welcome to the institute - ages
TRANSCRIPT
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.ages.at
Welcome to the Institute Marketing Authorisation of
Medicinal Products & Lifecycle Management
Dr. Peter Platzer Institut Zulassung & Lifecycle Management AGES MEA AGES-Gespräch „AGES Medizinmarktaufsicht – Erfahrung mit den neuen Strukturen“ Wien, 15. September 2014
MEA – Structure
2
Tasks of Institute LCM /1
•Regulatory Processing of all incoming applications covering national und European Procedures (Mutual Recognition and Decentralised) such as applications for new marketing authorisations, variations and renewals
•Scientific Assessment of Quality dossiers for human as well as for veterinary products (excluding biologicals) in national and all kinds of European Procedures
3
Tasks of Institute LCM /2
•Scientific Assessment of Preclinical and Clinical dossiers for human products, excluding biologicals, in national and European Procedures (Mutual Recognition and Decentralised)
•Classification of quality and production deficiencies as regards quality, safety and efficacy of medicinal products
•Participation in scientific Working Groups/Parties (national, EMA, Council of Europe)
4
Contact
5
Zuteilungsschema – Zulassung, Verlängerung Arzneimittel [email protected]
AT=RMS [email protected]
National [email protected]
AT=CMS [email protected]
Biologika
Gasser Beate
Veterinärarzneimittel
Gasser Beate
Ladstädter Ursula
Humanarzneimittel chemisch
Pflanzliche Arzneimittel
Humanarzneimittel chemisch
Neuzulassung Validierung Schütz Angela
Neuzulassung Endbegutachtung ATC-Code: A,B Kallin Raute ATC-Code: C, G, P, R Kiene Elisabeth ATC-Code: D, L, S, V Iro Veronika ATC-Code: N, M Zott Claudia ATC-Code: H, J Kaimbacher Renate
Verlängerungen Kreicy Christian
Pflanzliche Arzneimittel Homöopathika
Allergene
Seidl Martina
Biologika Achatzi Sabine
Veterinärarzneimittel National Haider Birgit
AT=CMS Weiss Martha
Radiopharmazeutika
Pongratz Markus
L_LCM_VIE_00QM_Z01_20 Gültig ab: Entwurf
Zuteilungsschema - Änderungen, Arzneimittel [email protected]
AT=RMS [email protected]
National [email protected]
AT=CMS [email protected]
Biologika
Achatzi Sabine
Biologika
Achatzi Sabine
Biologika Achatzi Sabine
Veterinärarzneimittel Veterinärarzneimittel Veterinärarzneimittel Weiss Martha Haider Birgit Weiss Martha
Pflanzliche Arzneimittel Homöopathika
Eisenwagner Beatrix Humanarzneimittel
chemisch Pflanzliche Arzneimittel
Pflanzliche Arzneimittel Homöopathika
Seidl Martina
Humanarzneimittel, chemisch
ATC-Code: A, D, J01-J02, J04, N01-N07
ATC-Code: B, C01-C09, G, J05, J07, R, S, V
ATC-Code: C10, H, L, M, P
Hofer Katharina Dorner Patricia
Schauer Claudia Zodl-Demir Helene
Eisenwagner Beatrix Potisk Rosemarie
ATC-Code: C, D, G, V Polly Sabine
ATC-Code: A, J, P, R Englert Monika
ATC-Code: N, S
Königshofer Sonja
ATC-Code: B, H, L, M Köstenberger Katrin
Homöopathika Seidl Martina
Namensprüfung Pongratz Markus Ladstädter Ursula
Trends AT CMS vs. AT RMS
9
10
Number of started human DCPs and MRPs with AT=RMS 2011-2014
New Marketing Authorisations vs. Variations in AT (MRP, DCP, national)
11
Further „AGES-Gespräche“
12
We are looking forward to further good cooperation ;-)
13
Thank you for your kind attention
14