With the entry into force of Regulation (EU) 2019/6, medicinal products for certain pet animals, which were previously not subject to a marketing authorization requirement under Section 7(4) of the AMG, may now only be marketed in Germany if they have been notified to the BASG.

Recall due to nitrosamine contamination above the permitted daily dose

Up-to-date information from the 06.11.-09.11.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Serbia, in addition to the regions already announced, confirmed human WNV infections have been recorded in the Moravicki region.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Romania, in addition to the regions already announced, confirmed human WNV infections have been recorded in the Cluj region.

Medtronic Notification of Stolen Defective Products – Potentially Defective McGRATH™ MAC Video Laryngoscopes NOTE: McGRATH™ MAC video laryngoscopes purchased directly from Medtronic or via its authorized distributors are not affected by this safety notice. The BASG strongly recommends that medical devices should only be purchased through trusted distribution channels.

#MedSafetyWeek from November 6 to 12, 2023 - Reporting suspected adverse drug reactions helps to improve the safety of medicines. In a joint "MedSafetyWeek" campaign, pharmaceutical authorities around the world are reminding people how important it is to report suspected cases of adverse drug reactions. This year's campaign focuses on the important role of healthcare professionals and patients, who contribute to the safety of medicines by reporting suspected side effects.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Meissen in Germany.

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

Up-to-date information from the 09.10.-12.10.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.