EU Guideline on Orphan Applications (for Designation and Transfer) - 2022/C 440/02

19 December 2022 – the European Commission published the guideline on orphan applications.

This guideline gives supplementary advice on the information sponsors must provide when applying for designation of a medicinal product as an orphan medicinal product. It covers both the format and content of the application, and should be followed unless good reasons are given for deviating from it.

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