Variations to MRP and DCP authorisations
"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.
Further inquiry note
Page last modified: 26/11/2014