Official announcements
Recall
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Medicines
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01/08/2019
The marketing authorisation holder informed its customers on August 1, 2019 that the outer packaging may leak.
messages in brief
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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 website of the Federal Office for Safety in Health Care (BASG) at www.basg.gv.at in the so-called Sales…
messages in brief
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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/ .
messages in brief
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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 necessary at that point of time. By that means, a lot of time can be saved. When all necessary documents…
messages in brief
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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 website of the European Commission. According to MDR/IVDR, manufacturers and authorised representatives…
messages in brief
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16/07/2019
For more information on this topic, follow the link to the security features .
Recall
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Medicines
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03/07/2019
The marketing authorisation holder informed its customers on July 3, 2019 that below mentioned batch of „Elotrace - Infusionszusatz“ show black visible particles.
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 .
