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 offic...

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Bibliographic Details
Published inPharmacological research Vol. 34; no. 1; pp. 3 - 7
Main Author MINGHETTI, P.
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier Ltd 01.07.1996
Subjects
definition of medicinal product
Drugs, Generic - standards
European Union
generic products
Humans
Legislation, Drug
medicinal administrative classification
Pharmaceutical Preparations - standards
Quality Control
Therapeutic Equivalency
medicinal administrative classification
generic products
definition of medicinal product
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Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
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ISSN:1043-6618
1096-1186
DOI:10.1006/phrs.1996.0055