ePI - Registration Guide

To access the PLM Portal - ePI you will need:

1. an active EMA user account — you can log in to your EMA account or create an account at EMA account management
2. the organisation you are working for listed in EMA’s Organisation Management Service (OMS) — if you have previously submitted applications, your organisation is probably listed in OMS.
   You can check whether your organisation is in OMS by searching using 'Request Access for Organizations' at EMA account management.
   In case your organisation is not in OMS, you can request a new organisation.  
3. ePI user access role(s) assigned to your EMA account — this guide provides information about the ePI roles available to pilot participants. Once you know which role you wish to apply for, you can request roles as described in the section below.

Applicant roles, admin roles and regulator roles are available for ePI. 

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 Manager of ePI X’ and ‘Applicant Contributor of ePI Y’. If a user holds the Applicant Manager 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 Manager of organisation X’ and ‘Applicant Contributor of organisation Y’.
For every organisation you belong to, you can request a different role type. 

Applicant roles

There are 2 applicant roles enabling different levels of access for management of ePI.

Please note that applicants participating in the pilot of the PLM Portal - ePI must request one or more of the above applicant roles, even if they have been previously involved with user acceptance testing and were assigned with a role in the testing 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.

Please note that authorities participating in the pilot of the PLM Portal - ePI must request one or more of the above regulator roles, even if they have been previously involved with user acceptance testing and were assigned with a role in the testing 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 your organisation has worked with eAF and/or IRIS, you probably have a user in the organisation with this role.

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

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

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 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.

Admin roles

The table below summarises the ePI 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 role requests, 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). 

1. To request ePI roles, first sign in to EMA account management 
2. Next click on 'Request Access for Organizations'. This will enable you to find and select your organisation.
3. Once you have selected your organisation, click 'Next'. The roles you can apply for will be displayed. Select the role and click 'Next'.
4. Your request will be submitted for approval of the IRIS/eAF Admin of your organisation.
5. To follow the status of your request, from the EMA account management homepage, go to 'Track My Requests'. 

To learn more about ePI roles and which role to request, see the above sections 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 EMA account management.

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 the EMA Service Desk.