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Regulatory Focus™ > News Articles > It’s the Law: Recent Changes in the EU SmPC Guideline

It’s the Law: Recent Changes in the EU SmPC Guideline

Posted 01 December 2010

Product information in the EU comprises the Summary of Product Characteristics (SmPC),1 the Patient Information Leaflet (PIL) and labeling on the primary and secondary containers. The PIL contains information on the product's use written in layman's terminology. The SmPC, the prescriber's information leaflet, includes more details on product characteristics, safe and effective product use and clinical and nonclinical trial results. The SmPC is an integral part of the marketing authorization and sets out the agreed position of the medicinal product as determined during the assessment process between the Competent Authority and the applicant. It cannot be changed without approval from the Competent Authority. This article points out and discusses recent major revisions in the SmPC guideline.


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