Messages in brief

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.

Due to current events, FAQ No. 2 on accessible information for use has been revised, to better reflect the current approach.

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.

The BASG participates in the worldwide social media campaign called #MedSafetyWeek to raise public awareness of the importance of adverse drug reaction reporting.

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

In the following cases Marketing Authorisation Holders/Holders of a Registration need to act, these tasks have to be finalised until 31.12.2020.

Please note that all package leaflets have to be published in an accessible format on Arzneispezialitätenregister at latest at 31.12.2020.

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.

Since 01.04.2020 the envelope symbol is controlled only by the eService users.

We have published updated versions for human accessible Package Leaflets and the QRD template!