The Life Sciences and Healthcare Newsletter provides monthly information on the main topics, laws, and regulations related to the life sciences and healthcare sector in Brazil. It is an opportunity to access legal information and comments on relevant market issues.

Enjoy reading!

Demarest’s Life Sciences and Healthcare Team

This material is for informative purposes only, and should not be used for decision-making. Specific legal advice can be provided by one of our lawyers.

NEWS

Chocolate Law: new product composition and labeling rules will enter into force in May 2027

Law No. 15.404/2026, popularly known as the “Chocolate Law,” provides for:

• Definitions and characteristics of cocoa-derived products
• The minimum percentage of cocoa in chocolates
• The display of the total cocoa percentage on product labels

The law covers domestic and imported products marketed in Brazil.

Published on May 11, 2026, Law No. 15.404/2026 will take effect on May 7, 2027. It will apply to the various agents involved in the production and marketing chain of these products in the Brazilian market. The new law prohibits products with less than 35% cocoa from being named “chocolate”; such products must use another name in line with their respective category.

In addition, Law No. 15.404/2026 establishes labeling obligations so that the actual percentage of cocoa is clearly, prominently, and objectively stated on the labels. The law stipulates that the cocoa percentage must be stated on the front label, occupy at least 15% of the label, and have adequate contrast to ensure that consumers can readily identify and understand it.

See our Client Alert for more details.

PUBLISHED REGULATIONS

MEDICINES

• CM-CMED RESOLUTION No. 7/2026 – Provides for the criteria for defining prices for new products and new pharmaceutical presentations – as referred to in Article 7 of Law No. 10.742/2003 – and for the procedure for submitting the Price Information Document (DIP).
• ANVISA NORMATIVE INSTRUCTION No. 441/2026 – Establishes the pilot project for the online optimized technical evaluation (ATOL) of the Active Pharmaceutical Ingredient Dossier (DIFA) in applications for a Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA) and its changes in the Active Pharmaceutical Ingredient Registration Department (COIFA).
• ANVISA NORMATIVE INSTRUCTION No. 442/2026 – Updates the requirements of the optimized analysis procedure using the Equivalent Foreign Regulatory Authority (AREE).
• ANVISA COLLEGIATE BOARD RESOLUTION No. 1,023/2026: Provides for the update of Annex I (Lists of Narcotics, Psychotropic Drugs, Drug Precursors and Others under Special Control) of SVS/MS Ordinance No. 344, dated May 12, 1998, and amendments to ANVISA RDC No. 1.013, dated January 30, 2026and ANVISA RDC No. 1.015, dated February 2, 2026.
• CTE-CMED RESOLUTION No. 1/2026 – Provides for the new list of products to which the Price Adequacy Coefficient (CAP) will be applied and updates its value, pursuant to CM-CMED Resolution No. 3, dated March 2, 2011.
• ANVISA NORMATIVE INSTRUCTION No. 444/2026 – Updates the Reference Listed Drugs (“LMR”) in Brazil.

PROFESSIONAL BOARDS

• CFM RESOLUTION No. 2.455/2026 – Provides for the technical standards required for the evaluation, treatment, and follow-up of patients with sexual development disorders.
• CFM RESOLUTION No. 2.457/2026 – Regulates the indication, execution and follow-up of cryotherapy and high-intensity focused ultrasound (HIFU) as an alternative treatment for prostate cancer.
• CFM RESOLUTION No. 2.458/2026 – Regulates the use of phenol for medical purposes in order to ensure patient safety.
• COFFITO RESOLUTION No. 657/2026 – Establishes and approves the Flows of the Reporting Channel of the Federal Council of Physiotherapy and Occupational Therapy (COFFITO), among other provisions.
• COFFITO RESOLUTION No. 655/2026 – Approves the Policy on Gifts, Presents and Hospitality within the scope of COFFITO.
• COFFITO RESOLUTION No. 653/2026 – Approves the Code of Ethics and Conduct within the scope of COFFITO, among other measures.
• COFFITO RESOLUTION No. 654/2026 – Approves the COFFITO Ethics and Conduct Committee Bylaws.
• COFFITO RESOLUTION No. 656/2026 – Approves the Policy for Preventing and Fighting Moral and Sexual Harassment within the scope of COFFITO.

CLINICAL RESEARCH

• GM/MS ORDINANCE No. 11.028/2026  – Provides for the National Clinical Research Program (PPClin) within the scope of the Brazilian Unified Healthcare System (SUS).
• RDC ANVISA No. 1.022/2026 – Amends Collegiate Board Resolution No. 997/2025 to establish that the deadline for compliance with requirements issued by Anvisa will be 60 days, counted from the date the interested party takes notice of the requirement.
• RESOLUTION – RCI MS/INAEP No. 2/2026 – Provides, on a transitional basis, for the procedures and requirements for the accreditation of Research Ethics Committees within the scope of the National System of Ethics in Research with Human Subjects.
• MS/INAEP ORDER No. 3/2026 – Provides for the single opinion system of the Single Ethical Opinion and Competence, the separation between Ethical and Administrative Analysis, Residual Competences and Local Monitoring, Transparency, and the Informed Consent Form (ICF).

HEALTH OVERSIGHT

• Ordinance No. 543/2026 – Establishes the Technical Chamber for Biovigilance (CATEBIO), pursuant to Ordinance No. 693/2020.

HEALTHCARE

• GM/MS ORDINANCE No. 11.179/2026 – Updates the National Registry of Healthcare Establishments (CNES), changes attributes of procedures, and establishes a financial increase for Specialized Treatment procedures in Nephrology within the SUS Table of Procedures, Medicines, Orthoses, Prostheses, and Special Materials.
• LAW No. 15.413/2026 – Amends the Statute of Children and Adolescents to ensure access to mental health programs promoted by SUS for preventing and treating mental health issues.

SUPPLEMENTARY HEALTH

• ANS ADMINISTRATIVE RESOLUTION No. 89, DATED MAY 18, 2026 – Provides for the establishment, organization, and processing of the Special Audit Proceeding (TCE) within the scope of the ANS, as well as its submission to Brazil’s Federal Court of Accounts (TCU).

PUBLIC CONSULTATIONS

• ANVISA/MS PUBLIC CONSULTATION No. 1,394/2026 – Proposed establishment of authorized technological functions, maximum limits, and conditions of use for food additives and processing aids.
  Deadline for submissions: July 7, 2026/
• CMED/SCMED PUBLIC CONSULTATION No. 2/2026 – Proposed grouping of pharmaceutical forms that have the same therapeutic indications, routes of administration, and forms of medicine release, for the purpose of medicine pricing.
  Deadline for submissions: July 27, 2026
• ANS PUBLIC CONSULTATION No. 170/2026 – Proposed normative resolution on contracting between private healthcare plan operators and healthcare service providers.
  Deadline for submissions: July 3, 2026