Search
Close this search box.
Logo Asphalion
iris portal

Mandatory use of IRIS portal for Orphan Drug Designation (ODD) by EMA

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).

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).
October 18, 2018
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: info@asphalion.com

Search News & Events

  • Filter by category

Share

Related news and events

Christmas season greatings

Season’s Greetings

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting