orphan designation graphic de

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EU-Regulierungsprozess für Orphan-Arzneimittel

Regulierungsprozesse in der Europäischen Gemeinschaft

EU-Regulierungsprozess für Orphan-Arzneimittel

Zusammenfassungen der Packungsbeilage (PL) Europäischen Öffentlichen Zusammenfassung der Beurteilungsberichte Produktmerkmale (SmPC) (EPAR)

Sponsor

Sponsor Antrag auf Designation

Designation

ProtokollAssistenz

Antrag auf Marktzulassung

European Medicines Agency (EMA)

Marktzulassung

Informationen für Patienten und die Öffentlichkeit

European Medicines Agency (EMA)

Industrie-(Sponsor) EMA Interaktion während der Entwicklung

Arzneimittele Identifizierung ntdeckung von

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Präklinische Tests

Klinische Entwicklung Phase IV Phase I

Phase II

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