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New process for orphan drug designation becomes mandatory from 19th Sept 2018

New process for orphan drug designation becomes mandatory from 19th Sept 2018
August 3, 2018 SueCarr

The new process for orphan drug designation which was introduced on the 19th June will be made mandatory from the 19th September 2018. It requires certain steps to be completed before any activity relating to an orphan designation procedure can be carried out using the new IRIS Portal.

To access the regulatory and procedural guidance forms, please click here.