Messages in brief
Human Plasma Report
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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…
Result customer survey 2009
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…
Paiyouji warning
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)…
The new variation Regulation
messages in brief
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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
messages in brief
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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.…
Electronic Application Forms eAF - new version 1.23
messages in brief
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New versions of the electronic Application Forms (eAF v. 1.23) and related documents are available via the EMA-website (http://esubmission.ema.europa.…
Electronic Application Forms eAF - new version 1.23
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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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