Regulation (EU) 2019/6 of the European Parliament and of the CouncilDangos y teitl llawn

1. Introductory Text

2. CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

   1. Article 1. Subject matter

   2. Article 2. Scope

   3. Article 3. Conflict of laws

   4. Article 4. Definitions

3. CHAPTER II MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS

   1. Section 1 General provisions

      1. Article 5. Marketing authorisations

      2. Article 6. Submission of applications for marketing authorisations

      3. Article 7. Languages

   2. Section 2 Dossier requirements

      1. Article 8. Data to be submitted with the application

   3. Section 3 Clinical trials

      1. Article 9. Clinical trials

   4. Section 4 Labelling and package leaflet

      1. Article 10. Labelling of the immediate packaging of veterinary medicinal products

      2. Article 11. Labelling of the outer packaging of veterinary medicinal products

      3. Article 12. Labelling of small immediate packaging units of veterinary medicinal products

      4. Article 13. Additional information on the immediate packaging or outer packaging of veterinary medicinal products

      5. Article 14. Package leaflet of veterinary medicinal products

      6. Article 15. General requirement regarding product information

      7. Article 16. Package leaflet of registered homeopathic veterinary medicinal products

      8. Article 17. Implementing powers with respect to this Section

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

      1. Article 18. Generic veterinary medicinal products

      2. Article 19. Hybrid veterinary medicinal products

      3. Article 20. Combination veterinary medicinal products

      4. Article 21. Application based on informed consent

      5. Article 22. Application based on bibliographic data

   6. Section 6 Marketing authorisations for limited market and in exceptional circumstances

      1. Article 23. Applications for limited markets

      2. Article 24. Validity of a marketing authorisation for a limited market and procedure for its re-examination

      3. Article 25. Applications in exceptional circumstances

      4. Article 26. Terms of the marketing authorisation in exceptional circumstances

      5. Article 27. Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination

   7. Section 7 Examination of applications and basis for granting marketing authorisations

      1. Article 28. Examination of applications

      2. Article 29. Requests to laboratories in the course of the examination of applications

      3. Article 30. Information on manufacturers in third countries

      4. Article 31. Additional information from the applicant

      5. Article 32. Withdrawal of applications

      6. Article 33. Outcome of the assessment

      7. Article 34. Classification of veterinary medicinal products

      8. Article 35. Summary of the product characteristics

      9. Article 36. Decisions granting marketing authorisations

      10. Article 37. Decisions refusing marketing authorisations

   8. Section 8 Protection of technical documentation

      1. Article 38. Protection of technical documentation

      2. Article 39. Periods of the protection of technical documentation

      3. Article 40. Prolongation and additional periods of the protection of technical documentation

      4. Article 41. Patent-related rights

4. CHAPTER III PROCEDURES FOR MARKETING AUTHORISATIONS

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

      1. Article 42. Scope of the centralised marketing authorisation procedure

      2. Article 43. Application for centralised marketing authorisation

      3. Article 44. Procedure for centralised marketing authorisation

      4. Article 45. Re-examination of the opinion of the Agency

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

      1. Article 46. Scope of national marketing authorisation

      2. Article 47. Procedure for national marketing authorisation

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

      1. Article 48. Scope of decentralised marketing authorisation

      2. Article 49. Procedure for decentralised marketing authorisation

      3. Article 50. Request by the applicant for re-examination of the assessment report

   4. Section 4 Mutual recognition of national marketing authorisations

      1. Article 51. Scope of mutual recognition of national marketing authorisations

      2. Article 52. Procedure for mutual recognition of national marketing authorisations

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

      1. Article 53. Subsequent recognition of marketing authorisations by additional Member States concerned

   6. Section 6 Review procedure

      1. Article 54. Review procedure

5. CHAPTER IV POST-MARKETING AUTHORISATION MEASURES

   1. Section 1 Union product database

      1. Article 55. Union database on veterinary medicinal products

      2. Article 56. Access to the product database

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

      1. Article 57. Collection of data on antimicrobial medicinal products used in animals

      2. Article 58. Responsibilities of the marketing authorisation holders

      3. Article 59. Small and medium-sized enterprises

   3. Section 3 Changes to the terms of the marketing authorisations

      1. Article 60. Variations

      2. Article 61. Variations that do not require assessment

      3. Article 62. Application for variations requiring assessment

      4. Article 63. Consequential changes to product information

      5. Article 64. Groups of variations

      6. Article 65. Work-sharing procedure

      7. Article 66. Procedure for variations requiring assessment

      8. Article 67. Measures to close the procedure for variations requiring assessment

      9. Article 68. Implementation of variations requiring assessment

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

      1. Article 69. Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product

      2. Article 70. Procedure for harmonisation of summaries of product characteristics for the reference veterinary medicinal products

      3. Article 71. Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products

      4. Article 72. Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products

   5. Section 5 Pharmacovigilance

      1. Article 73. Union pharmacovigilance system

      2. Article 74. Union pharmacovigilance database

      3. Article 75. Access to the pharmacovigilance database

      4. Article 76. Reporting and recording of suspected adverse events

      5. Article 77. Pharmacovigilance responsibilities of the marketing authorisation holder

      6. Article 78. Qualified person responsible for pharmacovigilance

      7. Article 79. Pharmacovigilance responsibilities of the competent authorities and the Agency

      8. Article 80. Delegation of tasks by competent authority

      9. Article 81. Signal management process

   6. Section 6 Union interest referral

      1. Article 82. Scope of the Union interest referral

      2. Article 83. Union interest referral procedure

      3. Article 84. Decision following the Union interest referral

6. CHAPTER V HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS

   1. Article 85. Homeopathic veterinary medicinal products

   2. Article 86. Registration of homeopathic veterinary medicinal products

   3. Article 87. Application and procedure for registration of homeopathic veterinary medicinal products

7. CHAPTER VI MANUFACTURING, IMPORT AND EXPORT

   1. Article 88. Manufacturing authorisations

   2. Article 89. Application for manufacturing authorisation

   3. Article 90. Procedure for granting of manufacturing authorisations

   4. Article 91. Database on manufacturing and wholesale distribution

   5. Article 92. Changes to manufacturing authorisations on request

   6. Article 93. Obligations of the holder of a manufacturing authorisation

   7. Article 94. Certificates of good manufacturing practice

   8. Article 95. Importers, manufacturers and distributors of active substances established in the Union

   9. Article 96. Record keeping

   10. Article 97. Qualified person responsible for manufacturing and batch release

   11. Article 98. Certificates of veterinary medicinal products

8. CHAPTER VII SUPPLY AND USE

   1. Section 1 Wholesale distribution

      1. Article 99. Wholesale distribution authorisations

      2. Article 100. Application and procedures for wholesale distribution authorisations

      3. Article 101. Obligations of wholesale distributors

      4. Article 102. Parallel trade in veterinary medicinal products

   2. Section 2 Retail

      1. Article 103. Retail of veterinary medicinal products and record keeping

      2. Article 104. Retail of veterinary medicinal products at a distance

      3. Article 105. Veterinary prescriptions

   3. Section 3 Use

      1. Article 106. Use of medicinal products

      2. Article 107. Use of antimicrobial medicinal products

      3. Article 108. Record-keeping by owners and keepers of food-producing animals

      4. Article 109. Record-keeping obligations for equine animals

      5. Article 110. Use of immunological veterinary medicinal products

      6. Article 111. Use of veterinary medicinal products by veterinarians providing services in other Member States

      7. Article 112. Use of medicinal products outside the terms of the marketing authorisation in non-food-producing animal species

      8. Article 113. Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species

      9. Article 114. Use of medicinal products for food-producing aquatic species

      10. Article 115. Withdrawal period for medicinal products used outside the terms of the marketing authorisation in food-producing animal species

      11. Article 116. Health situation

      12. Article 117. Collection and disposal of waste of veterinary medicinal products

      13. Article 118. Animals or products of animal origin imported into the Union

   4. Section 4 Advertising

      1. Article 119. Advertising of veterinary medicinal products

      2. Article 120. Advertising of veterinary medicinal products subject to veterinary prescription

      3. Article 121. Promotion of medicinal products used in animals

      4. Article 122. Implementation of advertising provisions

9. CHAPTER VIII INSPECTIONS AND CONTROLS

   1. Article 123. Controls

   2. Article 124. Audits by the Commission

   3. Article 125. Certificate of suitability

   4. Article 126. Specific rules on pharmacovigilance inspections

   5. Article 127. Proof of the product quality for veterinary medicinal products

   6. Article 128. Proof of the product quality specific for immunological veterinary medicinal products

10. CHAPTER IX RESTRICTIONS AND PENALTIES

    1. Article 129. Temporary safety restrictions

    2. Article 130. Suspending, revoking, or varying the terms, of marketing authorisations

    3. Article 131. Suspending or revoking a wholesale distribution authorisation

    4. Article 132. Removal of importers, manufacturers and distributors of active substance from the manufacturing and wholesale distribution database

    5. Article 133. Suspending or revoking manufacturing authorisations

    6. Article 134. Prohibiting the supply of veterinary medicinal products

    7. Article 135. Penalties imposed by Member States

    8. Article 136. Financial penalties imposed by the Commission on holders of marketing authorisation for centrally authorised veterinary medicinal products

11. CHAPTER X REGULATORY NETWORK

    1. Article 137. Competent authorities

    2. Article 138. Scientific opinion for international organisations for animal health

    3. Article 139. Committee for Veterinary Medicinal Products

    4. Article 140. Members of the Committee

    5. Article 141. Tasks of the Committee

    6. Article 142. Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products

    7. Article 143. Members of the coordination group

    8. Article 144. Tasks of the coordination group

12. CHAPTER XI COMMON AND PROCEDURAL PROVISIONS

    1. Article 145. Standing Committee on Veterinary Medicinal Products

    2. Article 146. Amendments to Annex II

    3. Article 147. Exercise of the delegation

    4. Article 148. Data protection

13. CHAPTER XII TRANSITIONAL AND FINAL PROVISIONS

    1. Article 149. Repeal

    2. Article 150. Relation with other Union acts

    3. Article 151. Prior applications

    4. Article 152. Existing veterinary medicinal products, marketing authorisations and registrations

    5. Article 153. Transitional provisions regarding delegated and implementing acts

    6. Article 154. Establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database

    7. Article 155. Initial input to the product database by competent authorities

    8. Article 156. Review of rules for environmental risk assessment

    9. Article 157. Commission report on traditional herbal products used to treat animals

    10. Article 158. Review of measures regarding animals of the equine species

    11. Article 159. Transitional provisions regarding certain certificates of good manufacturing practice

    12. Article 160. Entry into force and application

14. Signature

15. 1. ANNEX I

       INFORMATION REFERRED TO IN POINT (A) OF ARTICLE 8(1)

       1. 1. Legal basis for the application for the marketing authorisation

       2. 2. Applicant

       3. 2.1. Name or company name and permanent address or registered place...

       4. 2.2. Name or company name and permanent address or registered place...

       5. 2.3. Name and address of the sites involved in the different...

       6. 3. Identification of the veterinary medicinal product

       7. 3.1. Name of the veterinary medicinal product and Anatomical Therapeutic Chemical...

       8. 3.2. Active substance(s) and, if applicable, diluent(s)

       9. 3.3. Strength or, in case of immunological veterinary medicinal product, biological...

       10. 3.4. Pharmaceutical form

       11. 3.5. Route of administration

       12. 3.6. Target species

       13. 4. Manufacturing and pharmacovigilance information

       14. 4.1. Proof of a manufacturing authorisation or certificate of good manufacturing...

       15. 4.2. Reference number of pharmacovigilance system master file

       16. 5. Veterinary medicinal product information

       17. 5.1. Proposed summary of the product characteristics drawn up in accordance...

       18. 5.2. Description of the final presentation of the veterinary medicinal product,...

       19. 5.3. Proposed text of the information to be provided on the...

       20. 6. Other information

       21. 6.1. List of countries in which a marketing authorisation has been...

       22. 6.2. Copies of all the summaries of product characteristics as included...

       23. 6.3. List of countries in which an application has been submitted...

       24. 6.4. List of Member States in which the veterinary medicinal product...

       25. 6.5. Critical expert reports on quality, safety and efficacy of the...

    2. ANNEX II

       REQUIREMENTS REFERRED TO IN POINT (B) OF ARTICLE 8(1)

       1. INTRODUCTION AND GENERAL PRINCIPLES

          1. 1. The particulars and documents accompanying an application for marketing authorisation...

          2. 2. In assembling the dossier for application for marketing authorisation, applicants...

          3. 3. For veterinary medicinal products other than immunological veterinary medicinal products,...

          4. 4. The manufacturing process shall comply with the requirements of Commission...

          5. 5. All information which is relevant to the evaluation of the...

          6. 6. Pharmacological, toxicological, residue and safety tests shall be carried out...

          7. 7. Member States shall ensure that all experiments on animals are...

          8. 8. In order to monitor the risk/benefit assessment, any new information...

          9. 9. The environmental risk assessment connected with the release of veterinary...

          10. 10. In cases of applications for marketing authorisations for veterinary medicinal...

       2. TITLE I Requirements for veterinary medicinal products other than immunological veterinary medicinal products

          1. PART 1 summary of the dossier

             1. A. ADMINISTRATIVE INFORMATION

             2. B. SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

             3. C. DETAILED AND CRITICAL SUMMARIES

          2. PART 2 Pharmaceutical (physico-chemical, biological or microbiological information (quality))

             1. Basic principles and requirements

             2. A. QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS

                1. 1. Qualitative particulars

                2. 2. Usual terminology

                3. 3. Quantitative particulars

                   1. 3.1. In order to give ‘quantitative particulars’ of all the active...

                   2. 3.2. Active substances present in the form of compounds or derivatives...

                   3. 3.3. For veterinary medicinal products containing an active substance which is...

                4. 4. Development pharmaceutics

             3. B. DESCRIPTION OF THE MANUFACTURING METHOD

             4. C. CONTROL OF STARTING MATERIALS

                1. 1. General requirements

                   1. 1.1. Active substances

                      1. 1.1.1. Active substances listed in pharmacopoeias

                      2. 1.1.2. Active substances not in a pharmacopoeia

                      3. 1.1.3. Physico-chemical characteristics liable to affect bioavailability

                   2. 1.2. Excipients

                   3. 1.3. Container-closure systems

                      1. 1.3.1. Active substance

                      2. 1.3.2. Finished product

                   4. 1.4. Substances of biological origin

             5. D. CONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF THE MANUFACTURING...

             6. E. TESTS ON THE FINISHED PRODUCT

                1. 1. General characteristics of the finished product

                2. 2. Identification and assay of active substance(s)

                3. 3. Identification and assay of excipient components

                4. 4. Safety tests

             7. F. STABILITY TEST

                1. 1. Active substances(s)

                2. 2. Finished product

             8. G. OTHER INFORMATION

          3. PART 3 Safety and residues tests

             1. A. SAFETY TESTS

                1. Chapter I Performance of tests

                   1. 1. Precise identification of the product and of its active substance(s)...

                   2. 2. Pharmacology

                      1. 2.1. Pharmacodynamics

                      2. 2.2. Pharmacokinetics

                   3. 3. Toxicology

                      1. 3.1. Single-dose toxicity

                      2. 3.2. Repeat-dose toxicity

                      3. 3.3. Tolerance in the target species

                      4. 3.4. Reproductive toxicity including developmental toxicity

                         1. 3.4.1. Study of the effects on reproduction

                         2. 3.4.2. Study of developmental toxicity

                      5. 3.5. Genotoxicity

                      6. 3.6. Carcinogenicity

                      7. 3.7. Exceptions

                   4. 4. Other requirements

                      1. 4.1. Special studies

                      2. 4.2. Microbiological properties of residues

                         1. 4.2.1. Potential effects on the human gut flora

                         2. 4.2.2. Potential effects on the microorganisms used for industrial food processing...

                      3. 4.3. Observations in humans

                      4. 4.4. Development of resistance

                   5. 5. User safety

                   6. 6. Environmental risk assessment

                      1. 6.1. Environmental risk assessment of veterinary medicinal products not containing or...

                      2. 6.2. Environmental risk assessment for veterinary medicinal products containing or consisting...

                2. Chapter II Presentation of particulars and documents

             2. B. RESIDUE TESTS

                1. Chapter I Performance of tests

                   1. 1. Introduction

                   2. 2. Metabolism and residue kinetics

                      1. 2.1. Pharmacokinetics (absorption, distribution, metabolism, excretion)

                      2. 2.2. Depletion of residues

                   3. 3. Residue analytical method

                2. Chapter II Presentation of particulars and documents

                   1. 1. Identification of the product

          4. PART 4 Pre-clinical and clinical trial

             1. Chapter I Pre-clinical requirements

                1. A. PHARMACOLOGY

                   1. A.1. Pharmacodynamics

                   2. A.2. Development of resistance

                   3. A.3. Pharmacokinetics

                2. B. TOLERANCE IN THE TARGET ANIMAL SPECIES

             2. Chapter II Clinical requirements

                1. 1. General principles

                2. 2. Conduct of clinical trials

             3. Chapter III Particulars and documents

                1. 1. Results of pre-clinical trials

                2. 2. Results of clinical trials

       3. TITLE II Requirements for immunological veterinary medicinal products

          1. PART 1 Summary of the dossier

             1. A. ADMINISTRATIVE INFORMATION

             2. B. SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

             3. C. DETAILED AND CRITICAL SUMMARIES

          2. PART 2 Chemical, pharmaceutical and biological/microbiological information (quality)

             1. A. QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS

                1. 1. Qualitative particulars

                2. 2. ‘Usual terminology’

                3. 3. Quantitative particulars

                4. 4. Product development

             2. B. DESCRIPTION OF MANUFACTURING METHOD

             3. C. PRODUCTION AND CONTROL OF STARTING MATERIALS

                1. 1. Starting materials listed in pharmacopoeias

                2. 2. Starting materials not listed in a pharmacopoeia

                   1. 2.1. Starting materials of biological origin

                   2. 2.2. Starting materials of non-biological origin

             4. D. CONTROL TESTS DURING THE MANUFACTURING PROCESS

                1. (1) The dossier shall include particulars relating to the control tests,...

                2. (2) For inactivated or detoxified vaccines, inactivation or detoxification shall be...

             5. E. CONTROL TESTS ON THE FINISHED PRODUCT

                1. 1. General characteristics of the finished product

                2. 2. Identification of active substance(s)

                3. 3. Batch titre or potency

                4. 4. Identification and assay of adjuvants

                5. 5. Identification and assay of excipient components

                6. 6. Safety tests

                7. 7. Sterility and purity test

                8. 8. Residual humidity

                9. 9. Inactivation

             6. F. BATCH-TO-BATCH CONSISTENCY

             7. G. STABILITY TESTS

             8. H. OTHER INFORMATION

          3. PART 3 Safety tests

             1. A. INTRODUCTION AND GENERAL REQUIREMENTS

             2. B. LABORATORY TESTS

                1. 1. Safety of the administration of one dose

                2. 2. Safety of one administration of an overdose

                3. 3. Safety of the repeated administration of one dose

                4. 4. Examination of reproductive performance

                5. 5. Examination of immunological functions

                6. 6. Special requirements for live vaccines

                   1. 6.1. Spread of the vaccine strain

                   2. 6.2. Dissemination in the vaccinated animal

                   3. 6.3. Reversion to virulence of attenuated vaccines

                   4. 6.4. Biological properties of the vaccine strain

                   5. 6.5. Recombination or genomic reassortment of strains

                7. 7. User safety

                8. 8. Study of residues

                9. 9. Interactions

             3. C. FIELD STUDIES

             4. D. ENVIRONMENTAL RISK ASSESSMENT

             5. E. ASSESSMENT REQUIRED FOR VETERINARY MEDICINAL PRODUCTS CONTAINING OR CONSISTING OF...

          4. PART 4 Efficacy tests

             1. Chapter I

                1. 1. General principles

                2. 2. Performance of trials

             2. Chapter II

                1. A. GENERAL REQUIREMENTS

                   1. 1. The choice of antigens or vaccine strains shall be justified...

                   2. 2. Efficacy trials carried out in the laboratory shall be controlled...

                   3. 3. The efficacy of an immunological veterinary medicinal product shall be...

                   4. 4. The efficacy of each of the components of multivalent and...

                   5. 5. Whenever a product forms part of a vaccination scheme recommended...

                   6. 6. The dose to be used shall be the quantity of...

                   7. 7. If there is a compatibility statement with other immunological products...

                   8. 8. For diagnostic immunological veterinary medicinal products administered to animals, the...

                   9. 9. For vaccines intended to allow a distinction between vaccinated and...

                2. B. LABORATORY TRIALS

                   1. 1. In principle, demonstration of efficacy shall be undertaken under well-controlled...

                   2. 2. If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin)...

                3. C. FIELD TRIALS

                   1. 1. Unless justified, results from laboratory trials shall be supplemented with...

                   2. 2. Where laboratory trials cannot be supportive of efficacy, the performance...

          5. PART 5 Particulars and documents

             1. A. INTRODUCTION

             2. B. LABORATORY STUDIES

             3. C. FIELD STUDIES

          6. PART 6 Bibliographical references

       4. TITLE III Requirements for specific marketing authorisation applications

          1. 1. Generic veterinary medicinal products

          2. 2. Similar biological veterinary medicinal products

          3. 3. Well-established veterinary use

          4. 4. Combination veterinary medicinal products

          5. 5. Informed consent applications

          6. 6. Documentation for applications in exceptional circumstances

          7. 7. Mixed marketing authorisation applications

       5. TITLE IV Requirements for marketing authorisation applications for particular veterinary medicinal products

          1. 1. Immunological veterinary medicinal products

             1. A. VACCINE ANTIGEN MASTER FILE

             2. B. MULTI-STRAIN DOSSIER

          2. 2. Homeopathic veterinary medicinal products

             1. PART 2 The provisions of Part 2 shall apply to the documents...

                1. (a) Terminology

                2. (b) Control of starting materials

                3. (c) Control tests on the finished medicinal product

                4. (d) Stability tests

             2. PART 3 The provisions of Part 3 shall apply to the simplified...

    3. ANNEX III

       LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 136(1)

       1. the obligation, as an applicant, to provide accurate information and...

    4. ANNEX IV