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.

Source: EMA