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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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.…
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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…
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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
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…