significant benefit definition
significant benefit means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product if such an advantage or contribution benefits a substantial part of the target population;
significant benefit means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product;
significant benefit means that the degree of greater benefit justifies the cost for this patient.
More Definitions of significant benefit
significant benefit means a financial benefit that the trustee reasonably believes a person in the position of the person mentioned in subregulation (1) would reasonably expect to be told about.
significant benefit means a financial benefit that the trustee reasonably believes a member would reasonably expect to be told about.
significant benefit means a "clinically relevant advantage" or a "major contribution to patient care“(COM Reg. (EC) 847/2000). Further guidance about significant benefit in COM communication (2003/C 178/02).
significant benefit means a clinically relevant advantage or a major contribution to patient care of an orphan