Information: eService "Marketing Authorization and Lifecycle of Pharmaceutical Specialties
As of 01.07.2013, the transmission of Austrian product information texts is to take place via the eService "Marketing Authorization and Lifecycle Drug Specialties ". The e-mail address spc@ages.at will no longer be available as of 31.01.2014.
With the introduction of the eService "Marketing Authorization and Lifecycle Drug Specialties", the electronic transmission of texts or subsequent submission of documents will be simplified. Transmissions can now be directly assigned to current procedure numbers and uploaded. Transmission by e-mail is no longer necessary.
Registration is required for the eService "Marketing Authorization and Lifecycle Medicinal Products"; for this purpose, it is necessary to clarify the administrator role of the respective organization in advance. The administrator has the possibility to create additional users. To complete the registration, it is necessary to upload a Letter of Author ization as proof of legitimacy of the administrator and another document as proof of authentication of the specified organizational data (e.g. company register excerpt, trade register excerpt, or similar).
Further information:
Update: eService "Marketing authorization and lifecycle drug specialties", 26.06.2013.
Registration and eService "Marketing Authorization and Lifecycle Medicinal Specialties
Note: For dossier submissions, please continue to use the Common European Submission Platform (CESP) or DVD/CDs.
Queries:
BASG / AGES Medical Market Surveillance
Application Support
E-mail: basg-eservices@ages.at
