Electronic Product Information (ePI)
In a world that is evolving into a more and more digitalized world, the need for electronic product information is also growing. Nowadays, the latest approved versions of Product Information (PI) are already available on websites of national regulatory authorities and the European Medicines Agency. But what if the product information could be even more up to date, by having it available in an electronic format so that it can be adjusted directly when needed?
This might be closer than you think. The Dutch Medicines Evaluation Board (MEB) has started a pilot last month in cooperation with EMA and other national competent authorities from Denmark, Spain and Sweden to enable the use of electronic Product Information for human medicines in the European Union. During this pilot, participating companies will draft the PI in electronic format, which will be evaluated by the MEB. Afterwards, the PI will be available for publication on websites, apps and health care information systems.
The advantages of ePI are various. Apart from having it adjusted and available for health care professionals and patients sooner, the ePI can also be adjusted to personal needs of an individual patient. In addition, ePI will make the product information more accessible to patients who are blind or partially sighted by having the text read aloud thanks to the electronic structure. But also, searchability and multilingual capabilities will improve with ePI.
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