Purpose and context
This user guide describes how to create, author and submit electronic Product Information (ePI) for regulatory approval and publication.
With an ePI Applicant role, you can access the PLM portal and manage ePI for your organisation.
Please visit the EMA Account Management page to log in (or create an account first) and request an ePI Applicant role.
ePI Applicant roles and permissions are explained in the ePI registration guide.
For more information on the business process, please refer to the ePI procedural guide.
To access the data of published ePI, please visit the API website.
Visibility of ePIs
An ePI Applicant Manager will only see the ePIs they have created or been added to as a co-author.
An ePI Applicant Contributor will only see the ePIs they have been added to as a co-author.
Please refer to 'Grants provided by user access roles' in the ePI registration guide.
Navigate the ePI portal
Note: To be able to see the ePI menu and the 'ePI list' and 'New ePI' options, you have to have an ePI role and to be logged into the PLM portal.
Manage your ePIs by accessing the ePI list. There are two main 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.
Tooltips are available and can be viewed by hovering your mouse wherever you see this symbol:
Create ePI
Users with the ePI Applicant Manager role can create ePI.
To create a new ePI, log into the PLM portal and:
use the dropdown option on the top banner or
click on the button 'Create new ePI' on the PLM portal homepage or
click on the button '+ New ePI' in the ePI list.
1) Select ePI details
Follow the on-screen prompts to start creating an ePI. Complete the information in the 'Select ePI details' form and click on 'Create & Next' to create the ePI.
Create a new ePI
This option must be used for medicines where no ePI exists yet (e.g., in an initial marketing authorisation application or in a variation application for a marketing authorisation that does not already have an ePI).
Choose 'First-time ePI creation' to create an ePI from a blank template.
Select the domain: ePIs can currently only be created for human medicines.
Indicate the authorisation type: CAP (centrally authorised product), NAP (nationally authorised product) or MRP/DCP (product authorised by the Mutual Recognition Procedure or Decentralised Procedure).
If NAP or MRP/DCP is selected:
Under Medicines regulatory agency, select the national competent authority to whom the ePI will be submitted. Click on the magnifying glass and enter text (top left) to filter the results. Search using the authority's English name or acronym and use an asterisk to search using partial text. On the left-hand side column, select the radio button next to the authority and click on 'Select'.
The regulatory agency’s details will be displayed.If MRP/DCP is selected:
Indicate whether the medicines regulatory agency is the reference member state. If 'Yes' is selected, both the English and local language ePI templates will be included in the ePI. If 'No' is selected, only the local language ePI template(s) will be included in the ePI.
Select the QRD template version in which the ePI will be created. Only currently valid templates are available for selection.
Note: ePI must use the same QRD template as Word/PDF PI of the same procedure.Enter the name of the medicinal product. The name of medicinal product may be an invented name or may be either the INN/common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder, in accordance with the definition provided in Article 1(20) of Directive 2001/83/EC. This is a free text field. The name of the medicine can be edited later.
Under Reference MAH, select the organisation on whose behalf you are creating the ePI. Click on the magnifying glass and enter text (top left) to filter the results. Search using the organisation's English name and use an asterisk to search using partial text. On the left-hand side column, select the radio button next to the organisation and click on 'Select'.
The details of the selected reference MAH will be displayed.Enter one or multiple procedure numbers, if known. This field allows capital letters [A-Z], digits [0-9] and slashes [/]. Procedure numbers can also be added later.
Click on 'Create & Next'.
Create an updated version of an existing ePI
This option must be used for medicines with an already-published ePI (e.g., in a variation application) to ensure correct ePI versioning.
Choose 'Update existing ePI' if you are updating an existing ePI in the procedure.
Under Select ePI to update, select the ePI you wish to base your new ePI on. Click on the magnifying glass and enter text (top left) to filter the results. On the left-hand column, select the radio button next to the ePI you wish to update and click on 'Select'.
Note: You can only see the ePIs of your organisation(s) and that you have created / for which you have been added as a co-author.The details of the existing ePI will be displayed in a blue box. Check the 'Name of the medicinal product' and 'ePI ID' of the ePI selected to update. When updating an ePI, the domain, authorisation type, name of medicinal product and medicines regulatory authority are the same as the existing ePI.
Note: The currently published ePI for the same medicine will be replaced by the updated version, once it is authorised and published.In case the existing ePI was created in an older QRD template version and an updated template is available, you will see the following options:
if the older template version is still valid, you can select to create the new ePI in the older template or in the updated template.
if the older template is no longer valid, the new ePI will be created in the updated template.
Note: ePI must use the same QRD template as Word/PDF PI of the same procedure.
Under Reference MAH, the organisation on whose behalf the previous ePI was created is already pre-selected. You cannot change the reference MAH when creating a new version of an existing ePI.
Enter one or multiple procedure numbers, if known. This field allows capital letters [A-Z], digits [0-9] and slashes [/]. Procedure numbers can also be added later.
Click on 'Create & Next'.
2) Add co-authors
Users with the ePI Applicant Manager role can add or remove co-authors for an ePI they created/co-author.
You have the option to add co-authors for the ePI on the 'Add co-authors' page.
To skip this step, click on 'Next'. Co-authors can also be added later.
Add co-author affiliated with your organisation
Click on the 'Add co-authors' button. Under the 'My organisation' tab, users with ePI roles for your organisation are displayed.
Use the check boxes on the left-hand side to select co-author(s) and click on 'Save'.
Add co-author from another organisation
Click on the 'Add co-authors' button. Under the 'Outside my organisation(s)' tab, search for the email address of the user you wish to add as a co-author. Follow the instructions on screen.
If the email address is found in EMA Account Management, it will appear below. Click 'Save'.
Remove co-author
Use the trashcan icon on the right-hand side of a co-author's name to remove co-authors.
Note: An ePI must always have at least one co-author with an ePI Applicant Manager role.
After ePI creation, co-authors can be added or removed by selecting 'View/manage co-authors' from the right-hand side Actions in the 'ePI list'.
3) Manage ePI
On the 'Manage ePI' page, the QRD templates for all languages of a particular ePI are listed. For the ePI of the Reference Member State (RMS) of MRP/DCP products, the common language (English) template is also listed here, in addition to the QRD template in the language of the RMS.
When the ePI is first created, it may take several seconds for the QRD templates in the 'Manage ePI' tab to load, and the 'Available' column will read 'Loading'. Refresh your browser for the availability to be updated.
From the 'Manage ePI' tab, you can:
access the editor by selecting the language in which you wish to work and clicking 'Go to editor'. You can exit the editor at any time and return to the 'Manage ePI' tab by clicking 'Exit editor'.
import ePI in FHIR format by selecting the language for which you wish to import content and clicking 'Import FHIR'. You can only import FHIR for one language at a time.
export ePI to Word and FHIR formats and
Note: You can edit 'Medicine Name' and 'Procedure number' by clicking on the pencil icon next to the respective field. Confirm your changes by clicking the pencil icon again, or by clicking 'Save'.
4) Link product
Users with the ePI Applicant Manager or ePI Applicant Contributor role can link ePI to medicinal products from the Product Management System (PMS).
Linking products is currently optional. ePI documents (SmPC, PL, Labelling) that are linked to products contain the corresponding PMS IDs and Data Carrier Identifiers from PMS.
Each PMS ID represents a unique combination of one strength-one pharmaceutical form for that medicine.
The same medicine can have:
one combined SmPC for different strengths; in this case, there are several medicinal products (PMS IDs) that should be linked to this document.
Several PLs, one for each strength and pharmaceutical form; in this case, there is one medicinal product (PMS ID) linked to each PL document.
Add a link
On the 'Link product' page, select the ePI document that you want to link to a product. You can only link one document at a time. Then click the 'Link/unlink document-product' button.
Upon clicking the button, available products will appear. Available products are all the products of the organisation on whose behalf the ePI was created, with the same authorisation country as the ePI.
The default view is 10 products. You can view more products by changing the 'Show 10 rows' selection in the top menu to 'Show 100 rows'.The unfiltered view will give you the first 10 (or 100) products available for selection, sorted alphabetically by the medicine name. If you have more than 100 products available for selection, you might need to filter further to find the product(s) you wish to select.
Note: You will only be able to select products for the organisation on whose behalf your ePI was created, you will not see products from other companies even if you are affiliated to other organisations.Filter for a product by typing into the search field at the top of each column. You can enter multiple search criteria. Then start the search by pressing 'Enter' or clicking the magnifying glass to the left of the search filters.
Select the product(s) you wish to link to your ePI document by clicking on the check box or in the row of the product(s).
Once you have selected the products, click 'Update link(s)' at the top of the page. You will be directed back to the 'Link product' page.
Remove or update a link
On the 'Link product' page, select the ePI document for which you want to update or remove linked products. You can only select one document at a time. Then click the 'Link/unlink document-product' button.
Upon clicking the button, a search grid will appear. Click on the action 'View Linked Products' in the top menu to see all currently linked products. Products are highlighted with blue shading and the check box is ticked.
If you want to remove a product link, unselect the product by clicking on the check box or in the row of the product. The blue shading will disappear and the check box is now unticked.
If you want to link to a new or additional product, follow the steps as described above.
Once you have unselected the products you want to remove and selected any products you want to add, click 'Update link(s)' at the top of the page. You will be directed back to the 'Link product' page.
View linked products
When an ePI document has been linked to a product, the document name is shown as a clickable link. To view the products linked to the ePI document, click on the name. A table will expand under the document name, displaying for each linked product the full name and PMS ID.
If data carrier identifier information has been added to the product in PMS, you can display it by clicking on the arrow or product row in the table. A nested table will appear showing the MA number(s) and data carrier identifier information for each pack size.
5) Submit
Users with the ePI Applicant Manager role can submit ePI they have created/co-authored.
To submit ePI:
Check the appropriate box(es) to submit ePI in Draft status.
Enter the signatory details and date of submission.
Click on 'Submit'.
The ePI status is changed and you are directed to the appropriate tab of the 'ePI list' view.
ePI list
Use the ePI list to locate ePI that you have created or been added to as co-author.
Click on the EPI ID (left-hand side column) to go to the 'Manage ePI' page. Perform further actions via the 'Actions' (right-hand side column).
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 of that ePI. ePI can have the following statuses:
Draft
On creation ePI has the status Draft. Only ePI Applicant Managers can create Draft ePIs.
ePI Applicant Managers or ePI Applicant Contributors who are co-authors on the ePI can edit the ePI, change sections/section headings or import FHIR when ePI is in Draft status.
ePI Applicant Managers who are co-authors on the ePI can also link products or add/remove co-authors when ePI is in Draft status.
Submitted
ePI in Submitted status has formally been submitted to the regulator. Only ePI Applicant Managers can change ePIs to Submitted status.
ePI Applicant Managers or ePI Applicant Contributors who are co-authors on the ePI can edit 'Medicine Name' and 'Procedure number' when ePI is in Submitted status. If you go to the editor, a message appears to inform you that if you proceed, the ePI status will revert to Draft.
Published
ePI in Published status is the most up-to-date, authorised ePI for the medicine. The ePI has been published to the FHIR repository by the regulator. ePI in Published status can be accessed via the publicly available Application Programming Interface (API) and the public register of the PLM portal.
Only regulators can publish ePI to the FHIR repository.
Published ePI cannot be edited.
Archived
ePI in Archived status was published by the regulator but is no longer current. ePI moves to Archived status:
when the regulator publishes an updated version of the ePI;
when the regulator unpublishes the ePI and opts to move it to Archived status.
Archived ePI cannot be edited. It remains stored in the FHIR repository and can be accessed via the API.
Upon unpublishing an ePI, the regulator choses to move the ePI to either Deactivated or to Archived status, depending on the grounds for unpublishing.
Deactivated
ePI in Deactivated status has been discarded at some stage during the drafting and publishing process. ePI moves to Deactivated status:
when an ePI Applicant Manager moves the ePI to Deactivated status;
when the regulator unpublishes the ePI and opts to move it to Deactivated status.
ePI in Deactivated status can be deleted or moved back to Draft status. You can edit 'Medicine Name' and 'Procedure number' when ePI is in Deactivated status. If you go to the editor, a message appears to inform you that if you proceed the ePI status will revert to Draft.
Upon unpublishing an ePI, the regulator choses to move the ePI to either Deactivated or to Archived status, depending on the grounds for unpublishing.
Who can view ePI
Draft/Submitted/Deactivated ePI can be viewed via the ePI list by ePI Applicant Managers or ePI Applicant Contributors who are co-authors on the ePI and by regulators.
Published/Archived ePI can be viewed via the ePI list by ePI Applicant Managers or ePI Applicant Contributors who are co-authors on the ePI and by regulators. The can also be publicly accessed via the Application Programming Interface (API) and the public register 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 for ePI with each of these statuses: 'Draft', 'Submitted', 'Published', 'Archived' and 'Deactivated'.
Click on the 'All' tab to view all ePI that you have created or been added to as co-author.
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. For example, type part of the 'EPI ID', 'Name of medicinal product', 'Procedure number' or 'Authorisation type' to narrow the search.
Click on the 'All' tab to search across all ePI statuses.
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 ePI.
Click 'Download' to download a list of ePI. 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 of your ePIs.
Actions
Overview of Actions
The below table lists the Actions that appear on the Action menu of the ePI list depending on your role and the ePI status:
| Status | Actions: Applicant Manager | Actions: Applicant Contributor |
|---|---|---|
| Draft | - View/manage ePI - View/manage co-authors - Deactivate ePI - View versions | - View/manage ePI |
| Submitted | - View/manage ePI - View co-authors - Move ePI to Draft - Deactivate ePI - View versions | - View/manage ePI |
| Published | - View ePI - View co-authors - View versions | - View ePI |
| Archived | - View ePI - View co-authors - View versions | - View ePI |
| Deactivated | - View/manage ePI - View co-authors - Delete ePI - Move ePI to Draft - View versions | - View/manage ePI |
Use the 'Actions' in the right-hand side column to:
View/manage ePI 
You are directed to the 'Manage ePI' page, from where you can go to the editor, import FHIR, export and preview ePI, or navigate to 'Link product' or 'Submit' pages.
View/manage co-authors 
Users with the ePI Applicant Manager role can add/remove co-authors. You are directed to the page from where you can view/add/remove co-authors who are affiliated with your organisation or are from outside your organisation.
Deactivate ePI 
Users with the ePI Applicant Manager role can deactivate ePI. Only Deactivated ePIs can be deleted.
Deactivated ePI can also be restored to Draft. Select 'Move ePI to draft'.
Move ePI to draft 
Users with the ePI Applicant Manager role can move ePIs in Submitted or Deactivated status back to Draft.
Delete ePI 
Users with the ePI Applicant Manager role can delete ePI. Only Deactivated ePIs can be deleted. Select 'Delete ePI'.
Note: Deleted ePIs cannot be restored.
View versions 
Users with the ePI Applicant Manager role can view all ePIs created for a particular medicine. You are directed to a separate ePI list view. All usual actions are also available from this view.
Use the ePI editor to create documents (summary of product characteristics [SmPC], Annex II, Labelling and package leaflet [PL]) and to add content to sections (e.g., 1. NAME OF THE MEDICINAL PRODUCT, 2. QUALITATIVE AND QUANTITATIVE COMPOSITION etc.).
The editor supports ePI creation according to the QRD templates.
Note: You can edit 'Medicine Name' and 'Procedure number' by clicking on the pencil icon next to the respective field. Confirm your changes by clicking the pencil icon again or by clicking 'Save'.
Product information documents
A tree view on the left-hand side of the editor allows navigation to each of the sections of a document. Vertical tabs facilitate navigation to each of the document types.
By default, an ePI has one SmPC, one Labelling, one PL and for CAPs, one Annex II.
Add documents
Create additional SmPCs, Labelling and PLs by clicking on the ellipsis to the right of the document name and selecting:
Duplicate: adds a duplicate of the document, all the section headings and content are duplicated.
Add another: adds a new blank document underneath the current documents.
Each CAP ePI must have exactly one Annex II. It is not possible to duplicate or add Annex II documents. NAP ePIs do not have Annex II documents.
Rename documents
By default, document names reflect the document type and the order in which they were created (e.g., Copy1 Package Leaflet) . Edit document names by clicking on the ellipsis to the right of the document name and selecting:
Rename: opens a pop-up window where the document name can be edited and saved.
Document names are not part of the approved product information. They are intended to help users organise and keep track of their documents when working in the PLM portal, i.e. when working in the ePI editor or when linking to a product. It is hence recommended to name the documents with details of document type, strength and pharmaceutical form, such as:
SmPC strength 1, strength 2 pharmaceutical form
Labelling strength 1 pharmaceutical form
PL strength 1, strength 2 pharmaceutical form
Document names are displayed in the public register of the PLM portal just as they are shown in the tree view of the editor.Opens in new window or tab Document names are not however present in the FHIR ePI published in the ePI repository.
Re-order documents
Note: The portal does not currently allow documents to be moved up or down on the tree view for documents to be re-ordered. Documents are exported to Word in the same order in which they appear in the tree view.
Delete documents
Delete documents by clicking on the ellipsis to the right of the document name and selecting:
Delete: opens a pop-up window to confirm that you want to delete the document. The last remaining document of each document type cannot be deleted to ensure that every ePI has at least one full set of documents.
Preview documents
Preview a document by clicking on the ellipsis to the right of the document name and selecting:
Preview - new tab: a new tab opens displaying the entire document including the content of all sections. Content that has not been saved in the editor will not appear in the Preview tab.
Mandatory, non-mandatory and custom sections/subsections
ePI documents have mandatory, non-mandatory and custom sections and subsections.
Upon creation, each document includes all mandatory sections in the editor. Mandatory sections are required by the legislation and are defined in the QRD template. They cannot be moved or deleted.
For more information on general product information requirements, please refer to the QRD templates and related guidance.
Add non-mandatory sections
Non-mandatory sections are optional, however, their headings and position are defined in the QRD template. They cannot be re-ordered but can be renamed where necessary.
Non-mandatory sections can be created by clicking on the ellipsis to the right of the parent section name and selecting the non-mandatory section from the options provided.
An arrow to the right of a section name in the tree view indicates that the section has subsections. Clicking on the arrow opens or closes the subsections.
Add custom subsections
It is possible to create custom subsections, where necessary. They are optional and are not further defined in the QRD template - they cater for specific cases in some ePIs. They can be re-ordered and renamed.
Create a custom subsection by clicking on the ellipsis to the right of the parent section name and selecting:
Add new blank subsection: a pop-up window appears where the subsection heading can be entered and saved to create the subsection.
Under the following parent sections of the QRD template custom subsections can be created:
Under sections of the SmPC with third-level headings (headings numbered 2.1, 2.2, etc) and fourth-level headings (underlined headings in the QRD template)
Under sections of the PL with second-level headings (headings numbered 1., 2., etc)
Note: Custom subsections are only for use to create sections that do not appear in the QRD template. If a non-mandatory section is proposed in the parent section menu, always add the non-mandatory section from the menu rather than creating a custom subsection with the same section heading. This will ensure that information in your ePI remains searchable.
For the same reason, it is preferable to introduce text belonging to subsections by creating additional sections in your ePI whenever appropriate instead of including the text under the main section heading.
Rename sections
Edit section headings, where necessary, in the section heading field above the editor.
Re-order sections
Only sections that were created using the ‘Add new blank subsection’ action can be moved up or down. The order of mandatory or non-mandatory sections cannot be changed.
Re-order sections by clicking on the ellipsis to the right of the section name and selecting:
Move up / Move down: move the section one position up or down.
Sections can only be moved up or down within the same parent section.
Note: Save all edits before re-ordering sections to prevent changes being lost.
Delete sections
Delete sections by clicking on the ellipsis to the right of the section name and selecting:
Delete section: opens a pop-up window to confirm that you want to delete the section. Mandatory sections cannot be deleted.
Copy/pasting from Word
Add content to sections by authoring using the editor toolbar, which enables a range of supported editing options, and/or by copy/pasting from Word documents.
Text, lists and tables copy/pasted from Word keep part of their original formatting, including bold, italic, underline, sub- and superscript. All other formatting, including font type, font size, font colour, background colour etc. is automatically cleared upon copy/pasting.
Additional styling should only be added in the ePI when specifically required by the applicant/authority. This includes boxed warnings, black triangle, grey-shaded text or red text. These styles can be added directly from the editor toolbar.
For more information on the styling of ePI, please refer to the ePI style guide.
Note: Hyperlinks inserted in text do not work in the editor, but will work in the 'Preview' and when exported to Word or FHIR format.
Tables
Insert tables into sections by copy/pasting from Word documents or using 'Insert>Table' from the editor toolbar.
Table actions are available from the 'Table' dropdown in the editor toolbar or the Table menu that appears next to the table.
Copy/paste tables by selecting the whole table in Word and using Ctrl+C/V keyboard shortcuts. We recommend that you remove all unnecessary formatting by applying 'Clear formatting' from the editor toolbar.
If necessary, colour cells of a table using 'Table > Cell > Cell properties' from the 'Table' dropdown and selecting 'Advanced' and 'Background color'.
Display of tables
Tables will be automatically resized to a maximum width of 600px when exporting to Word.
When adding images in tables, images will be automatically resized to fit into the table.
Users may need to make manual adjustments in the exported Word if using complex or nested tabled or tables with images. Use of nested tables or overly complex table structure or unnecessary styling is strongly discouraged.
If it is necessary to use images in tables, a simple format, e.g. two columns with text in one column and images in the other column is preferred. For improved accessibility and readability on mobile devices, consider alternating text and images in paragraphs.
Images
Enter images using 'Insert > Image...' from the editor toolbar. Images should never be entered by copy/pasting from Word.
Add alternative text for images using the 'Alternative description' field in the 'Insert/Edit Image' pop-up window.
Image types supported
The following image file formats are supported by the editor: jpeg, jpg, jpe, jfi, jif, jfif, png, gif, bmp, webp.
The editor does not support images with overlaid text boxes copy/pasted from Word. To achieve the same effect, create an image with the text inside the image. Then insert the image as described above.
Error messages "Some images failed to import" or "Unsupported image type" may be encountered when entering images of unsupported file types in ePI.
Styling of images
Images will be automatically resized to a maximum width of 600px when exporting to Word.
When adding images in tables, images will be automatically resized to fit into the table (with the table maximum width of 600px). For improved accessibility and readability on mobile devices, avoid making extensive use of images within tables. Consider alternating text and images in paragraphs, for example in the instructions for use.
Summary of product characteristics
The SmPC for ePI follows the QRD templates. Refer to the ePI QRD template list for more information on the sections.
Additional monitoring
For products under additional monitoring, the black triangle and statements should be inserted in the section directly under the heading "SUMMARY OF PRODUCT CHARACTERISTICS".
Select the black triangle symbol directly from the editor toolbar and do not add it as image.
Boxed warning
Add a boxed warning to selected text by applying the 'Boxed warning' directly from the editor toolbar. The correct formatting will be applied automatically.
11. DOSIMETRY
To insert the non-mandatory section 11, click on the ellipsis to the right of the heading SUMMARY OF PRODUCT CHARACTERISTICS.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
To insert the non-mandatory section 12, click on the ellipsis to the right of the heading SUMMARY OF PRODUCT CHARACTERISTICS.
Date of revision of the text
The date should not be entered in ePI, as the date will not be known at the time of submission of ePI.
Annex II
The Annex II for ePI follows the QRD templates. Refer to the ePI QRD template list for more information on the sections.
Name and address of the manufacturer(s)
The 'Name and address of the manufacturer(s) of the biological active substance(s)' and 'Name and address of the manufacturer(s) responsible for batch release' are not considered as separate sections. They should be entered directly in the section 'A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE'.
E. Specific obligation to complete post-authorisation measures
To insert the non-mandatory section E, click on the ellipsis to the right of the heading ANNEX II.
Labelling
The Labelling for ePI follows the QRD templates. Refer to the ePI QRD template list for more information on the sections.
One labelling for the outer packaging/immediate packaging ('PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING>') is included in ePI by default. Mandatory sections are included in ePI by default.
An arrow to the right of a section name indicates that the section has subsections. Clicking on the arrow opens or closes the subsections in the tree view.
Labelling for blisters, strips or small immediate packaging can be created by clicking the ellipsis to the right of the heading 'LABELLING' and selecting 'Add MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS' and/or 'Add MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS'.
Creating additional labelling
Additional labelling within the same Labelling document (e.g. for immediate packaging) can be created by clicking the ellipsis to the right of the inner label heading and selecting:
Copy Section: a copy of the inner label and all its subsections and content is created underneath.
Note: The portal does not currently allow Labelling documents to be moved up or down on the tree view for documents to be re-ordered.
Labelling headings
Additional text added to the heading field can be viewed in the tree view and in the preview. It is not currently possible to expand or add new lines to the heading field. Therefore, {NATURE/TYPE} heading text that is usually added on a new line should be included in the same line as the preceding text, separated by a colon.
Grey shading
Add grey shading to selected text by applying the style 'Grey-shaded text' directly from the editor toolbar. The correct shading will be applied.
Package leaflet
The PL for ePI follows the QRD templates. Refer to the ePI QRD template list for more information on the sections.
Mandatory sections are included in ePI by default. Non-mandatory sections can be inserted by clicking the ellipsis to the right of the parent section name.
An arrow to the right of a section name indicates that the section has subsections. Click on the arrow to open or close the subsections in the tree view.
PACKAGE LEAFLET section
The standard opening texts of the package leaflet should be entered in the first section with the heading PACKAGE LEAFLET. These include:
Package leaflet: Information for the <patient> <user>
{(Invented) name strength pharmaceutical form}
{active substance(s)}
Additional monitoring symbol and text
Standard phrases for medicines available on prescription/without prescription
Table of contents
Additional monitoring
For products under additional monitoring, the black triangle and statements should be inserted in "PACKAGE LEAFLET" section, between the active substance and the standard prescription statement.
Select the black triangle symbol directly from the editor toolbar and do not add it as image.
Date of revision of the text
The date should not be entered in ePI, as the date will not be known at the time of submission of ePI.
Import FHIR
ePI in XML FHIR format can be imported when it is:
Compliant with the European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
Compliant with the Quality Review of Documents Product Information Templates
Important note: It is highly recommended that you check your XML in an XML validator to ensure that your document is well formatted and has correct syntax. It is possible that some characters in the narrative content need to be escaped. The following are the most common types of characters that need to be escaped and the corresponding character entities:
| Special character | Must be escaped in section heading? | Must be escaped in section content? | Escaped character sequence |
|---|---|---|---|
| & | Yes | Yes | & or & |
| < | Yes | Yes | < or < |
| > | Yes | Yes | > or > |
| " | Yes | Not necessary | " or " |
| ' | Yes | Not necessary | ' or ' |
1) Select XML files
In the 'ePI list' for an ePI in Draft status, select 'View/Manage ePI'.
On the 'Manage ePI' page, select a language and click on 'Import FHIR' at the top of the page.
Important note: You can only import for one language at a time. The language will be locked during import. It is advisable to ensure that co-authors are not working in the language at the same time, as their work will be overwritten.The 'File selection' window opens.
Click on 'Browse files' to select the files you wish to upload. You can select one or multiple files in .xml format. Use the Control key to select multiple files or return to the selection window by clicking on 'Browse files' again. Confirm your selection by clicking on 'Open'.
Once file upload is complete, you can click on 'Validate' to start validation.
For any issues with the file selection, refer to the error table below.
2) Validate ePI documents
During the validation process, your documents will be checked for their level of compliance with published standards. Only documents that pass validation can be imported into the portal.
After clicking 'Validate', the validation process begins. The 'Validation/Import' window opens.
In the window, a table displays all documents that were extracted from the uploaded .xml files. The document titles as stated in the .xml file and the associated document types (SmPC, PL, Annex II, Labelling) are displayed.
As validation progresses, the table confirms for every document whether it passed validation (green tick) or failed validation (red cross).
Click on the Download icon on the right side to download the validation report for each document and check the outcome of the validation process.Once validation is complete, a green banner is shown on the top stating 'Validation complete. More information in validation report.' If one or more documents have passed validation, you can click on 'Import' to start the import process.
What if my ePIs did not pass validation?
Download the validation reports to check why your documents have not passed validation and implement the necessary adaptations. Then try again. For a list of possible validation errors, refer to the error table below.
3) Import ePI documents
During the import process, your documents and all their content will be imported into the portal. New documents will be added to your ePI; existing documents will be overwritten and updated with the new content.
Warning: Do not refresh or close your page, do not click the back or forward buttons in your browser and do not sign out from the PLM portal while the Validation and Import processes are in progress. This might interfere with the process and lock the language you are currently importing, preventing you from progressing with your ePI.
After clicking on 'Import', a modal opens asking you to confirm that you want to proceed with the import. Note that some content of your ePI might be overwritten, and it is advisable to keep a backup of your current ePI. Once started, import cannot be cancelled.
Confirm by clicking on 'Import' on the modal.
As import progresses, the table confirms for every document whether it was imported (green tick) or failed import (red cross).If one or multiple documents are successfully imported, a green banner is shown on the top stating 'Import is complete.'
Click on 'Close' to finalise the import process.
We recommend navigating to the 'Editor' page to verify that your documents have been successfully imported. As the standard FHIR import creates new documents in your ePI, you might need to delete any old documents that are no longer needed.
For instructions on how to replace existing documents, refer to the section 'Replace existing ePI documents via FHIR import' below.
What if my ePIs were not imported?
If your ePIs cannot be imported due to a technical failure, the system will automatically create a backup of your ePI. Navigate to the 'Editor' page to delete any backups that are no longer needed.
Validation
During the validation process, your documents will be checked for their level of compliance with published standards:
FHIR profile according to the published ePI implementation guide (IG):
Structure: Does your file follow the correct structure and contain FHIR Bundle and Composition resources?
Order: Are all elements as defined in the FHIR profile in the correct order?
Cardinality: Do all elements appear exactly as often as required in the FHIR profile?
Profile conformance: Are all system and value elements present and correctly formatted?
Current QRD template for CAP, MRP/DCP and NAP:
All mandatory sections are present and include the correct Identifier value (see Quality Review of Documents Product Information Templates),
All mandatory sections are in the correct order,
Non-mandatory sections, if present, are in the correct order.
In addition, there are certain restrictions on which XHTML elements can be used, to ensure that the XML files are safe and compatible across different systems. This is to ensure that the content of the narrative is contained within the resource and that there is no active content. Such content would introduce security issues. If present, the elements below will cause validation to fail:
head, body elements: <head>, <body>
external stylesheet references: <link>
scripts: <script>
forms: <form>, <input>
base/link/xlink: <base>, <link> and xlink string
frames, iframes: <frame>, <iframe>, <frameset>, <noframes>, <audio>, <video>, <track>
objects and events: strings browserAction, browser.action, browser.menus, browser.notifications, bowser.pageAction, among others.
Validation errors
Here is an example of a validation error detailed in a validation report. In this example, the ePI document does not comply with the FHIR profile because the section '1. NAME OF THE MEDICINAL PRODUCT' is missing:
Check the Document Metadata Validation Summary to verify that your document uses the correct QRD template version and language.
Check the Detailed Validation Issues table for any other validation errors: Refer to the Path column to locate the error – the issue always relates to the last element cited in the path. Refer to the Message column for a description of the error.
You can find a list of possible validation errors below.
| Error message example | Description | Solution |
|---|---|---|
| Extracting ePI documents from files | ||
| Invalid XML format | Your file is empty or there is an error in the xml | Verify your xml is well-formed and valid |
| Invalid ePI structure: missing Bundle, Composition or List. | Your file does not contain a Bundle, Composition or List element, but these are required. | Verify your file contains all required root elements, including Bundle and Composition. |
| File size exceeds the limit of 200MB | Your file size is too big | Select a file smaller than 200MB; consider splitting a big file into multiple smaller files |
| FHIR structure validation | ||
| Encountered unrecognized element 'unexpectedElement' | Your element is not allowed in the profile but unexpectedly appears. | Remove the unexpected element at the indicated location. |
| Element 'repeatedElement' is not permitted to repeat | Your element appears more frequently than allowed in the profile. | Remove the abundant element at the indicated location. |
| Element 'Element' is not in the correct order | Your element does not appear in the order as defined in the profile. | Move the element to the correct position. |
| Element 'missingElement' with minimum cardinality 1 cannot be null | Your are missing a mandatory element. | Add the missing element at the indicated location. |
| 'ValueString' is not a correct literal for an Element | Your element value does not match the regular expression defined in the profile. | Correct the pattern to the regular expression defined in the profile. |
| Literal string 'ValueString' cannot be parsed as a 'ReferenceDataType' | Your element value does not conform to its required format. | Correct the format to the required format defined in the profile. |
| Attributes cannot be empty. Either they are absent, or they are present with at least one character of non - whitespace content | Your element contains an empty attribute and this is not allowed. | Add characters to your attribute or remove the empty attribute. |
| FHIR profile validation | ||
| Composition.language not found or doesn't match required value (en) | The language value in your file does not match the language you are importing. | Ensure that you are importing the correct language. |
| Composition.extension.ext-epi-version-number (…) not found or doesn't match required value (10.4) | The QRD template version of your document does not match the QRD template version of the ePI you are importing into. | Ensure that ePI you are importing was created for the expected QRD template version. |
| Composition.type.coding.code not found or doesn't match required value | You have at least one incorrect RMS code for the document type | Verify you are referencing the valid RMS codes for the document types |
| Instance count is 0, which is not within the specified cardinality of 1..1 | You are missing a mandatory element. | Add the missing element at the indicated location. |
| Value 'https://spor.ema.europa.eu/v1/lists/100000155531/terms/' does not match pattern 'http://ema.europa.eu/fhir/CodeSystem/100000155531' | Your element value does not match the pattern as defined in the profiles. In the example, the code system value of a section does not match the expected url. | Correct the element value to the required pattern defined in the profile. In the example, your file cites an outdated code system url. The url was since changed. Update all code system values with the up-to-date url. |
| Instance failed constraint 'dom-3' \”If the resource is…”\. | Your file does not comply with the FHIR Path constraint. | Correct the element or value that does not comply with the constraint. |
| QRD profile validation | ||
| Instance count is 0, which is not within the specified cardinality of 1..1 | Your file is missing a mandatory section as defined by the QRD template. | Add the missing section to your file. |
| Instance count is 16, which is not within the specified cardinality of 18..* | Your file has a section that requires to have 18 subsections but only has 16. | Add the missing mandatory sections to your file. |
| Element matches slice Bundle.entry[0].resource[0].section[0].section:QRD-200000029792', but this is out of order for group Bundle.entry... | The sections in your file are not in the correct order as defined by the QRD template. | Put the sections in the correct order. |
| Instance count is 3, which is not within the specified cardinality of 1..1 | Your file has a section that is repeated more than once. | Correct your file so that the section only appears once. |
| Element does not match any slice and the group is closed. | Your file has a section that is not defined in the QRD template. | Verify that your section has the correct code system and code assigned. If the parent section does not allow custom subsections, remove the section. |
| Code 'exampleCode' does not exist in the value set 'ValueSet' (http://ema.europa.eu/fhir/vs/epismpcqrdcodes) | Your element contains a code value that is not part of the value set as defined in the profiles. | Assign a valid code from the linked value set as defined in the profiles. |
| Unsafe content validation | ||
| The element 'div' in namespace 'http://www.w3.org/1999/xhtml' has invalid child element 'script' in namespace | Your file contains a <script> tag which is not allowed. | Remove the <script> tag from your file. |
| The element 'div' in namespace 'http://www.w3.org/1999/xhtml' has invalid child element 'iframe' in namespace | Your file contains a <iframe> tag which is not allowed. | Remove the <iframe> tag from your file. |
| The element 'div' in namespace 'http://www.w3.org/1999/xhtml' has invalid child element 'input' in namespace | Your file contains a <input> tag which is not allowed. | Remove the <input> tag from your file. |
| The element 'div' in namespace 'http://www.w3.org/1999/xhtml' has invalid child element 'u' in namespace | Your file contains a <u> tag which is not allowed. | Remove the <u> tag from your file. Instead use: { text-decoration: underline }. |
| Known warnings and information | ||
| The narrative SHALL have some non-whitespace content. | The section does neither contain text nor child elements. | Add meaningful text content to the section. For Labelling sections, you can mostly ignore the warning. |
| The required attribute 'alt' is missing. | Images should contain an alt attribute for alternative text to support accessibility. | Add the alt attribute and meaningful alternative text to the images. |
Replace existing ePI documents via FHIR import
During document extraction, the system checks the ePI ID, language code and bundle identifier to determine if the document is new or already exists for this ePI. New documents will be imported and added to the ePI, while existing documents will overwrite the document in the portal.
In order to replace an existing document of your ePI via FHIR import and to avoid having to manually delete documents, you must ensure that the language and bundle identifier in your FHIR xml file are identical to the document in the portal you want to replace.
ePI can be previewed from the 'Manage ePI' page or from the editor.
Select the language on the 'Manage ePI' page and click 'Preview' at the top of the page.
A new tab opens and the ePI preview is displayed.
Alternatively, access the editor by selecting the language from the 'Manage ePI' page and then clicking 'Go to editor'.
Click the ellipsis to the right of the document name and select 'Preview {doc type} - new tab' from the dropdown menu.
A new tab opens and the ePI preview is displayed. The preview has navigated to that document of the 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 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.