Report in accordance with Article 59(4) of Directive 2001/83/EC on the Community code relating to medicinal products for human use

The summary of product characteristics and the package leaflet form an intrinsic and integral part of the marketing authorisation for medicinal products in the Union in accordance with Article 6 of Directive 2001/83/EC and Article 3 of Regulation (EC) 726/2004. Article 8(3)(j) of the Directive and Article 6(1) of the Regulation require that, in order to obtain a marketing authorisation, a summary of product characteristics and a package leaflet must be included in the marketing authorisation application.

The summary of product characteristics is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. It is not in the remit of the summary to give general advice on the treatment of particular medical conditions. On the other hand specific aspects of the treatment related to use of the medicinal product or its effects should be mentioned in the summary. Similarly, general advice on administration procedures should not be included but any advice specific to the concerned medicinal product should be included.

The package leaflet provides a set of comprehensible information enabling the use of the medicinal product safely and appropriately. The package leaflet is primarily intended for the patient/user. If the package leaflet is well designed and clearly worded, this maximises the number of people who can use the information, including older children and adolescents, the elderly, those with poor literacy skills and those with some degree of sight loss.

This report is prepared pursuant to Article 59(4) of Directive 2001/83/EC according to which the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals.