EMA: Draft Reflection Paper on Linking ePI from Medicine Packages
EMA has published a draft reflection paper on linking electronic product information (ePI) from medicine packages. This paper describes components to be put in place to realise an EU-wide solution in which ePI could be easily accessed by citizens wherever they are in Europe, in their preferred language when available.
Development of electronic product information (ePI) for EU human medicines, compliant with a harmonised EU ePI Common Standard, is ongoing by the European Medicines Regulatory Network (EMRN) in collaboration with stakeholders. In the coming years, ePI will be created and updated for EU medicines as part of routine regulatory procedures.
This reflection paper calls on stakeholders to take action and invest in the development of such initiative at EU level, building on and complementing existing work to implement ePI in Europe. Opportunities, limitations and other relevant considerations are outlined. In addition, some existing EU and international examples are described.
Harmonised EU-wide linking from the medicines package to ePI of EU medicines, irrespective of the marketing authorisation holder, will require cross-stakeholder collaboration to achieve development, integration and maintenance of several components, which are described in the paper.
EMA is accepting feedback on the draft until 30 June 2025.
Source:
EMA: Reflection paper on linking to electronic product information (ePI) from EU medicine packages
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