EMA Guidance: Electronic product information (ePI) submission during centralised procedures

Sharan Murugan
44 minutes ago
5 min read

As medicines move toward electronic formats, accurate and up-to-date product information is increasingly important. The European Medicines Agency (EMA) has issued guidance, "Electronic product information (ePI) submission during centralised procedures," explaining how applicants should submit, create, update, and maintain electronic product information (ePI) for centrally authorised medicinal products.

The guidance provides practical instructions for managing ePI through the Product Lifecycle Management (PLM) Portal and explains how ePI should be handled alongside product information submitted in the electronic Common Technical Document (eCTD) during different regulatory procedures.

Understanding the Scope of ePI

The guidance applies to ePI for centrally authorised medicinal products. ePI covers Annex I, Annex II, Annex IIIA (labelling), and Annex IIIB (package leaflet) and does not include the other annexes to the European Commission Decision.

During the voluntary phase, ePI can be submitted in English, while translations into EU languages, including Icelandic and Norwegian, are optional. Submission of ePI in all languages is expected to become mandatory in the future. Once published, applicants are responsible for keeping the ePI aligned with the latest approved product information throughout subsequent procedures.

ePI and eCTD Product Information

Submitting ePI does not replace the requirement to submit product information in the eCTD.

Applicants must continue to provide the complete product information annexes in the required Word and PDF formats within the eSubmission package and relevant eCTD sequence. For marketing authorisation applications, applicants are also highly recommended to include the Word product information exported from the PLM Portal in the working documents folder.

When Should ePI Be Submitted?

The timing of ePI submission depends on the type of regulatory procedure.

For a marketing authorisation application, the English ePI is submitted with the procedure application, while the updated ePI in all languages is submitted with the final product information translations.

For Type IA/IAIN, Type IB without linguistic review, Article 61(3) without linguistic review, and transfers of marketing authorisation, ePI is submitted with the procedure application.

For other post-authorisation procedures involving linguistic review, ePI is submitted with the final product information translations.

For grouped submissions, applicants should follow the ePI requirements applicable to the highest variation included in the group.

Requirements for ePI Submission

An ePI is considered submitted when it is in Submitted status in the PLM Portal, its content corresponds to the final Annexes I, II, IIIA, and IIIB, and the relevant procedure number is entered when known.

An exception applies to marketing authorisation applications, where the ePI may remain in Draft status at the initial submission stage.

If changes to product information are required following assessment, applicants must update the ePI, move it to Submitted status at the required timepoint, and provide the EPI ID through the appropriate eSubmission or IRIS Industry Portal process.

Linking ePI to the Authorisation Medicinal Product

Each ePI is linked to a specific authorisation medicinal product and Marketing Authorisation number. When an ePI is updated through regulatory procedures, a new version with a new EPI ID is created.

Before submission, applicants must link the ePI to the correct authorisation medicinal product in the PLM Portal. An ePI cannot be moved to Submitted status unless this link has been established.

The procedure number should also be entered as soon as it becomes known. An ePI without at least one procedure number will not be published by the Agency.

Creating and Updating ePI

An ePI can be created for the first time during a marketing authorisation application or for an authorised medicine during a post-authorisation procedure.

For a new marketing authorisation, the ePI should be completed and kept in Draft status at initial eCTD submission, with content identical to the product information in eCTD Module 1. Following a favourable outcome, it should be updated according to the final product information and moved to Submitted status with the final translations.

For an authorised medicine without an existing ePI, it can be created during a post-authorisation procedure affecting the product information.

In specific circumstances, an ePI may also be created outside a regulatory procedure when no suitable procedure is expected within the following six months. This requires prior EMA agreement, and the ePI must follow the latest approved product information and corresponding QRD template version.

Managing ePI Updates

When a published ePI is affected by a post-authorisation procedure, applicants must create a new version using the Update existing ePI option in the PLM Portal. This ensures correct ePI versioning.

Changes from several procedures concluding at the same time may be consolidated into one ePI, with all relevant procedure numbers included.

For grouped variations and worksharing procedures involving several products, the ePI of each affected medicine must be updated and the appropriate procedure number recorded.

If an updated version of a published ePI is not submitted when required, the regulator may move the existing ePI to Archived status to prevent outdated information from remaining available.

Suspensions and Transfers of Marketing Authorisation

During a suspension, if an ePI has not been published, no action is required until the procedure concludes. If suspension is the final outcome, any Submitted ePI must be moved to Deactivated status within 15 working days of the CHMP Opinion.

Published ePIs remain published during a suspension.

For a transfer of marketing authorisation, the transferor and transferee have specific responsibilities for maintaining the ePI. The transferor creates a new ePI based on the published version, while the transferee designates a responsible contact person. After the Commission Decision granting the transfer, the Agency publishes the ePI associated with the transferee.

Name Changes, Withdrawal, and Refusal

Changes to the invented name of a medicine are handled through the relevant regulatory procedure. Applicants must update the name throughout the ePI, including relevant package leaflet headings and document names.

For withdrawal of a marketing authorisation application or post-authorisation procedure, related Submitted ePIs must generally be moved to Deactivated status within 15 working days after notification. Previously published ePIs remain available in the ePI repository.

For refusal, relevant ePIs must generally be moved to Deactivated status within 15 working days after the applicable unfavourable opinion. If re-examination is requested, the ePI may remain in its existing status pending the outcome.

Correcting Errors in ePI

If an unpublished ePI contains an error, applicants can correct it using the web-based text editor or import the correct content through FHIR import. An ePI in Submitted status must first be moved to Draft before editing.

For an ePI that has already been published or archived, the applicant should first contact the relevant product team, with corrections following the process used for the corresponding Word/PDF product information.

By following the defined submission timepoints, maintaining correct product links and procedure numbers, and keeping ePI aligned with approved product information, applicants can support consistent management of electronic product information throughout the lifecycle of centrally authorised medicines.