What's new
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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FAQ antibiotics flow New Legal questions (text is currently translated) Why are voluntary reporting requirements laid down in a regulation? I am a veterinarian and would like to register a TÄ-HAPO. I
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
Clinical investigations with medical devices Regulation on electronic submission Electronic Submission Form of the BASG General requirements for applications (technical validation) Clinical investigat