Plans For EU Electronic Product Information Move Up A Gear
Stakeholder agreement on the technical features of electronic product information (ePI) will pave the way for launching a proof-of-concept exercise and a roadmap on how ePI will be rolled out in the EU.
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The adoption of a new common standard opens the way to the implementation of EU-wide electronic formats for documents such as the summary of product characteristics and the patient information leaflet.
The coordination group for EU mutual recognition and decentralized procedures is inviting stakeholder feedback on its priorities for the coming years.
EU regulators have adopted key principles for using electronic product information for human medicines, which are now expected to be followed by all parties involved in developing and implementing ePI.