Since 19th of September of 2018, EMA made it mandatory to use IRIS portal in order to apply for an Orphan Drug Designation (ODD), amendment or Submit an annual report. For more information about the portal and submission types, see: https://iris.ema.europa.eu/
In order to access this portal it is necessary to have an active EMA account as well as having the affected organisation currently registered in OMS (Organisation Management System). This registration is not instant, as several registration steps are involved and there are some pre-requisites in case the active substance is new.
For this reason, it is highly recommended to start the process as soon as possible in order to avoid issues for the actual submission of the ODD.
At Asphalion, we can support you with the registration or we can even do the submission for you. If you have any question, don´t hesitate to contact us: [email protected]
