Messages in brief

News

Transition of clinical trials of medicinal products - the countdown is on! Top-News

messages in brief | 25/03/2024
All ongoing clinical trials need to be converted to Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU. Clinical trials that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.
Transition of clinical trials of medicinal products - the countdown is on! Read more
News

BASG becomes WHO Listed Authority New

messages in brief | 20/05/2024
After a review process lasting almost a year, the WHO decided on 14.05.2024 to include the European network of EU and EEA medicines authorities, of which the Federal Office for Safety in Health Care is an essential and active part, as a recognized "regional entity" in the list of WHO Listed Authorities (WLA) for human medicines and vaccines.
BASG becomes WHO Listed Authority Read more
News

Current issue of “RMS NEWS”

messages in brief | 31/03/2024
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

BASG/AGES eServices – Adaptation of electronic user administration (eBA)

messages in brief | 15/02/2024
Some improvements to the electronic user management of eServices are planned for the current year 2024, which we would like to point out to you below.
BASG/AGES eServices – Adaptation of electronic user administration (eBA) Read more
News

Current issue of “RMS NEWS”

messages in brief | 31/01/2024
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

Change in eService Marketing Authorisation and lifecycle

messages in brief | 05/12/2023
As part of the implementation of the ISO IDMP requirements in combination with the EU IG, it will be possible to enter marketing information per pack line from 06.12.2023.
Change in eService Marketing Authorisation and lifecycle Read more
News

#MedSafety Week 2023 - Every report counts. Call for patients and healthcare professionals to report suspected adverse reactions

messages in brief | 06/11/2023
#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.
#MedSafety Week 2023 - Every report counts. Call for patients and healthcare professionals to report suspected adverse reactions Read more
News

Current issue of “RMS NEWS”

messages in brief | 31/10/2023
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

CHESSMEN Board meets in Rome to discuss shortage prevention

messages in brief | 20/10/2023
CHESSMEN Board meets in Rome to discuss shortage prevention.
CHESSMEN Board meets in Rome to discuss shortage prevention Read more
News

Warning about counterfeit medicinal product Ozempic®

Safety warnings | messages in brief | 12/10/2023
BASG informs about current developments and necessary measures in case of counterfeiting of the medicinal product Ozempic® in German presentation.
Warning about counterfeit medicinal product Ozempic® Read more
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