"Summaries of Product Characteristics", "Labellings" and "Package Leaflets" have to be submitted via eService "Marketing Authorisation & Lifecycle Management of Medicines".

• In case of Type IA Variations the product information texts can be used immediately.
• In case of Type IB Variations the Austrian product information texts have to be submitted together with the submission of the Variation. Any changes made during the procedure must be incorporated into the Austrian texts as soon as possible and resubmitted.  The product information texts can be used immediately after finalisation of the variation on responsibility of the MAH.
• After finalisation of a Type II variation there will be five days time to submit the correct Austrian product information texts. The responsible case manager will contact you for discussion on the texts.  The texts must not be used earlier than 30 days after finalisation of the procedure. If this is done before being contacted by BASG (Federal Office for Safety in Health Care) this lies within the responsibility of the MAH.

Word doc and Word docx documents should be submitted.

The most recent version of the product information texts can be found in the Austrian medicinal product index.

Also the procedure including the revised product information texts will be published in the announcements of the Austrian Federal Office for Safety in Health Care and on eService.

Yes, for further details please see: conditional authorisation.