Disclaimer
This Frequently Asked Questions (FAQs) document is for information only and is based on frequently asked questions during the Quarterly System Demos on 28/09/2022, 21/12/2022 and 22/03/2023. Nothing in this document should be taken as an explicit commitment on behalf of the EMA, or the ePI product teams.
For convenience, many technical terms are explained in the table of abbreviations at the beginning of this document.
For general inquiries, please contact the ePI team via ePI@ema.europa.eu. For questions or comments around the content of this Q&A document, please raise a ticket via the EMA Service Desk.
Table of Contents
- What is ePI?
- What are the Key Principles for ePI?
- What is the EU ePI Common Standard?
- What is the ePI pilot project?
- When does the ePI pilot take place?
- Who can participate in the pilot and which procedures are involved?
- Who coordinates the pilot?
- What is an MVP?
- What are the functionalities of the MVP?
- What is the ePI authoring tool?
- How long does it take to create an ePI?
- What happens after creating the ePI in the pilot?
- What happens after the ePI is published in the pilot?
- How will the pilot be evaluated?
- What are the advanced features that will be developed in future?
- Where can I get more information about the ePI Pilot?
- When and how will ePI be implemented by EMA and the national competent authorities?
- Does ePI also cover veterinary medicinal products?
- How does ePI link to SPOR?
- How will ePI connect to the electronic application form (eAF)?
- How will legacy product information be handled in the context of ePI?
Acronym key and glossary terms
| AEMPS | Agencia Española de Medicamentos y Productos Sanitarios |
| API | Application Programming Interface |
| DKMA | Danish Medicines Agency |
| eAF | Electronic Application Form |
| ePI | Electronic Product Information |
| eCTD | Electronic Common Technical Document |
| EEA | European Economic Area |
| EMA | European Medicines Agency |
| EU | European Union |
| FAQs | Frequently Asked Questions |
| FHIR | Fast Healthcare Interoperability Resources |
| HMA | Heads of Medicines Agencies |
| KPI | Key Performance Indicators |
| MPA | Swedish Medical Products Agency |
| MEB | Medicines Evaluation Board |
| MVP | Minimum Viable Product |
| NCA | National Competent Authority |
| OMS | Organisation Management Services |
| PLM | Product Lifecycle Management |
| PMS | Product Management Services |
| RMS | Referentials Management Services |
| SPOR | Management Services for Substances, Products, Organisations and Referentials |
Electronic product information (ePI) refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print. In certain procedures, Annex II of the marketing authorisation (manufacturer(s) responsible for batch release, conditions and requirements of the marketing authorisation, other conditions or restrictions as applicable) is provided electronically in the ePI.
2 - What are the Key Principles for ePI?
In 2020, EMA, the Heads of Medicines Agencies (HMA) and European Commission published key principles to guide the development and use of ePI for human medicines in the EU.
They outline how ePI:
- Benefits public health
- Creates efficiency gains for regulatory systems
- Aligns with the existing legislative framework and complements the paper package leaflet
- Fits into the EU’s multilingual environment
- Interacts with other ongoing digital initiatives at EU and global level
3 - What is the EU ePI Common Standard?
The EU ePI Common Standard is a standard developed and adopted by the EU Network Data Board on behalf of the European Medicines Regulatory Network. It can enable user-friendly, multilingual ePI linked to SPOR master data system.
4 - What is the ePI pilot project?
The ePI pilot project runs throughout 2022-2024 and will develop tools and guidance to pilot the use of ePI prior to implementation. Using a minimum viable product (MVP), it envisages the initial introduction of ePI at the beginning (creation of ePI prior to submission) and end (publication via API) of the evaluation process. At a later stage, ePI can be integrated end-to-end into the procedure management.
5 - When does the ePI pilot take place?
The pilot takes place between July 2023 and July 2024.
6 - Who can participate in the pilot and which procedures are involved?
Pharmaceutical companies are participating in the ePI pilot. The procedures that are piloted primarily consist of variations, and they are selected by the medicines agencies involved in the pilot.
7 - Who coordinates the pilot?
The medicines agencies that coordinate the pilot include:
- European Medicines Agency
- Agencia Española de Medicamentos y Productos Sanitarios - AEMPS (Spain)
- Medicines Evaluation Board – MEB (The Netherlands)
- Läkemedelsverket (Sweden)
- Lægemiddelstyrelsen (Denmark)
Each of the medicines agencies will carry out their own pilot.
MVP stands for Minimum Viable Product. It is a version of a product with just enough features to be usable by early adopters who can then provide feedback for future product development.
9 - What are the functionalities of the MVP?
The MVP consists of an ePI authoring tool, repository and application programming interface, and associated guidance and business processes. Functionalities include:
- Rich text editing
- Adding a co-author
- Preview
- Duplication of ePI documents
- Export to Word
- Export to FHIR
- Publish via an application programming interface (API)
10 - What is the ePI authoring tool?
The ePI authoring tool is accessible via the Product Lifecycle Management (PLM) portal. However, ePI roles are currently only available to pilot participants. The ePI authoring tool facilitates the creation of ePI by the applicant using a rich text editor. The EU ePI Common Standard serves as the basis for the ePI.
11 - How long does it take to create an ePI?
The time needed to create an ePI in the PLM portal is expected to be similar to other methods of creating electronic product information in use by medicines information providers today. During the pilot, the time taken to create an ePI will be measured.
12 - What happens after creating the ePI in the pilot?
After creating the ePI, an export to Word can be carried out. Provision of ePI does not negate the requirement to submit product information annexes in eCTD. The relevant complete set of product information annexes must be submitted in Word and PDF formats in the eCTD sequence and working documents folder as described in the post-authorisation guidance. During the pilot, the ePI format is not assessed, and it is the responsibility of the applicant to ensure that, at the end of the procedure, the ePI is identical in content to the final PI in Word and PDF formats.
Following approval of (the changes to) the product information, the ePI is updated by the applicant in accordance with the approved version. The updated version of the ePI is subsequently published by the agency.
13 - What happens after the ePI is published in the pilot?
The ePI is then stored in a FHIR repository and made available for dissemination via the ePI API.
14 - How will the pilot be evaluated?
The pilot will be evaluated according to key performance indicators (KPIs). The KPIs will measure the usability of the tools and guidance as well as the impact of ePI creation and publishing on the regulatory procedures processes. The findings will be compiled in a report and will be used to plan ePI implementation.
15 - What are the advanced features that will be developed in future?
Functionalities to be developed in future development for implementation will be informed by pilot outcomes and stakeholder needs.
16 - Where can I get more information about the ePI Pilot?
Please contact the participating agencies for more information about the ePI Pilot:
- European Medicines Agency – EMA (EU): Elizabeth Scanlan, epi@ema.europa.eu
- Spanish Agency of Medicines and Medical Devices – AEMPS (Spain): Evinn Drusys, efoster_externo@aemps.eu
- Medicines Evaluation Board – MEB (The Netherlands): Erol Hofmans, epi@cbg-meb.nl
- Swedish Medical Products Agency – MPA (Sweden)Läkemedelsverket: Kim Sherwood, kim.sherwood@lakemedelsverket.se
- Danish Medicines Agency – DKMA (Denmark) Lægemiddelstyrelsen: Claus Bo Jorgensen, clbj@dkma.dk
17 - When and how will ePI be implemented by EMA and the national competent authorities?
All stakeholders, including pharmaceutical companies and regulators, are expected to commit to implementation of the common electronic standard for creation of ePI for all EU medicines. However, timelines and processes for implementation will be flexible and amenable to the available resources and priorities at national level.
Some early-adopter Member States may begin using ePI for their authorised medicines, whereas other Member States may have different priorities for implementation.
Support and flexibility in implementation for stakeholders including NCAs and in consultation with pharmaceutical companies will also be considered.
Flexible implementation should also include planning for conversion of existing PIs of authorised medicines to the new ePI format. This could be incorporated into post-authorisation procedures.
While some flexibility will apply for timelines for implementation, the EU regulatory network will all take a harmonised approach for ePI across the EU using the EU ePI Common Standard.
18 - Does ePI also cover veterinary medicinal products?
The current scope of this work is all human medicines authorised in the EU and EEA. However, the EU ePI Common Standard can also be applied in future to product information of veterinary medicines.
19 - How does ePI link to SPOR?
In the MVP, SPOR is used for aspects such as product information section headings (RMS), marketing authorisation holder and competent authority (OMS).
The objective is to fully maximise the use of SPOR data; in the MVP this will however not yet be the case. A stepwise approach is taken as per the Agile methodology.
20 - How will ePI connect to the electronic application form (eAF)?
The objective is to maximise the synergies with ePI and eAF, which are part of the same Project Lifecycle Management value stream. This is already evidenced by the sharing of the Product Lifecycle Management (PLM) portal.
21 - How will legacy product information be handled in the context of ePI?
ePI can be created by the applicant in the context of a variation, using the ePI authoring portal. Once ePI is implemented, the objective is to support strategies to ensure a significant proportion of ePIs will be achieved in a reasonable timeframe to maximise the realisation of the benefits of ePI.