Official announcements
Safety warnings
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Blood & Tissue
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03/07/2019
Only available in German
Enforcement
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29/05/2019
The product "Artrovex", which is distributed via international online sales platforms and various websites (e.g. www.health-at.live), is classified by the BASG as an illegal presentation medicinal product on the basis of its advertising.
Recall
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Medicines
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14/05/2019
The marketing authorisation holder informed its customers on May 13, 2019 that overweight capsules may be packed and distributed to the market.
messages in brief
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10/05/2019
The authorisation status of allergen products, both for diagnosis and therapy, in the European Union is heterogeneous. In order to facilitate harmonisation throughout the EU, the CMDh Drafting Group on harmonisation of the regulatory approaches for allergens created a guideline with intention to provide principles and guidance for the regulation of…
messages in brief
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07/05/2019
The Commission Implementing Decision is published. Further information can be found under: https://www.basg.gv.at/de/news-center/news/news-detail/article/valsartan-sartan-haltige-arzneimittel-pharmazeutische-unternehmen-sollen-herstellungsverfahren-ue/ For regulatory questions please consult nat@basg.gv.at .
Recall
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Medicines
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26/04/2019
"MEDIKUS medizintechnische und pharmazeutische Vertriebs GmbH" informed its customers on April 26, 2019 that metallic particles were detected in the infusion bags.
Enforcement
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26/04/2019
Amygdalin-containing veterinary drugs can cause severe side effects
messages in brief
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24/04/2019
Article 54 of the MDR regulates the consultation procedure related to the clinical evaluation of certain class III and class IIb devices. Regarding the exemption provisions to this procedure, an interpretative document has been published. Devices under the directives (AIMDD, MDD, IVDD) may be placed on the market, made available on the market or…
messages in brief
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23/04/2019
The purpose of the ‚Draft guideline on the non-clinical requirements for radiopharmaceuticals‘ (EMA/CHMP/SWP/686140/2018) is to provide guidance on the required nonclinical data needed to support clinical development and marketing authorisation of radiopharmaceuticals. Radiopharmaceuticals are a special, but clinically important group of medicinal…
