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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