For a medicinal product for where several indications have been designated with orphan drug status in the EU at different times, it is not possible to submit a single orphan drug application in Switzerland for all indications together. A separate application must be submitted for each orphan drug indication. These applications can however be combined in a single eCTD sequence. It should be clearly indicated in the scientific documents to be submitted in Switzerland (preferably in the leaf-title of the eCTD sequence or in the file name) which document belongs to which Orphan Drug indication. The costs are 3000 CHF per application i.e. per indication.
Dr. Katharina Oehler
Scientific and Managing Director
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