Life Sciences and Healthcare Newsletter | June 2025

The Life Sciences and Healthcare Newsletter brings information and news on the key issues and recent legislation related to the life sciences and healthcare sector in Brazil. This initiative encompasses transactional and regulatory industry matters and invites all market players to access relevant news of the sector and our comments on such topics.

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.

MAIN NEWS

Brazilian Congress overturns veto on Clinical Trials Law

On June 17, 2025, the Brazilian Congress overturned a presidential veto to a provision in the Clinical Trials Law (Law No. 14,874/24) that authorized the discontinuation of post-study supply to clinical trial subjects five years after the investigational medicine becomes available in Brazil (item VI, article 33).

The presidential veto imposed an indefinite obligation on sponsors of clinical trials to continue supplying medication, significantly reducing Brazil’s attractiveness for conducting innovative clinical trials. With the veto overturned, study sponsors may discontinue post-trial supply five years after the medicine becomes available in Brazil.

This veto’s rejection reinforces a commitment to advancing clinical trials in Brazil, establishing a necessary balance to attract investment in the research and development of innovative medicines in the country.

For more information, access our brochure on the new Clinical Trials Law.

Brazil’s Congress approves health registration waiver for artisanal cosmetics

Law No. 15.154/24, published on July 01, 2025, establishes simplified rules and a health registration waiver for artisanal cosmetics, personal hygiene products, perfumes, and comparable products.

The measure amends Law No. 6,360/76 to reduce red tape in the artisan sector, consequently stimulating entrepreneurship and the legitimization of small-scale producers. The approved wording of the new law waives registration of these products with the Brazilian Health Regulatory Agency (ANVISA), provided that they comply with the technical and safety criteria that ANVISA will establish.

For more information, please access the full report.

ANVISA issues new resolution to modernize health control in foreign trade

On June 5, 2025, ANVISA published Resolution No. 977, which establishes a new regulatory framework for the administrative control of goods and products subject to health oversight in foreign trade.

The new regulation provides for the following administrative procedures:

• Monitoring of foreign trade operations;
• Import or export authorization through licenses, permits, certificates, and other documents (LPCO);
• Health inspection; and
• Import or export ban.

The authorization may be granted for one or multiple operations, which must only be conducted within the LPCO term. A new LPCO will be required if the document is expired at the time of filing the import or export declaration.

The resolution also provides for the phased implementation of a health inspection process by gradually replacing the former Import License (LI) with the Unique Import Declaration (DUIMP).

For more information, please access the full resolution.

Ministry of Health sets out new radiotherapy expansion plan in SUS

On June 18, 2025, the Ministry of Health published GM/MS Ordinance No. 7,007/2025, which changes GM/MS Consolidation Ordinance No. 5/2017, to establish the II Radiotherapy Expansion Plan for the Brazilian Unified Health System (PERSUS II), under Brazil’s New Growth Acceleration Program (PAC).

PERSUS II aims to broaden and improve access to cancer treatment by replacing outdated radiotherapy equipment, installing new equipment in empty bunkers, and coordinating projects aligned with the technological demands of the Brazilian Unified Health System (SUS).

Public or private non-profit healthcare facilities with a valid Social Assistance Beneficent Entity Certification (CEBAS) may adhere to the plan, provided they are qualified as a High-Complexity Oncology Care Center (CACON), High-Complexity Oncology Care Unit (UNACON) or Hospital Complex Radiotherapy Service.

For-profit institutions, without a valid CEBAS, or those that already benefit from other Ministry of Health programs that supply radiotherapy equipment are excluded from PERSUS II.

Equipment will be supplied under an agreement providing for obligations such as:

• Appropriate structuring of the bunker within six months;
• Guarantee of human and technical resources;
• Equipment maintenance after the warranty expires; and
• Service provision to society.

The initiative reinforces the Brazilian government’s commitment to improving access to cancer treatment, renovating hospital infrastructure, and reducing regional inequalities within SUS through public-private partnerships.

For more information, please access the full ordinance.

SUS adopts amniotic membrane transplant to treat burns

On June 23, 2025, the Ministry of Health published SECTICS/MS Ordinance No. 46/25, publicizing the decision to incorporate amniotic membrane transplant into the treatment of skin burns through SUS.

The measure expands the availability of innovative regenerative therapies within SUS, as part of a recent set of innovations in the National Transplant System.

An amniotic membrane is a tissue collected during childbirth, upon informed consent, which can be used as a biological dressing to treat burns. The membrane works as a protective barrier against infectious agents and can reduce the formation of scars and keloids.

According to the General Coordinator of the National Transplant System, Patrícia Freire, this new therapy humanizes burn treatment and will be included for the first time in the National Transplant System’s Technical Regulation. Technical departments must provide the procedure in the public healthcare system within 180 days. In September, the National Transplant System will publish a new technical regulation to establish donation criteria.

For more information, please access the full report.

PUBLISHED REGULATIONS

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA)

RDC No. 981/25: Updates Collegiate Board Resolution No. 768, dated December 12, 2022; Collegiate Board Resolution No. 770, dated December 12, 2022; Collegiate Board Resolution No. 576, dated November 11, 2021; and Collegiate Board Resolution No. 721, dated July 1, 2022.

RDC No. 980/25: Updates Item III of Article 1 of ANVISA Collegiate Board Resolution No. 953, dated December 13, 2024, published in the Federal Official Gazette of Brazil No. 240-B, in December 13, 2024, Section 2, p. 1, replaced by the following: “III. Interim Director Frederico Augusto de Abreu Fernandes: Third Office, and” (new wording)

RDC No. 979/25: Updates Collegiate Board Resolution No. 88, dated June 29, 2016, which approves the technical regulation on cellulosic materials, packaging, and equipment intended to come into contact with food, among other provisions.

RDC No. 978/25: Provides for the operation of services that perform activities related to clinical analyses.

RDC No. 977/25: Provides for ANVISA’s administrative control in foreign trade involving goods and products subject to health oversight.

RDC No. 976/25: Establishes health requirements for infant formulas, specialized formulas for high-risk newborns, transitional foods and cereal-based foods for infants and children in early childhood, enteral nutrition formulas, and dietary supplements to address inborn errors of metabolism.

IN No. 374/25: Updates Normative Instruction No. 200, dated December 12, 2022.

IN No. 373/25: Updates Normative Instruction No. 28, dated July 26, 2018, which establishes the lists of ingredients, limits of use, alleged benefits, and supplementary labeling of food supplements.

IN No. 372/25: Provides for the inclusion of the monograph of active ingredient O22 – OOENCYRTUS SUBMETALLICUS in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published Normative Instruction No. 103, of October 19, 2021.

IN No. 371/25: Provides for the inclusion of the monograph of active ingredients in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published Normative Instruction No. 103, of October 19, 2021.

IN No. 370/25: Updates Normative Instruction No. 211, dated March 01, 2023, which establishes the technological functions, limits, and conditions of use for authorized food additives and processing co-formulants.

IN No. 369/25: amends Normative Instruction No. 211, dated March 01, 2023, which establishes the technological functions, limits, and conditions of use for authorized food additives and processing co-formulants.

IN No. 368/25: Amends Normative Instruction No. 281, dated February 22, 2024, which established the procedure and necessary documentation to bring different food and packaging categories in line with the regulation.

IN No. 367/25: Establishes lists of ingredients, limits of use, and authorized claims for infant formulas, specialized formulas for high-risk newborns, transitional foods and cereal-based foods for infants and children in early childhood, enteral nutrition formulas, and dietary supplements to address inborn errors of metabolism.

NATIONAL SUPPLEMENTARY HEALTHCARE AGENCY (“ANS”):

RN No. 635/25: Updates Normative Resolution (RN) No. 465, of February 24, 2021, which provides for the list of mandatory health events and procedures in supplementary healthcare, to regulate the mandatory coverage of immunobiological medicine tildrakizumabe, for treating moderate to severe psoriasis in adults that are eligible to systemic therapy or phototherapy, in compliance with the provisions of paragraphs 4, 7 and 8 of Article 10 of Law No. 9,656/1998.

RN No. 636/25: Provides for the transfer between private healthcare plan operators and the ANS of data files related to the Technical Note for Product Registration (NTRP) and the Collective Plan Adjustment Notices (RPC) through the File Transmission Program (PTA).

RN No. 637/25 Updates Normative Resolution No. 465, dated February 24, 2021, which provides for the list of mandatory health events and procedures in supplementary health, to update the mandatory coverage of the medicine romiplostim for treating children, adolescents, and adults with primary immune thrombocytopenic purpura (ITP) (refractory, chronic, or corticosteroid-dependent), related to the procedure “OUTPATIENT INJECTABLE MEDICINE THERAPY (WITH USE GUIDELINES); and to update the mandatory coverage of the procedure “STOOL PANCREATIC ELASTASE (WITH USE GUIDELINES)” to establish mandatory coverage for the diagnosis of Exocrine Pancreatic Insufficiency (EPI) in individuals regardless of underlying health conditions, in compliance with paragraphs 4 and 10 of Article 10 of Law No. 9,656/1998

RN No. 638/25: Updates Normative Resolution No. 623, dated December 17, 2024, which establishes rules for private healthcare plan operators and benefit administrators in coverage requests submitted by beneficiaries (either healthcare-related or not), in any type of contract.

DEPARTMENT OF SCIENCE, TECHNOLOGY AND INNOVATION AND OF THE ECONOMIC-INDUSTRIAL HEALTHCARE COMPLEX (SECTICS)

SECTICS Ordinance No. 16/25: Publicizes the decision to expand the use of positron emission tomography-computed tomography (PET-CT) within SUS for staging patients with locally advanced esophageal carcinoma that is not known to be metastatic (after inconclusive CT results).

SECTICS Ordinance No. 17/25: Publicizes the decision to incorporate Methotrexate into SUS for patients with moderate to severe atopic dermatitis, in compliance with the Clinical Protocol of the Ministry of Health.

SECTICS Ordinance No. 18/25: Publicizes the decision to incorporate 0.1% Mometasone Furoate into SUS for treating patients with atopic dermatitis, in compliance with the Clinical Protocol of the Ministry of Health.

BRAZILIAN FEDERAL MEDICINE COUNCIL (“CFM”):

CFM Resolution No. 2433/25: Repeals CREMER Resolutions 7/2024, 8/2024 and 8/2025.

CFM Resolution No. 2432/25: Extends the administrative intervention by the CFM in the Regional Council of Medicine of the state of Rio de Janeiro, and appoints the members of the provisional intervention board, among other provisions.

CFM Resolution No. 2431/25: Repeals N°SEI-6 Resolution of the Regional Council of Medicine of the State of Rio Grande do Sul (CREMERS), dated March 12, 2025.

SOCIAL PARTICIPATION

ANVISA Public Consultation No. 1335/25: To receive contributions on the proposed normative instruction that updates 21 monographs of active ingredients of pesticides, disinfesting sanitizers and wood preservatives, published in Normative Instruction No. 103, dated October 19, 2021: A12 – ASULAM, A60 – ABSCISIC ACID, B26 – BIFENTHRIN, B55 – EMAMECTIN BENZOATE, C07 – KASUGAMYCIN, C32 – CLETHODIM, C36 – CYPROCONAZOLE, D36 – DIFENOCONAZOLE, F69 – FLUPYRADIFURONE, G01 – GLYPHOSATE, G05 – GLUFOSINATE-AMMONIUM, H07 – HALOXYFOP-P-METHYL, I21 – INDOXACARB, I30 – IMPIRFLUXAM, I32 – ISOCYCLOSERAM, M32 – METHOXYFENOZIDE, P34 – PYRIPROXYFEN, P50 – PICOXYSTROBIN, P69 – PINOXADEN, S16 – SAFLUFENACIL, and S17 – SOPHORA FLAVESCENS.

Contribution deadline: August 16, 2025

ANVISA Public Consultation No. 1336/25: To obtain contributions on the proposed normative instruction that excludes citrus corps from monograph I19 – Imazalil, in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in Normative Instruction No. 103, dated October 19, 2021.

Contribution deadline: August 16, 2025

ANVISA Public Consultation No. 1337/25: To obtain contributions on the proposed normative instruction that updates monograph M47 – Melaleuca Alternifolia, in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in Normative Instruction No. 103, dated October 19, 2021.

Contribution deadline: August 29, 2025