Procedural Advice for Post-orphan Medicinal Product Designation Activities

On 21 December 2020 the EMA published the guidance for sponsors.

The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the EMA.

Following adoption of an opinion on orphan medicinal product designation by the COMP, the final COMP opinion (negative or positive) is forwarded to the European Commission (EC) and the sponsor. Relevant information is published in the COMP monthly reports and the meeting minutes on EMA website. The decision on the designation is adopted by the EC within 30 days of receipt of the COMP opinion and forwarded to the sponsor via courier.

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