Messages in brief

For the new QRD templates Vers. 9 veterinary, which take into account the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6, updated accessible Word templates are available for download.

With the entry into force of the Regulation (EU) 2019/6 a new procedure, the SPC harmonisation procedure, was created as per Section 4 of this Regulation.

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.