Variations to MRP and DCP authorisations

1. Where and when do I submit the Austrian "Summaries of Product Characteristics", "Labellings" and "Package Leaflets" in case of MR-/DC- procedures with Austria as CMS?

"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. Type IA Variations become provided that texts were presented immediately moved. Type IA variations to implement decisions of the commission are exceptions and will be handled like Type II variations.
  • In case of Type IB Variations the Austrian product information texts have to be submitted together with the submission of the Variation. After finalisation of the variation there will be five days for correction of the texts according to changes done during the procedure and to submit them again. 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.

2. Which electronic format is possible for the submission of product information texts?

Word doc and Word docx documents should be submitted.

3. How do I know when the processing of my variation to the product information texts is finished?

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.

4. Is it possible in case of a product licensed via MR-/DC-procedure to finalise the variation on national level without product information in German?

Yes, for further details please see: conditional authorisation.

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