Life Sciences and Healthcare Newsletter | September and October 2025

The Life Sciences and Healthcare Bulletin offers monthly updated information on the main topics, laws and standards related to the life sciences and health sector in Brazil and 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.

New law requires operational planning for medical equipment acquisition in SUS

On September 17, 2025, Law No. 15,210/2025 was published in the Federal Official Gazette of Brazil, establishing new criteria for acquiring medical equipment for tests and treatments within the Brazilian Unified Health System (“SUS”).

The law mandates that bid procedures for equipment exceeding the threshold for exemption from the tender must consider proper utilization and equipment lifespan.

Additionally, the bidding notice must:

• Demonstrate installed capacity to operate the equipment; or
• Present a plan to meet operational requirements.

Four provisions from the original bill were vetoed:

• Mandatory proof of budget adequacy for equipment maintenance and operation;
• Mandatory contracting of maintenance and repair services for the first five years;
• Schedules for training or hiring qualified personnel to operate the equipment;
• Liability for non-compliance with requirements.

The veto rationale stated that such obligations could increase the complexity of bid procedures and compromise the provision of healthcare services, particularly in cities with limited administrative capacity.

For more information, access Law No. 15,210/2025 in full. (PT only)

Brazilian Senate approves updated wording for bill authorizing pharmacies in supermarkets

On September 17, 2025, the Senate Committee on Social Affairs (“CAS”) approved the substitute proposal for Bill No. 2,158/2023, to propose amendments to Law No. 5,991/1973, which provides for health control in medicine commerce.

If enacted, the bill will authorize supermarkets that employ a pharmacist to sell and dispense over-the-counter medications. The proposal will now move forward to the Brazilian House of Representatives.

The amended bill establishes the following requirements for establishing pharmacies or drugstores in supermarkets:

• Dedicated and segregated space for pharmaceutical activities, with appropriate infrastructure for consultation rooms, product storage, and control of temperature, ventilation, lighting, humidity, and traceability;
• Mandatory presence of a licensed pharmacist during all operating hours, as per Law No. 13,021/2014;
• Authorization to dispense controlled substances (only after payment or transportation of the products from the counter to the payment area in a sealed, tamper-proof, and identifiable package);
• Prohibition of displaying medications in open or non-segregated areas, such as counters, stands, or shelves outside the designated pharmacy space;
• Permission to use digital channels and e-commerce platforms for logistics and delivery, provided that they comply with all applicable health regulations.

For more information, see Bill No. 2,158/2023 in full (PT only).

Brazil’s Supreme Court sets healthcare plan coverage criteria for treatments outside mandatory list

On September 18, 2025, the Federal Supreme Court (“STF”) of Brazil concluded the judgment of Direct Action for the Declaration of Unconstitutionality (ADI) No. 7,265, proposed by the National Union of Self-Managed Health Institutions (“UNIDAS”).

The action challenged the constitutionality of requiring healthcare plans to cover treatments and procedures not included in the list of the National Supplementary Health Agency (“ANS”) when there is scientific evidence of efficacy or a recommendation for incorporation by the National Commission for the Incorporation of Technologies in the Brazilian Unified Health System (“CONITEC”), as provided by Law No. 14,454/2022, which amended Law No. 9,656/1998 (“Healthcare Plans Law”).

The STF upheld the constitutionality of the law but established cumulative criteria that must be proven by the claimant to obtain coverage for procedures and treatments not listed by the ANS:

• Medical or dental prescription for the procedure or treatment;
• No express denial by ANS or pending analysis regarding inclusion of the procedure or treatment in a List Update Proposal (“PAR”);
• Lack of a suitable therapeutic alternative for the patient’s condition in the ANS list;
• High-level scientific evidence proving the efficacy and safety of the procedure or treatment;
• Registration of the procedure or treatment with the Brazilian Health Regulatory Agency (“Anvisa”), when legally required.

The STF also ruled that, when reviewing coverage requests, the Judiciary must:

• Verify any prior request to the healthcare plan operator, including denial, unreasonable delay, or omission in authorizing the non-listed treatment or procedure;
• Analyze any decision by the ANS to not include the procedure or treatment in their list. However, the Judiciary Branch may not review the technical-administrative merits of this decision.
• Consult the Judiciary Technical Support Center (“NatJus”) or technical specialists regarding the recommended procedure or treatment. However, the Judiciary Branch cannot base its decision solely on prescriptions, reports, or medical opinions presented by the party.

If coverage is granted, the Judiciary Branch must notify the ANS to assess the possibility of including the procedure or treatment in the mandatory coverage list.

For more information, please access the decision in full (PT only).

Brazilian Congress approves “Agora Tem Especialistas” program

On September 24, 2025, the Brazilian Congress approved Provisional Measure No. 1,301/2025, establishing the “Agora Tem Especialistas” Program to expand access to specialized healthcare services and reduce wait times for consultations, exams, and surgeries.

The initiative will be implemented through voluntary participation by private hospitals and practices (both non-profit and for-profit), as well as healthcare plan operators.

Key provisions include:

Services must follow SUS principles and comply with future regulations from the Minister of Health, including definitions of priority specialties and compensation values;

• Participation requires fiscal compliance with social security obligations, under penalty of exclusion;
• Accredited providers may receive financial credits up to BRL 2 billion per year to offset federal taxes, provided they meet operational requirements and waive administrative and judicial disputes;
• Credits will be used primarily to settle debts with the Federal Revenue Service and the Office of the General Counsel for the Federal Treasury;
• The program will be in effect until December 31, 2030, with penalties for non-compliance;
• The Ministry of Health will be in charge of evaluating and ensuring transparency of results.
• States, municipalities and the Federal District may hire providers accredited by the Ministry of Health, as per specific regulations.

The program will be implemented with the aim of qualifying and diversifying healthcare services offered to the population, expanding the availability of hospital beds and specialized care, and reducing waiting times for consultations, exams, and procedures.

For more information, see Provisional Measure No. 1,301/2025 in full. (PT only)

Decree regulates law on research involving human subjects and establishes the National System for Ethics in Research with Human Subjects

On October 7, 2025, Decree No. 12,651/2025 was published, regulating Law No. 14,874/2024, which provides for research involving human subjects in Brazil and establishes the National System of Ethics in Research Involving Human Subjects. 

The primary details of the new regulation are summarized as follows:

National System for Ethics in Research with Human Subjects

Decree No. 12,651/2025 appointed the Ministry of Health to structure and organize the National System of Ethics in Research with Human Subjects, which seeks to protect research participants and promote good scientific practices in the Brazilian territory.

The system is formed by the National Ethics in Research Authority and the Ethics Review Authority, which are represented by the Research Ethics Committees (“CEPs”).

Key highlights include:

• Detailed responsibilities and a multi-sectoral composition of the National Ethics in Research Body, including representatives from the Ministry of Health, National Health Council (“CNS”), Ministry of Science, Technology and Innovation (“MCTI”), Ministry of Education, Brazilian Health Regulatory Agency (“ANVISA”), National Council of State Research Foundations (“CONFAP”), and experts selected through a public tender.
• Guidelines for CEP accreditation and registration based on research risk classification, ensuring proportional procedures and distinct timeliness.
• Ethical review rules, including single-CEP review for multicenter studies with a unified protocol, and the possibility of conducting an integrated ethical and regulatory review with ANVISA.
• Prioritization criteria for studies of strategic interest to the Brazilian Unified Health System (“SUS”), with shortened review deadlines.
• Creation of a single electronic platform for research registration, submission, monitoring, and transparency, under the governance of the Ministry of Health.

Protection of research subjects

Decree No. 12,651/2025 tasks the National Ethics in Research Authority with regulating the monitoring and assistance plans for subjects in discontinued clinical trials, and with establishing guidelines for drafting, submitting, and conducting the ethical review of post-trial supply plans and programs.

Decree No. 12,651/2025 also specifies post-trial supply scenarios, requiring sponsors to provide the investigational product free of charge if the principal investigator deems it the best therapeutic option based on scientific evidence and a favorable risk-benefit assessment. Under Law No. 14,874/2024, “investigational product” encompasses investigational medicines, placebos, and comparator medicines.

Additionally, Decree No. 12,651/2025 identifies special groups that require special treatment throughout all study phases due to vulnerability or unique lifestyles, including:

• Children and adolescents
• Pregnant and lactating women
• Indigenous peoples
• Quilombola communities and other traditional peoples
• Persons deprived of liberty
• People with disabilities that impair the ability to consent

Use of human data and biological material

Under Decree No. 12,651/2025, biobanks and biorepositories will be regulated by the National Ethics in Research Authority and other competent authorities. The use of such materials must comply with applicable law and is limited to the purpose stated in the original clinical protocol, unless the informed consent form explicitly authorizes further research.

Research in the humanities and social sciences

The National Ethics in Research Authority must issue specific regulations for research in the humanities and social sciences, addressing methodological, epistemological, and sociocultural particularities, as well as individual and collective vulnerabilities. For studies classified as low risk, notification to CEPs or simplified review may be allowed, without prejudice to full compliance with ethical guidelines and the possibility of comprehensive review at any time.

Final and transitional provisions

Decree No. 12,651/2025 clarifies that:

• Existing CNS regulations remain valid, provided that they do not conflict with Law No. 14,874/2024 and Decree No. 12,651/2025, until the National Ethics in Research Authority issues new regulations.
• The National Research Ethics Commission (“CONEP”) will act as an appellate body until the new National Ethics in Research Authority members take office.
• Accredited and registered CEPs remain authorized to conduct ethical reviews until the National Ethics in Research Authority reassesses this matter.
• The Ministry of Health will establish, within 30 days, a three-month temporary working group, extendable for an equal period, to support guidelines and supplementary regulations for implementing the system.
• Funding agencies and support foundations covered by Law No. 10,973/2004 will not be considered sponsors for regulatory purposes.

For more information, see Decree No. 12,651/2025 in full. (PT only)

Ministry of Health includes pharmaceutical assistance component for oncology in SUS

On October 20, 2025, GM/MS Ordinance No. 8,477/2025 was published, establishing the Pharmaceutical Assistance Component in Oncology (“AF-Onco”) within the scope of the Brazilian Unified Health System (“SUS”).

The new ordinance regulates the financing, acquisition, distribution, and dispensing of oncology medicines, in addition to amending Consolidation Ordinance No. 06/2017. The measure stems from the National Cancer Prevention and Control Policy (“PNPCC”) established through Law No. 14,758/2023.

The primary details of the new regulation are summarized as follows:

• AF-Onco component structure

The Pharmaceutical Assistance Component in Oncology (“AF-Onco”) is a strategy designed to facilitate access to oncology medicines within SUS, adhering to PNPCC guidelines.

AF-Onco aims to ensure the comprehensiveness of cancer treatment based on the priority care guidelines set out in the Clinical Protocols and Therapeutic Guidelines (“PCDT”) and other clinical care protocols developed by the Ministry of Health. These protocols consolidate technical criteria that SUS officers must follow for diagnosis, treatment, dosage, clinical control, and evaluation of therapeutic results.

The list of oncology medicines will include those approved for use in SUS and provided for in the PNPCC, in line with clinical care protocols or a supplementary list of strategic medicines.

The ordinance establishes prioritization criteria for the incorporation of technologies in oncology by the National Committee for Health Technology Incorporation (“Conitec”), including:

• Severity
• Clinical benefit
• Strength of evidence
• Cost-effectiveness and budgetary impact
• Logistics and production feasibility
• Monitoring capability
• Alignment with strategies of the Health Economic-Industrial Complex
• Legal actions index

Methods for acquiring and dispensing cancer medicines

The ordinance establishes three main acquisition methods for cancer medicines:

• Centralized

The Ministry of Health purchases and distributes medicines directly to federative entities and hospitals under the federal government. This method applies to products that meet specific non-cumulative criteria, including products patented by a single holder, intended for highly complex or high-incidence neoplasms, with a high budgetary impact, included in projects of the Health Economic-Industrial Complex (“CEIS”), or eligible for risk-sharing agreements.

• National negotiation

The Ministry of Health coordinates the purchase in collaboration with other federative entities, including, where possible, accredited oncology services. This method of purchasing and dispensing medicines is carried out directly by the health departments of the states and the Federal District and applies in cases where overall demand is high and spread across different regions, or where distribution is uneven, with a consequent risk of shortages.

• Decentralized

Services contracted by the health departments of the states, the Federal District, and the municipalities are responsible for acquiring and executing this method. For municipalities, however, this only applies if they have accredited oncology services under their management.

• Planning, distribution, and financing

The states, Federal District, and municipalities are responsible for the supply planning and distribution of oncology medicines purchased through the centralized method, based on production data, inventories, and current contracts. The federal government will finance AF-Onco in its entirety, with the possibility of fund-to-fund transfers for decentralized implementation, depending on the type of acquisition. The budget forecast for new medicines will be incorporated into the Medium and High Complexity Ceiling (“MAC”), and may be preceded by financing via the Strategic Actions and Compensation Fund (“FAEC”), in accordance with the form of acquisition provided for in the regulation.

• Judicial Reimbursement and Monitoring

 The new regulation also provides for interfederative reimbursement related to legal action, based on Matter 1234 of the STF. For cases filed by June 9, 2024, if a conviction results in a court order to provide cancer treatment medication, the federal government will reimburse federative entities at a rate of 80%. A subsequent normative act may revise this rate.

AF-Onco implementation will be monitored through the APAC Prior Authorization System, the SUS Outpatient Information System (“SIA”), the Hospital Information System (“SIH”), the National Database of Pharmaceutical Assistance Actions and Services (“BNAFAR”), and the National Health Data Network (“RNDS”).

The standard covers several topics that will still require specific regulations. These include the list of medicines SUS must finance, the definition of prioritized technologies, the list of eligible services, the list of high-cost medicines with a high budgetary impact, and the definition of products to be purchased through national negotiation or decentralized acquisition. Such regulations must be issued within 60 to 180 days from the publication of the ordinance.

For more information, see GM/MS Ordinance No. 8,477/2025 in full. (PT only)

Anvisa bans substances linked to cancer and reproductive toxicity in nail products

On October 30, 2025, Collegiate Board Resolution (RDC) No. 995/2025 was published in the Federal Official Gazette of Brazil, adding two substances to the list of prohibited ingredients in personal hygiene products, cosmetics, and perfumes.

Anvisa’s Collegiate Board approved this measure at a meeting held on October 29, 2025, amending the Annex to RDC No. 529/2021. The goal is to protect the population’s health against cancer and reproductive toxicity risks, particularly from products used for artificial gel nails or gel nail polish that require exposure to ultraviolet (“UV”) or LED light.

Substances added to the ban list

• TPO (diphenyl [2,4,6-trimethylbenzene] phosphine oxide): Classified as toxic for reproduction, with the potential to impair fertility;
• DMPT (N,N-dimethyl-p-toluidine), also known as dimethyltolylamine (“DMTA”): Classified as a potential human carcinogen.

Rapporteur Daniela Marreco clarified that the decision considers the occupational and social risks associated with prolonged and repeated exposure to these substances, reinforcing the government’s role in adopting precautionary health measures. The standard also aligns Brazil with European Union regulatory standards, which have already banned these ingredients.

Transition rules and regulatory impact

RDC No. 995/2025 establishes deadlines and procedures for withdrawing products from the market:

• Immediately:

Bans the manufacture, import, and licensing of new products containing TPO or DMPT. Anvisa will deny all marketing authorization applications involving these substances.

As an exception, products whose shipment to Brazil can be proven to have taken place prior to the new regulation will be cleared through customs.

• Within 90 days:

Personal hygiene products, cosmetics, and perfumes containing TPO or DMPT may not be marketed or used in Brazil after 90 days from the publication of RDC No. 995/2025 in the Federal Official Gazette. Anvisa will cancel the registrations and notifications for these products, and the companies responsible for products containing these substances must recall any items still available on the market.

For more information, see RDC No. 995/2025 in full. (PT only)

Anvisa frames saline solutions for nasal irrigation as medical devices

On October 30, 2025, the Brazilian Health Regulatory Agency (“Anvisa”) approved the regulatory proposal that formally frames sodium chloride-based products for nasal irrigation as medical devices, concluding the transition that began in 2023.

The measure encompasses both saline powder products and 0.9% sodium chloride solutions. It establishes the regulatory effect of a previous ruling (Vote No. 128/2023/SEI/DIRE3/ANVISA) that had already mandated the reframing of these products, which were licensed as medicines, as medical devices.

Deadlines and regulatory impact

The proposed regulation establishes that sodium chloride-based products for nasal irrigation should be framed as Class IV medical devices, rule 14, in accordance with RDC No. 751/2022.

The proposal also provides for the use of a Good Manufacturing Practices Certificate (“CBPF”) for medicines in the marketing authorization, change of manufacturer, and revalidation of products as medical devices, without a time limit, as determined by Anvisa’s Collegiate Board. The measure eliminates one of the main obstacles reported by the manufacturing sector and complies with regulatory precedents enforced by Anvisa in similar cases, such as the reframing of “artificial tears” and ocular lubricants.

According to RDC No. 576/2021, companies have until May 30, 2026, to cancel notifications as medicines and obtain marketing authorizations for these products as medical devices. After that date, Anvisa will cancel all notifications still in effect as medicines.

For more information, see Vote No. 188/2023/SEI/DIRE3/ANVISA. (PT only)

• BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA)

RDC No. 990/25: Amends RDC No. 843/2024 on food and packaging regulation under the National Health Oversight System (“SNVS”) for distribution in Brazil.

RDC No. 991/25: Amends RDC No. 948, dated December 12, 2024, which provides for the health requirements for the legitimization of medicines for human use.

RDC No. 992/25: Sets health requirements for regenerated cellulose films for food packaging.

Collegiate Board Resolution (“RDC”) No. 993/25: Defines directors responsible for ANVISA boards.

RDC No. 994/25: Provides for temporary and extraordinary emergency authorization procedures for the manufacture of injectable ethyl alcohol.

RDC No. 995/25: Amends the Annex to RDC No. 529, dated August 4, 2021, which provides for the list of substances that cannot be used in personal hygiene products, cosmetics, and perfumes.

IN No. 397/25: Provides for the amendment of the monograph of active ingredient M47 – MALELUCA ALTERNIFOLIA in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 398/25: Provides for the inclusion of the monograph of active ingredient O23 – OCIMUM BASILICUM in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 399/25: Provides for the update of the monograph of active ingredients in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

IN No. 400/25: Amends Normative Instruction (“IN”) No. 389, dated July 29, 2025, which sets temporary health measures for ports and airports in response to the current epidemiological situation, according to Article 12 and Article 19 of RDC No. 932/2024.

IN No. 401/25: Provides for the update of the list of Brazilian Common Denominations (“DCB”). 

• NATIONAL SUPPLEMENTARY HEALTHCARE AGENCY (“ANS”):

RN No. 645/25: Updates Normative Resolution (“RN”) No. 465, dated February 24, 2021, which provides for the list of mandatory health events and procedures in supplementary healthcare to regulate the mandatory coverage of immunobiological medicines anifrolumab and belimumab for treating systemic lupus erythematosus (“SLE”) in adults with high disease activity despite standard therapy, in compliance with paragraphs 4, 7 and 8 of article 10 of Law No. 9,656/1998.

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

SECTICS Ordinance No. 65/25: Announces the decision not to include semaglutide into SUS for the treatment of patients with grade II and III obesity, without diabetes, aged 45 or older and with established cardiovascular disease. Ref: 25000.189404/2024-40.

SECTICS Ordinance No. 66/25: Announces the decision to expand the use of hepatic elastography within SUS for diagnosing hepatic fibrosis in patients with schistosomiasis. Ref: 25000.040076/2025-65.

Sectics Ordinance No. 67/25: makes public the decision not to incorporate liraglutide into the SUS for the treatment of patients with obesity and type 2 diabetes mellitus. Ref: 25000.197755/2024-24.

SECTICS Ordinance No. 68/25: Announces the decision to include subcutaneous infliximab in SUS for treating patients with moderate to severe Crohn’s disease who did not respond adequately to conventional therapies and present with complex perianal fistula, in accordance with the Ministry of Health’s clinical protocol. Ref: 25000.104396/2023-99.

SECTICS Ordinance No. 69/25: Announces the decision to include sunitinib in SUS for treating individuals with advanced or metastatic gastrointestinal stromal tumors (“GIST”) after treatment failure with imatinib, according to the clinical protocol of the Ministry of Health.

SECTICS Ordinance No. 70/25: Announces the decision to include in SUS the adsorbed hexavalent acellular vaccine for children up to 6 years, 11 months and 29 days who are immunocompromised, have special clinical conditions, or are at increased risk of adverse events, in accordance with the National Immunization Program strategy.

SECTICS Ordinance No. 71/25: Announces the decision to include larotrectinib in SUS for pediatric patients with locally advanced or metastatic solid tumors that are positive for NTRK gene fusion.

SECTICS Ordinance No. 72/25: Announces the decision to include in SUS the robot-assisted radical prostatectomy for treating patients with clinically localized or locally advanced prostate cancer.

SECTICS Ordinance No. 73/25: Announces the decision not to include fingolimod hydrochloride in SUS as a first-line treatment for patients with relapsing-remitting multiple sclerosis of low to moderate activity, either switching between first-line drugs or treatment-naïve.

SECTICS Ordinance No. 74/25: Announces the decision not to include selumetinib in SUS for treating pediatric patients with neurofibromatosis type 1 (“NF1”) and symptomatic inoperable plexiform neurofibroma.

SECTICS Ordinance No. 75/25: Announces the decision to include regorafenib in SUS for treating individuals with advanced or metastatic gastrointestinal stromal tumors after treatment failure with imatinib or sunitinib.

SECTICS Ordinance No. 76/25: Announces the decision to exclude selegiline from SUS for treating Parkinson’s disease.

SECTICS Ordinance No. 77/25: Announces the decision to include rituximab in SUS for treating children and adolescents with primary steroid-dependent nephrotic syndrome and frequent relapses, according to the Ministry of Health’s clinical protocol.

SECTICS Ordinance No. 78/25: Announces the decision to include in SUS the enzyme immunoassay test to detect the Histoplasma capsulatum galactomannan antigen for diagnosing histoplasmosis.

SECTICS Ordinance No. 79/25: Announces the decision to include mycophenolate mofetil and sodium mycophenolate in SUS for treating children and adolescents with primary nephrotic syndrome, according to the Ministry of Health’s clinical protocol. Ref: 25000.040182/2025-49

SECTICS Ordinance No. 80/25: Announces the decision to incorporate arsenic trioxide into SUS as a first-line treatment for low- to intermediate-risk acute promyelocytic leukemia. Ref: 25000.183517/2024-31

SECTICS Ordinance No. 81/25 Announces the decision not to incorporate extended-release tacrolimus in SUS for treating immunosuppression in adult patients who underwent liver transplantation. Ref: 25000.058687/2025-60

SECTICS Ordinance No. 82/25: Announces the decision to incorporate spinal cord stimulators for treating chronic pain into SUS, in accordance with the clinical protocol of the Ministry of Health. Ref.: 25000.182953/2024-93

SECTICS Ordinance No. 83/25: Announces the decision to incorporate spinal cord stimulators for treating chronic pain into SUS, in accordance with the clinical protocol of the Ministry of Health. 25000.182953/2024-93

SECTICS Ordinance No. 84/25: Announces the decision to include sirolimus in SUS for treating immunosuppression in adult patients who underwent liver transplantation during childhood, in accordance with the clinical protocol of the Ministry of Health. Ref: 25000.056356/2025-95.

SECTICS Ordinance No. 85/25: Establishes a Temporary Working Group (“GTT”) to support the implementation process of the National System for Ethics in Research with Human Subjects and the National Ethics in Research Authority (“Inaep”).

SECTICS Ordinance No. 86/25: announces the decision to exclude crizotinib from SUS for the first-line treatment of adult patients with advanced or metastatic ALK+ non-small cell lung cancer. Ref: 25000.077287/2025-53.

• BRAZILIAN FEDERAL MEDICINE COUNCIL (“CFM”):

CFM Resolution No. 2446/25: Extends the administrative intervention by the Federal Medical Council (“CFM”) in the Regional Medical Council of the State of Rio de Janeiro (“CREMERJ”), among other provisions.

CFM Resolution No. 2447/25: Sets the annual fees of the CFM for the 2026 fiscal year, among other provisions.

ANVISA Public Consultation No. 1349/25: Proposed normative instruction that amends the item referring to toxicological characteristics and includes subcode T84.2 – Hydroalcoholic Extract of Thymus vulgaris in the monograph T84 – Thymus vulgaris in the List of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

Contribution deadline: November 13, 2025

ANVISA Public Consultation No. 1350/25: Proposed normative instruction that updates the monographs of Active Ingredients of Pesticides, Disinfesting Sanitizers and Wood Preservatives, published in IN No. 103, dated October 19, 2021.

Contribution deadline: November 21, 2025

ANVISA Public Consultation No. 1351/25: Proposes the inclusion of the general method for determining total polyphenols, the inclusion of the monographs for avocado tree (fluid extract), cipó-cabeludo (leaf), cipó-cabeludo (fluid extract), and the revision of the monographs for aloe vera (leaf), hawthorn (leaf and flower), hawthorn (fluid extract), devil’s claw (root), guava tree (leaf), jucá (bark), jucá (fruit), kola nut (seed), chanca piedra (Phyllanthus niruri, aerial part), and chanca piedra (Phyllanthus tenellus, aerial part).

Contribution deadline: November 13, 2025

CP Anvisa No. 1352/25: Proposed normative instruction establishing groups of personal hygiene products, cosmetics, and perfumes that can be produced artisanally.

Contribution deadline: November 26, 2025

CP Anvisa No. 1353/25: Proposed RDC providing for the regulation of Law No. 15,154, dated June 30, 2025, and establishing technical requirements and simplified procedures for artisanal personal hygiene products, cosmetics, and perfumes.

Contribution deadline: November 26, 2025