Electronic product information for human medicines in the EU: key principles

On 29 January 2020 the EMA published the key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the EU.

The key principles describe the benefits ePI can deliver for public health and the efficiencies it may introduce in regulatory procedures. They explain how ePI will comply with the existing legislative framework: it will be provided as open access information that complements the paper package leaflet. They also outline a flexible, harmonised approach to implementation across the EU, and describe how ePI will work in the EU’s multilingual environment and will interact with other ongoing digital initiatives at EU and global level.

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