Messages in brief

News

Increased Capacity for Batch testing

messages in brief |
The OMCL of the Austrian Medicines and Medical Devices Agency
has due to automation of analytical methods and optimization of processes
significantly…
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Save the date

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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.…
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News

Electronic Application Forms eAF - new version 1.23

messages in brief |
New versions of the electronic Application Forms (eAF v. 1.23) and related documents are available via the EMA-website (http://esubmission.ema.europa.…
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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…
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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…
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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…
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News

eCTD/VNeeS will be mandatory for national applications

messages in brief |
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 Read more
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