Life Sciences Newsletter | July and August 2024

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

NEWS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

ANVISA announces new import administrative proceedings

On July 03, 2024, ANVISA announced the entry into force of new administrative proceedings for imported products subject to health control.

The revision of the MERCOSUR Common Nomenclature (MCN) for imported products listed in Law 9,782/1999 and RDC 81/2008 aims to simplify the selection of products subject to health inspection. The measure is a preparatory step for ANVISA’s inclusion into Brazil’s New Import Process (NPI) – Duimp (Single Import Declaration).

Importers must register the Import Declaration (DI) through Siscomex (Integrated Foreign Trade System) to initiate customs clearance with the Brazilian Federal Revenue Office. The new administrative proceedings encompass several product categories, and the importer must select the specific regulatory category of the end product targeted in the import process.

The product categories are:

• Foods
• Cosmetics, perfumes, and hygiene products
• Medical devices
• Medicines
• Controlled substances
• Sanitizing products
• Human blood, tissue, and organs
• Fumigants
• Other products

ANVISA publishes new guide on food shelf life

On July 03, 2024, ANVISA provided a new guide for establishing the shelf life of foods sold in Brazil. 

The guide, which is already in force, was developed to improve food safety standards according to international best practices. The goal is to provide a reference for enforcing regulatory health requirements.

The guidelines will be available for contributions by December 30, 2024. The consultation seeks to improve the approach of procedures, methods, and protocols related to this matter.

ANVISA publishes the list of the first companies certified as authorized economic operators

On July 29, 2024, ANVISA announced the first companies certified in ANVISA’s Authorized Economic Operator (AEO) Program (Programa OEA-Anvisa).

The program is managed by the Federal Revenue Office and certifies companies as low-risk and dependable operators. Certified companies will be entitled to all benefits established by the Federal Revenue Office in Collegiate Board Resolution (RDC) 845/2024, such as:

• Reduced allocation of import proceedings to inspection channels that analyze documents and inspect goods and products subject to health oversight under RDC 228, dated May 23, 2018.
• Prioritized analysis of import processes.
• Prioritized inspection of imports selected for this procedure.
• Direct communication channel with companies certified in the AEO-Integrated Anvisa Program.

New standard operating procedure announced for medication assessments

On July 11, 2024, ANVISA published a new standard operating procedure (SOP) for medicines related to RDC 823/2023, introducing risk-based guidelines to assess the quality of registration and post-registration changes for synthetic and semi-synthetic medicines.

RDC 823/2023 standardizes decisions regarding registration filing and subsequent changes to medicines. Any flagged requirements must be classified according to RDC 823/2023 and SOP guidelines.

The SOP establishes an optimized assessment based on health risk to verify whether documents submitted to ANVISA in registration and post-registration procedures comply with the applicable technical requirements. The method applies to members of the Synthetic Medicines Quality Assessment Management (GQMED) who are in charge of assessing registration and post-registration change filings.

This measure aims to reduce the number of requirements issued against companies seeking to regularize medicines.

New Q&A on nutrition labeling published

On July 12, 2024, ANVISA published the.

This issue offers clarifications regarding RDC No. 429/2020, which provides for the nutrition labeling of packaged foods, and Normative Instruction No. 75/2020, which establishes technical requirements for nutrition labeling in packaged foods.

Key changes include:

• Nutrition labeling of sweeteners due to product changes in RDC 818/2023;
• Proof of use safety for new foods and ingredients to adapt the information regarding RDC 839/2023;
• Inclusion of information regarding additional nutrients that must be declared in the nutrition facts label of special purpose foods;
• Revision of clarifications regarding added sugars in ingredients used as a source of dietary fiber, according to the diversity of nomenclature, composition, and methods employed in the production of these ingredients;
• Legibility requirements for the simplified nutrition declaration and the linear declaration;
• Clarification regarding the scope of tolerance limits for the % DV information.

The measure seeks to guide food producers and Brazilian Health Oversight System entities in appropriately implementing and monitoring regulations.

National Prescription Control System enters into force.

On July 18, 2024, Brazil’s National Prescription Control System (“SNCR”) entered into force to improve the safety and control of medicines subject to special control.

In this regard, the control system was implemented as a national database to distribute the numbering of prescriptions and prescription pad notifications to prescribing professionals, hospital units, or any other equivalent healthcare entity. The measure aims to facilitate the control and supervision of the prescription of medicines and products subject to special control by health authorities.

All competent health authorities must use the control system as of January 1, 2025, and all health oversight units must register and train users by December 31, 2024.

Failure to implement the control system will be deemed a health code violation, for which the offender will be subject to all penalties provided for in the current health legislation, in addition to other applicable civil or criminal sanctions.

New pre-market food control standards enter into force

On September 01, 2024, RDC No. 843/2024 and Normative Instruction No. 281/2024 entered into force, which will improve pre-market food control based on risk criteria.

This new regulatory framework was developed to meet the demand for improved pre-market control to regularize food and packaging, given the low efficiency of the bureaucratic and outdated current procedures.

The regulation provides for three regularization methods:

• Registration with Anvisa:

Mandatory registration products, such as formulas for infants and enteral nutrition, still require prior approval from Anvisa.

• Notice to Anvisa:

Intermediate-risk products, such as desalinated seawater, transition foods, cereals for children’s food, and recycled packaging, may be regularized through notice. Food supplements and weight-control foods must also be notified to Anvisa.

• Reporting to local health oversight agencies:

Low-risk products require reporting to local health oversight authorities when production or importing procedures are initiated.

Superior Court of Justice decides that ANVISA is not competent to restrict medicine advertising.

On August 13, 2024, the First Panel of the Superior Court of Justice (“STJ”) ruled on Special Appeal No. 2035645-DF, deciding that ANVISA has no regulatory powers to restrict commercial advertisements for pharmaceutical products, especially when these restrictions contradict Federal Law No. 9,297/1996.

The decision analyzed the restriction on the advertising of medicines provided for in RDC No. 96/2008. While the ruling is not legally binding on ANVISA’s actions, this is a significant position regarding the advertising of medicines, especially since the STJ, while informing the decision, recognized that the Ministry of Health and the National Congress must establish a dialogue.

In Brazil, only four companies are authorized to import human gametes and embryos.

ANVISA has released the list of companies authorized to import gametes and human embryos into Brazil. Only four companies have obtained this authorization, using banks from four different countries: the United States, Spain, Denmark, and Argentina.

In this regard, RDC No. 771/2022 established new standards for good practices involving germ cells, germ tissue, and human embryos for therapeutic use. This topic was previously only regulated by RDC No. 81/2008.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Court bans healthcare plans from excluding people with autism

On May 22, 2024, the Superior Court of Justice of the Brazilian Federal District issued a preliminary injunction that banned healthcare plan operators from excluding beneficiaries with Autistic Spectrum Disorder (ASD) and ordered the reinstatement of contracts terminated unilaterally within the same context.

The decision reinforces the ANS’s understanding, released through a Note, that operators cannot select risks when caring for, contracting with, or excluding beneficiaries in any form of healthcare plan. In addition, beneficiaries can neither be prevented from contracting a healthcare plan due to their health condition or age nor denied coverage or excluded from a plan by operators due to existing health conditions.

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

ANVISA establishes transition guidelines for implementing electronic package inserts

On July 12, 2024, RDC No. 886/2024 was published, repealing regulations published by ANVISA in 2023-2024.

Several regulations still in force in ANVISA’s regulatory stock were flagged as obsolete, ineffective, and outdated.

The measure seeks to ensure that the population’s needs regarding current health regulations are fully met and to comply with the provisions for reviewing and consolidating regulations established in Decree No. 10,139/2019. These changes are aimed at modernizing and simplifying compliance with the regulation and rendering the regulatory stock more compact and accessible.

ANVISA repeals and updates obsolete regulation

On July 12, 2024, RDC No. 886/2024 was published, repealing regulations published by ANVISA in 2023-2024.

Several regulations still in force in ANVISA’s regulatory stock were flagged as obsolete, ineffective, and outdated.

The measure seeks to ensure that the population’s needs regarding current health regulations are fully met and to comply with the provisions for reviewing and consolidating regulations established in Decree No. 10,139/2019. These changes are aimed at modernizing and simplifying compliance with the regulation and rendering the regulatory stock more compact and accessible.

Regulation establishes medicinal gas guidelines.

On July 12, 2024, RDC No. 887/2024 was published, which provides for good practices in the distribution, storage, transportation, and dispensing of medicinal gases due to the regulatory gap regarding these matters.

The measure seeks to ensure the quality and safety of products by regulating other agents within the pharmaceutical consumption chain, such as distributors, carriers, and storage companies. The guidelines were created to meet the demand for increased product quality through the regulation of post-production steps.

The RDC also provides for traceability and compliance with current health regulations and will enter into force in July 2026.

Food additive limits updated

Normative Instruction No. 306/2024 was published on July 03, 2024, to provide for the technological functions, limits, and conditions of use for authorized food additives and processing co-formulants.

The measure adds calcium carbonate and mono- and diglycerides of fatty acids to the list of authorized substances, with specifications on their technological functions and their maximum limits of use in different food categories.

Regulation updates Brazilian Common Denominations.

On August 29, 2024, RDC No. 895/2024 entered into force, including new denominations into the list of Brazilian Common Denominations (DCB) approved by RDC No. 469/2021.

The DCB are official denominations attributed to pharmaceutical inputs in Brazil. Updating the list is necessary to meet demands from the regulated sector and internal Anvisa departments.

ANVISA changes regulations on smoking products

In August 2024, two rules amending the current regulation of smoking products were published:

• RDC No. 896/2024, which provides for the registration of tobacco-derived smoking products and repeals RDC No. 559/2021, which addressed this topic; and
• Normative Instruction 312/2024 provides for the inclusion of information on any changes to ingredients on the packaging of tobacco-derived smoking products and repeals Normative Instruction 72/2020 on this topic.

This topic, which is included in ANVISA’s Regulatory Agenda for 2024 and 2025, aims to align regulatory restrictions and requirements with the current health landscape.

ANVISA consolidates regulations on personal hygiene products, cosmetics, perfumes, and sanitizers

In August 2024, two rules on personal hygiene products, cosmetics, perfumes, and sanitizers were published:

• 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 post-regularization changes to sanitizing products.

According to ANVISA, this is just a consolidation of rules without any change in merit.

CMED – DRUGS MARKET REGULATION CHAMBER

CMED establishes a table of maximum prices for medicines

On August 13, 2024, the Drugs Market Regulation Chamber (“CMED”) published Resolution No. 2/2024, which provides for how to define the factory price and the maximum price for consumers of medicines.

Conversion factors were established according to the Brazilian Value-Added Tax (“ICMS”) rate, and these parameters will enter into force on September 12, 2024.

New deadline for submitting drug marketing reports

On July 29, 2024, the Executive Secretariat of the Drugs Market Regulation Chamber (“SCMED”) informed that the Drugs Market Monitoring System (“SAMMED”) has been available since September 02, 2024, for submitting marketing reports for the first half of 2024.

The marketing report must be submitted by individuals or legal entities under public or private law that operate in the medicines market, providing details on the obligations relating to each group of medicines. As established in CMED Resolution No. 2/2019, the submission of reports will be mandatory for Group 2 and 3 drugs but waived for Group 1.

The report must be submitted through the SAMMED system between September 02 and 30, 2024. Failure to submit the report and incomplete, inconsistent, or late submission will be considered infringements of the regulation of the medicines market under the terms of CMED Resolution No. 2/2018.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Bill bans healthcare plans from excluding older individuals and people with disabilities.

Bill No. 2,036/2024 was presented in response to the increase in user complaints regarding the unilateral cancellations of healthcare plans.

The bill bans healthcare plan operators from unilaterally canceling contracts with older individuals or people with disabilities. This would apply to both employer—and association-based group policies.

Currently, the legislation allows operators to cancel contracts unilaterally if such a measure is provided for in a contract and executed with a 60-day notice.

ANS pushes entry into force of new regulations on disaccredited hospitals due to budget cuts

The ANS announced it will postpone the entry into force of new regulations that would benefit healthcare plan beneficiaries in cases of disaccredited hospitals or emergency services, regulated through Normative.

The changes were initially set to enter into force on September 01, 2024, but will now only be implemented in December 2024.

Among the main innovations is portability without a grace period, which authorizes beneficiaries who are unsatisfied with the exclusion of health services to change operators immediately. Such grace period currently ranges from one to three years.

PUBLIC CONSULTATIONS
AND HEARINGS

Deadline extended for public consultation on economic activity risk classification.

On July 11, 2024, the contribution period for a proposed RDC that provides for the risk identification and classification of economic activities subject to health oversight was extended for 60 days. 

The measure aims to increase society’s participation in regulating the licensing, inspection, supervision, control, and monitoring of entrepreneurs and legal entities.

The public consultation will receive contributions by September 09, 2024.

Proposal to amend technical regulations on packaging is subject to public consultation.

On September 05, 2024, Public Consultation No. 1276/2024 was opened to receive contributions on the proposed amendment of DRC No. 88/2016, which approves the technical regulation on cellulosic materials, packaging, and equipment intended to come into contact with food, and includes other provisions.

The proposed amendment to the RDC aims to review the restriction on the amount of diisopropyl naphthalene (“DPIN”) contaminants imposed by the requirement currently standardized in Mercosur. According to ANVISA, this restriction is excessive and not in accordance with international reference standards, creating unjustified barriers to trade.

Contributions can be submitted by October 21, 2024.

Public consultation analyzes proposals to review technical regulations on cleaning products.

On September 05, 2024, Public Consultation No. 1275/2024 was opened. It discusses the proposed review of the Mercosur Technical Regulation for Cleaning and Related Products (GMC Resolution No. 47/07, which corresponds to RDC No. 694/2022), which provides for criteria to regulate cleaning and related products and on the biodegradability of anionic surfactants.

According to ANVISA, this is a periodic review of the Mercosur regulations, which must be reviewed after they have been in force for ten years.

Contributions can be submitted by November 04, 2024.

Regulations on health warnings on the packaging of smoking products are subject to public consultation.

On September 02, 2024, Public Consultation No. 1273/2024 was opened to receive contributions on the proposal for a normative instruction that aims to establish the health warnings and messages to be used on the packaging of smoking products derived from tobacco, as provided for in RDC No. 838/2023, and repeal current Normative Instruction No. 271/2023.

The review of RDC No. 840/2023 is also under Public Consultation No. 1274/2024, which addresses the sale and marketing of smoking products derived from tobacco.

ANVISA intends that the warnings correspond to current studies and information on the use of smoking products.

Contributions can be submitted by October 16, 2024.