The product called "Viazene Bleu" is marketed as an all-natural dietary supplement specifically for men. However, it is to be classified as an illegal medicinal product.

The product called "Maxviril" is marketed as a purely herbal food supplement especially for men. However, it is to be classified as an illegal medicinal product.

Up-to-date information from the 21.02-24.02.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Up-to-date information from the 24.01.-27.01.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Recall due to nitrosamine contamination above the permitted daily dose

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.