![]() ![]() Orphan drug designation may be granted for: On this page: Eligibility for orphan drug designation | Orphan drug designation | Supporting documentation requirements | Content of the designation application | Definitions | Flowchart guide to determine eligibility for standard orphan designation | References Eligibility for orphan drug designationĬonsider all of the eligibility criteria below before you lodge a designation application. Please read the guidance on the Prescription medicines registration process for assistance with registration. This guidance is for sponsors preparing an application for orphan drug designation and covers eligibility criteria and supporting documentation.įor assistance with the orphan designation process, please refer to the guidance for sponsors seeking prescription medicines orphan drug designation. ![]()
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