Veterinary Medicinal Products (S.L. 437.47)

Inhalt

1. Art. 1 Title and scope.
2. Art. 2 Definitions.
3. TITLE II
4. Art. 3 Applicability.
5. Art. 4 Non-inactivated immunological veterinary medicinal products.
6. Art. 4A Veterinary medicinal products for research purposes.
7. Art. 4B Samples and demonstration packs of veterinary medicinal products.
8. Art. 4C Obligations relating to veterinary medicinal products.
9. Art. 4D Veterinary medicinal products obtained from other countries for personal use.
10. TITLE III
11. Art. 5 Marketing authorisation issued by the Veterinary Services.
12. Art. 6 Active substances in veterinary medicinal product.
13. Art. 7 Authorisation of the marketing or administration to animals of veterinary medicinal products.
14. Art. 7A Registration of veterinary medicinal products according to regulation 7.
15. Art. 8 Serious disease epidemic.
16. Art. 9 Administration of veterinary medicinal product to animals.
17. Art. 10 Exception granted by the Veterinary Services.
18. Art. 10A Importation of veterinary medicinal products for non-food animals by veterinary surgeons.
19. Art. 11 Records and furtherdetailstobe kept by veterinary surgeon.
20. Art. 11A Importation of veterinary medicinal products for food producing animals by veterinary surgeons.
21. Art. 12 Marketing authorisation for veterinary medicinal product.
22. Art. 13 Derogation.
23. Art. 13A Derogation.
24. Art. 13B Active substances.
25. Art. 13C Use of documentation.
26. Art. 13D Derogation.
27. Art. 14 Summary of product characteristics.
28. Art. 15 Necessary arrangements for documents to be drafted by experts.
29. Art. 16 Registration or authorisation of homeopathic veterinary medicinal products.
30. Art. 17 Homeopathic veterinary medicinal products which may be authorised.
31. Art. 18 Simplified application for registration.
32. Art. 19 Otherhomeopathic veterinary medicinal products.
33. Art. 20 Immunological homeopathic veterinary medicinal products.
34. Art. 21 Procedure for authorisation to place a veterinary medicinal product on the market.
35. Art. 22 Authorisation to forward the assessment report.
36. Art. 23 Examination of application found under regulations 12 and 13.
37. Art. 24 Duties to be taken up by the Veterinary Services.
38. Art. 25 Summary of the product characteristics.
39. Art. 26 Other particulars essential for safety or health protection.
40. Art. 27 Holder to take account of scientific and technical progress.
41. Art. 27A Holder to inform the Veterinary Services.
42. Art. 28 Validity and renewal of authorisation.
43. Art. 29 General legal liability of manufacturer.
44. Art. 30 Instances when the marketing authorisation shall be withheld.
45. Art. 31 Procedure before submitting an application for mutual recognition of marketing practices.
46. Art. 32 Procedure by the VeterinaryServices upon grounds for supposing that the marketing authorisationofthe veterinary medicinal product concerned may present a risk to human health or animal health.
47. Art. 33 Several applications for marketing authorisation for a particular veterinary medicinal product.
48. Art. 34 Situation when the matter has to be referred to the Committee before reaching a decision.
49. Art. 35 Necessity for variation of the terms of a marketing authorisation.
50. Art. 36 Application of articles 39 and 40 of European Union Council Directive 2001/82/EC.
51. Art. 37 Non-application to homeopathic veterinary medicinal products.
52. TITLE IV
53. Art. 38 Manufacturing and importation regulations.
54. Art. 39 Manufacturing authorisation for veterinary medicinal products and active substances.
55. Art. 40 Renewal of a manufacturing and import Authorisation.
56. Art. 41 Time taken for the procedure to grant the authorisation.
57. Art. 42 Variation of a manufacturing and import Authorisation.
58. Art. 43 Suspension of a manufacturing and import Authorisation.
59. Art. 44 Obligations of the holder of manufacturing authorisation and manufacturer of active substance.
60. Art. 44A Starting materials.
61. Art. 45 Additional information pursuant to the application of a manufacturing and import Authorisation.
62. Art. 46 Qualified person.
63. Art. 47 Qualifications of the qualified person.
64. Art. 48 Qualified persons in current employment.
65. Art. 49 Responsibilities of the qualified person.
66. Art. 50 Duties of the qualified person.
67. Art. 50A Confirmation of a qualifiedpersonby the competent authority.
68. Art. 50B Registration of active substances importers, exporters, distributors and manufacturers.
69. Art. 50C Importation for re- export.
70. Art. 50D Other licences that may be required apart from a manufacturing and import Authorisation.
71. TITLE V
72. Art. 51 Information regarding labelling and packages.
73. Art. 52 Information regarding ampoules.
74. Art. 53 No outer package.
75. Art. 54 Inclusion of a package insert.
76. Art. 55 Suspension or withdrawal of marketing authorisation.
77. Art. 56 Non-applicability of this Title.
78. Art. 57 Labelling of homeopathic veterinary medicinal product.
79. TITLE VI
80. Art. 58 Wholesale distribution of veterinary medicinal product.
81. TITLE VII
82. Art. 58A Retail supply of veterinary medicinal products.
83. TITLE VIII
84. Art. 59 Dispensing by pharmacists, veterinary surgeons and suitably qualified persons.
85. TITLE IX
86. Art. 59A Prescribing by veterinary surgeons.
87. Art. 60 Prescription for dispensing products to the public.
88. Art. 61 Veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti- inflammatory, hormonal or psychotropic properties.
89. Art. 62 Obligations of owners or keepers of food-producing.
90. Art. 63 Administration of small quantities of readymade veterinary medicinal products.
91. Art. 64 Use of immunological veterinary medicinal products for the eradication or control of animal disease.
92. Title X
93. Art. 65 Suspected adverse reactions to veterinary medicinal products.
94. Art. 66 Participation in the veterinary pharmacovigilance system.
95. Art. 66A Management of funds.
96. Art. 67 Qualified person responsible for pharmacovigilance
97. Art. 68 Detailed records of suspected adverse reactions.
98. Art. 69 Reports of suspected serious adverse reactions andhumanadverse reactions to be made available to theAgency and the Member States.
99. Art. 70 Facilitation of exchange of information regarding pharmacovigilance
100. Art. 71 Procedureuponthe result of the evaluation.
101. TITLE XI
102. Art. 72 Repeated inspections.
103. Art. 73 Proofofthecontrol tests which were carried out.
104. Art. 74 Samples to be submitted.
105. Art. 75 Suspension or withdrawal of marketing authorisation.
106. Art. 76 Regulations dealing with the prohibition or withdrawal of the supply of a veterinary medicinal product.
107. Art. 77 Suspension or withdrawal of the manufacturing authorisation.
108. Art. 77A Advertising of veterinary medicinal products regulations.
109. Art. 78 Applicability of this Title.
110. Art. 79 Measures to be taken by the Veterinary Services.
111. TITLE XII
112. Art. 79A Administration of veterinary medicinal products and medicinal products to animals.
113. Title XIII
114. Art. 80 Changes to be made to the Schedule.
115. TITLE XIV
116. Art. 81 Communication betweencompetent authorities.
117. Art. 82 VeterinaryServices to inform Agency on decisions which grant or refuse marketing authorisation.
118. Art. 83 Communication of information necessary to guarantee the quality and safety of homeopathic veterinary medicinal products.
119. Art. 84 Certificationonthe possession of a manufacturing authorisation.
120. Art. 85 Decision taken by the Veterinary Services.
121. Art. 86 Foodstuffs taken from test animals.
122. Art. 87 Disposal of veterinary medicinal products waste.
123. Art. 88 Offences and penalties.
124. Art. 89
125. Art. 90
126. Art. 91
127. Art. 92 Other offences.
128. Art. 93