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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26/07/2019
Situation in Austria Imurek-50 mg Film-Coated Tablets are currently temporarily unavailable due to increased demand beyond national borders, and associated capacity constraints at the manufacturer. This information is publicly available on the…
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18/07/2019
Please find new and updated FAQ's regarding "Accessible Patient Information Leaflet" at https://www.basg.gv.at/en/medicines/faqs-about-medicinal-products/accessible-patient-information-leaflet/ .
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18/07/2019
The concept of parallel submission in official control authority batch release means that the applicant sends samples to the BASG-OMCL (Official Medicines Control Laboratory) while he is still testing them himself. Complete documentation is not…
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17/07/2019
Manufacturers of an implantable device shall provide information for identification of the device on an implant card in accordance with Article 18 MDR. More detailed guidance on a uniform format of an implant card have now been published on the…
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.
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07/05/2019
The Commission Implementing Decision is published. Further information can be found under:…
Enforcement
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26/04/2019
Amygdalin-containing veterinary drugs can cause severe side effects
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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.