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)
- 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
- ANNEX I
- INFORMATION REFERRED TO IN POINT (A) OF ARTICLE 8(1)
- ANNEX II
- REQUIREMENTS REFERRED TO IN POINT (B) OF ARTICLE 8(1)
- (
- *1
- )
- INTRODUCTION AND GENERAL PRINCIPLES
- TITLE I
- Requirements for veterinary medicinal products other than immunological veterinary medicinal products
- PART 1
- summary of the dossier
- A. ADMINISTRATIVE INFORMATION
- B. SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
- C. DETAILED AND CRITICAL SUMMARIES
- PART 2
- Pharmaceutical (physico-chemical, biological or microbiological information (quality))
- Basic principles and requirements
- A. QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
- 1.
- Qualitative particulars
- 2.
- Usual terminology
- 3.
- Quantitative particulars
- 4.
- Development pharmaceutics
- B. DESCRIPTION OF THE MANUFACTURING METHOD
- C. CONTROL OF STARTING MATERIALS
- 1.
- General requirements
- 1.1.
- Active substances
- 1.1.1. Active substances listed in pharmacopoeias
- 1.1.2. Active substances not in a pharmacopoeia
- 1.1.3. Physico-chemical characteristics liable to affect bioavailability
- 1.2.
- Excipients
- 1.3.
- Container-closure systems
- 1.3.1. Active substance
- 1.3.2. Finished product
- 1.4.
- Substances of biological origin
- D. CONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF THE MANUFACTURING PROCESS
- E. TESTS ON THE FINISHED PRODUCT
- 1.
- General characteristics of the finished product
- 2.
- Identification and assay of active substance(s)
- 3.
- Identification and assay of excipient components
- 4.
- Safety tests
- F. STABILITY TEST
- 1.
- Active substances(s)
- 2.
- Finished product
- G. OTHER INFORMATION
- PART 3
- Safety and residues tests
- A. SAFETY TESTS
- Chapter I
- Performance of tests
- 1.
- Precise identification of the product and of its active substance(s)
- 2.
- Pharmacology
- 2.1.
- Pharmacodynamics
- 2.2.
- Pharmacokinetics
- 3.
- Toxicology
- 3.1.
- Single-dose toxicity
- 3.2.
- Repeat-dose toxicity
- 3.3.
- Tolerance in the target species
- 3.4.
- Reproductive toxicity including developmental toxicity
- 3.4.1. Study of the effects on reproduction
- 3.4.2. Study of developmental toxicity
- 3.5.
- Genotoxicity
- 3.6.
- Carcinogenicity
- 3.7.
- Exceptions
- 4.
- Other requirements
- 4.1.
- Special studies
- 4.2.
- Microbiological properties of residues
- 4.2.1. Potential effects on the human gut flora
- 4.2.2. Potential effects on the microorganisms used for industrial food processing
- 4.3.
- Observations in humans
- 4.4.
- Development of resistance
- 5.
- User safety
- 6.
- Environmental risk assessment
- 6.1.
- Environmental risk assessment of veterinary medicinal products not containing or consisting of genetically modified organisms
- 6.2.
- Environmental risk assessment for veterinary medicinal products containing or consisting of genetically modified organisms
- Chapter II
- Presentation of particulars and documents
- B. RESIDUE TESTS
- Chapter I
- Performance of tests
- 1.
- Introduction
- 2.
- Metabolism and residue kinetics
- 2.1.
- Pharmacokinetics (absorption, distribution, metabolism, excretion)
- 2.2.
- Depletion of residues
- 3.
- Residue analytical method
- Chapter II
- Presentation of particulars and documents
- 1.
- Identification of the product
- PART 4
- Pre-clinical and clinical trial
- Chapter I
- Pre-clinical requirements
- A. PHARMACOLOGY
- A.1.
- Pharmacodynamics
- A.2.
- Development of resistance
- A.3.
- Pharmacokinetics
- B. TOLERANCE IN THE TARGET ANIMAL SPECIES
- Chapter II
- Clinical requirements
- 1.
- General principles
- 2.
- Conduct of clinical trials
- Chapter III
- Particulars and documents
- 1.
- Results of pre-clinical trials
- 2.
- Results of clinical trials
- TITLE II
- Requirements for immunological veterinary medicinal products
- PART 1
- Summary of the dossier
- A. ADMINISTRATIVE INFORMATION
- B. SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
- C. DETAILED AND CRITICAL SUMMARIES
- PART 2
- Chemical, pharmaceutical and biological/microbiological information (quality)
- A. QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
- 1.
- Qualitative particulars
- 2.
- ‘Usual terminology’
- 3.
- Quantitative particulars
- 4.
- Product development
- B. DESCRIPTION OF MANUFACTURING METHOD
- C. PRODUCTION AND CONTROL OF STARTING MATERIALS
- 1.
- Starting materials listed in pharmacopoeias
- 2.
- Starting materials not listed in a pharmacopoeia
- 2.1.
- Starting materials of biological origin
- 2.2.
- Starting materials of non-biological origin
- D. CONTROL TESTS DURING THE MANUFACTURING PROCESS
- E. CONTROL TESTS ON THE FINISHED PRODUCT
- 1.
- General characteristics of the finished product
- 2.
- Identification of active substance(s)
- 3.
- Batch titre or potency
- 4.
- Identification and assay of adjuvants
- 5.
- Identification and assay of excipient components
- 6.
- Safety tests
- 7.
- Sterility and purity test
- 8.
- Residual humidity
- 9.
- Inactivation
- F. BATCH-TO-BATCH CONSISTENCY
- G. STABILITY TESTS
- H. OTHER INFORMATION
- PART 3
- Safety tests
- A. INTRODUCTION AND GENERAL REQUIREMENTS
- B. LABORATORY TESTS
- 1.
- Safety of the administration of one dose
- 2.
- Safety of one administration of an overdose
- 3.
- Safety of the repeated administration of one dose
- 4.
- Examination of reproductive performance
- 5.
- Examination of immunological functions
- 6.
- Special requirements for live vaccines
- 6.1.
- Spread of the vaccine strain
- 6.2.
- Dissemination in the vaccinated animal
- 6.3.
- Reversion to virulence of attenuated vaccines
- 6.4.
- Biological properties of the vaccine strain
- 6.5.
- Recombination or genomic reassortment of strains
- 7.
- User safety
- 8.
- Study of residues
- 9.
- Interactions
- C. FIELD STUDIES
- D. ENVIRONMENTAL RISK ASSESSMENT
- E. ASSESSMENT REQUIRED FOR VETERINARY MEDICINAL PRODUCTS CONTAINING OR CONSISTING OF GENETICALLY MODIFIED ORGANISMS
- PART 4
- Efficacy tests
- Chapter I
- 1.
- General principles
- 2.
- Performance of trials
- Chapter II
- A. GENERAL REQUIREMENTS
- B. LABORATORY TRIALS
- C. FIELD TRIALS
- PART 5
- Particulars and documents
- A. INTRODUCTION
- B. LABORATORY STUDIES
- C. FIELD STUDIES
- PART 6
- Bibliographical references
- TITLE III
- Requirements for specific marketing authorisation applications
- 1.
- Generic veterinary medicinal products
- 2.
- Similar biological veterinary medicinal products
- 3.
- Well-established veterinary use
- 4.
- Combination veterinary medicinal products
- 5.
- Informed consent applications
- 6.
- Documentation for applications in exceptional circumstances
- 7.
- Mixed marketing authorisation applications
- TITLE IV
- Requirements for marketing authorisation applications for particular veterinary medicinal products
- 1.
- Immunological veterinary medicinal products
- A. VACCINE ANTIGEN MASTER FILE
- B. MULTI-STRAIN DOSSIER
- 2.
- Homeopathic veterinary medicinal products
- PART 2
- (a) Terminology
- (b) Control of starting materials
- (c) Control tests on the finished medicinal product
- (d) Stability tests
- PART 3
- ANNEX III
- LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 136(1)
- ANNEX IV
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