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Access & submission
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.