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.