Anvisa’s Board of Directors approved the opening of a Public Consultation to propose authorization for the skinny label practice
At the last meeting of 2022, held on December 22, Anvisa’s Board of Directors approved a Public Consultation to amend Resolution-RDC 47/2009 – which sets forth rules for the elaboration, harmonization, updating, publication, and availability of labels of medicines for patients and health care professionals.
The proposed revision seeks to exclusively amend art. 14 of RDC 47/2009 to the following wording:
Art. 14.
§1 The labels for generic and branded generic drugs may differ from the respective label of the reference listed drug in the specific information for each product that must comply with the pharmacotechnical characteristics approved in the registration contained in the parts.
(…)
§3 In addition to the items mentioned in the previous paragraph, labels for generic and branded generic drugs may differ from the label of the reference listed drug (RLD) in relation to the therapeutic indications protected by patent.
The proposal aims to accept the skinny label practice. This exception already exists in other markets, which consists of the authorization for generic and branded drugs to enter the markets by excluding therapeutic indications under patent protection from their labels to avoid patent infringement.
A regulatory impact analysis did not precede the proposal mentioned above. The Reporting Director of the proposal informed that the legal opinions that analyzed the measure’s legality would also be disclosed with the public consultation.
Our Life Sciences & Healthcare team will monitor the publication of the draft submitted to Public Consultation and publish a new client alert on the subject. In the meantime, we are available via email: lifesciences@soutocorrea.com.br.
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