Argentina recognises Brazilian reference substances, requires BA/BE studies
This article was originally published in SRA
Argentina's National Medicines, Food and Medical Technology Administration, ANMAT, has decided to recognise a number of primary reference substances for physicochemical evaluations that are already established by the Brazilian regulatory authority, ANVISA1. The move is part of a bilateral agreement between the two regulators under the framework of Mercosur, the trade group made up of Argentina, Brazil, Paraguay and Uruguay.
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