EMA Update: Post-Orphan Medicinal Product Designation Procedures for Sponsors

published 12 Jul 2019

The EMA has released an updated guideline, dated 8 July 2019, detailing post-orphan medicinal product designation procedures for sponsors, as part of their guidance for sponsors submitting an application via the IRIS online portal (EMA/469917/2018, Rev 3).

IRIS is a secure online portal for sponsors to submit applications for orphan medicinal product designation and to manage post-designation activities, for which use is now mandatory for all post-designation activities.

This guideline covers the information and procedures applicable to orphan-designated products, including:

  • Incentives – such as protocol assistance during product development, reduced fees and market exclusivity;
  • Annual reports – required content and timelines for submission;
  • Transfer of the orphan designation to a new sponsor;
  • Change of sponsor’s name and/or address;
  • Amendment of designated condition – criteria and procedural steps;
  • Marketing authorisation application and review of the orphan medicinal product designation criteria;
  • Removal of orphan designation.

Source: EMA