Module 6

04/10/2024

Product Information

What is the Product Information?

Documents providing officially approved information for healthcare professionals and patients on a medicine. ● Annex I – Summary of Product Characteristics ● Annex II – reflects the CHMP opinion on conditions and specific obligations ● Annex IIIA – Labelling ● Annex IIIB – Patient Leaflet EMA provides guidance and templates to provide marketing authorisation applicants with practical advice on how to draw up the product information for human medicines Product Information templates – defines format and layout with guidance on content, developed by EMA’s working group on Quality Review of Documents (QRD) – currently Version 10.4 Resides in Module 1.3.1 of the eCTD

The Organisation for Professionals in Regulatory Affairs

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Electronic Product Information (ePI)

• ePI refers to the authorised, statutory product information for medicines (including the SmPC, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print. • Transitioning to ePI offers advantages such as improved accessibility , searchability and multilingual capabilities. • ePI can integrate with electronic healthcare systems , enabling healthcare professionals and patients to access accurate and up-to-date product information more conveniently.

The Organisation for Professionals in Regulatory Affairs

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