FAQ User rights

Since when has it been possible to nominate users for the communication platform? Is it possible to nominate external consultants as users?

For procedures according to the Austrian Medicinal Products Importation Act (Arzneiwareneinfuhrgesetz), registration has been possible since 23 April 2013, for the eService "Marketing Authorisation & Lifecycle Management of Medicines" since 01 July 2013. Please note that staff members of a consultancy gain access to all pending procedures of a company/organisation, if they are included as staff members of the company/organisation. If staff members of a consultancy should be provided with access to certain pending procedures only, the consultancy has to register, and be assigned one of the four roles for the respective procedure:

  • "Marketing authorisation holder"
  • "Applicant"
  • "Person authorised for communication on behalf of the applicant after authorisation"
  • "Person authorised for communication on behalf of the applicant during the procedure" (unless the procedure was started before 01 July 2013)

Can the administrator (who has already been registered for "Einfuhrmeldungen") assign access rights for the eService "Marketing Authorisation & Lifecycle Management of Medicines" too?

The administrator can assign additional access and user rights. Additional administrators can then be assigned by the company/organisation itself. If applicable, an additional administrator can be provided with restricted rights.

Is it possible to assign an external administrator (e.g. consultant) who is not a staff member of the company/organisation of the MAH?

Administrators are responsible for the administration of staff members of the respective company/organisation. Technically, external staff members can hold this function as well. The administrator is appointed via the form "F_M70_Ermaechtigung_Administrator_Portal".

How can the administrator be changed?

The administrator can be changed by the company/organisation itself. Please note that the current administrator assigns all rights to the new administrator via the "Administration of users and user rights". Then the newly assigned administrator withdraws all rights of the former administrator via the "Administration of users and user rights". Finally, please inform the Austrian Medicines and Medical Devices Agency about the transfer of administrator rights via email to basg.fakturierung @ages .at ("F_M70_Ermaechtigung_Administrator_Portal"). In case the administrator is not available anymore, and can thus not initiate the change, please contact us via basg-eservices @ages .at.

As administrator, how can I nominate and maintain additional users for my company/organisation?

Please refer to the "Guidance notes for the administration of users and user rights".

How can I change data regarding the address or the administrator?

If data of registered organisations or administrators of the organisation change, it is not necessary to newly register for the platform. To update data, please send an email to basg.fakturierung @ages .at. basg.fakturierungagesat

As administrator, when creating a new user, the system shows an error message. What should I do?

It is currently not possible for the administrator to create user rights for a staff member who has already been created in a different organizational unit/company. This applies to internal as well as external staff members (e.g. of a consultant company). In this case please contact us via email to basg-eservices @ages .at so that our support can enter data accordingly. Further, please refer to the "Guidance notes for the administration of users and user rights".

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