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Union","art-74",{"norm_key":604,"title":605,"chapter":525,"slug":606},"Art. 75","Zugang zur Pharmakovigilanz-Datenbank","art-75",{"norm_key":608,"title":609,"chapter":525,"slug":610},"Art. 76","Meldung und Erfassung mutmaßlich unerwünschter Ereignisse","art-76",{"norm_key":612,"title":613,"chapter":525,"slug":614},"Art. 77","Pharmakovigilanz-Pflichten des Zulassungsinhabers","art-77",{"norm_key":616,"title":617,"chapter":525,"slug":618},"Art. 78","Für die Pharmakovigilanz verantwortliche qualifizierte Person","art-78",{"norm_key":620,"title":621,"chapter":525,"slug":622},"Art. 79","Pharmakovigilanz-Pflichten der zuständigen Behörden und der Agentur","art-79",{"norm_key":624,"title":625,"chapter":525,"slug":626},"Art. 80","Übertragung von Aufgaben durch die zuständige Behörde","art-80",{"norm_key":628,"title":629,"chapter":525,"slug":630},"Art. 81","Signalmanagementprozess","art-81",{"norm_key":632,"title":633,"chapter":525,"slug":634},"Art. 82","Anwendungsbereich der Befassung im Interesse der Union","art-82",{"norm_key":636,"title":637,"chapter":525,"slug":638},"Art. 83","Verfahren zur Befassung im Interesse der Union","art-83",{"norm_key":640,"title":641,"chapter":525,"slug":642},"Art. 84","Beschluss nach der Befassung im Interesse der Union","art-84",{"norm_key":644,"title":645,"chapter":646,"slug":647},"Art. 85","Homöopathische Tierarzneimittel","KAPITEL V HOMÖOPATHISCHE TIERARZNEIMITTEL","art-85",{"norm_key":649,"title":650,"chapter":646,"slug":651},"Art. 86","Registrierung homöopathischer Tierarzneimittel","art-86",{"norm_key":653,"title":654,"chapter":646,"slug":655},"Art. 87","Antrag und Verfahren der Registrierung homöopathischer Tierarzneimittel","art-87",{"norm_key":657,"title":658,"chapter":659,"slug":660},"Art. 88","Herstellungserlaubnis","KAPITEL VI HERSTELLUNG, EINFUHR UND AUSFUHR","art-88",{"norm_key":662,"title":663,"chapter":659,"slug":664},"Art. 89","Beantragung einer Herstellungserlaubnis","art-89",{"norm_key":666,"title":667,"chapter":659,"slug":668},"Art. 90","Verfahren der Erteilung der Herstellungserlaubnis","art-90",{"norm_key":670,"title":671,"chapter":659,"slug":672},"Art. 91","Herstellungs- und Großhandelsvertriebsdatenbank","art-91",{"norm_key":674,"title":675,"chapter":659,"slug":676},"Art. 92","Anträge auf Änderung einer Herstellungserlaubnis","art-92",{"norm_key":678,"title":679,"chapter":659,"slug":680},"Art. 93","Pflichten des Inhabers einer Herstellungserlaubnis","art-93",{"norm_key":682,"title":683,"chapter":659,"slug":684},"Art. 94","Zertifikate über die gute Herstellungspraxis","art-94",{"norm_key":686,"title":687,"chapter":659,"slug":688},"Art. 95","In der Union niedergelassene Importeure, Hersteller und Händler von Wirkstoffen","art-95",{"norm_key":690,"title":691,"chapter":659,"slug":692},"Art. 96","Buchführung","art-96",{"norm_key":694,"title":695,"chapter":659,"slug":696},"Art. 97","Für die Herstellung und die Chargenfreigabe verantwortliche sachkundige Person","art-97",{"norm_key":698,"title":699,"chapter":659,"slug":700},"Art. 98","Zertifikate für Tierarzneimittel","art-98",{"norm_key":702,"title":703,"chapter":704,"slug":705},"Art. 99","Großhandelsvertriebserlaubnis","KAPITEL VII ABGABE UND ANWENDUNG","art-99",{"norm_key":707,"title":708,"chapter":704,"slug":709},"Art. 100","Antragstellung und Verfahren für eine Großhandelsvertriebserlaubnis","art-100",{"norm_key":711,"title":712,"chapter":704,"slug":713},"Art. 101","Pflichten der Großhändler","art-101",{"norm_key":715,"title":716,"chapter":704,"slug":717},"Art. 102","Parallelhandel mit Tierarzneimitteln","art-102",{"norm_key":719,"title":720,"chapter":704,"slug":721},"Art. 103","Einzelhandel mit Tierarzneimitteln und Buchführung","art-103",{"norm_key":723,"title":724,"chapter":704,"slug":725},"Art. 104","Einzelhandel mit Tierarzneimitteln im Fernabsatz","art-104",{"norm_key":727,"title":728,"chapter":704,"slug":729},"Art. 105","Tierärztliche Verschreibungen","art-105",{"norm_key":731,"title":732,"chapter":704,"slug":733},"Art. 106","Anwendung von Arzneimitteln","art-106",{"norm_key":735,"title":736,"chapter":704,"slug":737},"Art. 107","Anwendung von antimikrobiell wirksamen Arzneimitteln","art-107",{"norm_key":739,"title":740,"chapter":704,"slug":741},"Art. 108","Buchführung durch Eigentümer und Halter von der Lebensmittelgewinnung dienenden Tieren","art-108",{"norm_key":743,"title":744,"chapter":704,"slug":745},"Art. 109","Pflicht zur Buchführung in Bezug auf Equiden","art-109",{"norm_key":747,"title":748,"chapter":704,"slug":749},"Art. 110","Anwendung immunologischer Tierarzneimittel","art-110",{"norm_key":751,"title":752,"chapter":704,"slug":753},"Art. 111","Anwendung von Tierarzneimitteln durch in anderen Mitgliedstaaten tätige Tierärzte","art-111",{"norm_key":755,"title":756,"chapter":704,"slug":757},"Art. 112","In den Zulassungsbedingungen nicht genannte Anwendung von Arzneimitteln bei nicht der Lebensmittelgewinnung dienenden Tierarten","art-112",{"norm_key":759,"title":760,"chapter":704,"slug":761},"Art. 113","In den Zulassungsbedingungen nicht genannte Anwendung von Arzneimitteln bei der Lebensmittelgewinnung dienenden landlebenden Tierarten","art-113",{"norm_key":763,"title":764,"chapter":704,"slug":765},"Art. 114","Anwendung von Arzneimitteln bei der Lebensmittelgewinnung dienenden im Wasser lebenden Tierarten","art-114",{"norm_key":767,"title":768,"chapter":704,"slug":769},"Art. 115","Wartezeit für Arzneimittel, die nicht gemäß der Zulassung bei der Lebensmittelgewinnung dienenden Tierarten angewendet werden","art-115",{"norm_key":771,"title":772,"chapter":704,"slug":773},"Art. 116","Gesundheitslage","art-116",{"norm_key":775,"title":776,"chapter":704,"slug":777},"Art. 117","Sammlung und Entsorgung von Abfällen von Tierarzneimitteln","art-117",{"norm_key":779,"title":780,"chapter":704,"slug":781},"Art. 118","In die Union eingeführte Tiere oder Erzeugnisse tierischen Ursprungs","art-118",{"norm_key":783,"title":784,"chapter":704,"slug":785},"Art. 119","Werbung für Tierarzneimittel","art-119",{"norm_key":787,"title":788,"chapter":704,"slug":789},"Art. 120","Werbung für verschreibungspflichtige Tierarzneimittel","art-120",{"norm_key":791,"title":792,"chapter":704,"slug":793},"Art. 121","Absatzförderung von Arzneimitteln, die bei Tieren angewendet werden","art-121",{"norm_key":795,"title":796,"chapter":704,"slug":797},"Art. 122","Umsetzung der Bestimmungen zur Werbung","art-122",{"norm_key":799,"title":800,"chapter":801,"slug":802},"Art. 123","Kontrollen","KAPITEL VIII INSPEKTIONEN UND KONTROLLEN","art-123",{"norm_key":804,"title":805,"chapter":801,"slug":806},"Art. 124","Audits der Kommission","art-124",{"norm_key":808,"title":809,"chapter":801,"slug":810},"Art. 125","Eignungszertifikat","art-125",{"norm_key":812,"title":813,"chapter":801,"slug":814},"Art. 126","Besondere Bestimmungen für Inspektionen zur Pharmakovigilanz","art-126",{"norm_key":816,"title":817,"chapter":801,"slug":818},"Art. 127","Nachweis der Produktqualität von Tierarzneimitteln","art-127",{"norm_key":820,"title":821,"chapter":801,"slug":822},"Art. 128","Nachweis der für immunologische Tierarzneimittel spezifischen Produktqualität","art-128",{"norm_key":824,"title":825,"chapter":826,"slug":827},"Art. 129","Befristete Sicherheitsbeschränkungen","KAPITEL IX BESCHRÄNKUNGEN UND SANKTIONEN","art-129",{"norm_key":829,"title":830,"chapter":826,"slug":831},"Art. 130","Aussetzung bzw. Ruhen, Widerruf oder Änderung der Zulassungsbedingungen","art-130",{"norm_key":833,"title":834,"chapter":826,"slug":835},"Art. 131","Aussetzung bzw. Ruhen oder Widerruf einer Großhandelserlaubnis","art-131",{"norm_key":837,"title":838,"chapter":826,"slug":839},"Art. 132","Entfernung von Importeuren, Herstellern und Händlern von Wirkstoffen aus der Herstellungs- und Großhandelsvertriebsdatenbank","art-132",{"norm_key":841,"title":842,"chapter":826,"slug":843},"Art. 133","Aussetzung bzw. Ruhen oder Widerruf der Herstellungserlaubnis","art-133",{"norm_key":845,"title":846,"chapter":826,"slug":847},"Art. 134","Verbot der Abgabe von Tierarzneimitteln","art-134",{"norm_key":849,"title":850,"chapter":826,"slug":851},"Art. 135","Von den Mitgliedstaaten verhängte Sanktionen","art-135",{"norm_key":853,"title":854,"chapter":826,"slug":855},"Art. 136","Von der Kommission gegen Inhaber von Zulassungen für zentral zugelassene Tierarzneimittel verhängte finanzielle Sanktionen","art-136",{"norm_key":857,"title":858,"chapter":859,"slug":860},"Art. 137","Zuständige Behörden","KAPITEL X NETZ DER AN DER REGULIERUNG BETEILIGTEN STELLEN","art-137",{"norm_key":862,"title":863,"chapter":859,"slug":864},"Art. 138","Wissenschaftliche Gutachten für internationale Tiergesundheitsorganisationen","art-138",{"norm_key":866,"title":867,"chapter":859,"slug":868},"Art. 139","Ausschuss für Tierarzneimittel","art-139",{"norm_key":870,"title":871,"chapter":859,"slug":872},"Art. 140","Mitglieder des Ausschusses","art-140",{"norm_key":874,"title":875,"chapter":859,"slug":876},"Art. 141","Aufgaben des Ausschusses","art-141",{"norm_key":878,"title":879,"chapter":859,"slug":880},"Art. 142","Koordinierungsgruppe für die gegenseitige Anerkennung von Tierarzneimitteln und dezentralisierte Verfahren","art-142",{"norm_key":882,"title":883,"chapter":859,"slug":884},"Art. 143","Mitglieder der Koordinierungsgruppe","art-143",{"norm_key":886,"title":887,"chapter":859,"slug":888},"Art. 144","Aufgaben der Koordinierungsgruppe","art-144",{"norm_key":890,"title":891,"chapter":892,"slug":893},"Art. 145","Ständiger Ausschuss für Tierarzneimittel","KAPITEL XI ALLGEMEINE BESTIMMUNGEN UND VERFAHRENSBESTIMMUNGEN","art-145",{"norm_key":895,"title":896,"chapter":892,"slug":897},"Art. 146","Änderungen des Anhangs II","art-146",{"norm_key":899,"title":900,"chapter":892,"slug":901},"Art. 147","Ausübung der Befugnisübertragung","art-147",{"norm_key":903,"title":904,"chapter":892,"slug":905},"Art. 148","Datenschutz","art-148",{"norm_key":907,"title":908,"chapter":909,"slug":910},"Art. 149","Aufhebung","KAPITEL XII ÜBERGANGS- UND SCHLUSSBESTIMMUNGEN","art-149",{"norm_key":912,"title":913,"chapter":909,"slug":914},"Art. 150","Verhältnis zu anderen Rechtsakten der Union","art-150",{"norm_key":916,"title":917,"chapter":909,"slug":918},"Art. 151","Bereits validierte Anträge","art-151",{"norm_key":920,"title":921,"chapter":909,"slug":922},"Art. 152","Bestehende Tierarzneimittel, Zulassungen und Registrierungen","art-152",{"norm_key":924,"title":925,"chapter":909,"slug":926},"Art. 153","Übergangsbestimmungen im Hinblick auf delegierte Rechtsakte und Durchführungsrechtsakte","art-153",{"norm_key":928,"title":929,"chapter":909,"slug":930},"Art. 154","Erstellung der Pharmakovigilanz-Datenbank und der Herstellungs- und Großhandelsvertriebsdatenbank","art-154",{"norm_key":932,"title":933,"chapter":909,"slug":934},"Art. 155","Beitrag der zuständigen Behörde zur Erstellung der Produktdatenbank","art-155",{"norm_key":936,"title":937,"chapter":909,"slug":938},"Art. 156","Prüfung der Vorschriften für die Umweltverträglichkeitsprüfung","art-156",{"norm_key":940,"title":941,"chapter":909,"slug":942},"Art. 157","Bericht der Kommission über traditionelle pflanzliche Erzeugnisse zur Behandlung von Tieren","art-157",{"norm_key":944,"title":945,"chapter":909,"slug":946},"Art. 158","Prüfung der Maßnahmen im Hinblick auf Equiden","art-158",{"norm_key":948,"title":949,"chapter":909,"slug":950},"Art. 159","Übergangsbestimmungen im Hinblick auf bestimmte Zertifikate über die gute Herstellungspraxis","art-159",{"norm_key":952,"title":953,"chapter":909,"slug":954},"Art. 160","Inkrafttreten und Anwendung","art-160",{"norm_key":956,"title":957,"chapter":958,"slug":959},"Anhang I","INFORMATIONEN GEMÄß ARTIKEL 8 ABSATZ 1 BUCHSTABE A","Anhänge","anhang-i",{"norm_key":961,"title":962,"chapter":958,"slug":12},"Anhang II.1","EINLEITUNG UND ALLGEMEINE GRUNDLAGEN",{"norm_key":964,"title":965,"chapter":958,"slug":12},"Anhang II.2","Vorschriften für nicht immunologische tierarzneimittel",{"norm_key":967,"title":968,"chapter":958,"slug":12},"Anhang II.3","A. ADMINISTRATIVE ANGABEN",{"norm_key":970,"title":971,"chapter":958,"slug":12},"Anhang II.4","B. ZUSAMMENFASSUNG DER MERKMALE DES TIERARZNEIMITTELS, ETIKETTIERUNG UND PACKUNGSBEILAGE",{"norm_key":973,"title":974,"chapter":958,"slug":12},"Anhang II.5","C. AUSFÜHRLICHE KRITISCHE ZUSAMMENFASSUNGEN",{"norm_key":976,"title":977,"chapter":958,"slug":12},"Anhang II.6","Wesentliche Grundsätze und Vorschriften",{"norm_key":979,"title":980,"chapter":958,"slug":12},"Anhang II.7","1. Zusammensetzung nach Art",{"norm_key":982,"title":983,"chapter":958,"slug":12},"Anhang II.8","2. Allgemein gebräuchliche Bezeichnungen",{"norm_key":985,"title":986,"chapter":958,"slug":12},"Anhang II.9","3. Zusammensetzung nach Menge",{"norm_key":988,"title":989,"chapter":958,"slug":12},"Anhang II.10","4. Pharmazeutische Entwicklung",{"norm_key":991,"title":992,"chapter":958,"slug":12},"Anhang II.11","B. ANGABEN ÜBER DIE HERSTELLUNGSWEISE",{"norm_key":994,"title":995,"chapter":958,"slug":12},"Anhang II.12","1. Allgemeine Vorschriften",{"norm_key":997,"title":998,"chapter":958,"slug":12},"Anhang II.13","1.1. Wirkstoffe",{"norm_key":1000,"title":1001,"chapter":958,"slug":12},"Anhang II.14","1.1.1. In Arzneibüchern aufgeführte Wirkstoffe",{"norm_key":1003,"title":1004,"chapter":958,"slug":12},"Anhang II.15","1.1.2. In Arzneibüchern nicht aufgeführte Wirkstoffe",{"norm_key":1006,"title":1007,"chapter":958,"slug":12},"Anhang II.16","1.1.3. Physikalisch-chemische Eigenschaften, die die Bioverfügbarkeit beeinflussen können",{"norm_key":1009,"title":1010,"chapter":958,"slug":12},"Anhang II.17","1.2. Arzneiträgerstoffe",{"norm_key":1012,"title":1013,"chapter":958,"slug":12},"Anhang II.18","1.3.1. Wirkstoff",{"norm_key":1015,"title":1016,"chapter":958,"slug":12},"Anhang II.19","1.3.2. Fertigerzeugnis",{"norm_key":1018,"title":1019,"chapter":958,"slug":12},"Anhang II.20","1.4. Stoffe biologischer Herkunft",{"norm_key":1021,"title":1022,"chapter":958,"slug":12},"Anhang II.21","D. IN-PROZESS-KONTROLLEN",{"norm_key":1024,"title":1025,"chapter":958,"slug":12},"Anhang II.22","E. PRÜFUNGEN AM FERTIGERZEUGNIS",{"norm_key":1027,"title":1028,"chapter":958,"slug":12},"Anhang II.23","1. Allgemeine Merkmale des Fertigerzeugnisses",{"norm_key":1030,"title":1031,"chapter":958,"slug":12},"Anhang II.24","2. Identitätsnachweis und Gehaltsbestimmung der Wirkstoffe",{"norm_key":1033,"title":1034,"chapter":958,"slug":12},"Anhang II.25","3. Identitätsnachweis und Gehaltsbestimmung der Bestandteile des Hilfsstoffs",{"norm_key":1036,"title":1037,"chapter":958,"slug":12},"Anhang II.26","4. Unbedenklichkeitsversuche",{"norm_key":1039,"title":1040,"chapter":958,"slug":12},"Anhang II.27","1. Wirkstoff(e)",{"norm_key":1042,"title":1043,"chapter":958,"slug":12},"Anhang II.28","2. Fertigerzeugnisse",{"norm_key":1045,"title":1046,"chapter":958,"slug":12},"Anhang II.29","G. SONSTIGE INFORMATIONEN",{"norm_key":1048,"title":1049,"chapter":958,"slug":12},"Anhang II.30","Unbedenklichkeits- und rückstandsversuche",{"norm_key":1051,"title":1052,"chapter":958,"slug":12},"Anhang II.31","Durchführung der versuche",{"norm_key":1054,"title":1055,"chapter":958,"slug":12},"Anhang II.32","1. Genaue Identifizierung des Arzneimittels und seiner Wirkstoffe",{"norm_key":1057,"title":1058,"chapter":958,"slug":12},"Anhang II.33","2. Pharmakologie",{"norm_key":1060,"title":1061,"chapter":958,"slug":12},"Anhang II.34","2.1. Pharmakodynamik",{"norm_key":1063,"title":1064,"chapter":958,"slug":12},"Anhang II.35","2.2. Pharmakokinetik",{"norm_key":1066,"title":1067,"chapter":958,"slug":12},"Anhang II.36","3. Toxikologie",{"norm_key":1069,"title":1070,"chapter":958,"slug":12},"Anhang II.37","3.1. Toxizität bei einmaliger Verabreichung",{"norm_key":1072,"title":1073,"chapter":958,"slug":12},"Anhang II.38","3.2. Toxizität bei wiederholter Verabreichung",{"norm_key":1075,"title":1076,"chapter":958,"slug":12},"Anhang II.39","3.3. Verträglichkeit bei der Zieltierart",{"norm_key":1078,"title":1079,"chapter":958,"slug":12},"Anhang II.40","3.4.1. Untersuchungen der Auswirkungen auf die Fortpflanzung",{"norm_key":1081,"title":1082,"chapter":958,"slug":12},"Anhang II.41","3.4.2. Untersuchung der Auswirkungen auf die Entwicklungsfähigkeit",{"norm_key":1084,"title":1085,"chapter":958,"slug":12},"Anhang II.42","3.5. Genotoxizität",{"norm_key":1087,"title":1088,"chapter":958,"slug":12},"Anhang II.43","3.6. Kanzerogenität",{"norm_key":1090,"title":1091,"chapter":958,"slug":12},"Anhang II.44","3.7. Ausnahmen",{"norm_key":1093,"title":1094,"chapter":958,"slug":12},"Anhang II.45","4.1. Spezielle Untersuchungen",{"norm_key":1096,"title":1097,"chapter":958,"slug":12},"Anhang II.46","4.2.1. Potenzielle Auswirkungen auf die Darmflora des Menschen",{"norm_key":1099,"title":1100,"chapter":958,"slug":12},"Anhang II.47","4.2.2. Potenzielle Auswirkungen auf die Mikroorganismen, die bei der industriellen Lebensmittelbearbeitung und -verarbeitung Anwendung finden",{"norm_key":1102,"title":1103,"chapter":958,"slug":12},"Anhang II.48","4.3. Beobachtungen am Menschen",{"norm_key":1105,"title":1106,"chapter":958,"slug":12},"Anhang II.49","4.4. Resistenzentwicklung",{"norm_key":1108,"title":1109,"chapter":958,"slug":12},"Anhang II.50","5. Anwendersicherheit",{"norm_key":1111,"title":1112,"chapter":958,"slug":12},"Anhang II.51","6.1. Umweltverträglichkeitsprüfung für Tierarzneimittel, die genetisch veränderte Organismen weder enthalten noch aus solchen bestehen",{"norm_key":1114,"title":1115,"chapter":958,"slug":12},"Anhang II.52","6.2. Umweltverträglichkeitsprüfung für Tierarzneimittel, die genetisch veränderte Organismen enthalten oder aus solchen bestehen",{"norm_key":1117,"title":1118,"chapter":958,"slug":12},"Anhang II.53","Vorlage der angaben und unterlagen",{"norm_key":1120,"title":1121,"chapter":958,"slug":12},"Anhang II.54","1. Einleitung",{"norm_key":1123,"title":1124,"chapter":958,"slug":12},"Anhang II.55","2.1. Pharmakokinetik (Absorption, Verteilung, Stoffwechsel, Ausscheidung)",{"norm_key":1126,"title":1127,"chapter":958,"slug":12},"Anhang II.56","2.2. Abbau von Rückständen",{"norm_key":1129,"title":1130,"chapter":958,"slug":12},"Anhang II.57","3. Methoden der Rückstandsanalyse",{"norm_key":1132,"title":1133,"chapter":958,"slug":12},"Anhang II.58","1. Identifikation des Arzneimittels",{"norm_key":1135,"title":1136,"chapter":958,"slug":12},"Anhang II.59","Vorklinische und klinische prüfungen",{"norm_key":1138,"title":1139,"chapter":958,"slug":12},"Anhang II.60","Vorklinische vorschriften",{"norm_key":1141,"title":1142,"chapter":958,"slug":12},"Anhang II.61","A.1. Pharmakodynamik",{"norm_key":1144,"title":1145,"chapter":958,"slug":12},"Anhang II.62","A.2. Resistenzentwicklung",{"norm_key":1147,"title":1148,"chapter":958,"slug":12},"Anhang II.63","A.3. Pharmakokinetik",{"norm_key":1150,"title":1151,"chapter":958,"slug":12},"Anhang II.64","B. VERTRÄGLICHKEIT BEI DEN ZIELTIERARTEN",{"norm_key":1153,"title":1154,"chapter":958,"slug":12},"Anhang II.65","1. Allgemeine Grundsätze",{"norm_key":1156,"title":1157,"chapter":958,"slug":12},"Anhang II.66","2. Durchführung der klinischen",{"norm_key":1159,"title":1160,"chapter":958,"slug":12},"Anhang II.67","Angaben und unterlagen",{"norm_key":1162,"title":1163,"chapter":958,"slug":12},"Anhang II.68","1. Ergebnisse der vorklinischen Prüfungen",{"norm_key":1165,"title":1166,"chapter":958,"slug":12},"Anhang II.69","2. Ergebnisse der klinischen Prüfungen",{"norm_key":1168,"title":1169,"chapter":958,"slug":12},"Anhang II.70","Vorschriften für immunologische tierarzneimittel",{"norm_key":1171,"title":968,"chapter":958,"slug":12},"Anhang II.71",{"norm_key":1173,"title":1174,"chapter":958,"slug":12},"Anhang II.72","B. ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS, ETIKETTIERUNG UND PACKUNGSBEILAGE",{"norm_key":1176,"title":974,"chapter":958,"slug":12},"Anhang II.73",{"norm_key":1178,"title":1179,"chapter":958,"slug":12},"Anhang II.74","Chemische, pharmazeutische und biologische\u002Fmikrobiologische daten (qualität)",{"norm_key":1181,"title":980,"chapter":958,"slug":12},"Anhang II.75",{"norm_key":1183,"title":983,"chapter":958,"slug":12},"Anhang II.76",{"norm_key":1185,"title":986,"chapter":958,"slug":12},"Anhang II.77",{"norm_key":1187,"title":1188,"chapter":958,"slug":12},"Anhang II.78","4. Produktentwicklung",{"norm_key":1190,"title":1191,"chapter":958,"slug":12},"Anhang II.79","B. BESCHREIBUNG DER HERSTELLUNGSWEISE",{"norm_key":1193,"title":1194,"chapter":958,"slug":12},"Anhang II.80","C. HERSTELLUNG UND KONTROLLE DER AUSGANGSSTOFFE",{"norm_key":1196,"title":1197,"chapter":958,"slug":12},"Anhang II.81","1. In Arzneibüchern aufgeführte Ausgangsstoffe",{"norm_key":1199,"title":1200,"chapter":958,"slug":12},"Anhang II.82","2.1. Ausgangsstoffe biologischer Herkunft",{"norm_key":1202,"title":1203,"chapter":958,"slug":12},"Anhang II.83","2.2. Ausgangsstoffe nicht biologischer Herkunft",{"norm_key":1205,"title":1206,"chapter":958,"slug":12},"Anhang II.84","D. KONTROLLEN WÄHREND DES HERSTELLUNGSPROZESSES",{"norm_key":1208,"title":1209,"chapter":958,"slug":12},"Anhang II.85","E. KONTROLLEN AM FERTIGERZEUGNIS",{"norm_key":1211,"title":1028,"chapter":958,"slug":12},"Anhang II.86",{"norm_key":1213,"title":1214,"chapter":958,"slug":12},"Anhang II.87","2. Identitätsnachweis der Wirkstoffe",{"norm_key":1216,"title":1217,"chapter":958,"slug":12},"Anhang II.88","3. Titer oder Potenz der Charge",{"norm_key":1219,"title":1220,"chapter":958,"slug":12},"Anhang II.89","4. Identitätsnachweis und Gehaltsbestimmung von Adjuvanzien",{"norm_key":1222,"title":1223,"chapter":958,"slug":12},"Anhang II.90","5. Identitätsnachweis und Gehaltsbestimmung der Bestandteile von Hilfsstoffen",{"norm_key":1225,"title":1226,"chapter":958,"slug":12},"Anhang II.91","6. Unbedenklichkeitsversuche",{"norm_key":1228,"title":1229,"chapter":958,"slug":12},"Anhang II.92","7. Prüfungen auf Sterilitäts- und Reinheit",{"norm_key":1231,"title":1232,"chapter":958,"slug":12},"Anhang II.93","8. Feuchtigkeitsrückstände",{"norm_key":1234,"title":1235,"chapter":958,"slug":12},"Anhang II.94","9. Inaktivierung",{"norm_key":1237,"title":1238,"chapter":958,"slug":12},"Anhang II.95","F. GLEICHBLEIBENDE QUALITÄT DER CHARGEN",{"norm_key":1240,"title":1241,"chapter":958,"slug":12},"Anhang II.96","G. HALTBARKEITSVERSUCHE",{"norm_key":1243,"title":1244,"chapter":958,"slug":12},"Anhang II.97","H. SONSTIGE ANGABEN",{"norm_key":1246,"title":1247,"chapter":958,"slug":12},"Anhang II.98","A. EINLEITUNG UND ALLGEMEINE VORSCHRIFTEN",{"norm_key":1249,"title":1250,"chapter":958,"slug":12},"Anhang II.99","1. Unbedenklichkeit der Verabreichung einer Einzeldosis",{"norm_key":1252,"title":1253,"chapter":958,"slug":12},"Anhang II.100","2. Unbedenklichkeit der Verabreichung einer einzigen Überdosis",{"norm_key":1255,"title":1256,"chapter":958,"slug":12},"Anhang II.101","3. Unbedenklichkeit der wiederholten Verabreichung einer Einzeldosis",{"norm_key":1258,"title":1259,"chapter":958,"slug":12},"Anhang II.102","4. Untersuchung der Fortpflanzungsfähigkeit",{"norm_key":1261,"title":1262,"chapter":958,"slug":12},"Anhang II.103","5. Untersuchung immunologischer Funktionen",{"norm_key":1264,"title":1265,"chapter":958,"slug":12},"Anhang II.104","6.1. Übertragung des Impfstammes",{"norm_key":1267,"title":1268,"chapter":958,"slug":12},"Anhang II.105","6.2. Verbreitung im geimpften Tier",{"norm_key":1270,"title":1271,"chapter":958,"slug":12},"Anhang II.106","6.3. Virulenzreversion attenuierter Impfstoffe",{"norm_key":1273,"title":1274,"chapter":958,"slug":12},"Anhang II.107","6.4. Biologische Eigenschaften des Impfstammes",{"norm_key":1276,"title":1277,"chapter":958,"slug":12},"Anhang II.108","6.5. Rekombination oder Genom-Reassortment von Stämmen",{"norm_key":1279,"title":1280,"chapter":958,"slug":12},"Anhang II.109","7. Anwendersicherheit",{"norm_key":1282,"title":1283,"chapter":958,"slug":12},"Anhang II.110","8. Rückstandsversuche",{"norm_key":1285,"title":1286,"chapter":958,"slug":12},"Anhang II.111","9. Wechselwirkungen",{"norm_key":1288,"title":1289,"chapter":958,"slug":12},"Anhang II.112","C. FELDVERSUCHE",{"norm_key":1291,"title":1292,"chapter":958,"slug":12},"Anhang II.113","D. UMWELTVERTRÄGLICHKEITSPRÜFUNG",{"norm_key":1294,"title":1295,"chapter":958,"slug":12},"Anhang II.114","E. BEURTEILUNGSPFLICHT FÜR TIERARZNEIMITTEL, DIE GENETISCH MODIFIZIERTE ORGANISMEN ENTHALTEN ODER AUS IHNEN BESTEHEN",{"norm_key":1297,"title":1154,"chapter":958,"slug":12},"Anhang II.115",{"norm_key":1299,"title":1300,"chapter":958,"slug":12},"Anhang II.116","2. Durchführung der Versuche",{"norm_key":1302,"title":1303,"chapter":958,"slug":12},"Anhang II.117","A. ALLGEMEINE VORSCHRIFTEN",{"norm_key":1305,"title":1306,"chapter":958,"slug":12},"Anhang II.118","B. LABORVERSUCHE",{"norm_key":1308,"title":1289,"chapter":958,"slug":12},"Anhang II.119",{"norm_key":1310,"title":1311,"chapter":958,"slug":12},"Anhang II.120","A. EINLEITUNG",{"norm_key":1313,"title":1306,"chapter":958,"slug":12},"Anhang II.121",{"norm_key":1315,"title":1289,"chapter":958,"slug":12},"Anhang II.122",{"norm_key":1317,"title":1318,"chapter":958,"slug":12},"Anhang II.123","Quellenangaben",{"norm_key":1320,"title":1321,"chapter":958,"slug":12},"Anhang II.124","1. Tierarzneimittel-Generika",{"norm_key":1323,"title":1324,"chapter":958,"slug":12},"Anhang II.125","2. Biologische Arzneimittel, die im Wesentlichen einem bereits zugelassenen Tierarzneimittel gleichen",{"norm_key":1326,"title":1327,"chapter":958,"slug":12},"Anhang II.126","3. Allgemeine tiermedizinische Verwendung",{"norm_key":1329,"title":1330,"chapter":958,"slug":12},"Anhang II.127","4. Tierarzneimittel aus kombinierten Wirkstoffen",{"norm_key":1332,"title":1333,"chapter":958,"slug":12},"Anhang II.128","5. Anträge aufgrund einer in Kenntnis der Sachlage erteilten Einwilligung des Genehmigungsinhabers",{"norm_key":1335,"title":1336,"chapter":958,"slug":12},"Anhang II.129","6. Unterlagen für Anträge unter außergewöhnlichen Umständen",{"norm_key":1338,"title":1339,"chapter":958,"slug":12},"Anhang II.130","7. Kombinierte Genehmigungsanträge",{"norm_key":1341,"title":1342,"chapter":958,"slug":12},"Anhang II.131","Vorschriften für zulassungsanträge für besondere tierarzneimittel",{"norm_key":1344,"title":1345,"chapter":958,"slug":12},"Anhang II.132","A. IMPFANTIGEN-STAMMDOKUMENTATION",{"norm_key":1347,"title":1348,"chapter":958,"slug":12},"Anhang II.133","B. MULTI-STRAIN-DOSSIER",{"norm_key":1350,"title":1351,"chapter":958,"slug":12},"Anhang II.134","2. Homöopathische tierarzneimittel",{"norm_key":1353,"title":1354,"chapter":958,"slug":12},"Anhang II.135","TEIL 2",{"norm_key":1356,"title":1357,"chapter":958,"slug":12},"Anhang II.136","a) Terminologie",{"norm_key":1359,"title":1360,"chapter":958,"slug":12},"Anhang II.137","b) Kontrolle der Ausgangsstoffe",{"norm_key":1362,"title":1363,"chapter":958,"slug":12},"Anhang II.138","c) Kontrollprüfungen des Fertigarzneimittels",{"norm_key":1365,"title":1366,"chapter":958,"slug":12},"Anhang II.139","d) Haltbarkeitsversuche",{"norm_key":1368,"title":1369,"chapter":958,"slug":12},"Anhang II.140","TEIL 3",{"norm_key":1371,"title":1372,"chapter":958,"slug":1373},"Anhang III","VERZEICHNIS DER VERPFLICHTUNGEN GEMÄß ARTIKEL 136 ABSATZ 1","anhang-iii",{"norm_key":1375,"title":1376,"chapter":958,"slug":1377},"Anhang IV","ENTSPRECHUNGSTABELLE","anhang-iv"]