EMA Update: Post-Orphan Medicinal Product Designation Procedures for Sponsors – UPDATED 11 Oct 2019
The EMA has released a revision to the guideline “Post-orphan medicinal product designation procedures”, dated 1 October 2019, part of their guidance for sponsors submitting an application via the IRIS online portal (EMA/469917/2018, Rev 4).
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.
The 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.
This revision updates the information on the maintenance of the orphan designation after validation of the Marketing Authorisation, and the European Commission email address.