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Austrian Federal Office for Safety in Health Care Austrian Medicines and Medical Devices Agency

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Federal Office for Safety in Health Care (BASG) and AGES

The Federal Office for the Safetyin Health Care (BASG) / AGES was set up in January 2006 and is responsible for marketing authorisation of medicinal products in Austria and assessment of medicinal products and medical devices which are already on the market regarding efficacy, adverse reactions, production, shipment and storage.

 

Fully owned by the Republic of Austria, BASG / AGES acts on behalf of the Republic as represented by the Federal Ministry of Health (BMG).

 

The Federal Office for Safety in Health Care (BASG) is responsible for carrying out public services undertakings. BASG is directly subordinate to the Federal Ministry of Health (BMG). It consists of three members, which are appointed by the Federal Minister of Health. One of these members was delegated by the BMG, another by AGES; the third member is the head of BASG / AGES.

 

AGES is thus connected closely to the BASG; it is represented by two members in the Federal Office and provides it with services, staff and facilities. The employees of BASG / AGES are responsible for carrying out public services undertakings and act on behalf of the Federal Office. The written decisions issued by the BASG are not subject to reversal change by the administration, thus making it the first and final authority.

The instituts of the Austrian Medicines and Medical Devices Agency:

  1. Institute Pharmakovigilance (Head: Dr. Bettina Schade)
  2. Institute OMCL (Head: Dr. Gerhard Beck)
  3. Institut Marketing Authorisation & Lifecycle Management (Head: Dr. Christa Wirthumer-Hoche)
  4. Institute Inspections, Medical Devices & Haemovigilance (Head: DDr. Alexander Hönel)

 

Head of the Austrian Medicines and Medical Devices Agency: Ao. Univ.-Prof. Dr. Marcus Muellner

 

 

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Created: 06.04.2009 | Page last modified: 21.03.2012

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