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Posted 25 June 2012 | By Ansis Helmanis,
Brazil's National Health Surveillance Agency (ANVISA) published a new proposed rule on medicines used as reference products for generic equivalents (RDC No. 35/12) on 19 June 2012.
According to the proposal, the List of Reference Medicines shall consist of three groups of drugs:
Drugs that have been withdrawn from the market or have safety, efficacy or quality concerns will be excluded from the List.
RDC No. 35/12
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Tags: Generic, pharmaceutical, brazil, drug, Biosimilars, Biologics
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