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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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Quality Management New The quality system of the Austrian federal Office for Safety in Health Care is operated by the Austrian Medicines and Medical Devices Agency and implements the requirements of I
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
Draft monographs for comments Only available on our German website
Drug-Device Combinations New 1. Which legal- and guideline framework is applicable for drug device combinations in the EU? New Medicinal products are increasingly marketed in combination with a medica
European Network New
European Network New About the European Network The European Medicines Agency (EMA) in Amsterdam is the scientific coordinative body for marketing authorisation and safety of medicinal products in Eur
Clinical investigations with medical devices Regulation on electronic submission Electronic Submission Form of the BASG General requirements for applications (technical validation) Clinical investigat