This user guide describes how to approve and publish electronic Product Information (ePIs) after they have been submitted by a pharmaceutical company.
With an ePI Approver or 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 Approver and/or ePI Publisher role.
ePI Approver/Publisher roles and permissions are explained in the ePI registration guide.
For more information on the business process, please refer to the ePI procedural guides.
Visibility of ePIs
An ePI Approver/Publisher will only see those ePIs that have been submitted to their own medicines regulatory agency for regulatory approval and publication.
Manage ePI 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 link 'ePI >' on the PLM Portal homepage.
Note: To be able to see the ePI menu and the 'ePI list' option, you have to be logged into the PLM portal.
Tooltips are available and can be viewed by hovering your mouse wherever you see this symbol:
ePI list
Use the ePI list to locate ePI 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 on the top right 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.
Submission: ePI in Submission status has formally been sent to the regulator. ePI Approvers can approve ePI in Submission status for publication. ePI Publishers can publish approved ePI.
Update: ePI in Update status has formally been sent to the regulator. ePI Approvers can approve ePI in Update status for publication. ePI Publishers can publish approved ePI.
Published: ePI in Published status has been approved and 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Archived: ePI in Archived status had been approved and published by the regulator but is no longer current. ePI moves to Archived status:
when an ePI Publisher publishes a new version of the same ePI;
after being unpublished by an ePI Publisher.
ePI in Archived status cannot be deleted or moved to Draft status.
Deactivated: ePI in Deactivated status has been discarded at some stage during the drafting, approval 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: Deactivated ePIs are not available in the FHIR repository. Deactivated 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', 'Updated', 'Published', 'Archived' and 'Deactivated'.
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.
'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 clicked on the 'All' tab to download a complete list.
Actions
Use the 'Action' dropdown to perform the actions described. The actions displayed in the dropdown depend on your role and the ePI status, as shown in the table.
- View/Manage ePI - Publish (all) - Publish Only English
Published
- View ePI
- View ePI - Unpublish
Archived
- View ePI
- View ePI
Deactivated
- View/Manage ePI - Move ePI to Draft
- View/Manage ePI
View/Manage ePI
You are directed to the 'Manage ePI' tab, from where you can export and preview the ePI.
Note: The actions 'Go to Editor' and 'Upload FHIR' are not active for users with ePI Approver and ePI Publisher roles.
Approve for publication/Remove approval
Users with the ePI Approver role can approve ePI in Submission/Update status for publication. They can also remove approval from ePI in Submission/Update status.
Publish/unpublish ePI
Users with the ePI Publisher role can publish ePI in Submission/Update status, after their approval. They can also unpublish ePI.
Deactivate ePI
Users with the ePI Approver role can deactivate ePI. Deactivated ePIs are visible under 'Deactivate' and 'All' tabs.
Deactivated ePI can be restored to Draft. Select 'Move ePI to draft'.
Approve and publish ePI
Approve ePI for publication
Users with the ePI Approver role can approve ePI in Submission status for publication.
Navigate to the Submission tab in the 'ePI List' and locate your ePI, then click on the Action dropdown menu on the right-hand side.
Select 'Approve for publication'.
A pop-up window will open to confirm that you want to approve the selected ePI for publication.
Once an ePI is approved, it is moved to the top of the ePI list and a vertical green bar is displayed to the left of the ePI list entry.
You can also remove approval from an ePI in Submission status via the Action dropdown menu, by selecting 'Remove approval'. The vertical green bar will be removed from the ePI list entry.
Publish ePI
Users with the ePI Publisher role can publish ePI in Submission status which have previously been approved.
Navigate to the Submission tab in the 'ePI List', locate your ePI and ensure it has been approved. Approved ePI are marked with a green bar in the left of their EPI ID. Click on the Action dropdown menu on the right-hand side.
Select 'Publish'.
For multi-language ePI, select 'Publish All' to publish all languages or 'Publish Only English' to only publish the English ePI.
A pop-up window will open to confirm that you want to publish the selected ePI.
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, then click on the Action dropdown menu on the right-hand side.
Select '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 'Unpublish and replace with previous version EPI/YY/XXXX'. 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 'Unpublish and move to Deactivated'. The unpublished ePI will be moved to Deactivated status. The deactivated ePI will not 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 'Unpublish and move to Archived'. You might want to use this action if this medicinal product is no longer available.
Select your 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/Manage ePI' or 'View ePI'.
On the 'Manage ePI' page, select the language and click 'Preview' at the bottom 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/Manage ePI' or 'View ePI'.
On the 'Manage ePI' page, select the language and click 'Export' at the bottom 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.
