Conditional Authorisation: Marketing authorisation / renewal / variation without national product information
Generally, the MAH/applicant is asked to submit national translations of the final product information within 5 days after closure of the procedure to all CMS.
If no marketing of the medicinal product is planned in Austria in the foreseeable future, we provide the opportunity to apply for a conditional authorisation in Austria.
A conditional authorisation is issued without national product information on condition that the national product information will be submitted to BASG 4 months prior to the planned market launch of the medicinal product at the latest.
Conditional authorisation :
Please fill in form: application for conditional approval (F_Z130) and submit it via eServices (document type: "request for conditional authorisation”). The request form can be found in the Downloads section.
The national authorisation will be issued without national product information (SmPC, PL, labelling). No texts will be available at the Austrian Medicinal Product Index.
Further life cycle:
All subsequent variations will be finalised without national product information until the MAH submits the texts (see market launch).
The national product information must be submitted to BASG 4 months prior to the planned market launch.
Submission of the texts with no open procedures: via Cesp
Please fill in the comment field with "Erfüllung einer Auflage".
In case variations concerning the product information were positively closed after the MR-/DC-procedure, these changes must be implemented in the national product information as well.
Finally the MAH will receive an approval letter (Genehmigungsschreiben) from BASG referring to the already issued conditional authorisation including the national product information. From that moment on, SPC and PIL are going to be available at the Austrian Medicinal Product Index.
Please note: The date of a conditionally issued marketing authorisation is relevant for the Sunset-Clause regulation according to § 22 Austrian Medicinal Products Act (AMG).