On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow generics and branded generics (also called “similar” drugs) to remove patented uses from their labels – i.e., skinny labeling. The change will come into effect 60 days after the amended text of Rule No. 47/2009 is published in the Federal Register.
The Brazilian Federal legislation does not allow skinny label or carve out (per article 3 of Law #6,360 of 1976) as it clearly establishes that a generic or similar (branded generic) must have the same therapeutic indications as the reference drug (i.e., both are a “drug is that which contains the same active ingredient or ingredients and that has the same concentration, pharmaceutical form, administration route, posology and therapeutic indication and is equivalent to the drug already registered with the Food and Drug Agency, permitted to differ only in characteristics relative to size and form of the product, expiration date, packaging, excipients and vehicles“)…
