Orphan Drug (OD) Applications

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.