European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Maintenance of orphan designation criteria

Orphan designation - Maintenance of orphan designation criteria
When sponsors of an orphan-designated medicinal product submit a marketing authorisation application, they should submit in parallel a report on maintenance of the orphan designation criteria, which will be reviewed by the COMP.

A template to be used for this purpose is available here:

•Sponsor’s report on the maintenance of the designation criteria at the time of marketing authorisation application (June 2010)

open here please:
European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Maintenance of orphan designation criteria