January 12, 2026

The Drug Market Regulation Chamber (CMED) has published Public Consultation Notice #1/2026 in the Federal Register of January 8, 2026. The Public Consultation seeks to collect comments and suggestions on the text of the proposed Rule for setting and adjusting drug prices in sales made to the government for court-ordered supplies of medicines.
The proposed Rule defines the following criteria for setting maximum sales prices of medicines for the Government in such cases, always applying the lowest price among them:
Furthermore, if a medication is incorporated only by a specific state or municipal government, the price of such incorporation will replace the reference price for incorporation into SUS by the MoH, following CONITEC’s recommendation.
However, when the court-ordered purchase is conducted through a bidding process, the only applicable criterion will be the PMVG limit in effect at the time of the bid. In other words, for bidding processes, even if justified to meet a legal demand, a bidder may offer a price up to the PMVG limit, regardless of the government's historical median purchase prices or the Conitec-recommended incorporation price.
Finally, the proposed Rule provides that the maximum price foreseen must be verified at the time the court-ordered medication purchase is fulfilled and must be updated according to the maximum percentages of annual adjustments authorized by CMED Council’s Rules.
Interested parties may submit their suggestions using the form available on the Anvisa’s website within 60 days, starting from the 7th day after the publication of the notice, i.e., between January 15, 2026 and March 16, 2026.
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