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Medicamentos genéricos no Brasil : panorama histórico e legislação
- Source :
- Repositório Institucional da UFOP, Universidade Federal de Ouro Preto (UFOP), instacron:UFOP
- Publication Year :
- 2010
-
Abstract
- The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of implementing this policy allowed the introduction and discussion of concepts that had never before been used in the context of drug registration in Brazil: bioavailability, bioequivalence, pharmaceutical equivalence, generic drugs, biopharmaceutical classification system, biowaiver. The present article provides definitions for these concepts in the context of Brazilian legislation as well as a historical and chronological description of the implementation of the generic drugs policy in Brazil, including a list of current generic drug legislation. This article contributes to the understanding of the Brazilian generic drugs policy and facilitates the search for information concerning the legal requirements for registration of drugs in Brazil.
- Subjects :
- education.field_of_study
business.industry
Management science
media_common.quotation_subject
Population
Public Health, Environmental and Occupational Health
Historical Article
Context (language use)
Legislation
Biopharmaceutical
Disponibilidade biológica
Generic drug
Medicine
Equivalência farmacêutica
Quality (business)
business
education
Health policy
media_common
Subjects
Details
- Language :
- Portuguese
- Database :
- OpenAIRE
- Journal :
- Repositório Institucional da UFOP, Universidade Federal de Ouro Preto (UFOP), instacron:UFOP
- Accession number :
- edsair.doi.dedup.....7e12457e53a4adbbf7992fc945abfc7f