IRIS Industry Users should note that uploading a Letter of Authorization is not required in IRIS for Paediatric submissions (or for Scientific Advice, PRIME, Orphan, or ITF submissions), since the portal already performs authentication of the user at login. In addition, there is no need to create and upload also the old Part A PDF form, since the information required is already included in the webforms of the IRIS Industry Portal, or to upload previous EMA paediatric decisions for the same product.
EMA aims at improving and simplifying submissions for scientific procedures via the IRIS portal.
