In this paper the new procedures for the marketing authorisation are considered from the point of the view of their influence on the medicinal product presentation (labelling and package leaflet), dispensing and distribution. The legal status of some active ingredients in different countries as well as the situation in the Italian domestic market have been analysed. Even if the European directive is completely implemented, the harmonisation process appears difficult in consideration of the different social, political and economical characteristics of the different countries, and is going to cover many years.