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BASG - Federal Office for Safety in Health Care / AGES MEA - Austrian Medicines and Medical Devices Agency
As of January 2, 2006, the BASG commenced its work as the national authority for medicines, medical devices, blood and tissue together with the Austrian Medicines and Medical Devices Agency, a business division of the Austrian Agency for Health and FoodSafety (AGES MEA, until January 1, 2012 AGES PharmMed); prior to this, it was spun off from the Federal Ministry of Health and Women's Affairs (BMGF).
The BASG has been entrusted with a large number of tasks in the fields of drug approval, clinical trials of drugs and medical devices, pharmacovigilance and vigilance in the field of medical devices and inspection and is responsible for which drugs are newly approved in Austria. The BASG monitors - nationally and in concert with the European sister agencies - the medicinal products and medical devices already on the market with regard to their efficacy, any side effects, their production, transport and storage.
The BASG also performs blood and tissue vigilance tasks.
AGES has close organizational ties with BASG. It provides the Federal Office with services, personnel and buildings.
The employees of AGES MEA shall act on behalf of the BASG during the sovereign execution.
Legal basis: Health and Food Safety Act
BASG and AGES MEA
The Federal Office for Safety in Health Care (BASG) is entrusted with the execution of sovereign tasks.
The BASG is an authority subordinate to the BMG. The Federal Office consists of three members appointed by the Federal Minister. One member each from the BMG and AGES was appointed. The third member is the head of AGES MEA.
The AGES MEA provides two members of the Federal Office.
Structure of the BASG
The BASG consists of three members
Chair | SC Dr. Katharina Reich |
1. substitute member | DI Dr. Martin Renhardt |
2. substitute member | Mag. Daniel D'Orlando |
Procedural Member | Dipl.-Ing. Dr. Günter Waxenecker, MDRA |
1. substitute member | Mag. Thomas Reichhart |
2. substitute member | Dipl.-Ing. Dr. Ronald Bauer |
Member | Dr. Gerhard Beck |
1. substitute member | Mag. Andreas Kraßnigg |
2. substitute member | Dr. Christoph Baumgärtel |
Head of the office of the BASG | Mag. Thomas Reichhart |
Official hours and times set for the communication of parties
Pursuant to Section 13(5) of the General Administrative Procedures Act 1991, the following official hours and times designated for the communication of parties (by prior appointment) are announced for the Federal Office for Safety in Health Care:
Monday until Thursday | 9.00 - 15.00 h |
Friday | 9.00 - 12.00 h |
AGES MEA as a division of AGES
The Austrian Agency for Health and Food Safety (AGES) is the leading expert organisation for risk minimisation in the fields of health, food safety and consumer protection. AGES is wholly owned by the Republic of Austria and is divided into several strategic business and specialist divisions to fulfil its tasks.
The Austrian Medicines and Medical Devices Agency (AGES MEA) is responsible for all operational tasks of the BASG; the employees of AGES MEA act on behalf of the BASG.
The client and owner of AGES MEA is the Republic of Austria, represented by the Federal Ministry of Health (BMG).
Structure of the AGES MEA
Head of AGES MEA
Dipl.-Ing. Dr. Günter Waxenecker, MDRA
Heads of the Institutes of the AGES MEA
Institute Marketing Authorisation & Lifecycle Management | Head: Mag. Dr. Peter Platzer |
Institute Assessment & Analytics | Head: Dr. Gerhard Beck |
Institute Surveillance | Head: Dipl.-Ing. Dr. Ronald Bauer |