Brazilian FDA calls for contributions on the possibility of allowing skinny labeling in Brazil

December 29, 2022

On December 28th, the Brazilian Food & Drug Agency (called “Anvisa” in the Portuguese acronym) published a call for comments (#1,137 of 2022) on its proposal to amend its Board of Director's Rule #47 of 2009, whereby an exemption will be made, allowing generics and branded generics (called also “similar”) to omit patented uses in their labels.

As of now, skinny labeling is illegal in Brazil since current legislation requires that generic and branded generics must have all and the same therapeutic indications as their reference-listed drug.

Article 14 of Rule #47 of 2009 sets that labels for generics and branded generics must be in line with that of the reference-listed drug (which is considered the “Standard Label”). In addition, its first paragraph establishes exactly which pieces of information may differ, always product-specific, such as the drug's identification and its MA holder's identification, storage precautions and shelf life. The amendment proposal, which is now subjected to public consultation, is to include a third paragraph in Article 14 creating the following exemption: “labels of generics and branded generics may differ from their Standard Label with respect to patented therapeutic indications”.

This first official step taken by Anvisa is probably a result from previous discussion with Generics-based companies, which were already unlawfuly omitting patented uses from their drugs' labels by simply filing their labels without the patented therapeutic indication before the Agency.  

Anvisa's Board of Directors seems to have recognized the need to change its label regulation, thus, unanimously approving during the 24th Ordinary Public Meeting, held on December 22, 2022, the call for contributions, as per the vote of Reporting Director Meiruze Freitas (Vote #291 of 20221).

The call will have a 60-day period, ending on March 6th, 2023. Comments must be sent through an electronic form available at the Agency's website (link). Foreign companies may physically file their comments at Anvisa's headquarters in Brasilia.

For more information on the subject, please e-mail us at info@lickslegal.com.

1 Portuguese version available at: link.