CMED and Brazilian Tax Reform: consultation period opened for contributions to the list of medicines subject to a zero rate

In brief

On Friday, July 3, the Brazilian Drug Market Regulation Chamber (“CMED”) held a meeting with the regulated sector to present the progress made and the outlook for the implementation of Supplementary Law No. 214/2025 (“LC No. 214/2025”), with emphasis on the opening of a period for contributions to the preparation of the preliminary list of medicines that will be entitled to a zero rate of the Tax on Goods and Services (“IBS”) and the Contribution on Goods and Services (“CBS”).

In more detail

LC No. 214/2025 provides for a zero rate on medicines deemed priority, namely those intended for rare diseases, neglected diseases, oncology, diabetes, HIV/AIDS and other sexually transmitted infections (“STIs”), cardiovascular diseases, and for the Brazilian Popular Pharmacy Program (Programa Farmácia Popular do Brasil) or equivalent. Under the legislation, a joint act of the Ministry of Finance and the IBS Managing Committee (“CGIBS”), after consultation with the Ministry of Health, will release, every 120 days, the list of medicines subject to a zero IBS and CBS rate.

During the meeting, CMED reiterated that the criterion for inclusion in the list of medicines subject to a zero IBS and CBS rate will follow the lines of care set forth in Article 146 of LC No. 214/2025, and confirmed that pharmaceutical companies may take part in preparing the list, under the following guidelines:

• CMED provided industry associations with an Excel spreadsheet containing the information required to prepare the list. The requested data are: (i) manufacturer; (ii) National Corporate Taxpayer Registry (“CNPJ”); (iii) trade name; (iv) active ingredient; (v) therapeutic class (as classified by the Brazilian Health Regulatory Agency – Anvisa); (vi) line of care; (vii) product presentation; (viii) marketing authorization number; (ix) marketing authorization expiration date; and (x) 13-digit European Article Number (“EAN”).
• Manufacturers must send their respective industry associations the information on products that, in their view, fall within the regime of Article 146 of LC No. 214/2025.
• The industry associations, in turn, must submit the consolidated spreadsheet to the Ministry of Health by August 7, 2026, via e-mail to cgpr.decis@saude.gov.br.

CMED further clarified that the information provided by manufacturers will undergo a validation process by the Ministry of Health, the Brazilian Federal Revenue Service (RFB), and CGIBS, meaning that submitting the data does not guarantee that the medicine will be included in the list to be released.

The positions reported above are preliminary and may change until the guidelines are definitively consolidated by CMED and the other authorities involved.