Preparatory activities are continuing in anticipation of the submission and publication of electronic product information (ePI), including electronic package leaflets and other product information documents, as part of the broader implementation of the new European pharmaceutical legislation.
The European Medicines Agency (EMA) has published guidance on the procedures to be followed for ePI relating to centrally authorised products. The guidance applies exclusively to applications submitted after the planned implementation “go-live” date (see the implementation roadmap). EMA emphasizes that this new guidance does not replace any of the regulatory documents currently in force.
Key guidance on ePI submission and publication
Electronic Product Information (ePI) encompasses the Summary of Product Characteristics (SmPC), labelling, and the package leaflet. For centrally authorised medicinal products, submission of these documents in electronic format will remain voluntary until the new Directive on medicinal products for human use becomes fully applicable. During this transitional phase, ePI may be submitted in English, while submission in other EU languages, as well as Icelandic and Norwegian, remains optional. This situation may change in the future, with mandatory submission of ePI in all relevant languages. Once published, electronic product information must be kept aligned with the latest approved version under the responsibility of the applicant.
EMA’s guidance provides instructions on when ePI should be submitted through the Product Lifecycle Management (PLM) Portal, in parallel with the various regulatory procedures affecting a medicinal product throughout its lifecycle. It also highlights that electronic product information, including any subsequent versions, is always linked exclusively to the product’s marketing authorisation number. The connection between the ePI and the medicinal product authorisation must be established through the PLM Portal before ePI submission. The guidance then describes the entire process through to publication of the ePI. Specific recommendations are also provided for small and medium-sized enterprises (SMEs) submitting ePI as applicants.
Creation and update of electronic product information
A dedicated section is devoted to the initial creation of electronic product information, both within the context of a new marketing authorisation application and for products that have already been authorised. The guidance also explains the process for updating ePI following its initial publication and outlines how different post-authorisation procedures may affect those updates. Finally, the document provides guidance on the management of ePI in cases involving suspension, transfer, withdrawal, or refusal of a marketing authorisation, as well as changes to a medicinal product’s brand name.
 has published guidance on the procedures to be followed for ePI relating to centrally authorised products){kind=link}