GENERIC MEDICINES REGULATION IN BRAZIL
Abstract
The regulation of medicines in Brazil has proven to be one of the major concerns of government policies in recent decades. In order to improve access to quality medicines for the population, the National Drug Policy was instituted, culminating in the creation of the National Health Surveillance Agency (ANVISA) and the implementation of generic medicines policy.
The generic medicines was effectively introduced in Brazil with the publication of the Law nº 9.787 in 1999, resulting from an objective of the Ministry of Health to significantly reduce the costs of pharmacological therapy, stimulate commercial competition and facilitate the population's access to drug treatment. In the same year the resolution no 391/1999 regarding the technical requirements for the registration of generics in Brazil was published. Since 1999, several legislation has been published in order to regulate the generic policy in Brazil.
The present article summarises the legal framework for the implementation of the generic medicines in Brazil. It also describes the current technical requirements and legislation for the registration and maintenance of the register of generics in Brazil, according to ANVISA.
Keywords:
Generic drugs, Legislation, ANVISA, Registration, Technical requirements, Dossier.
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References
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http://portal.anvisa.gov.br/medicamentos-genericos-registrados
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47. BRASIL. Resolution of the collegiate board of ANVISA nº 96/2008. Official Diary of the Union; 2008 Dec 18 [Cited 2017 Aug 20]. Available from:
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Cardoso, P. A. “GENERIC MEDICINES REGULATION IN BRAZIL”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 3, Sept. 2017, pp. 1-9, doi:10.22270/ijdra.v5i3.201.
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