Part of the marketing authorisation of a medicinal product setting out the agreed position of the product as distilled during the course of the assessment process which includes the information described in Article 11 of Directive 2001/83/EC. It is the basis of information for healthcare professionals on how to use the product safely and effectively. The package leaflet is drawn in accordance with the summary of product characteristics (based on A Guideline on Summary of Product Characteristics, Volume 2C of the Rules Governing Medicinal Products in the EU Rev 2). GVP Annex I - Definitions (Rev 5)