The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA).
Source: Regulatory and procedural guidelines (human and veterinary)
SEQ Limited | Pharmaceutical Regulatory Affairs Consultants | UK | EU
SEQ Limited | Pharmaceutical Regulatory Affairs Consultants | UK | EU
Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018