Up-to-date information from the February 27.03.-30.03.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

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 committee on herbal medicinal products (HMPC) of the European Medicines Agency (EMA) published the revised Public Statement on the use of herbal medicinal products1 containing estragole.

Up-to-date information from the February 19.02.-22.02.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

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.

Up-to-date information from the January 22.01.-25.01.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

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 December 11.12.-14.12.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

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.