Abstract
Even if a specific directive has been approved many years ago, the situation of self-medication products (OTC) in EU countries is still far from being harmonized. In Italy the market is lower than that of most other countries; in order to solve some of the major problems that led to this situation a guideline, concerning the criteria for the definition of an OTC product, and the characteristics of the label and the package leaflet, was recently published. In this document the characteristics of OTC, such as composition, indications and duration of the treatment are assessed. The European Commission has recently published a guideline on the readability of labels and package leaflets of medicinal products for human use. The two documents stated the same principles and the Italian document is in agreement with the European guidelines. In this paper the Italian situation of OTC products (definition and presentation) is presented and discussed.
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