Messages in brief

News

Current issue of "RMS NEWS" New

messages in brief | 29/09/2020
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
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News

BREXIT – current challenges for Marketing Authorisation Holders New

messages in brief | 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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News

Creating Accessible Documents New

messages in brief | 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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News

COVID-19 New

messages in brief | 23/09/2020
An overview of information by BASG to the novel Corona virus SARS-CoV-2 and the COVID-19 disease as well as links to websites with further information.
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News

Creating Accessible Package Leaflets – FAQ Update

messages in brief | 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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News

Creating Accessible Package Leaflets

messages in brief | 27/07/2020
We have published updated versions for human accessible Package Leaflets and the QRD template!
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News

BREXIT Transition period

messages in brief | 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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News

Creating Accessible Package Leaflets

messages in brief | 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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News

Save the Date: BASG-dialogue “Meet the Case Manager”

messages in brief | 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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