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.

An overview of information by BASG to the novel Corona virus SARS-CoV-2 and the COVID-19 disease as well as links to websites with further information.

Representatives of PEI and AGES-MEA again discussed national legal requirements and cooperation on allergens.

The new legal framework for veterinary medicines (Regulation 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database, which will be implemented from 28 January 2022.

This webinar is an introduction to Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users.

This event aims to inform SMEs and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.