Minghetti P
Istituto di Chimica Farmaceuticae Tossicologica, Milano, Italy.
Pharmacol Res. 1996 Jul-Aug;34(1-2):3-7. doi: 10.1006/phrs.1996.0055.
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 (copy 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 formal characteristics of medicaments, as well as the different possible producers (industry or pharmacy) will be considered also in relation to the interchangeability of medicaments and the role of generic products.
本文讨论了药品的定义和分类。从监管和行政角度来看，药品可分为：专利药品（仿制药和新药）、其他工业来源药品以及药店配制的法定和药用配方（也称为“通用产品”）。只有在考虑药品的经济影响时，“通用产品”一词才有意义。还将结合药品的可互换性和通用产品的作用，考虑药品的形式特征以及不同的可能生产商（工业或药店）。
