Austrian Federal Office for Safety in Health Care
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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Katinko Ointment New
Enforcement
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18/12/2024
"Katinko Ointment" contained the declared substances methyl salicylate, menthol and camphor and is therefore to be classified as an illegal medicinal product.
Katinko Ointment
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Aboniki Balm New
Enforcement
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18/12/2024
"Aboniki Balm" contained the declared substances methyl salicylate, menthol, camphor and eucalyptol and is therefore to be classified as an illegal medicinal product.
Aboniki Balm
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Robb Well Being New
Enforcement
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18/12/2024
"Robb Well Being" contained the declared substances methyl salicylate, menthol, camphor and eucalyptol and is therefore to be classified as an illegal medicinal product.
Robb Well Being
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Moov Pain Relief Specialist New
Enforcement
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18/12/2024
"Moove Pain Relief Specialist" contained the declared substances methyl salicylate, menthol and eucalyptol and is therefore to be classified as an illegal medicinal product.
Moov Pain Relief Specialist
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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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Hoe Hin White Flower Olie New
Enforcement
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17/12/2024
"Hoe Hin White Flower Olie" contained the declared active substances methyl salicylate, menthol, camphor and eucalyptol and is therefore to be classified as an illegal medicinal product.
Hoe Hin White Flower Olie
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