| Generics: what is the role of registration authorities. | |
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MedLine Citation:
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PMID: 18292608 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Substitution of branded medicines by cheaper generic medicines has been and is subject for debate in the Netherlands. One of the tasks of the Dutch Medicines Evaluation Board (CBG) is the evaluation of generic medicines. The way the CBG approves generics, as outlined in this paper, is based on assessment of the quality of the medicine and bioequivalence testing according to strict European guidelines. Registration of generic medicines in the Netherlands will only take place when bioequivalence has been demonstrated. Once bioequivalence has been demonstrated, the CBG is convinced that the generic has the same efficacy and safety as the branded medicine. Consequently, the CBG is of the opinion that the branded medicine can be safely exchanged with the generic medicine. However, for the acceptance of generics in daily practice adequate communication to the patient by prescriber, pharmacist, health insurance company and patient organisations is essential. |
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Authors:
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C Versantvoort; M Maliepaard; F Lekkerkerker |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: The Netherlands journal of medicine Volume: 66 ISSN: 0300-2977 ISO Abbreviation: Neth J Med Publication Date: 2008 Feb |
Date Detail:
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Created Date: 2008-02-22 Completed Date: 2008-05-13 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0356133 Medline TA: Neth J Med Country: Netherlands |
Other Details:
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Languages: eng Pagination: 62-6 Citation Subset: IM |
Affiliation:
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Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen), The Hague, the Netherlands. c.versantvoort@aig.umcn.nl |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Drugs, Generic* Governing Board Netherlands Registries* |
| Chemical | |
Reg. No./Substance:
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0/Drugs, Generic |
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