What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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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…
Enforcement
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06/04/2019
Great hopes of physicians as well as patients are attached to stem cell and other cell-based therapies. Major progress is expected particularly in the areas of difficult-to-treat and chronic diseases. In order to prevent hope to be transformed into a “trade with hope”, it is important for authorities to monitor this new therapeutic area.
Safety warnings
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messages in brief
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14/02/2019
During the transitional phase, strict limits are already in place for these impurities.
Safety warnings
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Medicines
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14/02/2019
During the transitional phase, strict limits are already in place for these impurities.
Safety warnings
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Medical devices
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22/01/2019
The product "Raindrop Near Vision Inlay" is a medical device for the treatment of presbyopia.
(presbyopia). It is implanted into the cornea of an eye and causes a change in the shape of the cornea.
Cornea, which is intended to improve sharp near vision.
messages in brief
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22/01/2019
A team from the Austrian Federal Office for Safety in Health Care (BASG) was a guest at the Paul Ehrlich Institute (PEI) on Jan. 14, 2019. The aim was to cooperate more closely in the future in the regulation of medicinal products for the diagnosis…
Safety warnings
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Medicines
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21/12/2018
No acute danger, all packages available in Austria have already been recalled by BASG.
Safety warnings
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messages in brief
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21/12/2018
Situation in Austria The Federal Office for Safety in Health Care (BASG) has received information that several packages of the drug "ALIMTA 500 mg Powder for the Preparation of a Concentrate for the Preparation of an Infusion Solution", for which…
Enforcement
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19/12/2018
Supposed natural products turn out to be counterfeit drugs.