The regulatory processes for combined medicinal product and medical device studies are being simplified in Austria. The new regulation for lead ethics committees harmonises the responsibilities of the ethics committees and enables a coordinated assessment. As a result, combination studies will start faster and more smoothly in future.

Starting in July 2025, BASG/AGES MEA will provide an Excel export of the packages available in our database for each human medicinal product. This is also intended to support data entries in SPOR-PMS and XEVMPD (Article 57). Detailed information can be found in the following guide (L_Z34).

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

To better monitor and, if necessary, counteract supply shortages of medicinal products at EU level, the European Shortages Monitoring Platform (ESMP) was established by the EMA in accordance with the Regulation (EU) 2022/123. The full version of the platform was launched in January 2025.

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.

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.