Messages in brief

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.

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.

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!

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.

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.

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!