Views:

Purpose and context

This article lists issues in the PLM Portal - ePI that the ePI team is aware of and details of workarounds where available.
Should you encounter one of the issues below, it is not necessary to open a Service Desk ticket, as the team is already working on these issues.
If your issue is not listed, please open a Service Desk ticket.
 

 

Issue Name

Summary

Steps to reproduce

Expected result

Actual result ​​​​​

Workaround

Status

Incorrect formatting of pasted bulleted lists

When bulleted lists are pasted into the editor, the bullet type changes and/or the bulleted text is not correctly justified

Copy and paste bulleted list into the editor window using CtrlC-CtrlV.

Bulleted list appears in the editor window with the exact same formatting as in Word.

Bullet type changes and/or the second and following lines of the bullet text are not correctly justified to the first line.

Paste the list as unformatted text. Then, in the editor, click on 'Bullet list' at the top of the editor window. The bullet type may not be identical to the QRD template, this will be tolerated for ePI.

ePI will only allow bullet types supported by html, namely disc, circle and square. Any of these three bullet types can be used in ePI.

Incorrect justification of bullet text is a current limitation of the text editor.

 

Issue NameSummarySteps to reproduceExpected resultActual result ​​​​​WorkaroundStatus
Short underline appearing in blank lineIn pasted text, short underlines, that were not present in the original text, appear in otherwise empty lines. While these lines appear empty in the source Word document, in fact they are formatted as underline + italic or as underline + bold.Copy and paste text into the editor window using CtrlC-CtrlV.Text appears in the editor window with the exact same formatting as in Word.A short underline appears in an otherwise blank line. This issue can be overcome in 2 ways:
1. In the empty line in the Word document, remove the underline, bold or italic styling, alternatively
2. in the editor window, manually remove the unwanted underline.		Including underline on blank lines is a current limitation of the text editor.

 

Issue NameSummarySteps to reproduceExpected resultActual result ​​​​​WorkaroundStatus
Line spacing too wide in pasted textIn pasted text with single line spacing, line spacing in some paragraphs of the text appears wider in the editor. Copy and paste paragraphs of text into the editor window using CtrlC-CtrlV.Text appears in the editor window with the exact same line spacing as in Word.In some cases, paragraphs appear to have wider line spacing and are not consistent with surrounding paragraphs.Prior to pasting the text, ensure all paragraphs in Word have the same Style associated with them.As this issue relates to the styling of the Word document, it will need to be resolved in Word prior to pasting. The ePI team will report here in case this changes.

 

Issue NameSummarySteps to reproduceExpected resultActual result ​​​​​WorkaroundStatus
Subscript and superscript create uneven line spacingIn pasted text with subscript and/or superscript the line spacing is uneven in the editor. Copy and paste text containing subscripts/superscripts into the editor window using CtrlC-CtrlV. Text appears in the editor window with the exact same line spacing as in Word.Line spacing is uneven to accommodate subscript/superscript.Uneven line spacing is tolerated in ePI.The ePI team will work on this issue in future improvements to the editor.

 

Issue NameSummarySteps to reproduceExpected resultActual result ​​​​​WorkaroundStatus
Sub-sections can only be re-ordered in the editor and not directly in FHIRBlank sub-sections can be added in documents to include sub-sections that are not in the QRD template. These sub-sections can only be re-ordered manually, using the editor of the ePI portal. If a user implements a new order of sub-sections directly in FHIR (so outside the ePI portal), the new order is not kept after the FHIR is uploaded in the ePI portal.At the "Manage ePI" page, select the language you wish to import and click on "Upload FHIR". From your local area, select a FHIR file whose sub-sections have been previously reordered in a FHIR/xml editor and click "OK".The order of the blank sub-sections in the portal is updated to reflect the order of the imported FHIR file.The blank sub-sections have not been re-ordered as desired.User can re-order blank sub-sections manually, using the editor of the ePI portal (click on the ellipsis to the right of the sub-section name, and select "Move up"/"Move down".The ePI team will work on this issue in future improvements to the Upload FHIR functionality.

 

Issue NameSummarySteps to reproduceExpected resultActual result ​​​​​WorkaroundStatus
Title pages of exported Word documents are not in the correct language.In the exported Word document, the names of product information documents on the title pages (e.g. Summary of Product Characteristics, Labelling, Package Leaflet) appear in English and not in the expected language.At the "Manage ePI" page, select the language you wish to export and click on "Export". In the "Export" window, select the format "Word (all ePI documents in one file with title pages)". Then click "Export".The document names on the title pages: "Summary of Product Characteristics", "Annex II" "Labelling", "Package Leaflet" are in the language of the template in the exported Word document.The names of the documents are in English.Manually change the names of the product information documents in the exported Word documents.The ePI team will work on this issue in future improvements.

​

Issue NameSummarySteps to reproduceExpected resultActual result ​​​​​WorkaroundStatus
Reordering blank sub-sections will affect the order of non-mandatory sub-sections later on

It is currently possible to add blank sub-sections in order to include sub-sections that are not in the QRD template. Once added, these sub-sections can then be reordered in the editor.
If a user moves up a blank sub-section and then within the same parent section inserts one or several non-mandatory sub-sections, the latter are not inserted in the correct order in the tree view (as per the order in the QRD template). 

In the editor, navigate to a parent section where several non-mandatory sections can be added according to QRD rules (e.g. section 4.6 of the SmPC or section 2 of the package leaflet).

Click on the ellipsis menu to the right of the parent section name. Add both a blank sub-section and a non-mandatory (pre-defined) sub-section.

Click on the ellipsis menu to the right of the blank sub-section name and select "Move up" once or several times.
Add the remaining available non-mandatory sub-sections.
 

  The order of the non-mandatory sub-sections in the editor is as per the QRD template.

The non-mandatory sub-sections are in a different order than in the QRD template. If the user removes and adds the non-mandatory sub-sections again, they will still be listed in the wrong order. The ellipsis menu will also display them in the wrong order afterwards.

User should first add the non-mandatory sub-sections. If additional blank sub-sections are needed, they should be added afterwards.The ePI team will work on this issue in future improvements.

 

  
Issue NameSummarySteps to reproduceExpected resultActual result ​​​​​WorkaroundStatus
ePI editing and publishing not possible for Irish national products (NAPs) and MRP/DCP products with Ireland as Concerned Member State (CMS).

Applicants are not able to access the editor of ePIs for Irish national products (NAPs) and for Mutual Recognition/Decentralised (MRP/DCP) products where Ireland is a Concerned Member State (CMS).

In addition, the Irish medicines regulator is not able to publish these ePIs.

  •  Accessing the editor for NAPs (only for applicants):

On the “Create New ePI” page, select the following options: “Domain: Human”, “Authorisation type: NAP”, “Medicines Reg. Agency: Ireland”. Type the name of the medicine and select the relevant marketing authorisation holder. Click on “Save and Next”.

At the “Add Co-author” page, click on Next.

At “Manage ePI” page, select EN, then click on ”Go to Editor”.

  • Accessing the editor for MRP/DCP products (only for applicants)

On the “Create New ePI” page, select the following options: “Domain: Human”, “Authorisation type: MRP/DCP”, “Medicines Reg. Agency: Ireland”. Answer “No” to the question “Is this the reference member state?”. Type the name of the medicine and select the relevant marketing authorisation holder. Click on “Save and Next”.

At the “Add Co-author” page, click on "Next".

At “Manage ePI” page, select EN, then click on ”Go to Editor”.

  • Publishing the Irish NAPs and MRP/DCP products with Ireland as CMS (only for Irish medicines agency users):

On the “ePI list” page, navigate to the Submission tab, locate an ePI that is either an Irish NAP or an MRP/DCP product with Ireland as CMS. Ensure it has been approved. Approved ePI are marked with a green bar to the left of their EPI ID. Click on the Action dropdown menu on the right-hand side. Select 'Publish'. 

 The applicant sees the editor with its tree navigation menu and is able to insert text.


The regulator sees a pop-up window to confirm that the user wants to publish the selected ePI. Once published, the ePI is publicly available.

The applicant sees a spinning wheel and an error message in the background. The editor is not accessible.


The regulator sees a red modal with an error message. The ePI is not published.

There is no workaround at the moment. The ePI team is working to resolve the issue.

  

  
Issue NameSummarySteps to reproduceExpected resultActual result ​​​​​WorkaroundStatus
Export to FHIR not workingIt is not possible to export to FHIR from the "Manage ePI" page.At the "Manage ePI" page, select the language you wish to export and click on "Export". In the "Export" window, select to export in FHIR format. Click "Export". The ePI is exported to your local downloads folder. User sees an error message and no FHIR file is downloaded.It is possible to export to FHIR the ePIs available on the "Published ePIs" page. There is no workaround to export to FHIR the ePIs that are not published.The ePI team is working to resolve the issue.

 

 

 

Keywords: issues, bugs, workarounds