Purpose and Context
This user guide describes how to publish electronic Product Information (ePI) that has been submitted by a pharmaceutical company.
With the ePI Publisher role, you can access the PLM Portal and manage ePI submitted to your medicines regulatory agency for regulatory approval and publication.
Please visit the EMA Account Management page to login (or create an account first) and request an ePI Publisher role.
The ePI Publisher role and permissions are explained in the ePI registration guide.
For more information on the business process, please refer to the ePI procedural guides.
Navigate the ePI portal
Manage ePIs by accessing the ePI list. There are two entry points to the ePI list (see screenshot):
use the dropdown option on the top banner to access the ePI list or
click on the button 'ePI list' on the PLM Portal homepage.
Note: To be able to see the ePI menu and the 'ePI list' option, you have to be logged in to the PLM portal.
ePI list
Use the ePI list to locate ePIs that have been submitted to your medicines regulatory agency for regulatory approval and publication.
ePI statuses
The ePI status is visible from the 'ePI list'. In addition, the status of an ePI appears in the information banner of all pages displaying that particular ePI. ePI can have the following statuses:
Draft: on creation, ePI has the status Draft. Only users with the ePI Applicant Manager role can create ePI.
Submitted: ePI in Submitted status has formally been sent to the regulator. Once an ePI is in Submitted status, an ePI Publisher can publish the ePI to the FHIR repository.
Published: ePI in Published status has been published by the regulator and is stored in the FHIR repository. ePI in Published status can be accessed via the publicly available Application Programming Interface and the public register of the PLM Portal.
Archived: ePI in Archived status had been published by the regulator but is no longer current. ePI moves to Archived status:
when an ePI Publisher publishes an updated version of the same ePI;
after being unpublished by an ePI Publisher.
ePI in Archived status cannot be deleted; it remains stored in the FHIR repository and can be accessed via the API. Exceptionally, ePIs in Archived status can be deactivated by the regulator.
Deactivated: ePI in Deactivated status has been discarded at some stage during the drafting and publishing process. It can be deleted or moved back to Draft status by the ePI Applicant Manager.
Upon unpublishing an ePI, the ePI Publisher choses to move the ePI to either Deactivated or to Archived status, depending on the grounds for unpublishing it.
Note: Draft, Submitted and Deactivated ePIs are not available in the FHIR repository. These ePIs can only be accessed by relevant logged-in users via the ePI list of the PLM portal.
More information on ePI statuses in regulatory procedures is available in the ePI procedural guide.
Filter for ePI
Locate an ePI by using the various filter options.
Tabs
When navigating to the 'ePI list', the 'All' tab is shown by default.
Click on the different tabs to filter and display only ePI with the relevant status: 'Draft', 'Submitted', 'Published', 'Archived' and 'Deactivated'.
Load more
When navigating to the 'ePI list', up to 50 ePIs are displayed in any given status tab. Click on the blue 'Load more' button in the bottom right corner of the list to load all remaining ePIs.
Search
Enter text in the 'Search' field to search for and locate an ePI. Type part of the 'EPI ID', 'Name of medicinal product', 'Procedure number', 'Authorisation type' or 'Reference MAH' to narrow the search.
Columns
Click on a column heading to re-order the list according to the column.
Use the 'Column visibility' dropdown to remove columns from view or restore them.
Use 'Refresh' to get the latest list of ePIs.
Click 'Download' to download a list of ePIs. The list will reflect the tab view displayed. Ensure you have selected the 'All' tab and clicked on the 'Load more' button to download a complete list.
Actions
Use the 'Action' icons in the right-most column to perform the actions described. The actions available depend on the ePI status, as shown in the table.
| Status | Actions: ePI Publisher |
| Draft | - View ePI - Deactivate ePI - View versions |
| Submitted | - View ePI - Publish ePI - View versions |
| Published | - View ePI - Unpublish - View versions |
| Archived | - View ePI - Deactivate ePI - View versions |
| Deactivated | - View ePI - View versions |
View ePI
You are directed to the 'Manage ePI' page, from where you can export and preview the ePI.
Note: The actions 'Go to editor' and 'Import FHIR' are not active for users with the ePI Publisher role.
Publish/unpublish ePI
Users with the ePI Publisher role can publish ePI in Submitted status. They can also unpublish ePI.
Deactivate ePI
Users with the ePI Publisher role can exceptionally deactivate ePI from the Archive. You might want to use this action if you moved an ePI to the Archive in error. Note that you cannot reinstate this ePI back to the Archive.
Publish ePI
Users with the ePI Publisher role can publish ePI in Submitted status.
Navigate to the Submitted tab in the 'ePI list' and locate your ePI.
In the Actions column, select the icon for 'Publish'.
A pop-up window will open to confirm that you want to publish the selected ePI.
If you publish an update to an existing ePI, the pop-up window will inform you that the current version of this ePI will be moved to Archived status.
Once published, the ePI is publicly available.
Unpublish ePI
Users with the ePI Publisher role can unpublish ePI in Published status.
Navigate to the Published tab in the 'ePI list' and locate your ePI.
In the Actions column, select the icon for 'Unpublish'.
A pop-up window will open to confirm that you want to unpublish the selected ePI.
If you want to deactivate this ePI and re-publish the previous version, select 'Move EPI/YY/XXXX to Deactivated and replace with most recent Archived version: EPI/YY/XXXZ'.
The unpublished ePI will be moved to Deactivated status. The previous version of this ePI will be moved to Published status and be publicly available.
You might want to use this action if you published an ePI in error and you need to revert to the previous version.If you want to deactivate this ePI and you do not want to re-publish a previous version, select 'Move EPI/YY/XXXX to Deactivated'.
The unpublished ePI will be moved to Deactivated status. The deactivated ePI will no longer be publicly available.
You might want to use this action if you need to temporarily disable an ePI, e.g. if you want to correct a typo.If you want to archive this ePI, select ''Move EPI/YY/XXXX to Archived'.
You might want to use this action if this medicinal product is no longer available.
Select your desired option and confirm by clicking on 'Unpublish'.
Preview ePI
To preview the full ePI in one language:
In the 'ePI list', for an ePI in any given status, select 'View ePI'.
On the 'Manage ePI' page, select the language and click 'Preview' at the top of the page.
A new tab opens and the ePI preview is displayed.
Export ePI
ePI can only be in exported one language at a time. To export ePI:
In the 'ePI list', for an ePI in any given status, select 'View ePI'.
On the 'Manage ePI' page, select the language and click 'Export' at the top of the page.
In the 'Export' window, select whether you wish to export:
in FHIR format,
in Word, all documents in one file with title pages (as required for submission to EMA) or
in Word, each document in a separate file (as required for submission to NCAs).
Note: It is only possible to export one format at a time.
Select your option and click 'Export'. The ePI is exported to your local Downloads folder.