Read all of this leaflet carefully. It contains important information about preparing your organisation for ePI implementation.
Keep the QR code for accessing your electronic leaflet. You may need to read it again as your ePI journey progresses.
If you need further information or support, contact Billev Pharma East.
The Future of Product Information Starts Here
Europe is transforming how medicinal Product Information is created, managed and shared.
Electronic Product Information (ePI) is authorised Product Information adapted for handling in electronic format and dissemination via the web, e-platforms and other channels. It includes the SmPC, Package Leaflet and labelling.
Built on the EU ePI Common Standard and HL7 FHIR, ePI introduces a structured, machine-readable digital layer to Product Information while complementing existing formats.
What ePI can enable
Digital healthcare integration
Enable Product Information to connect with the wider digital healthcare ecosystem.
ePI is more than a new format. It represents a fundamental shift from document-based regulatory content to structured regulatory data.
Do not delay ePI implementation if:
Warnings and precautions
Preparing for ePI involves more than introducing new technology. Before implementation, consider how the change will affect your Product Information, regulatory processes, systems and teams.
Consider how Product Information is currently:
Existing document-based workflows may need to be adapted to support structured Product Information.
Assess whether your current technology and system landscape can support structured Product Information and evolving ePI processes.
ePI implementation may affect Regulatory Affairs, Labelling, IT, Medical, Translation and other functions. Responsibilities, governance and ways of working should be defined before implementation begins.
Late preparation may lead to:
An early ePI readiness assessment can help identify gaps in your content, technology, processes and internal capabilities before they become implementation barriers.
Before selecting or implementing an ePI solution, make sure you understand your current level of readiness and the changes required across your organisation.
Before you start
Assess your current situation, including:
This will help identify gaps that should be addressed before implementation.
Plan your implementation
Based on the results of your readiness assessment:
Do not select an ePI solution before understanding what your organisation actually needs.
Selecting the right ePI solution
Choose a solution that fits your organisation, rather than adapting your organisation to a particular technology.
Consider whether the solution supports your:
Independent, vendor-neutral assessment can help ensure that technology decisions are based on your regulatory and operational requirements.
Preparing your Product Information
Once the appropriate approach and technology are in place, existing Product Information will need to be prepared for structured use.
This may include:
After implementation
Do not treat ePI as a one-time conversion exercise.
Integrate ePI into your existing regulatory lifecycle so that future variations, translations, Product Information updates, submissions and other regulatory changes can be managed consistently.
If additional expertise or capacity is required, Billev Pharma East can support individual activities or your complete ePI journey — from readiness assessment and planning to implementation, validation and lifecycle support.
Delaying preparation for ePI may make the transition more complex and place additional pressure on your organisation.
The following effects may occur if preparation starts too late:
Increased implementation pressure
Product Information and process challenges
Technology-related challenges
Loss of control over implementation
Starting too late may leave less flexibility to determine your preferred implementation approach, allocate resources and introduce changes according to your own priorities.
Instead of following a planned roadmap, your organisation may need to respond to external timelines and regulatory developments as they arise.
What to do if these effects occur
Do not panic. Contact Billev Pharma East.
An ePI readiness assessment can help determine your current position, identify critical gaps and define the actions needed to move forward.
Early preparation can help keep your ePI transition manageable, planned and under control.
The ePI regulatory, technical and implementation environment continues to evolve.
Monitor relevant EMA and HMA developments and assess whether changes require updates to your processes, systems or ways of working.
Do not treat ePI as a one-time conversion.
After initial implementation, make sure that your processes continue to support changes to Product Information and the corresponding structured content.
Keep your Product Information up to date
When Product Information changes:
Maintain your processes and systems
Regularly review whether your ePI operating model continues to support your regulatory activities.
This includes:
Follow regulatory and technical developments
ePI requirements, guidance and supporting systems continue to evolve. Monitor relevant EMA and HMA developments and assess whether changes require updates to your processes, systems or ways of working.
Keep your organisation ePI-ready
Your ePI process should support the complete lifecycle:
Regulatory change → Product Information update → Structured content → Review and validation → Submission → Publication → Lifecycle maintenance
Review your ePI readiness periodically and address new gaps as your portfolio, regulatory requirements and technology evolve.
If you need support maintaining your ePI processes, Billev Pharma East can provide ongoing regulatory, technical and lifecycle support.
ePI expertise at the source
Katja Pečjak Reven, M.Sc. Pharm.
Industry Subject Matter Expert for the EMA/HMA ePI Project since 2022
Billev Pharma East brings first-hand industry insight into the evolving European ePI environment, combined with practical regulatory and implementation expertise.
Through Katja Pečjak Reven’s role as an Industry Subject Matter Expert and her long-standing involvement in European ePI initiatives, our team understands both the regulatory direction of ePI and the practical implications for pharmaceutical companies preparing for implementation.
What Billev Pharma East provides
Billev Pharma East provides independent, vendor-neutral support tailored to your organisation’s current level of ePI readiness, portfolio, processes and internal capabilities.
Support can be provided for individual activities or throughout your complete ePI journey.
Readiness and strategy
Selection and implementation
Execution and lifecycle
Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202
1000 Ljubljana
Slovenia
We do not sell an ePI software platform. Our recommendations are based on your portfolio, processes, systems and regulatory needs — not on a specific technology solution.
More than 17 years of regulatory consulting experience across 50+ countries, combined with extensive experience in regulatory digitalisation and Product Information.
We help translate ePI requirements into practical processes, responsibilities and implementation activities that work within your organisation.
Whether you need targeted expertise for a specific activity or support throughout the complete transition, Billev Pharma East can assist from initial readiness assessment and strategic planning through implementation, execution and ongoing lifecycle management.
With a focus on expert guidance and strategic insights, we propel your projects forward with confidence, ensuring every step is handled with precision.
Regulatory Affairs
Pharmacovigilance
Medical Consultancy
Medical Affairs
Quality/GxP
Digital Consultancy
Medical Devices and In Vitro Diagnostics
