Regulatory Focus™ > News Articles > Brazil: Risk Management Plans Shouldn't Prevent Drug Access for Generic Companies

Brazil: Risk Management Plans Shouldn't Prevent Drug Access for Generic Companies

Posted 18 June 2012 | By Ansis Helmanis

A proposed new standard that defines the criteria for inclusion and exclusion of drugs in list of drugs used as the reference drugs by generics (Reference Listed Drug) was adopted by the Board of Brazil's national regulatory agency, Anvisa, on 14 June.

A key provision of the proposal would require the reference drug manufacturer to provide the drug for purchase by a generic company. The purpose of the provision is to ensure that generic companies can obtain the drug in order to conduct the bioequivalence testing needed for the registration of a generic version of the reference drug.

Generic companies now run into problems obtaining such drugs that are restricted to hospital use or are distributed only in specific programs.


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Anvisa - Health product may have the instruction manual online

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