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Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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Rules of Procedure (in German only) New Current rules of procedure and annex New Rules of procedure of the BASG (L_M71) | 99 KB Rules of Procedure of the Federal Office for Safety in Health Care valid
AGES eValidator New
AGES eValidator New Installation New Instructions for installing the eValidator 24.1 The following basic requirements must be met: administrator privileges Microsoft Windows Installer 3.1 Microsoft .N
About us New
About us New 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
Clinical investigations with medical devices Regulation on electronic submission Electronic Submission Form of the BASG General requirements for applications (technical validation) Clinical investigat
SmPC and PL New
SmPC and PL New 1. For which proprietary medicinal products do the readability, clarity, and user-friendliness have to be assessed in a readability test? When do the results of the readability test ha
Veterinary Antimicrobial Consumption New NEWS Recording and reporting the use of veterinary antibiotics The new application report is available for the year 2023 as a separate data set. The option to
GMP/ GDP New
GMP/ GDP Processing status Electronic submission Organisation Management Service (OMS) - Integration in EudraGMDP Information on inspection preparation Good Manufacturing Practice (GMP) refers to the
Pharmaceutical companies Register of authorised pharmaceutical companies in Austria This register provides an overview of the companies authorised in Austria pursuant to § 63 / § 63a of the Austrian M
Register of retailers Register of pharmaceutical retailers The register provides an overview of the notifications received by the BASG from pharmaceutical intermediaries pursuant to Section 71a of the