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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 login (or create an account first) and request an ePI Applicant role. ePI Applicant roles are currently only available to participants in the ePI pilot.

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. Similarly, 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 '+ Create New ePI' in the ePI list.

1) Select ePI details

Follow the on-screen prompts to start creating an ePI. Complete the information under tab '1 Select ePI details' and click on 'Save & Next' to create the ePI. You may then click 'Cancel' and return at a later stage to continue authoring and submit the ePI.

create or update ePI

Create new ePI

For medicines where no ePI exists yet (e.g., in an initial marketing authorisation application or where no ePI has previously been created for the medicine).

Choose 'New ePI' 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).
1. If NAP 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 right) to filter the results. Search using the authority's English name and use an asterisk to search using partial text. On the left-hand side column, check the box next to the authority and click on 'Select'.
2. If 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 right) to filter the results. Search using the authority's English name and use an asterisk to search using partial text. On the left-hand side column, check the box next to the authority and click on 'Select'.
  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 will be included in the ePI.
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 right) 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, check the box next to the organisation and click on 'Select'.
Enter the procedure number, if known. This is a free text field. The procedure number can be added later.
Click on 'Save & Next'.

Create an updated version of an existing ePI

For medicines with an existing ePI (e.g., in a variation application), when the existing ePI will be replaced by the updated version following the conclusion of a post-authorisation procedure.

Choose 'Existing ePI' if you are updating an existing ePI in the procedure.
Under Select ePI to update, select the ePI you wish to update. Click on the magnifying glass and enter text (top right) to filter the results. On the left-hand column, check the box next to the ePI you wish to update and click on 'Select'. (Currently all your ePI in Published status are available for selection).
Check the 'Name of the medicinal product' and 'ePI ID' of the ePI selected to update. When updating an ePI, the domain, authorisation type and name of medicinal product are the same as the existing ePI.
Note: The existing ePI will be replaced by the updated version, once it is authorised and published.
Under Reference MAH, select the organisation on whose behalf you are creating the ePI. Click on the magnifying glass and enter text (top right) 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, check the box next to the organisation and click on 'Select'.
Enter the procedure number, if known. This is a free text field. The procedure number can be added later.
Click on 'Save & Next'.

2) Add Co-Author

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 under tab '2 Add Co-Author'.

To skip this step, click on 'Next'.

Add co-author affiliated with your organisation

Click on the 'Add Co-Author' button. Users with ePI roles for your organisation are displayed.
Use the check boxes on the left-hand side to select author(s) and click on 'Save'.

Add co-author from another organisation

It is not currently possible to add a co-author from another organisation.

Remove co-author

Use the dropdown 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 from the 'ePI List' view by selecting 'View/Manage Co-authors' from the right-hand side Action menu.

3) Manage ePI

Under the 'Manage ePI' tab, the QRD templates for all languages of a particular ePI are listed. For MRP/DCP products, the common language (English) template is also listed here, in addition to the QRD template in the language of the Reference Member State (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'. You can only open and work in the editor for one language at a time.
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
preview ePI.

4) Link PMS ID

The feature to link ePI to medicinal products is planned for future development. Click 'Next' to proceed to the next tab.

5) Finalisation

Users with the ePI Applicant Manager role can finalise ePI they have created/co-authored.

To finalise and submit ePI:

Check the appropriate box(es) to finalise ePI in either Submission or Update status.
Enter the Signatory details. The date will be added automatically.
Click on 'Submission' or 'Update'.
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 'Action' dropdown menu (right-hand side column).

ePI list display with columns and action dropdown

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. You can change sections or section headings or add/remove co-authors only when ePI is in Draft status.

Submission: ePI in Submission status has formally been sent to the regulator. You can edit 'Name of medicinal product' and 'Procedure Number' when ePI is in Submission status. You cannot edit sections or section headings. If you go to the editor, a message appears to inform you that if you proceed the ePI status will revert to Draft. Only ePI Applicant Managers can change ePI to Submission status.

Update: ePI in Update status has formally been sent to the regulator. The Update status indicates that there have been changes to the ePI since the initial submission. You can edit 'Name of medicinal product' and 'Procedure Number' when ePI is in Update status. You cannot edit sections or section headings. If you go to the editor, a message appears to inform you that if you proceed the ePI status will revert to Draft. Only ePI Applicant Managers can change ePI to Update status.

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. Only regulators can change ePI to Published status.

Archived: ePI in Archived status had been approved and published by the regulator but is no longer current. ePI moves to Archived status:

when the regulator publishes a new updated version of the same ePI;
when the regulator unpublishes the ePI and opts to move it to Archived status.

ePI in Archived status cannot be deleted or moved to Draft status and you cannot edit 'Name of medicinal product', 'Procedure Number', sections or section headings.

Upon unpublishing an ePI, the regulator choses to move the ePI to either Deactivated or to Archived status, depending on the grounds for unpublishing it.

Deactivated: ePI in Deactivated status has been discarded at some stage during the drafting, approval 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 either be deleted or moved back to Draft status. You can edit 'Name of medicinal product' and 'Procedure Number' when ePI is in Deactivated status. You cannot edit sections or section headings. 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 it.

More information on ePI statuses in regulatory procedures is available in the ePI procedural guide.

Filter for ePI

Tabs

When navigating to the 'ePI List', the 'Draft' tab is shown by default.
Click on the different tabs to filter and see ePI with each of these statuses: 'Draft', 'Submission', 'Update', 'Published', 'Archived' and 'Deactivated'.
Click on the 'All' tab to view all ePI that you have created or been added to as co-author.

Search

Enter text in the 'Search' field to locate an ePI. 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 clicked on the 'All' tab to download a complete list of your ePIs.

Actions

Use the 'Action' dropdown to:

View/Manage ePI

You are directed to the 'Manage ePI' tab, from where you can go to the editor, upload FHIR, export and preview ePI, finalise your ePI and submit it to the regulator for approval and publication.

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 own organisation.

Deactivate ePI

Users with the ePI Applicant Manager role can deactivate ePI. Deactivated ePI are visible under the 'Deactivated' and 'All' tabs.

Deactivated ePI can be restored to Draft. Select 'Move ePI to draft'.

Delete ePI

Users with the ePI Applicant Manager role can delete ePI. Only deactivated ePI can be deleted. Click on 'Delete ePI'. Note that deleted ePI cannot be restored.

Editor

Use the ePI editor to create documents (e.g., 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.

Product information documents

A tree view on the left-hand side of the editor allows navigation to each of the sections of a document and tabs across the top allow 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 underneath the current documents, all the section headings and content are duplicated.
Add another: adds a new blank document underneath the current documents.

Each CAP ePI must have only one Annex II. It is not possible to duplicate or add Annex II documents. NAP ePIs do not have Annex II documents.

Screenshot of document name menu

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 the new name saved.

It is recommended to name the documents with details of 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

Important 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 top-most document cannot be deleted to ensure that every ePI has at least one of each document type.

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. (Note: this function allows previewing of individual documents. To preview the entire ePI for one language, use the 'Preview' button in the 'Manage ePI' tab.)

Mandatory, non-mandatory and additional sections

ePI documents have mandatory, non-mandatory and additional sections.

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.

Screenshot of menu with non-mandatory headings

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 additional sections

It is possible to create additional sections, where necessary. They are optional and are not further defined in the QRD template - they cater for specific cases in some ePI. They can be re-ordered and renamed.

Create an additional section 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 additional sections 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: If a non-mandatory section is proposed in the parent section menu, always add the non-mandatory section from the menu rather than creating an additional section with the same section heading. This will ensure that information in your ePI is stored in the right place and 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 of 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.

Important 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.

Rich-text editor and copy/pasting from Word

Tables

Images

Summary of product characteristics

The SmPC for ePI follows the QRD templates.

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.

Note: The portal does not currently allow SmPC documents to be moved up or down on the tree view for documents to be re-ordered.

Overview of SmPC sections

The below table details features of SmPC sections in the editor. See also the RMS list Quality Review of Documents Product Information Template.

Section heading	Level	Mandatory?	Procedure types	Blank subsections allowed underneath?	How to add to ePI
SUMMARY OF PRODUCT CHARACTERISTICS	1	Yes	CAP/NAP/MRP/DCP	No	Included by default
1. NAME OF THE MEDICINAL PRODUCT	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
2. QUALITATIVE AND QUANTITATIVE COMPOSITION	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
2.1 General description	3	No	CAP	Yes	Use ellipsis beside 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.2 Qualitative and quantitative composition	3	No	CAP	Yes	Use ellipsis beside 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipient(s) with known effect	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
4. CLINICAL PARTICULARS	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
4.1 Therapeutic indications	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
4.2 Posology and method of administration	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Posology	4	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Paediatric population	5	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside Posology
Method of administration	4	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Precautions to be taken before handling or administering the medicinal product	5	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside Method of administration
4.3 Contraindications	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
4.4 Special warnings and precautions for use	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Traceability	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 4.4 Special warnings and precautions for use
Paediatric population	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Paediatric population	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Pregnancy	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 4.6 Fertility, pregnancy and lactation
Breast-feeding	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 4.6 Fertility, pregnancy and lactation
Fertility	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
4.8 Undesirable effects	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Paediatric population	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 4.8 Undesirable effects
Reporting of suspected adverse reactions	4	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
4.9 Overdose	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Paediatric population	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
5.1 Pharmacodynamic properties	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Mechanism of action	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.1 Pharmacodynamic properties
Pharmacodynamic effects	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.1 Pharmacodynamic properties
Clinical efficacy and safety	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.1 Pharmacodynamic properties
Paediatric population	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Absorption	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.2 Pharmacokinetic properties
Distribution	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.2 Pharmacokinetic properties
Biotransformation	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.2 Pharmacokinetic properties
Elimination	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.2 Pharmacokinetic properties
Linearity/non-linearity	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.2 Pharmacokinetic properties
Pharmacokinetic/pharmacodynamic relationship(s)	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.2 Pharmacokinetic properties
5.3 Preclinical safety data	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Environmental risk assessment (ERA)	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
6.1 List of excipients	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
6.2 Incompatibilities	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
6.3 Shelf life	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
6.4 Special precautions for storage	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
6.5 Nature and contents of container <and special equipment for use, administration or implantation>	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
6.6 Special precautions for disposal <and other handling>	3	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Use in the paediatric population	4	No	CAP/NAP/MRP/DCP	Yes	Use ellipsis beside 6.6 Special precautions for disposal <and other handling>
7. MARKETING AUTHORISATION HOLDER	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
8. MARKETING AUTHORISATION NUMBER(S)	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
10. DATE OF REVISION OF THE TEXT	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
11. DOSIMETRY	2	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside SUMMARY OF PRODUCT CHARACTERISTICS
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS	2	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside SUMMARY OF PRODUCT CHARACTERISTICS

Additional monitoring

For products under additional monitoring, the black symbol and statements should be inserted in the section directly under the heading "SUMMARY OF PRODUCT CHARACTERISTICS".

Boxed warning

Boxed warnings can be created by authoring using the rich-text editor or by copy/pasting from Word documents:

To author using the rich-text editor, create a table with one cell and write the warning text inside the cell,
To copy/paste from Word, create boxed warning using a table or using text with borders and copy/paste into the editor. The formatting will be maintained.

Date of revision of the text

The date should not be entered in ePI, as the date may not be known at the time of finalisation of ePI.

Annex II

The Annex II for ePI follows the QRD templates.

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.

Overview of Annex II sections

The below table details features of Annex II sections in the editor. See also the RMS list Quality Review of Documents Product Information Template.

Section heading	Level	Mandatory?	Procedure types	Blank subsections allowed underneath?	How to add to ePI
ANNEX II	1	Yes	CAP	No	Included by default
A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE	2	Yes	CAP	No	Included by default
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE	2	Yes	CAP	No	Included by default
Official batch release	3	No	CAP	No	Use ellipsis beside B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION	2	Yes	CAP	No	Included by default
Periodic safety update reports (PSURs)	3	Yes	CAP	No	Included by default
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT	2	Yes	CAP	No	Included by default
Risk management plan (RMP)	3	Yes	CAP	No	Included by default
Additional risk minimisation measures	3	No	CAP	No	Use ellipsis beside D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Obligation to conduct post-authorisation measures	3	No	CAP	No	Use ellipsis beside D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR <THE CONDITIONAL MARKETING AUTHORISATION> <THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES	2	No	CAP	No	Use ellipsis beside ANNEX II

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 sections. They should be entered 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 section heading ANNEX II.

Labelling

The Labelling for ePI follows the QRD templates.

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 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 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.

Overview of Labelling sections

The below table details features of Labelling sections in the editor. See also the RMS list Quality Review of Documents Product Information Template.

Section heading	Level	Mandatory?	Procedure types	Blank subsections allowed underneath?	How to add to ePI
LABELLING	1	Yes	CAP/NAP/MRP/DCP	No	Included by default
PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}	2	Yes	CAP/NAP/MRP/DCP	No	Included by default
1. NAME OF THE MEDICINAL PRODUCT	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
2. STATEMENT OF ACTIVE SUBSTANCE(S)	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
3. LIST OF EXCIPIENTS	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
4. PHARMACEUTICAL FORM AND CONTENTS	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
5. METHOD AND ROUTE(S) OF ADMINISTRATION	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
7. OTHER SPECIAL WARNING(S), IF NECESSARY	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
8. EXPIRY DATE	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
9. SPECIAL STORAGE CONDITIONS	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
12. MARKETING AUTHORISATION NUMBER(S)	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
13. BATCH NUMBER<, DONATION AND PRODUCT CODES>	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
14. GENERAL CLASSIFICATION FOR SUPPLY	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
15. INSTRUCTIONS ON USE	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
16. INFORMATION IN BRAILLE	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
17. UNIQUE IDENTIFIER - 2D BARCODE	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}	2	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside LABELLING
1. NAME OF THE MEDICINAL PRODUCT	3	Yes if blisters/strips label	CAP/NAP/MRP/DCP	No	Included by default in blisters/strips label
2. NAME OF THE MARKETING AUTHORISATION HOLDER	3	Yes if blisters/strips label	CAP/NAP/MRP/DCP	No	Included by default in blisters/strips label
3. EXPIRY DATE	3	Yes if blisters/strips label	CAP/NAP/MRP/DCP	No	Included by default in blisters/strips label
4. BATCH NUMBER<, DONATION AND PRODUCT CODES>	3	Yes if blisters/strips label	CAP/NAP/MRP/DCP	No	Included by default in blisters/strips label
5. OTHER	3	Yes if blisters/strips label	CAP/NAP/MRP/DCP	No	Included by default in blisters/strips label
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}	2	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside LABELLING
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION	3	Yes if immediate units label	CAP/NAP/MRP/DCP	No	Included by default in immediate units label
2. METHOD OF ADMINISTRATION	3	Yes if immediate units label	CAP/NAP/MRP/DCP	No	Included by default in immediate units label
3. EXPIRY DATE	3	Yes if immediate units label	CAP/NAP/MRP/DCP	No	Included by default in immediate units label
4. BATCH NUMBER<, DONATION AND PRODUCT CODES>	3	Yes if immediate units label	CAP/NAP/MRP/DCP	No	Included by default in immediate units label
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT	3	Yes if immediate units label	CAP/NAP/MRP/DCP	No	Included by default in immediate units label
6. OTHER	3	Yes if immediate units label	CAP/NAP/MRP/DCP	No	Included by default in immediate units label

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 in the editor. The texts can be manually separated onto different lines in the exported Word document.

Grey shading

Add grey shading to text by selecting 'Format > Background color > Custom color' and in the 'Color Picker' window, specifying R211 G211 B211 or #D3D3D3.

Package leaflet

The PL for ePI follows the QRD templates.

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.

Overview of PL sections

The below table details features of PL sections in the editor. See also the RMS list Quality Review of Documents Product Information Template.

Section heading	Level	Mandatory?	Procedure types	Blank subsections allowed underneath?	How to add to ePI
PACKAGE LEAFLET	1	Yes	CAP/NAP/MRP/DCP	No	Included by default
1. What X is and what it is used for	2	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
2. What you need to know before you <take> <use> X	2	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Do not <take> <use> X	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
Warnings and precautions	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
Children <and adolescents>	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 2. What you need to know before you <take> <use> X
Other medicines and X	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
X with <food> <and> <,> <drink> <and> <alcohol>	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 2. What you need to know before you <take> <use> X
Pregnancy <and> <,> breast-feeding <and fertility>	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
Driving and using machines	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
X contains {name the excipient(s)}	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 2. What you need to know before you <take> <use> X
3. How to <take> <use> X	2	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Use in children <and adolescents>	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 3. How to <take> <use> X
If you <take> <use> more X than you should	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 3. How to <take> <use> X
If you forget to <take> <use> X	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 3. How to <take> <use> X
If you stop <taking> <using> X	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 3. How to <take> <use> X
4. Possible side effects	2	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
Additional side effects in children <and adolescents>	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 4. Possible side effects
Reporting of side effects	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
5. How to store X	2	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
6. Contents of the pack and other information	2	Yes	CAP/NAP/MRP/DCP	Yes	Included by default
What X contains	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
What X looks like and contents of the pack	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
Marketing Authorisation Holder and Manufacturer	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
This medicine is authorised in the Member States of the European Economic Area <and in the United Kingdom (Northern Ireland)> under the following names:	3	No	NAP/MRP/DCP	No	Use ellipsis beside 6. Contents of the pack and other information
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.	3	Yes	CAP/NAP/MRP/DCP	No	Included by default
Other sources of information	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 6. Contents of the pack and other information
The following information is intended for healthcare professionals only:	3	No	CAP/NAP/MRP/DCP	No	Use ellipsis beside 6. Contents of the pack and other information

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

Date of revision of the text

The date should not be entered in ePI, as the date may not be known at the time of finalisation 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 Template at the Referentials Management System

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:

& → & or &
< → < or <
> → > or >
" → " or "
' → ' 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 bottom 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 'Import FHIR: 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.

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 '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 title as stated in the .xml file and the associated document type (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.

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.

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 RMS code (see 'Quality Review of Documents Product Information Template' list at the Referentials Management System),
- 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 FHIR profile error where the Bundle identifier element is missing:

You can find a list of possible validation errors below. Check the error details for a description of the error. Refer to the location to find the error in your .xml file.

Error code	Error message example	Description	Solution
Extracting ePI documents from files
	“No file uploaded”	Your file is empty or does not contain a bundle of type collection or document	Select a file to upload that contains content and is of type bundle collection or document
	“File not found”	File has not uploaded successfully	Retry the file selection process
	“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
	“Uploaded file is not an XML file”	Your file is not XML format	Verify your file is an XML file
	“Invalid document type RMS code”	You have at least one incorrect RMS code for the document type	Verify you are referencing the valid RMS codes for the
	“Document title required”	Your composition does not contain a document title while this is required	Add a document title to your composition
FHIR profile validation
Invalid	"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.
Required	"Element 'meta' must appear at least once."	Your element appears less frequently than required in the profile.	Add the required element at the indicated location.
Structure	Encountered unrecognized element 'unexpectedElement'	Your element is not allowed in the profile but unexpectedly appears.	Remove the unexpected element at the indicated location.
Structure	Element 'identifier' is not permitted to repeat At Bundle.identifier	Your element appears more frequently than allowed by the profile.	Remove the abundant element at the indicated location.
Type	"Element 'identifier.value' must be of type 'string', but found 'integer'."	Your element uses a data type different from what is defined in the profile.	Correct the data type to the data type defined in the profile.
Pattern	"Element 'id' does not match the required pattern '[A-Za-z0-9\-\.]{1,64}'."	Your element does not match the regular expression defined in the profile.	Correct the pattern to the regular expression defined in the profile.
Invalid	"Element 'lastUpdated' must be a valid date-time format."	Your element does not conform to its required format.	Correct the format to the required format defined in the profile.
Invalid	"Reference 'invalidReferenceFormat' is not a valid reference."	Your reference does not follow the correct format.	Correct the reference as defined in the profile.
Reference	"Reference 'urn:uuid:nonexistent' could not be resolved."	Your reference does not exist or cannot be accessed.	Change to a valid reference.
Invariant	"Constraint 'inv-1' failed: 'Bundle.identifier.exists()'."	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
Invalid	“Value 'en' does not match pattern 'es'”	The language value in the your file does not match the language you are importing	Verify you are importing the correct language; language selected on the Manage ePI page and language value of your file must coincide
Invalid	“Instance count is 0, which is not within the specified cardinality of 1..1”	Your XML document is missing a mandatory section as defined by the QRD template.	Add the missing section to your XML file.
Invalid	"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 xml document are not in the correct order as defined by the QRD template.	Put the sections in the correct order.
Invalid	"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.
Unsafe content validation
Invalid	"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.
Invalid	"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.
Invalid	"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.
Invalid	"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 }.

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Keywords: epi, user guide, applicant manager, epi applicant managers, electronic product information, contributor

ePI - User Guide for Applicants

Purpose and context

Visibility of ePIs

Navigate the ePI portal

Create ePI

1) Select ePI details

2) Add Co-Author

3) Manage ePI

4) Link PMS ID

5) Finalisation

ePI list

ePI statuses

Filter for ePI

Tabs

Search

Columns

Actions

Editor

Product information documents

Mandatory, non-mandatory and additional sections

Add non-mandatory sections

Add additional sections

Rename sections

Re-order sections

Delete sections

Rich-text editor and copy/pasting from Word

Tables

Images

Summary of product characteristics

Annex II

Labelling

Package leaflet

Import FHIR

1) Select XML files

2) Validate ePI documents

3) Import ePI documents

Validation

Validation errors

Preview ePI

Preview individual ePI documents

Preview full ePI for one language

Export ePI