Official announcements
Recall
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Medicines
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06/11/2007
Information on the suspension of marketing of parenterally administrable drug products containing aprotinin. See related files.
Recall
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Medicines
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31/08/2007
Information on market withdrawal of Clobutinol-containing drugs (Silomat®) up to and including patient level. See related files.
Medicines
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01/01/2006
Information on processing open registration and amendment requests submitted prior to Jan. 1, 2006. See related file.
messages in brief
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01/01/1970
The new RMS Flyer 2018 has been published on the BASG website: https://www.basg.gv.at/en/news-center/public-information-campaigns/austria-as-rms/rms-flyer/ . Looking forward to be the RMS for your products in the upcoming future!
messages in brief
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01/01/1970
Following the EMA Management Board confirmation and announcement in May 2017 that the database has achieved full functionality, the new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and…
messages in brief
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01/01/1970
According to eSubmission-Roadmap purely national variation and renewal applications have to be submitted mandatorily in eCTD/VNeeS format after January 1, 2019. Please find further information at https://www.basg.gv.at/en/eservices/ectdvnees/ .
messages in brief
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01/01/1970
As pubished an 29.06.2018 the Federal Office for Safety in Health Care (BASG), was obliged in an arbitration process according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of a Marketing…
messages in brief
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01/01/1970
BASG-Dialogue "Quality Day" on 29 May 2018 and 13 June 2018 During this event you will hear a lot about relevant documentation in Module 3. Furthermore you have the possibility to meet the Quality Assessors and to address your questions directly to…
messages in brief
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01/01/1970
The OMCL of the Austrian Medicines and Medical Devices Agency has due to automation of analytical methods and optimization of processes significantly increased the capacity for official control authority batch testing of plasma products and vaccines.…
messages in brief
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01/01/1970
In February 2017 an updated version of the eSubmission-Roadmap was published, setting implementation dates for mandatory use of eCTD/VNeeS format in purely national new applications (01.07.2018) respectively for purely national variation and renewal…