In December 2022, the European Commission released a Guideline on the applications for orphan designation. It covers the format, contents and the transfer of designations from one sponsor to another.

In detail, this guideline gives supplementary advice on the information that sponsors must provide when applying for designation of a medicinal product as an orphan medicinal product.

The guidance explains the steps that must be completed before submitting an online application via the IRIS platform. Each application for orphan designation for a medicinal product must be submitted to the European Medicines Agency (EMA) and must contain the information specified in this guideline. In particular, section G of the guideline provides advice on transferring the designation of an orphan medicinal product to another sponsor, while section H provides advice on amending an existing designation of an orphan medicinal product. The guideline should be read in conjunction with existing guidance available on the EMA website.

Read the guidance here.

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