BASG and healthcare professionals
News
Transition of clinical trials of medicinal products - the countdown is on! Top-News
messages in brief
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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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Entry into force of the amended Regulation 1234/2008/EC on the examination of variations to the terms of marketing authorisations for medicinal products for human use on 01.01.2025 New
messages in brief
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18/12/2024
Regulation 1234/2008/EC was amended by Delegated Regulation (EU) 2024/1701 and will enter into force on 1 January 2025.
Entry into force of the amended Regulation 1234/2008/EC on the examination of variations to the terms of marketing authorisations for medicinal products for human use on 01.01.2025
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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”
messages in brief
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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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