Messages in brief
The new variation Regulation
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22/03/2009
In 2006, after the completion of the major review of pharmaceutical legislation, the Commission published ideas to further improve the legislation of…
Increased Capacity for Batch testing
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The OMCL of the Austrian Medicines and Medical Devices Agency
has due to automation of analytical methods and optimization of processes
significantly…
Increased Capacity for Batch testing
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has due to automation of analytical methods and optimization of processes
significantly…
Save the date
messages in brief
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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.…
Templates and User-Guide for creation of Accessible Package Leaflets
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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…
Templates and User-Guide for creation of Accessible Package Leaflets
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eCTD/VNeeS will also be mandatory for purely national lifecycle applications
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According to eSubmission-Roadmap purely national variation and renewal applications have to be submitted mandatorily in eCTD/VNeeS format after…
eCTD/VNeeS will also be mandatory for purely national lifecycle applications
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EMA EudraVigilance Umstellungsphase
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Following the EMA Management Board confirmation and announcement in May 2017 that the database has achieved full functionality, the new version of Eud…
EMA EudraVigilance Umstellungsphase
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RMS Flyer 2018
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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…
RMS Flyer 2018
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eCTD/VNeeS will be mandatory for national applications
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In February 2017 an updated version of the eSubmission-Roadmap was published, setting implementation dates for mandatory use of eCTD/VNeeS format in…
eCTD/VNeeS will be mandatory for national applications
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