REGULATORY STATUS OF MEDICINAL PRODUCTS FOR HUMAN-BEINGS IN THE EUROPEAN-UNION - THE ROLE OF GENERIC PRODUCTS

In this paper the definition and classification of medicinal products are discussed. Medicinal products from a regulatory and administrative point of view can be classified as: proprietary medicinal products (c opy and new drugs), other medicinal products of industrial origin and, magistral and officinal formulas prepared by pharmacies (also called 'generic products'). The term 'generic product' becomes relevant only when the economic impact of medicinal products is considered. The form al characteristics of medicaments, as well as the different possible p roducers (industry or pharmacy) will be considered also in relation to the interchangeability of medicaments and the role of generic product s. (C) 1996 The Italian Pharmacological Society