Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.ages.at
Herzlich Willkommen
Dr. Peter Platzer Institut Zulassung & Lifecycle Management
AGES MEA
AGES-Gespräch „Gut zu Wissen – Aktuelle Themen aus dem Bereich der Arzneimittelzulassung – Tipps & Tricks“
Wien, 24. Juni 2014
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AGES - Vision
“Health for Humans, Animals and Plants”
AGES Organigramm
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MEA - Organigramm
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An wen kann ich mich wenden?
http://www.basg.gv.at/arzneimittel/faq/zuteilungsschema/
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An wen kann ich mich wenden?
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An wen kann ich mich wenden?
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An wen kann ich mich wenden?
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http://www.basg.gv.at/ueber-uns/kontakt/
An wen kann ich mich wenden?
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AGES MEA in European Network
We as NCA cooperate and contribute in various worksharing projects, e.g. • CEP assessment (most active NCA in EU ranking)
• MRP/DCP role of RMS (#7 in EU ranking)
• CP role of Rapporteur/Co-Rapporteur (#9 in EU ranking)
• ASMF-Worksharing: AT is Rapporteur of European ASMF number 00001, ASMF Worksharing project helps to save ressources on all sides (NCAs, EDQM and industry) and ensures harmonized and rapid assessment
• EMA scientific advices (#3 in EU ranking)
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Participation of AT as RMS in DCP/MRP (source CMDh)
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Participation of AT as Rapporteur/ Co-Rapporteur in CP (source EMA)
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Competent Partner
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Medicinal Products in AT
Human Medicinal Products 13.462
Thereof authorised 9.216
Thereof registered 4.246
Veterinary Medicinal Products 1.305
Withdrawals in 2013 967
As regards Human Medicinal Products 877
As regards Veterinary Medicinal Products 90
Authorised human OTC Products 1.447
Registered OTC Products 4.246
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Status: December 2013
Wir freuen uns auf die Zusammenarbeit ;-)
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Thank you very much for your attention
Do you have any questions ???
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