The new EU Veterinary Medicinal Products Regulation, which entered into force on 27/01/2019, is applicable from 28/01/2022. According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary medicinal products shall be submitted to the competent authority of the Member State in which the clinical trial is to be conducted.

The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2022/2023 (published 29 March 2022).

Clinical studies and the war in Ukraine - Information for Consumers.

Clinical studies and the war in Ukraine - Information for Healthcare Professionals.

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

Reporting suspected adverse reactions to veterinary drugs is possible using an online form.

With the AMG amendment of 14.02.2022, § 21(2) was changed to the effect that the BASG must now be notified four months (instead of the previous two months) in advance of a temporary or permanent discontinuation of the marketing of medicinal products.

The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022.

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

On Monday 31st January 2022 at 9:00 a.m. CET, the Clinical Trials Information System (CTIS) has gone live. CTIS is the backbone of the Clinical Trials Regulation that will harmonise the assessment and supervision of clinical trials in the EU and the EEA.