Messages in brief

News

European System for Application and Surveillance of Clinical Trials online with 31.01.2022

messages in brief | 31/01/2022
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.
European System for Application and Surveillance of Clinical Trials online with 31.01.2022 Read more
News

COVID-19

messages in brief | 16/12/2021
An overview of information by BASG to the novel Corona virus SARS-CoV-2 and the COVID-19 disease as well as links to websites with further information.
COVID-19 Read more
News

Organisation Management Service (OMS) - Integration in EudraGMDP

messages in brief | 17/11/2021
The new legal framework for veterinary medicines (Regulation 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database, which will be implemented from 28 January 2022.
Organisation Management Service (OMS) - Integration in EudraGMDP Read more
News

Clinical Trials Information System (CTIS): Virtual information day – 26.10.2021

messages in brief | 06/10/2021
The aim of this event is to help future CTIS users prepare for submitting and evaluating clinical trial applications in CTIS after its go-live on 31 January 2022.
Clinical Trials Information System (CTIS): Virtual information day – 26.10.2021 Read more
News

Current issue of “RMS NEWS”

messages in brief | 30/09/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS” Read more
News

Shelf-life of Comirnaty extended

messages in brief | 20/09/2021
The Product Information has been updated with the new shelf-life for the frozen vial, that has been extended from 6 months to 9 months. The storage conditions remain unchanged (-90 °C to -60 °C).
Shelf-life of Comirnaty extended Read more
News

SARS-CoV-2 rapid antigen test registry

messages in brief | 19/07/2021
The registry lists in a new form - with search and filter options - those SARS-CoV-2 rapid antigen tests that can be placed on the Austrian market for self-testing.
SARS-CoV-2 rapid antigen test registry Read more
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Further inquiry note