Use the ePI list to locate ePI that have been submitted to your medicines regulatory agency for regulatory approval and publication.
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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Archived: ePI in Archived status had been approved and published by the regulator but is no longer current.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- after being unpublished by an ePI Publisher.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.
| Status | Actions: ePI Approver | Actions: ePI Publisher |
| Draft | - View/Manage ePI
- Deactivate ePI | - View/Manage ePI |
| Submission/Update | - View/Manage ePI
- Deactivate ePI
- Approve for publication
- Remove approval | - 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'.
