To use IRIS as a logged-in user to submit your application, you need to complete a few registration steps. A quick interactive guide to the IRIS registration process provides you with a summary of actions to ensure that:

✔ You have an active EMA account

✔ Your organisation is registered in EMA's Organization Management Service (OMS)

✔ You have the appropriate user access role and affiliation to an organization

✔ You have a valid Research Product Identifier (RPI) for scientific applications such as orphan designation, scientific advice or ITF

✔ You have a customer account number if your application requires a fee.

For more detailed information describing each of the registration steps including the log-in refer to the IRIS guide to registration. To send your submission, follow the instructions contained in the IRIS guide for applicants (scientific applications for industry and individual applicants) and IRIS guide for parallel distribution applicants.

If you wish to discuss anything other than a new medicinal product with the ITF (e.g. a new technology, a group of products or other subject) you should contact itfsecretariat@ema.europa.eu for assistance in obtaining an RPI.