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The Brazilian Health Regulatory Agency (Portuguese: Agência Nacional de Vigilância Sanitária, Anvisa, literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during President Fernando Henrique Cardoso's term of office.
The Brazilian Controlled Drugs and Substances Act (Portuguese: Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial), officially Portaria nº 344/1998, [1] is Brazil's federal drug control statute, issued by the Ministry of Health through its National Health Surveillance Agency (Anvisa).
The Brazilian Nonproprietary Name or DCB, from the Portuguese Denominação Comum Brasileira is the official Portuguese nomenclature for drugs or active ingredients that have been approved by the Brazilian Health Regulatory Agency (ANVISA) for use in Brazil. [1] [2] The consolidated list from October 2021 contains just over 12,300 items. [3]
Therapeutic goods in Brazil are regulated by the Ministry of Health of Brazil, through its Brazilian Health Regulatory Agency (Anvisa), equivalent to the US Food and Drug Administration. There are six main categories: [citation needed]
The 2009 Brazilian Federal Law 11.903 and subsequent regulations of the National Agency for Sanitary Surveillance in Brazil (ANVISA) require that a 2D data matrix code be put on all secondary packaging. Under these provisions, manufacturers will be required to maintain a database of all transactions from manufacturing to dispensing, while ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Agency for Medicinal Products and Medical Devices of Croatia Agencija za lijekove i medicinske proizvode (HALMED) 2016 Cyprus: Pharmaceutical Services (CyPHS) 2008 Czech Republic: State Institute for Drug Control Státní Ústav pro Kontrolu Léčiv (SÚKL) Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM) 1997 2005 ...
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