Messages in brief
Transition of clinical trials of medicinal products - the countdown is on! Top-News
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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!
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NEWSTICKER 30.11.2024
messages in brief
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19/11/2024
The BASG reminds marketing authorization holders/registration holders that submissions by a third party (e.g. a consultant) are only valid with the appropriate authorization.
NEWSTICKER 30.11.2024
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#MedSafetyWeek 2024 - Austria joins global campaign for the safe use of medicines
messages in brief
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04/11/2024
Every report counts: Call from 4 to 10 November for healthcare professionals and patients to report suspected side effects.
#MedSafetyWeek 2024 - Austria joins global campaign for the safe use of medicines
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Current issue of “RMS NEWS”
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30/09/2024
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”
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Current issue of “RMS NEWS”
messages in brief
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30/06/2024
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”
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CHMP Meeting Highlights May 2024
messages in brief
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10/06/2024
Up-to-date information from the 27.05.-30.05.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
CHMP Meeting Highlights May 2024
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BASG becomes WHO Listed Authority
messages in brief
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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
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Current issue of “RMS NEWS”
messages in brief
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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”
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BASG/AGES eServices – Adaptation of electronic user administration (eBA)
messages in brief
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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)
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Current issue of “RMS NEWS”
messages in brief
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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”
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