EMA: Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product

Article 5(10) of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products requires sponsors to submit annual reports on the state of development of designated medicinal products to the European Medicines Agency (EMA). This guideline is intended to provide advice on the preparation of these reports. Annual reports are specific to each designation. As a consequence, when one active substance is the subject of several designations, a separate report should be prepared for each designation.