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 & Lifecycle Management of Medicines" on https://eservices.basg.gv.at. By then, texts and documents are no longer requested to be submitted via email. From 31 January 2014, the email addresses spc@ages.at and mrp-spc@ages.at will not be available anymore.


In order to be able to use the PHAROS eService "Marketing Authorisation & Lifecycle Management of Medicines", you have to get your organisation registered on https://forms.ages.at/kundenregistrierung. One person within your company has to be nominated as administrator. Subsequently, the administrator can provide access to additional users. To conclude your registration, you will have to upload

 

  1. a letter of authorisation (the relevant form, F_M70 'Ermaechtigung_Administrator_Portal,' is available for download from http://www.basg.gv.at/en/ages-eservices/forms) proving that the administrator is duly authorised and
  2. a document proving the correctness and authenticity of the organisational data entered into the system (e.g., excerpt from the commercial  or companies register, or equivalent).
    For more information on the PHAROS eService "Marketing Authorisation & Lifecycle Management of Medicines" refer to FAQ.

 

 

Please note:

  • For the submission of dossiers or responses to dossiers continue to use the Common European Submission Platform (CESP) or DVD/CDs.
  • With effect from 20 June 2013 the PharmaIS web portal for data entry regarding the "sunset-clause" will be closed and you will not be able to see your data entries. Submissions of marketing data for your medicinal product as well as questions concerning this should be sent to "rnat@ages.at", subject "sunset clause".


If you have any further questions, don't hesitate to send an email to basg-eservices@ages.at.

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