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 (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.
Minghetti
P
P
Istituto di Chimica Farmaceuticae Tossicologica, Milano, Italy.
D016568:Drugs, Generic / Q000592:standards*; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D013810:Therapeutic Equivalency
D016568:Drugs, Generic; D004364:Pharmaceutical Preparations