BASG and companies

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.

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