ePI registration guide

To sign into the PLM Portal - ePI you will need:

• an active EMA user account — How to create and manage an EMA account
• the organisation you are working for listed in EMA’s Organisation Management Service (OMS) — How to request access for your organisation
• ePI user access role(s) assigned to that account — How to request roles

The PLM Portal - ePI Identity Access Management has applicant roles, admin roles and regulator roles. A single user must have no more than two roles per organisation – one applicant role and one admin role.

Roles are assigned to single users and are granted at organisation level – not at ePI level. For instance, a user should not be referred to as an ‘Applicant Coordinator of ePI X’ and ‘Applicant Manager of ePI Y’. If a user holds the Applicant Coordinator role, s/he plays that role for the organisation on whose behalf s/he is acting. A user may be referred to as an ‘Applicant Coordinator of organisation X’ and ‘Applicant Manager of organisation Y’.
For every organisation you belong to, you can request a different role type. You can be contributor on ORG1 and, manager on ORG2 and ORG3, and coordinator on ORG4

Applicant roles

There are 3 applicant roles enabling different levels of access for management of ePI.

The roles identified in the column above ‘in UAT environment’ are only needed when you are involved in a testing activity of the PLM Portal - ePI. Please note that participants in the pilot of the PLM Portal - ePI must request an applicant role from the ‘in Production environment’ column, even if previously assigned with a role ‘in UAT environment’.

Regulator roles

There are 4 regulator roles. Users with these roles work for EMA or an NCA and are able to approve or publish ePI on behalf of their authority.

The roles identified in the column above ‘in UAT environment’ are only needed when you are involved in a testing activity of the PLM Portal - ePI. Please note that participants in the pilot of the PLM Portal - ePI must request a regulator role from the ‘in Production environment’ column, even if previously assigned with a role ‘in UAT environment’.

Admin roles

There are 2 admin roles. Users with these roles are able to approve or reject roles requests from within their organisation. 

The admin roles are shared with the PLM Portal - eAF and the IRIS Portal.

If you are already have an admin role for IRIS or eAF, and if your organisation is participating in the ePI pilot, you will automatically be an admin-user for ePI. 

The above roles can approve/reject ePI applicant or ePI regulator roles during the ePI pilot (although ePI is not mentioned in all role names). 

The admin roles can approve/reject access roles requests in both Production and UAT environments.

Applicant and regulator roles

The table below summarises the operations that each applicant and regulator role can perform in the PLM Portal - ePI.        

We recommend granting the role that allows the user to access only the resources necessary for its purpose. When requesting/granting roles keep in mind:

• The ePI Applicant Coordinator role can perform all actions on all ePI of a given organisation.
• The ePI Applicant Manager role can perform all actions on ePI they create or co-author.
• The ePI Applicant Contributor can edit ePI, but cannot create, submit or delete.
• Each Industry organisation should have at least one user with the ePI Applicant Coordinator role.
• A maximum of two roles are to be requested per individual user (one admin-related role and one applicant-related role).

Admin roles

The table below summarises the roles that each admin role can approve or reject for their organisation.

If organisations intend to have more than a user accessing the PLM Portal - ePI, then it is required that some user performs the access management for that organisation. In that case:

• Each industry organisation should have at least one user with the IRIS / eAF Industry Admin role;
• Each National Competent Authority should have at least one user with the IRIS / eAF Competent Authority Admin role.

Prior to the submission of access role(s) request(s), you must ensure that you have an active EMA account and that the organisation on whose behalf you will be acting is listed in the EMA’s Organisation Management Service (OMS). 

To request ePI roles, first log in to EMA Access Management and next click on 'Request Access for Organizations'. This will enable you to find your organisation and request associated roles (see Request user access webpage ).

To learn more about ePI roles and which role to request, see ePI user access roles and Grants provided by user access roles.

Logging into the PLM Portal requires multi-factor authentication (MFA).

This means that, in addition to the standard username and password, you are required to verify your identity with an additional authentication method. MFA adds a layer of security to access your account and it protects your data from being accessed by an unauthorised third party.

The additional authentication step can be using an app – the Microsoft Authenticator app – considered the most secure method. A SMS sent to a mobile phone number or calls to an office or a mobile phone number are other possible authentication methods. Please access My Account to manage/setup your MFA authentication methods.

Authentication steps when signing in to the PLM portal

1. On clicking Sign in at the PLM portal, pick an account

Important note: You must sign in with your username followed by @id.ema.europa.eu: for example, surname_n@id.ema.europa.eu

2. Enter password

Use the same EMA account password you use at the EMA Account Management portal.

3. Verify your identity

Select one of the following authentication methods to verify your identity:

• Microsoft Authenticator app
  The authenticator app is considered the most secure and convenient authentication method. Use the Microsoft Authenticator app in your registered mobile device to prove who you are either by:
  Approve a request on your Microsoft Authenticator app
  You receive a notification in your registered mobile device, which will direct you to the Microsoft Authenticator app. There, a pop-up will be displayed which you must Approve/Deny the sign in attempt.
  Use a verification code
  In the Microsoft Authenticator app, every 30 seconds a verification code is generated. Enter the code generated in the Microsoft Authenticator app.
• SMS
  You receive a verification SMS code in your registered mobile phone. Add that code to sign in.
• Call
  You receive a phone call in your registered mobile phone. In the call, approve/deny the sign in attempt. 

4. Set up of multifactor authentication

Access My Account to manage/setup your MFA authentication methods. In this link, you can find guidance on how to setup the above-mentioned authentication methods.

Registration for PLM portal – ePI is currently restricted to ePI pilot participants only. Pilot participants experiencing any issue with user registration should contact their EMA/NCA contact person.