Official announcements
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29/09/2020
In the following cases Marketing Authorisation Holders/Holders of a Registration need to act, these tasks have to be finalised until 31.12.2020.
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29/09/2020
Please note that all package leaflets have to be published in an accessible format on Arzneispezialitätenregister at latest at 31.12.2020.
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24/09/2020
Three different test methods for the detection of COVID-19 are currently in use in Austria: PCR (polymerase chain reaction) tests, antibody tests and antigen tests.
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10/09/2020
Since July, it has been possible request conversion to accessible product information texts, even for several products together, if this cannot be done within ongoing regulatory procedures. Based on previous experience, the corresponding FAQ No. 2 has now been updated and supplemented regarding this approach.
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04/09/2020
Since 01.04.2020 the envelope symbol is controlled only by the eService users.
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27/07/2020
We have published updated versions for human accessible Package Leaflets and the QRD template!
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09/07/2020
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.
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01/07/2020
In an arbitration process, the Federal Office for Safety in Health Care (BASG) was obliged according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of a Marketing authorization/Registration/Parallel import license to provide their Package Leaflets (PL) in an accessible format corresponding to the standard PDF-UA until 31.12.2020.
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30/06/2020
In 2017, we have received a lot of positive feedback for our first BASG-dialogue “Meet the Case Manager”. Therefore, we are very happy to announce your next chance to meet with us in person!
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30/06/2020
Also in the future, we want to continue to inform our applicants of marketing authorisation procedures with Austria as RMS with relevant news from the committees or exciting innovations such as the slot application via our eServices!