Module 6

04/10/2024

Electronic Product Information (ePI) cont.

• EMA and a group of EU national competent authorities tested the use of ePI in a one year pilot project from July 2023 to July 2024. The pilot has concluded. Its achievements include: • Enabling companies to create and manage ePIs during regulatory procedures by using an ePI authoring tool on the Product Lifecycle Management Portal

• Making ePIs created during the pilot publicly available on the portal and via an application programming interface (API)

• The pilot covered both centralised and national regulatory procedures.

• Participating countries included Denmark, the Netherlands, Spain and Sweden.

Note: EU guidance documents already permit mobile scanning and other technologies (including QR codes) to be added to packs. An exception was also granted for COVID-19 vaccines which allowed the leaflet to be printed in English only and a QR code provided (either on the carton and leaflet or via a separate card) linking to national translations of the PIL

The Organisation for Professionals in Regulatory Affairs

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Summary of Product Characteristics (SmPC)

What is the SmPC? ● Basis of information for healthcare professionals on how to use the medicinal product safely and effectively ● Legal document that sets out the agreed position of the medicinal product as distilled during the course of the assessment period ● Must be included to obtain a marketing authorisation ● Scientific assessment should evaluate how the SmPC will optimise the benefits and manage the risks ● Content cannot be changed except with the approval of the originating competent authority

The Organisation for Professionals in Regulatory Affairs

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