All ongoing clinical trials need to be converted to Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU. Clinical trials that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.

The pilot phase for the new medicines information system of the Federal Office for Safety in Health Care (BASG) begins on 21 January 2025.

Regulation 1234/2008/EC was amended by Delegated Regulation (EU) 2024/1701 and will enter into force on 1 January 2025.

The BASG reminds marketing authorization holders/registration holders that submissions by a third party (e.g. a consultant) are only valid with the appropriate authorization.

Every report counts: Call from 4 to 10 November for healthcare professionals and patients to report suspected side effects.

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

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

Up-to-date information from the 27.05.-30.05.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

After a review process lasting almost a year, the WHO decided on 14.05.2024 to include the European network of EU and EEA medicines authorities, of which the Federal Office for Safety in Health Care is an essential and active part, as a recognized "regional entity" in the list of WHO Listed Authorities (WLA) for human medicines and vaccines.

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