Life Sciences and Healthcare Newsletter | April 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

ANVISA approves mandatory prescription retention for the sale of semaglutide, liraglutide, dulaglutide, exenatide, tirzepatide, and lixisenatide products

On April 16, 2025, the Brazilian Health Regulatory Agency (“ANVISA”) approved two normative acts to establish the mandatory retention of medical prescriptions by pharmacies and drugstores when dispensing GLP-1 receptor agonist medicines. This category includes medicines such as semaglutide, liraglutide, dulaglutide, exenatide, tirzepatide, and lixisenatide – popularly known as “slimming injections” –, but which are indicated initially for treating diabetes.

Currently, consumers must provide a medical prescription to purchase these “red line” medicines, in compliance with Resolution of the Collegiate Board (“RDC”) No. 471/21, which establishes and updates the criteria for prescribing, selling, controlling, packaging, and labeling medicines based on substances classified as antimicrobials for prescribed use, whether alone or in combination.  However, the new regulation seeks to enhance oversight by requiring the prescription to be submitted and retained at the time of purchase.

On April 24, 2025, Normative Instruction (“IN”) No. 360/25 was published – defining the list of isolated or combined substances used for medicines subject to prescription submission and retention – as well as RDC No. 973/25, which amends RDC No. 471/21, to establish mandatory prescription retention for GLP-1 receptor agonist medicines.

The new regulations come into force on June 23, 2025. Pharmacies that fail to comply with the regulation will be subject to fines and can even have their license suspended. The health regulatory agency will also intensify oversight in collaboration with state and municipal health authorities.

For more information, access our client alert.

ANVISA approves first-ever medicine against Alzheimer’s disease

Approved by Resolution (“RE”) No. 1,533, on April 22, 2025, Kisunla (donanemab), is a monoclonal antibody that binds to a protein called beta-amyloid. In Alzheimer’s disease, clusters of beta-amyloid protein form plaques in the brain. Donanemab binds to these clusters and reduces them, thus delaying the progression of the disease.

The marketing authorization application of Kisunla was framed as a priority under item I of Section 3 of RDC No. 204/2017, granted in compliance with RDC No. 55/2010.

For more information, access ANVISA’s website.

ANVISA amends RDC on General Guidelines for Good Manufacturing Practices

On April 22, 2025, ANVISA approved RDC No. 972/25, amending RDC No. 658/22, which addresses the General Guidelines for Good Manufacturing Practices (“GMP”).

The key change involves the implementation of online controls – as provided for in Section 215 –, which can now be waived upon technical justification. Thus, provided that companies adopt other suitable control strategies based on quality risk management, they will be able to benefit from greater adaptability.

Brazil’s Federal Government seeks new partnerships with private sector to streamline SUS healthcare assistance

On April 29, 2025, the Minister of Health, Alexandre Padilha, announced that the Federal Government is developing a new management method to reduce waiting times in the Unified Health System (“SUS”). The proposal includes extending partnerships with private hospitals, healthcare plan operators, and supplementary medicine structures to streamline the population’s access to specialized consultations, exams and surgeries.

The main purpose is to ensure quality and timely healthcare for SUS patients, taking advantage of the installed capacity of private hospitals and outpatient clinics. A study carried out in collaboration with the Medical Campus of Universidade de São Paulo (USP) indicates a strong concentration of medical specialists in the private sector who do not provide services to SUS.

This measure aims to ensure compliance with legal assistance deadlines, such as providing cancer diagnosis within 30 days so that treatment can start within 60 days. Integrating with the private sector is considered to be a fundamental measure towards accomplishing this demand promptly and efficiently. The aim is to ensure access to specialized medical care within the appropriate time span for more people, as early as 2025.

Anvisa opens public consultation on veterinary drug residue limits in food of animal origin

On April 1^st, 2025, ANVISA published Public Consultation No. 1,318/25, which aims to update Normative Instruction (IN) No. 162/22. This regulation establishes the acceptable daily intake (ADI), acute reference dose (ARfD), and maximum residue limits (MRLs) for veterinary drugs in food of animal origin, in accordance with the new parameters recently approved by the Codex Alimentarius.

The Public Consultation seeks to update the ADI, ARfD, and/or MRL parameters for the active pharmaceutical ingredients ivermectin, clopidol, imidacloprid, and lufenuron, according to the different edible animal tissues detailed in the consultation.

This proposed update is part of ANVISA’s ongoing international convergence strategy, which aims to reduce barriers to international trade and align national regulations with international standards, ensuring that the rules are based on recent and high-quality scientific evidence.

The deadline for submitting contributions is May 22, 2025. For more details on the proposed changes, access the full consultation.

PUBLISHED REGULATIONS

BRAZILIAN HEALTH REGULATORY AGENCY (ANVISA)

RDC No. 972/25: Changes RDC No. 658, of March 30, 2022, which provides for the General Guidelines for GMP.

RDC No. 973/25: Changes RDC No. 471, of February 23, 2021, which provides for the criteria for prescribing, selling, controlling, packaging, and labeling medicines based on substances classified as prescription antimicrobial agents, whether alone or in combination, listed in a specific IN.

RDC No. 974/25: 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, of May 12, 1998.

IN No. 356/25: Changes IN No. 211, of March 01, 2023, which establishes the technological functions, maximum limits, and conditions of use for food additives and processing aids authorized for use in food.

IN No. 357/25: Publishes the List of Reference Medicines.

IN No. 358/25: Changes IN No.123, of March 24, 2022, approving the Roadmap for Inspection in Bioavailability/Bioequivalence Medicine Centers.

IN No. 359/25: Provides for the composition of seasonal influenza vaccines to be used in Brazil.

IN No. 360/25: Provides for the list of isolated or combined substances used for medicines subject to prescription and retention, which is addressed in RDC No. 471, of February 23, 2021.

NATIONAL SUPPLEMENTARY HEALTHCARE AGENCY (“ANS”):

Normative Resolution (“RN”) No. 630/25: Changes RN No. 507, of March 30, 2022, which provides for the Accreditation Program for Operators of Private Healthcare Plans.

RN No. 631/25: Provides for the bylaws of the Committee for Standardization of Supplementary Health Information and repeals ANS IN No. 5, of March 30, 2022.

MINISTRY OF HEALTH (MS):

Ministry of Health (“GM/MS”) Ordinance No. 6892/25: Changes Ordinance No. 6,691, of March 11, 2025, to include new measures and strategic goals to be monitored and to establish the Technical Support Group for the Situation Room and Support for Agile SUS Management (“SAGA-SUS”).

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

SECTICS Ordinance No. 15/25: Publicizes the decision to incorporate nirsevimab within SUS in the prevention of lower respiratory tract infection associated with respiratory syncytial virus, for premature infants under 37 weeks and children under 2 years old with comorbidities, according to the Clinical Protocol of the Ministry of Health.

BRAZILIAN FEDERAL MEDICINE COUNCIL (“CFM”):

CFM Resolution No. 2424/25: Changes CFM Resolution No. 2,306/2022, which approved the Code of Professionalism and Ethics (“CPEP”) within the framework of the CFM and the Regional Councils of Medicine (“CRM”).

CFM Resolution No. 2427/25: Changes the ethical and technical criteria for providing care to people with incongruence and/or gender dysphoria, among other provisions.

FEDERAL COUNCIL OF BIOMEDICINE (“CFBM”):

Resolution CFBM No. 393/25: Establishes the procedure for the Precautionary Suspension of Professional Practice in Biomedicine within the scope of the Federal Council and the Regional Councils of Biomedicine.

SOCIAL PARTICIPATION

ANVISA Public Consultation (“CP”) No. 1318/25: To receive contributions on the proposal to amend paragraph 162, of July 01, 2022, establishing the acceptable daily intake (“IDA”), the acute reference dose (“DRfA”), and the maximum residue limits for active pharmaceutical inputs (“IFA”) of veterinary medicinal products in foods derived from animal inputs.

Contribution deadline: May 22, 2025

ANVISA CP No. 1319/25: To receive contributions on the proposed IN that includes the active ingredient B72 – Baculovirus Plutella Xylostella Granulovirus in the List of Active Ingredients of Pesticides, Sanitizers, Disinfectants, and Wood Preservatives, addressed in IN No. 103, of October 19, 2021.

Contribution deadline: June 14, 2025

ANVISA CP No. 1320/25: To receive contributions on the proposed IN seeking to amend the List of Over-the-Counter Medicines, and further lists the non-granted applications for inclusion.

Contribution deadline: May 21, 2025

ANVISA CP No. 1321/25: To receive contributions on the proposed IN updating the toxicological classification of the monograph of the active ingredient C39 – Cyanamide, in the List of Active Ingredients of Pesticides, Sanitizing Disinfectants, and Wood Preservatives, published in IN No. 103, of October 19, 2021.

Contribution deadline: June 15, 2025

ANVISA CP No. 1322/25: To receive contributions on the proposed IN that updates the Monographs of 23 Active Ingredients of Pesticides, Sanitizing Disinfectants and Wood Preservatives, published in IN No. 103, of October 19, 2021: A04 – Gibberellic Acid A66 – Indoleacetic Acid A71 – Aminocyclopropane Carboxylic Acid B26 – Bifenthrin C32 – Clethodim C63 – Lambda-Cyhalothrin D36 – Difenoconazole D44 – Diflufenican F40 – Formetanate Hydrochloride F46 – Flumioxazin F47 – Fluazinam F82 – Fluoxastrobin G05 – Glufosinate Ammonium H07 – Haloxyfop-P Methyl I22 – Iodosulfuron-Methyl-Sodium L05 – Lufenuron M14 – Methidathion M19 – Metribuzin P50 – Picoxystrobin R03 – Reynoutria Sachalinensis S13 – S-Metolachlor S17 – Sophora Flavescens S20 – Saccharomyces Cerevisiae

Contribution deadline: June 15, 2025

ANVISA CP No. 1323/25: To receive contributions on the DRC proposal providing sanitary security in airports and aircraft, and further establishes obligations for airport administrators and airlines.

Contribution deadline: July 21, 2025

ANVISA CP No. 1324/25: To receive contributions on the IN proposal establishing the identity, purity, and composition specifications of ingredients authorized for use in food.

Contribution deadline: July 26, 2025

ANVISA CP No. 1325/25: To receive contributions on the RDC proposal amending RDC No. 243, of July 26, 2018, establishing sanitary requirements for food supplements; RDC No. 839, of December 14, 2023, which provides for proof of safety and authorization for using new foods and ingredients; and IN No. 28, of July 26, 2018, which establishes the lists of constituents, limits of use, justifications, and supplementary labeling for food supplements.

Contribution deadline: July 16, 2025

ANVISA CP No. 1327/25: To receive contributions on the proposed IN that includes the active ingredient P77 – Paenibacillus Ottowii in the List of Active Ingredients of Pesticides, Sanitizing Disinfectants, and Wood Preservatives, published in IN No. 103, of October 19, 2021.

Contribution deadline: July 26, 2025

ANVISA Public Consultation No. 1328/25: To receive contributions on the proposed IN that includes the active ingredient T84 – Thymus Vulgaris in the List of Active Ingredients of Pesticides, Sanitizers, Disinfectants and Wood Preservatives, published in IN No. 103, of October 19, 2021.

Contribution deadline: July 26, 2025