title: [Generics: authorization to market and quality guarantees].
abstract: The act of July 3, 1969, concerning the registration of drugs includes the European Directive, more specifically for the generic, the definition using three axes of comparison as essentially similar to the original registered drug. This definition invites comments, e.g. on the pharmaceutical and therapeutic quality of the generic drug. The promotion of generics in Europe necessarily implies a better quality control that would give the generic an identical label as the reference drug.
authors.forename: J A
authors.initials: JA
authors.lastname: De Muylder
mesh_terms: D001530:Belgium; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic / Q000737:chemistry / Q000494:pharmacology / Q000592:standards* / Q000600:supply & distribution; D005060:Europe; D005062:European Union; D006801:Humans; D011786:Quality Control; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic