EMA advises against ivermectin use for prevention or treatment of COVID-19 outside randomised clinical trials

There are indications that the COVID-19 mRNA vaccine "Comirnaty" is being offered as counterfeit on the internet and directly by telephone.

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

The fees valid on the date of application at BASG after 01.01.2021.

Referenced at:

• Fees

Advice) V.3.a bei im EWR neuen Wirkstoffen (new active substances), sowie Biosimilars 9.508 EURO V.3.b bei im EWR bekannten Wirkstoffen (existing active substances) 5.943 EURO V.4 Labortechnische Analysen

Referenced at:

• Official announcements

A presumed medicinal product offered illegally via the internet, was found to contain an undeclared active substance after examination by the Austrian Official Medicines Control Laboratory (OMCL).

Gemäß § 8. (2) Gewebeviglianzverordnung ist das BASG dazu verpflichtet, die von der Europäischen Kommission verfasste Zusammenfassung der von den Mitgliedstaaten eingegangenen Berichte zu veröffentlichen (Bericht nur auf englisch verfügbar).

Referenced at:

• Tissue vigilance

manufacture or control medicinal products. The activities have to encompass the qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing required to ensure [...] training or the qualified activity is equivalent to the requirements in § 8 para 2 or § 9 para 2 AMBO 2009 . Note: If the relevant professional training or qualified activity was acquired or carried out [...] processes, stores or distributes human blood or blood components without any further manufacturing activities must have a Responsible Person at its disposal. Therefore, according to § 5 (4) QS-VO Blut, changes

Zusammenfassung der jährlichen Berichterstattung über ernste unerwünschte Reaktionen und Zwischenfälle bei Blut und Blutbestandteilen (2019) - Bericht nur auf englisch verfügbar

Referenced at:

• Haemovigilance

Excipients used in the manufacture of active ingredients (such as lactose, whey, sucrose, honey, ethanol, glycerol) that may be present in trace amounts in the finished product have been re-evaluated according to the Excipients guideline and no longer need to be mentioned in the product information if they are less than or equal to a certain threshold. Above this threshold, a listing in FI and GI is required and the corresponding warnings must be mentioned in the product information.