Up-to-date information from the 17.05.-20.05.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

On May 28, 2021, the use "for active immunization of individuals 12 years of age and older" was extended by the EMA.

As of 22.5.2021, the function "Withdrawal according to §23 AMG" will be available in the area "Overview Medicinal Products".

The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2021/2022 (published 30 March 2021)

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

National Vaccination Committee recommends extended dosage intervals for mRNA vaccines

The Austrian Federal Office for Safety in Health Care (BASG) informs that the temporarily put on hold batch ABV 5300 of AstraZeneca's COVID 19 vaccine has been released again and can be vaccinated.

Currently, there is no evidence of a causal relationship with vaccination.

In cooperation with the pharmaceutical industry, the BASG has produced a guideline for processing DHPC (Direct Healthcare Professional Communication) and Educational Material.

On 29. January 2021, "COVID-19 Vaccine AstraZeneca" was authorised in the European Union as the third vaccine against SARS-CoV2.