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edited by AIFA’s Office of Osmed and HTA


The legal basis for the summary of product characteristics is contained in Article 8(3)(j) of Directive 2001/83/EC and Article 6(1) of Regulation (EC) 726/2004. It is stated that in order to obtain a marketing authorisation, an application must contain a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC. For decisions concerning centralised marketing authorisations, the SmPC forms part of the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP). According to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC is addressed and notified to the Marketing Authorisation Holder. In accordance with Directive 2001/83/EC, when the marketing authorisation is issued the competent authorities of the Member States concerned shall inform the Marketing Authorisation Holder of the SmPC that was approved. The SmPC is part of the Product Information (PI) which comprises of the SmPC, the manufacturing authorization holder responsible for batch release, conditions of the marketing authorization, labeling and Package Leaflet (PL). The Package Leaflet (PL) is drawn up in accordance with the SmPC. The SmPC has two defined roles. In the first instance, it sets out the position of the medicinal product as agreed during the course of the assessment process of the marketing authorisation application. As such, the content of the SmPC cannot be changed except with the approval of the CHMP. In a second instance, the SmPC also forms the basis of information for healthcare professionals on how to use the medicinal product safely and effectively, and relates specific advice on aspects concerned with the treatment or its side effects on the patient. It is not the remit of the SmPC to give general advice on the treatment of particular medical conditions or general advice on administration procedures. Further information on the SmPC can be found in the SmPC guideline that provides advice on the principles of presenting information in the SmPC:
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