Orphan Drug Designation EU | Work process

June 8, 2022

The Orphan Drug Designation (ODD) is a status assigned by EMA to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market.

We have summarized the work process for you to have always at hand.

Have a look at the complete process:

ODD Key facts Asphalion

For further information, queries or assistance, contact us at: info@asphalion.com

 

 

 

 

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | Medicines for Europe annual conference

Asphalion’s Managing Director, Núria Romero, and Lidia Cánovas, Key Accounts Director will be joining the Medicines for Europe annual conference in Malta next week. The

NEW | MHRA announces new recognition routes

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners.
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners.

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