CMED Resolution No. 1/2025, published in Brazil’s Official Gazette on March 31, 2025, authorizes the adjustment of prices for medicines sold in the country. The price update is already in effect and must be applied in accordance with the limits and requirements established in the regulation.
The annual adjustment is an important step to ensure a balance between access to medicines for the population and the economic sustainability of the pharmaceutical sector.
Maximum adjustment percentages
The authorized rates vary according to the level of participation of generic medicines within each therapeutic class:
- Level 1 – up to 5.06%
For classes with generic participation equal to or greater than 20% - Level 2 – up to 3.83%
For classes with generic participation between 15% and 20% - Level 3 – up to 2.60%
For classes with generic participation below 15%
These percentages must be applied to the most recent Factory Price (PF), available on the CMED price list published on Anvisa’s official portal.
Key points for companies
Correct application of the price adjustment requires attention to several regulatory obligations. The main ones include:
Submission of the Marketing Report. Submitting the report to CMED is mandatory, even for companies that choose not to apply the adjustment. Inconsistent, incomplete, or late submissions may result in fines and sanctions.
Price update and disclosure. Companies must ensure that updated prices are published in specialized media. Market prices must not exceed the official ceilings established by CMED.
Retail compliance. Pharmacies and drugstores must maintain updated price lists, available to both consumers and regulatory agencies. Transparency and alignment with official prices are essential to avoid penalties.
Importers. Companies authorized to import medicines must also submit the Marketing Report with detailed sales and billing data by presentation, as required by CMED.
Risks of non-compliance
Failure to comply with the requirements of CMED Resolution No. 1/2025 may result in:
- Administrative fines
- Warnings
- Suspension of commercialization
- Reputational damage
That’s why it’s essential to review internal processes, align pricing, regulatory, and commercial teams, and ensure timely submission of all required information.
Review your company’s compliance to avoid fines and regulatory penalties.
If your company operates in the pharmaceutical sector and needs support to properly apply the adjustment and meet CMED’s regulatory requirements, feel free to contact our team.
We’re ready to help.
