How to apply to the European Medicines Agency for orphan designation for a medicine
On 19 June 2018, EMA will launch a new secure online portal for sponsors to submit applications for orphan designation and to manage post-designation activities.
EMA strongly encourages sponsors to start using the new portal from 19 June onwards, although it will continue to accept applications via existing processes until 19 September 2018.
On 19 June, EMA will provide a link and simple guidance on how to use the portal. In the meantime, sponsors do not need to take any action.