As previously announced, the following e-mail addresses spc@ages.at and mrp-spc@ages.at are deactivated on 31.01.2014.

Austrian "Summaries of Product Characteristics", "Labellings" and "Patient Information Leaflets" should now be submitted via PHAROS eService "Marketing Authorisation & Lifecycle Management of Medicines": https://eservices.basg.gv.at/.

If you are not registered for eService yet, you can do so at:

https://forms.ages.at/kundenregistrierung/.

Please check in advance with your organisation who is or is going to be an administrator. Administrators can assign further users.

For finalising your registration the following documents need to be uploaded:
1.    letter of authorisation proving that the administrator is duly authorised:

<link uploads media f_m70_ermaechtigung_administrator_portal.docx>

www.basg.gv.at/uploads/media/F_M70_Ermaechtigung_Administrator_Portal.docx

2.    a document proving the correcteness and authenticity of the provided organisational data (e.g. excerpt from the commercial or companies register or equivalent)

For further information on eService and registration please refer to <link en ages-eservices faq>

www.basg.gv.at/en/ages-eservices/faq/

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eService provides you with an overview on your procedures as well as downloadable approved SmPC, Labelling and PIL in WORD-format.

Please note:
Dossiers or responses should still be submitted via the Common European Submission Platform (CESP) or DVD/CD.

For technical enquiries please contact:

basg-eservices@ages.at

In case of urgent questions concerning text implementation please turn to the responsible regulatory expert:
<link en medicines faq assignment-scheme>

www.basg.gv.at/en/medicines/faq/assignment-scheme/

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