Brazilian FDA/EMA amends its regulation to allow the practice of skinny labeling in Brazil

December 7, 2023

Brazilian FDA/EMA amends its regulation to allow the practice of skinny labeling in Brazil

On December 6, during the 20th Ordinary Public Meeting, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (called “Anvisa” in the Portuguese acronym) approved the proposal to amend Anvisa’s Rule #47/2009, which establishes requirements for drug labels. The amendment is specifically to allow skinny labeling in Brazil.

Before the amendment, labels of generics and branded generics had to have all and the same therapeutic indications of the reference-listed drug, with no exceptions permitted. The approved proposal includes paragraphs three to six into article 14 of Anvisa’s Rule #47/2009 to create the skinny labeling exception for this rule.

Paragraph third provides that marketing approval (MA) holders of generics and branded generics may exclude from their product’s labels the therapeutic indications that are subjected to patent protection or whose protection is claimed in published patent applications. Paragraphs four to six establish how the skinny labeling shall be implemented, requiring, for instance, that the label contain a note informing that therapeutic indications have been excluded and, once the patent application is rejected by the BRPTO or the patent expires, such indications must be included again in the label.

In addition, the approved proposal includes item VIII in article 16 of Anvisa’s Rule #47/2009 which determines that such changes can be implemented by MA holders in their product labels regardless of Anvisa’s prior approval.  

The approved amendment will be published in the Brazilian Federal Official Gazette in the following days and will come into force within 60 days after its publication.

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