[Professional profile and responsibility of the qualified person within the European Union]

The European Community has established a fundamental condition for opening a pharmaceutical laboratory, i.e. the designation of a qualified person having the professional profile detailed in the European Community Directive and who is responsible for implementing specific obligations. It is the final responsibility of this qualified person to release medicine on the market. Do to the importance of this person, we have analyzed his/her functions, obligations and responsibilities. The training required to fulfil the functions of a qualified person is presented. The profiles of qualified persons in the most representative European countries are discussed to demonstrate analogies and differences in national legislations and their adaptation to European Community regulations.