Committee for Orphan Medicinal Products (COMP) – Meeting Minutes 13-15 June 2017
This meeting report includes the following topics: Orphan medicinal product designation, Request for protocol assistance with significant benefit question, Review of orphan designation for orphan medicinal products at time of initial marketing authorisation, Review of orphan designation for authorised orphan medicinal products at time marketing authorisation extension, Application of Article 8(2) of the Orphan Regulation, and Organisational, regulatory and methodological matters.
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