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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06/12/2018
In the past, "Poppers" have been defined as functional drugs by the Federal Office for Safety in Health Care (BASG). This classification was also confirmed in 2014 by a ruling of the Administrative Court (see below), whereby the provisions of the Medicines Act applied to the marketing of "Poppers". By a later decision of the European Court of Justice (ECJ, see below) from the same year, the classification of "Poppers" as functional drugs was revoked and is therefore no longer applicable.
Safety warnings
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messages in brief
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30/11/2018
Action at EU level The European Medicines Agency (EMA) has scientifically reassessed the serious, disabling and potentially permanent side effects of quinolone and fluoroquinolone antibiotics taken orally, injected or inhaled. This assessment also…
messages in brief
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28/11/2018
On November 27, 2018 a big "round table" took place on the topic of availability of medicines in Austria. At the top-class event, which was organised by the Federal Office for Safety in Health Care (BASG), more than 30 representatives of the Austrian…
messages in brief
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26/11/2018
The WHO-National Control Laboratory Network for Biologicals was established to facilitate the availability of WHO pre-qualified vaccines. The WHO pre-qualification programme provides independent opinion/advice on the quality, safety and efficacy of…
Safety warnings
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Medicines
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23/11/2018
Recall of certain lots of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" containing valsartan active ingredient manufactured by "Mylan Laboratory Limited".
Safety warnings
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messages in brief
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23/11/2018
"Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" (active ingredient: valsartan) have been approved for the treatment of hypertension since August 16, 2013. In the course of…
messages in brief
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19/11/2018
To summarize legal provisions, requirements regarding content as well as information how to submit and handle Mock-Ups a new Guidance Document was set up, which can be found under…
Safety warnings
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Medicines
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25/10/2018
No acute danger, recall purely as a precautionary measure
Safety warnings
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messages in brief
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25/10/2018
Situation in Austria: The Federal Office for Safety in Health Care has received information that several packages of the drug Jakavi 15 mg tablets, for which there is an urgent suspicion of counterfeiting, have entered the legal distribution chain as…
Safety warnings
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Medical devices
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11/09/2018
The Federal Office for Safety in Health Care (BASG) has been informed that "LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H., Gösserstraße 11, 8700 Leoben" (Logimed), which was liquidated in 2011, has no legal successor who continues to fulfil the manufacturer obligations arising from the Medical Devices Act (MPG), Federal Law Gazette No. 657/1996, as amended. These obligations include Post Market Surveilance System (PMS), which includes the investigation of incidents and, where appropriate, the initiation of safety corrective actions in the field.