Messages in brief
COVID-19
messages in brief
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13/01/2021
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.
COVID-19
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Accessible Patient Information leaflet
messages in brief
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17/12/2020
Due to current events, FAQ No. 2 on accessible information for use has been revised, to better reflect the current approach.
Accessible Patient Information leaflet
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Project Monitoring of advertising material for medicinal products in 2020
messages in brief
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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.
Project Monitoring of advertising material for medicinal products in 2020
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#MedSafetyWeek 2020 - Every report counts. An appeal to patients and health professionals to report suspected adverse reactions from 2-8 November 2020
messages in brief
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30/10/2020
The BASG participates in the worldwide social media campaign called #MedSafetyWeek to raise public awareness of the importance of adverse drug reaction reporting.
#MedSafetyWeek 2020 - Every report counts. An appeal to patients and health professionals to report suspected adverse reactions from 2-8 November 2020
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Current issue of "RMS NEWS"
messages in brief
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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"
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BREXIT – current challenges for Marketing Authorisation Holders
messages in brief
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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.
BREXIT – current challenges for Marketing Authorisation Holders
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Creating Accessible Documents
messages in brief
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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.
Creating Accessible Documents
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Creating Accessible Package Leaflets – FAQ Update
messages in brief
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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.
Creating Accessible Package Leaflets – FAQ Update
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Control of the envelope symbol in the eServices “Authorisation and lifecycle MP”
messages in brief
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04/09/2020
Since 01.04.2020 the envelope symbol is controlled only by the eService users.
Control of the envelope symbol in the eServices “Authorisation and lifecycle MP”
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Creating Accessible Package Leaflets
messages in brief
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27/07/2020
We have published updated versions for human accessible Package Leaflets and the QRD template!
Creating Accessible Package Leaflets
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