Check out our monthly Life Sciences Newsletter, which gathers information about recent legislation, news, public consultations, and bills concerning the health and agriculture sectors in Brazil.
For more information, please contact our legal team.
Enjoy reading!
Demarest’s Life Sciences Team
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
Resolution bans the use of phenol in aesthetic or health procedures
A resolution was published on September 27, 2024, to issue a precautionary ban on the import, production, handling, sale, marketing, and use of phenol-based products (CAS 108-95-2) in health-related or aesthetic procedures.
Resolution No. 3.600/2024 was enacted before the expiration of the previous provisional measure in Resolution RE 2,384 of June 24, 2024. ANVISA is still assessing and investigating the use of phenol through data submitted by trade associations and other health organizations.
ANVISA updates express shipping import form for Cannabis products
On September 26, 2024, ANVISA announced the update of the form used in the Solicita system for the importing of Cannabis products by individuals for personal use through express shipping.
The update will enable the system to validate data automatically, and the information submitted will be used to request import authorization. The measure will speed up the completion of the form and improve service quality and health safety.
Please find the guide (in Portuguese) to complete the form in the Solicita Express Shipping Request Guide or the Solicita User Manual.
The measure came into force on October 01, 2024.
Annual Good Clinical Practice Inspection Report published
The 1st Annual Report on Good Clinical Practice Inspection Metrics was published on September 19, 2024. It contains data regarding nine inspections conducted in 2023 by health inspection teams in the field of medication and biological product clinical trials.
These inspections assess the compliance of research sites, sponsors, and staff with good clinical practice (GCP) in clinical trials. GCP guidelines ensure the protection of the rights, safety, and well-being of clinical trial subjects and the accuracy and reliability of the results and data obtained to support medication registration by ANVISA.
List of active ingredients in medication pending registration published
On September 25, 2024, a platform was created to provide access to the list of active ingredients in medications with registration applications pending before ANVISA, including generic, similar, specific, herbal, dynamized, biological, radiopharmaceuticals, and advanced therapy products.
The list will be updated monthly, and users can identify, by regulatory category and quantity, all active ingredients in medication awaiting ANVISA’s approval.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
ANS discusses pricing and readjustment for healthcare plans
On September 27, 2024, the ANS approved the implementation of a project to update and improve the pricing and readjustment policy for private healthcare plans.
The proposal will be discussed at a public hearing on October 7, 2024. The update seeks to expand competition among operators and, consequently, the diversity of offers to consumers.
In addition, the update establishes clear criteria to make readjustments more predictable, which benefits consumers and healthcare plan operators. These changes are part of an ongoing effort by the ANS to improve the supplementary health sector regulation in Brazil.
The public hearing will discuss:
- Readjustment of collective plans;
- Financial regulation mechanisms (copayments and deductibles);
- Online sale of plans;
- Technical review of individual/family plan prices and
- Exclusive outpatient plans.
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
Ownership transfer and registration data update procedures for products subject to health oversight updated
On September 09, 2024, RDC No. 903/2024 was published to update procedures for:
- Transferring the ownership of registration of products subject to health oversight;
- The global transfer of clinical trial liability; and
- Updating the registration data related to the operation and certification of companies within the context of corporate or commercial operations.
The resolution updates procedures adopted in case of corporate and commercial transactions between companies that conduct activities provided for in the federal health legislation and that result in the need for transfers and updates of the data mentioned above.
New regulation authorizes new documents in appeals to renew medication registration
On September 24, 2024, RDC No. 911/2024 was published to provide for the possibility of producing documents on administrative appeal against the denial of a request to renew a medication registration.
This measure authorizes the production of new documents on appeal against a decision that denied the request to renew registrations filed by June 30, 2013. The documents that can be produced on appeal are:
- Those referring to studies of bioequivalence, stability, or validation of analytical methodologies initiated before the filing of the appeal; or
- Those that, although not initiated, are duly justified in the initial petition.
Regulation establishes legality requirements for medication
RDC No. 912/2024 was published on September 24, 2024, to provide effective terms and necessary documentation for maintaining a medication’s legality.
The regulation states that registration is valid for five years following the first renewal, and this term increases to ten years after the second renewal.
The resolution requires the following documents to renew registration:
- Petition forms, duly completed and signed;
- Proof of payment of the Health Oversight Inspection Fee (TFVS) and the respective Brazilian Federal Revenue collection slip (GRU), or of exemption, when applicable;
- Proof of sale, categorized into dosage form and concentration, for at least the two last thirds of the expired registration’s effective term; and
- Proof of submission of documentation proving compliance with completed commitments or justifying failure to submit such documents for medication whose registration was granted upon a consent decree.
ANVISA issues regulation to address changes in the registration of biological products
On September 24, 2024, RDC No. 913/2024 entered into force to provide for post-registration changes and the cancellation of biological product registration.
The measure establishes procedures and requirements for submitting changes related to biological products after initial registration, including the necessary documentation and submission deadlines. The new resolution is the result of a process to review and consolidate ANVISA’s regulations.
ANVISA publishes regulation on the registration of industrialized allergenics
RDC No. 915/2024 was published on September 24, 2024, to provide for the registration of industrialized allergenic substances.
The measure seeks to ensure the quality, safety, and efficacy of these products, which include allergen-specific vaccines based on individual prescriptions and products for the use of qualified professionals.
The resolution mainly requires documentation proving the quality, safety, and efficacy of allergenic products applied for registration, including clinical research, product data, and quality control information. In addition, post-registration changes, such as in the composition, production process, quality controls, analytical methods, equipment, facilities, or information on the package insert and label, must be submitted for ANVISA’s approval.
The new resolution establishes requirements for using medical devices
On September 24, 2024, RDC No. 925/2024 established requirements for producing, selling, importing, and using custom-made medical devices.
The measure seeks to ensure the safety and efficacy of custom-made devices that meet patients’ specific needs. The resolution also regulates exposure to the use of these devices, demanding that they be used only by qualified professionals and in compliance with ANVISA’s guidelines.
ANVISA reviews and consolidates medical device regulation
On September 24, 2024, RDC No. 922/2024 of September 19, 2024, was published, which bans the production, import, sale, and use in health services of mercury thermometers and sphygmomanometers.
The regulation was republished as a result of the review and consolidation of normative acts provided for by Decree 12,002/2024. The measure seeks to improve the legislation by eliminating ambiguity and updating the language used. The new resolution entered into force on September 29, 2024, and failure to comply is a health infraction.
ANVISA establishes new certification rules for medication bioavailability and bioequivalence studies
On September 24, 2024, RDC No. 926/2024 was published. This document provides for the Certification of Good Practices for conducting medication bioavailability and bioequivalence studies and defines which studies must be conducted in certified research sites.
The resolution establishes that all bioavailability and bioequivalence studies must be conducted in research sites certified by ANVISA to ensure qualified and reliable results. Such research sites must comply with strict quality standards, including the validation of analytical methods and quality control procedures.
In addition, the regulation specifies that any changes, for example, to protocols or analysis methods, must be previously approved by ANVISA.
Resolution establishes legality requirements for personal hygiene products, cosmetics, and perfumes
On September 23, 2024, RDC No. 907/2024 was published, which provides for the definition, classification, labeling, and packaging technical requirements, microbiological control parameters, and technical requirements necessary to bring personal hygiene products, cosmetics, and perfumes into good standing.
The measure establishes the classification of products, their technical labeling and packaging requirements, and their microbiological safety and quality parameters. In addition, the regulation defines the procedures and documentation necessary to bring the products into good standing with ANVISA.
ANVISA updates food supplement regulation
On September 20, 2024, Normative Instruction No. 318/2024 entered into force, amending Normative Instruction No. 28/2018, which establishes the lists of ingredients, limits of use, alleged benefits, and supplementary labeling of food supplements.
The measure updates the list of ingredients and their allowed usage limits in food supplements, including new ingredients that have been evaluated and approved by ANVISA. The regulation also establishes supplementary labeling requirements, including additional information that must be provided to the consumer.
The new regulation provides for a 24-month deadline for adjusting the labels of food supplements that contain any of the ingredients that the National Health Oversight System has legitimized by September 20, 2024.
Regulations on COVID-19 vaccine update approved
On September 20, 2024, RDC No. 905/2024 and Normative Instruction No. 316/2024 were published. These documents specifically provide for the update of COVID-19 vaccines to be used in Brazil.
The approved regulations establish which strains must compose vaccines and clear rules for their updating. They also seek to ensure that vaccines remain effective against new variants to continuously and efficiently protect public health.
Resolution establishes packaging requirements for the updated formula of products subject to health inspection
On September 06, 2024, RDC No. 902/2024 was published, which establishes the obligation to declare formula updates in the labels of products subject to health inspection. Such information can be provided through a sticker on the package, provided that it is protected from being removed.
ANVISA reviews and consolidates regulations on cosmetics and sanitizing products
In September, ANVISA reviewed and consolidated cosmetics and sanitizing product regulations and published four new regulations as part of the process provided for by Decree No. 12.002/2024.
These reviews aim to repeal outdated regulations and consolidate the legislation by eliminating ambiguity and updating the language used. In addition, the reviews seek to ensure that regulations are up-to-date and transparent, assisting regulated sectors in interpreting and enforcing them. The published regulations were:
- RDC No. 898/2024, which establishes the obligation to describe the composition, in Portuguese, on the labeling of personal hygiene products, cosmetics, and perfumes; and
- RDC No 899/2024, which provides for procedures related to changes performed after the sanitizing products were legitimized.
- RDC No. 906, of September 19, 2024, which provides for the procedures and requirements to legitimize cosmetic products to straighten or curl hair.
- RDC No 907 of September 19, 2024, which provides for the definition, classification, labeling, and packaging technical requirements, microbiological control parameters, technical requirements, and procedures to legitimize personal hygiene products, cosmetics, and perfumes.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
ANS launches a guide on governance and socio-environmental responsibility
On September 05, 2024, the ANS launched the ESG Guidelines as part of an integrated policy to foster good governance practices and socio-environmental responsibility by authorities.
The guide provides detailed guidelines for enforcing ESG practices, highlighting the importance of transparency, ethics, and sustainability in ANS operations. The ANS Executive Secretary stressed that the release of the guide is an important step in consolidating these practices and fostering good regulatory practices.
PUBLIC CONSULTATIONS
AND HEARINGS
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
Public consultation addresses consent decrees to register medication and biological products
On September 19, 2024, Public Consultation No. 1,282/2024 was initiated to receive contributions on the proposed execution of consent decrees for the registration or post-registration of medication and biological products.
The goal is to make consent decrees an alternative to registration denial, allowing incomplete dossiers to be approved upon the subsequent submission of missing documents.
Contributions can be submitted by November 13, 2024.
Public consultation addresses health requirements applicable to cellulose films for food packaging
On September 30, 2024, Public Consultation No. 1.281/2024 began receiving contributions regarding the collegiate board resolution that provides for health requirements for regenerated cellulose film wrappers for use with food.
The goal is to ensure that the regulation is aligned with international standards, thys protecting the population from health risks related to contamination from cellulose film.
Contributions can be submitted by November 13, 2024.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
ANS opens public consultation on the Accreditation Manual of Dental Operators
On September 13, 2024, Public Consultation No. 136 began receiving contributions on the proposed amendment to Normative Resolution No. 30 of March 2022, which provides for the Private Healthcare Plan Operators Accreditation Program.
Accreditation ensures that dental operators comply with current regulations and offer a high-quality service, increasing the safety and satisfaction of beneficiaries.
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