The Brazilian Drug Market Regulation Chamber (CMED) published, in the Federal Register of June 5, 2025, CMED's Rule #2, of June 3, 2025. This new rule revokes the long-standing CMED's Rule #3 of July 29, 2003, and establishes a fully revised Internal Regulation governing the structure and procedures of CMED.

Among the most relevant updates, the new framework formalizes the regulation of so-called “omissive cases,” which refer to pricing requests that do not fall into the previously defined categories. In such cases, decisions issued by CMED's Executive Secretariat will be subject to mandatory review by the Technical-Executive Committee, if the regulated company submits no appeal. Although the company continues to have the right to appeal, this new provision institutes a procedure that allows for a second-layer review without requiring action from the regulated party.  

Also, if the Committee's decision results in a lower price than the one initially established, the company may file a request for reconsideration, which will be analyzed with devolutive effect. When a price decision is upheld following an appeal or reconsideration, the amount will be corrected using the annual adjustment indices set out in Law #10,742/2003, referring to the period in which the proceeding was under review, thereby mitigating potential losses resulting from regulatory delays.

The new rule also improves participation rights of the private companies on the pricing proceeding, by formally recognizing the right to request pre-submission meetings and technical hearings during the review of pricing dossiers. In addition, companies may request oral arguments before the Committee, which must be granted if requested at least one business day before the session. These procedural guarantees are accompanied by the establishment of binding deadlines for decisions: 120 days for appeals and mandatory reviews in pricing procedures, and 180 days for sanctioning proceedings. This introduces a level of predictability that was lacking under the previous regime.

In sum, CMED's Rule #2/2025 represents a structural improvement in CMED's regulatory stance, with a strong emphasis on procedural regularity, more rights of participation, and greater predictability for companies subject to price regulation.

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