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.

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.

Some improvements to the electronic user management of eServices are planned for the current year 2024, which we would like to point out to you below.

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

As part of the implementation of the ISO IDMP requirements in combination with the EU IG, it will be possible to enter marketing information per pack line from 06.12.2023.

#MedSafetyWeek from November 6 to 12, 2023 - Reporting suspected adverse drug reactions helps to improve the safety of medicines. In a joint "MedSafetyWeek" campaign, pharmaceutical authorities around the world are reminding people how important it is to report suspected cases of adverse drug reactions. This year's campaign focuses on the important role of healthcare professionals and patients, who contribute to the safety of medicines by reporting suspected side effects.

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

CHESSMEN Board meets in Rome to discuss shortage prevention.