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Regulatory Focus™ > News Articles > Brazil: Anvisa Publishes New Reference Product Proposal

Brazil: Anvisa Publishes New Reference Product Proposal

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: 

Group A for medicines that contain only one active pharmaceutical ingredient;
Group B for medicines that contain two or more active ingredients in a single dosage form; and
Group C for products containing two or more active ingredients in the same or different dosage forms.

Drugs that have been withdrawn from the market or have safety, efficacy or quality concerns will be excluded from the List.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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