Excipients used in the manufacture of active ingredients (such as lactose, whey, sucrose, honey, ethanol, glycerol) that may be present in trace amounts in the finished product have been re-evaluated according to the Excipients guideline and no longer need to be mentioned in the product information if they are less than or equal to a certain threshold. Above this threshold, a listing in FI and GI is required and the corresponding warnings must be mentioned in the product information.

The new position paper focuses on managing supply bottlenecks by improving processes and transparency and serves to clarify the role of players in the distribution chain.

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.

Three different test methods for the detection of COVID-19 are currently in use in Austria: PCR (polymerase chain reaction) tests, antibody tests and antigen tests.

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.