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European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet for medicinal products

14 April 2017

Focus on Regulation

The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report identifies shortcomings concerning the SmPC and the PIL, and provides recommendations on the way in which SmPC and PIL could be improved.

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