News | Skinny Labeling – ANVISA publishes Rule regulating the practice

On December 11, 2023, the Collegiate Board of the Brazilian Health Regulatory Agency (ANVISA) published, in the Federal Official Gazette, Rule (RDC) No. 831, regulating the practice of skinny labeling in Brazil.

The new Rule amends RDC No. 47, of September 8, 2009, and will come into force on February 6, 2024.

Among the changes, it is highlighted that the leaflets of generic and similar drugs may differ from the standard leaflets regarding specific information for each product, which must be in accordance with the pharmacotechnical characteristics approved in the registration, contained in the parts.

Furthermore, the new text of Article 14 § 3 establishes that the leaflets of generic and similar drugs may differ from their respective Standard leaflets in relation to indications protected by patent or claimed in published patent applications. In these cases, it becomes mandatory to insert the phrase “The information referring to the indications of the medicine protected by patent has been suppressed.” in the section “1. WHAT IS THIS MEDICATION INDICATED FOR?”, in the patient leaflet, and “1. INDICATIONS”, in the health professional’s leaflet.

In cases of the patent application rejection or the expiration of the letter’s patent validity period, the drugs leaflets must:

I – add the indications highlighted in Art. 14 § 3; and

II – remove the sentence indicated above.

To check RDC No. 831, please visit https://www.simoes-ip.com/wp-content/uploads/2023/12/www.simoes-ip.com-rdc-831-2023–1.pdf