Standardize and Harmonize Product Information with Fonto: Advancing the ePI Initiative

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In the ever-evolving landscape of pharmaceutical regulations and information management, the need to standardize and harmonize product information has become increasingly crucial. At the forefront of this movement is the Swedish Medical Products Agency, Läkemedelsverket, which has recently made significant strides with their ePI (electronic Product Information) Proof of Concept. In this post, we’re sharing …

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Update on national pilot study for pharmaceutical companies creating ePI

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In 2022, the Swedish Medical Products Agency (Swedish MPA) selected Fonto as the editor of choice for the creation of electronic structured SmPC’s. Over the past few months, the Swedish MPA has developed an XML template adapted for Fonto. Electronic product information In a Proof-of-Concept model, information elements are divided into categories depending on the …

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Swedish Medical Products Agency selects Fonto

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Hurra! Fonto has been selected as the XML editor of choice by the Swedish Medical Products Agency (Swedish MPA) for a national pilot study for pharmaceutical companies creating ePI.  Electronic Product Information (ePI) ePI refers to the authorized, statutory product information for medicines (including the Summary of Product Characteristics, Package leaflet and labelling) adapted for …

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