The EC has published a useful summary of applicable EU rules after the end of the transition period. You can find the link here on the website of the BASG.

Central contact points in each federal state survey needs and coordinate distribution

NTA Vol. 2C: The "Guideline on the Packaging Information of medicinal products for human use authorised by the Community" - so called "Blue-Box Guideline für zentralen Zulassungen" can be found on the following website::…

The National Immunization Schedule 2020 is now available.

Measures at EU level At the request of the European Commission, the European Medicines Agency (EMA) has begun reviewing medicines containing ranitidine after investigations found contamination with N-nitrosodimethylamine (NDMA). NDMA is classified as…

Situation in Austria Imurek-50 mg Film-Coated Tablets are currently temporarily unavailable due to increased demand beyond national borders, and associated capacity constraints at the manufacturer. This information is publicly available on the…

Please find new and updated FAQ's regarding "Accessible Patient Information Leaflet" at https://www.basg.gv.at/en/medicines/faqs-about-medicinal-products/accessible-patient-information-leaflet/ .

The concept of parallel submission in official control authority batch release means that the applicant sends samples to the BASG-OMCL (Official Medicines Control Laboratory) while he is still testing them himself. Complete documentation is not…

Manufacturers of an implantable device shall provide information for identification of the device on an implant card in accordance with Article 18 MDR. More detailed guidance on a uniform format of an implant card have now been published on the…

For more information on this topic, follow the link to the security features .