Messages in brief

News

Accessible Patient Information leaflet

messages in brief | 17/12/2020
Due to current events, FAQ No. 2 on accessible information for use has been revised, to better reflect the current approach.
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News

Project Monitoring of advertising material for medicinal products in 2020

messages in brief | 09/12/2020
In order to monitor the advertising regulations according to the regulations of the Austrian Medicines Act, advertising is always checked to ensure that it complies with the legal requirements.
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News

Current issue of "RMS NEWS"

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.
Current issue of "RMS NEWS" Read more
News

BREXIT – current challenges for Marketing Authorisation Holders

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

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

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.
BREXIT Transition period Read more
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