web
You’re offline. This is a read only version of the page.
close
IRIS
  • Home
  • Forum
  • SPOR
    • SPOR
    • Medicinal Products
    • RMS
    • OMS
    • SMS
  • IAM
  • Sign in

Guidance & Support

EMA Account Management Portal

To sign in you need an active EMA user account with the necessary user access roles. You can create a new user account, apply for user access roles, reset your password or recover your username using the EMA Account Management Portal.

IRIS Registration Guide

Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration

IRIS Registration process

Quick interactive guide to IRIS registration process

Notice to Applicants (NTA)

Delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities.

FHIR Applications

Delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities.

Regulations

Delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities.

Support on Application Forms

Delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities.

Release Notes

Delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities.

QPPV Registration

Delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities.
  • EMA Service Desk
  • eSubmissions

© 2023. European Medicines Agency. All rights reserved.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.