Messages in brief

News

Deactivation of the e-mail address "spc-vete@ages.at" for veterinary medicines

messages in brief | 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 Read more
News

Federal Office for Safety in Health Care

messages in brief | 26/06/2013
Please note that, with effect from 1 July 2013, product information texts should be submitted via the PHAROS eService "Marketing Authorisation &…
Federal Office for Safety in Health Care Read more
News

AGES PharmMed

messages in brief | 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…
AGES PharmMed Read more
News

Clinical Trials

messages in brief | 03/03/2011
[Translate to english:] EudraCT - Umstellung auf Version 8
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News

Marketing Authorisation & Lifecycle Management

messages in brief | 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…
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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…
Increased Capacity for Batch testing Read more
News

Save the date

messages in brief |

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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News

Templates and User-Guide for creation of Accessible Package Leaflets

messages in brief |
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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News

eCTD/VNeeS will also be mandatory for purely national lifecycle applications

messages in brief |
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 Read more
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