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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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messages in brief
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16/04/2009
The Austrian drug approval agency AGES PharmMed states that both patients and physicians can assume that the benefit of a drug used in its field of application is in an acceptable ratio to the risk. The task of AGES PharmMed as the national drug…
messages in brief
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06/04/2009
BASG / AGES PharmMed states that the repeatedly cited AGES report is a document from March 2008. The results of the investigation documented in the report are now obsolete. The proceedings against Humanplasma, which were ongoing at that time, have…
messages in brief
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31/03/2009
In January 2009, AGES PharmMed conducted the second customer survey since its foundation in 2006. As in the previous survey, marketing authorization holders of proprietary medicinal products were addressed. In contrast to the first survey, the survey…
messages in brief
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23/03/2009
BASG/AGES PharmMed warn against the use of the weight loss tea "Paiyouji". Analyses in the Austrian Drug Control Laboratory (OMCL of AGES PharmMed) showed that this product contains a possibly carcinogenic indicator substance as well as a chemical…
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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.…
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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…