To simplify the reporting of suspected adverse reactions of medicines and vaccines a revised online form is now available for patients.

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

The United Kingdom has left the European Union and the transition period ended on 31 December 2020. This article gives a short overview about the current applicable rules.

On 06. January 2021, "COVID-19 Vaccine Moderna" was authorised in the European Union as the second vaccine against SARS-CoV2.

Based on the recommendation by the European Medicines Agency (EMA), the European Commission issued the marketing authorisation for the COVID-19 vaccine Comirnaty (BioNTech).

In Austria, adverse reactions can be voluntarily reported directly to the Federal Office for Safety in Health Care (BASG) by patients as well as their relatives.

Due to current events, FAQ No. 2 on accessible information for use has been revised, to better reflect the current approach.

In order to monitor the advertising regulations according to the regulations of the Austrian Medicines Act, advertising is always checked to ensure that it complies with the legal requirements.

Keine Wirkung gegen COVID-19 und begründeter Verdacht auf schädliche Wirkungen.

The BASG participates in the worldwide social media campaign called #MedSafetyWeek to raise public awareness of the importance of adverse drug reaction reporting.