Messages in brief
Deactivation of the e-mail address "spc-vete@ages.at" for veterinary medicines
messages in brief
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17/04/2014
Austrian "Summaries of Product Characteristics", "Labellings" and "Patient Information Leaflets" should now be submitted via PHAROS eService…
Deactivation of the e-mail address "spc-vete@ages.at" for veterinary medicines
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Federal Office for Safety in Health Care
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26/06/2013
Please note that, with effect from 1 July 2013, product information texts should be submitted via the PHAROS eService "Marketing Authorisation &…
AGES PharmMed
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29/08/2011
With the new DCP-slot alert mailing list applicants have the opportunity to be informed immediately whenever a new version of the availability…
Clinical Trials
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03/03/2011
[Translate to english:] EudraCT - Umstellung auf Version 8
Clinical Trials
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Marketing Authorisation & Lifecycle Management
messages in brief
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02/02/2011
AGES PharmMed is receiving a high number of requests to act as Reference Member State for the Mutual Recognition and Decentralised Procedure. The…
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
messages in brief
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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
messages in brief
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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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