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
There are two main entry points to managing ePI:
- ePI list: use the dropdown option on the top banner to access your ePI list and edit an ePI that has already been created.
- New ePI: use the dropdown option on the top banner (or the tile on the PLM Portal homepage or the '+ Create New ePI' button on the ePI list) to create an ePI either from a blank template or from an existing ePI. This option is visible to users with the ePI Applicant Manager role.
Tooltips are available and can be viewed by hovering your mouse wherever you see this symbol:
Users with the ePI Applicant Manager role can create ePI.
After logging on to the PLM portal, click on 'New ePI', either on the ePI tile on the homepage or using the dropdown menu (top right).
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 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).
- 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'. - 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.
- If NAP is selected:
- 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.
- export ePI to Word and FHIR formats
- preview ePI and
- upload ePI in FHIR format.
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 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.
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.
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.
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
Add content to sections by authoring using the editor's toolbar, which enables a range of editing options, and/or by copy/pasting from Word documents.
Text and tables copy/pasted from Word keep their original formatting by default.
Note: Hyperlinks inserted in text do not work in the editor, but will work in the 'Preview' and when exported to Word or FHIR ePI.
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.
Colour cells of a table using 'Table > Cell > Cell properties' from the 'Table' dropdown and selecting 'Advanced' and 'Background color'.
Enter images using 'Insert > Image...' from the editor toolbar. Images should not 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.
Error messages "Some images failed to import" or "unsupported image type" may be encountered when entering images of unsupported file types in ePI.
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.
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 |
Creating outer and inner labels
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.
Additional outer labels can be added by clicking the ellipsis to the right of the document name and selecting:
- Duplicate Label or
- Add another Label
Inner labels 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'.
Additional inner labels 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.
Label 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.
Preview individual ePI documents
- 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 document preview is displayed.
Preview full ePI for one language
- Select the language on the 'Manage ePI' page and click 'Preview' at the bottom of the page.
- A new tab opens and the ePI preview is displayed.
ePI can only be in exported one language at a time. To export ePI:
- In the 'ePI list', for an ePI in any given status, select 'View/Manage ePI' or 'View ePI'.
- On the 'Manage ePI' page, select the language and click 'Export' at the bottom of the page.
- In the 'Export' window, select whether you wish to export:
- in FHIR format,
- in Word, all documents in one file with title pages (as required for submission to EMA) or
- in Word, each document in a separate file (as required for submission to NCAs).
Note: It is only possible to export one format at a time.
- Select your option and click 'Export'. The ePI is exported to your local downloads folder.
To upload ePI in FHIR format, it is currently required to use a FHIR ePI created in the portal as basis for the imported FHIR:
- Create ePI.
- Export ePI in FHIR format in the required language(s).
- The exported FHIR ePI can be edited as required and prepared for import.
- From the 'Manage ePI' page, select the language for import.
- Click on 'Upload FHIR' and locate and select the file to upload.
- A banner appears at the top of the page informing you when the ePI is successfully uploaded/when uploading has failed.