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Skinny Labeling is approved by ANVISA 

By: Silvia Costa

December 18, 2023

As published in the Federal Official Gazette No. 234, of December 11, 2023, the new Ordinance (RDC) No. 831, of December 6, 2023 establishes changes in the regulations on medicine labels, including the possibility of removing patented uses from generics labels, previously not allowed. Such changes will be effective from February 6, 2024. 

From that date onwards, generic, and similar medicines will be permitted to adopt labels different from their respective standard labels, especially regarding indications protected by patents or claimed in published patent applications. This will be possible due to the approval by the ANVISA Collegiate Board of Directors of the modification of article 14 of RDC No. 47/2009, which previously prohibited labels for generic and similar drugs from being different from the respective standard label. Now, such labels may differ, especially when it comes to therapeutic indications protected by patents. 

The inclusion of the passage “Information referring to patent-protected indications of the medicine has been suppressed” in bold type becomes mandatory in the patient’s label and in the healthcare professional’s label, making clear the removal of the therapeutic indication protected by patent. Within 90 days of publication of entry into the public domain (patent expired, rejected or annulled), such passage must be removed and the previously suppressed therapeutic indications will be introduced in the new label.

While the changes provide positive opportunities for generic and similar manufacturers seeking to diversify their therapeutic indications, it is crucial to highlight that the adoption of “skinny labeling” can directly influence the effectiveness of applying second-use patents, since the new rule makes more difficult to highlight possible infringements.

By leaving open aspects such as the supervision of sales for the specific therapeutic indication and control of medical prescriptions, which currently do not mention the therapeutic indication, the perspective is that the implementation of the new resolution will result in an increase in the judicialization of cases related to this matter.

We are available to clarify any doubts on this topic by contacting brj@clarkemodet.com.br  

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