The deadline for submitting contributions ends on July 10, 2025, and they can be sent by filling out a specific electronic form available at this link. The text of the proposed new Resolution can be accessed at this link. Below are the key changes. 

New categories of medicines:  

The proposal for the new drug pricing regulation has a new categorization for new products and new presentations, now expressly including: 

• Medicines with incremental innovation, 

• Non-new biological products and biosimilars; 

• Medicines resulting from transfer of ownership.  

Category 1 remains applicable to new products with a molecule that is the subject of a patent in the country and that brings therapeutic gain compared to the existing therapeutic alternative in the country.  

Thus, for Category 1, the only proposed change regarding the requirement for patented molecules is to clarify that molecules whose patent applications have been rejected by the Brazilian Patent and Trademark Office (BRPTO) or whose patents are no longer in force will not be considered patented. Additionally, the revised rule eliminates the current requirement to demonstrate a significant reduction in the total cost of treatment for this category.  

The public consultation proposal adds another new category: medicines with incremental innovation, as Category 3. The draft defines a medicine with incremental innovation as one that demonstrates innovative activity compared to an originator medicine already registered in the country, consisting of a new association, new monodrug, new route of administration, new concentration, new pharmaceutical form, new packaging, or other incremental innovation, excluding merely aesthetic or commercial changes.  

The draft transformed into Category 4 the new presentations of medicines already marketed by the same company (currently listed as Category 3).  

Other novelties include the creation of Categories 7 and 8, aimed respectively at non-new biological products or biosimilars and medicines resulting from transfer of ownership.  

The figure of the omissive case remains in the new proposed norm, in the same way as the resolution currently in force.

Deadline for submitting the Price Information Document (DIP) and expansion of the content and required documents: 

The proposal establishes that, from the publication of the approval of Anvisa’s marketing authorization, the company has 60 days to file the DIP of all registered medicines with CMED, regardless of the prioritization of the registration process, through an electronic system. Non-compliance may result in the initiation of an ex officio procedure for defining the Factory Price (PF) by CMED.  

Additionally, the draft proposes that the DIP becomes more robust in terms of documents and information. Thus, the expectation is that, with the new rules, the new DIP should contain more robust clinical, pharmacoeconomic, and scientific evidence, as well as documents proving the performance of innovative activities in the country.  

It is possible to use the simplified DIP modality, applicable to companies holding drug registrations that already have a PF defined by CMED and that choose to comply with simplified sanitary registration procedures. 

Changes in price definition criteria and the basket of countries:  

The rule that the requested PF cannot exceed the lowest PF practiced in reference countries (price basket) remains, although it has received an expansion of the countries involved: 

• Germany, Norway, Japan, Mexico, Australia, Canada, Spain, United States, South Africa, France, Greece, Italy, Portugal, United Kingdom, and the country of origin of the product.
  • Today the basket consists of Australia, Canada, Spain, United States, France, Greece, Italy, New Zealand, and Portugal.

It is also proposed to increase the minimum number of countries for comparison and approval of definitive PF: from three, as provided since 2004, to five countries.  

Medicines developed and manufactured in Brazil are exempt from the requirement to be marketed internationally for the definition of the definitive PF.  

Regarding the definition of provisional price, the draft also expands the situations in which CMED can establish a provisional price, including: 

1. Medicines with active marketing authorization since March 2, 2004, that still do not have a defined price (medicines whose registration holder has never submitted the DIP). 

2. Medicines whose DIP was not filed within 60 days after registration. 

3. Medicines that are not marketed in at least five countries in the reference basket. 

4. Drugs for which the marketing approval is subject to a post-registration requirement for additional data and evidence, in which case the company must submit to CMED’s Executive Secretariat a Technical Report with evidence of the product’s efficacy and safety whenever such data are submitted to Anvisa’s Drug General Office. 

Deadlines for CMED to communicate its decisions on DIPs: 

• Up to 60 days for products classified in Categories 4, 5, 6, and 8; and 

• Up to 90 days for products classified in Categories 1, 2, 3, 7 or considered an omitted case.  

The Life Sciences & Healthcare team at Souto Correa Advogados will monitor the developments of the CP and is available to further explore the proposed changes.

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Em razão das mudanças, o PGR (Programa de Gerenciamento de Riscos) deverá ser atualizado para contemplar:

• Identificação e avaliação dos riscos psicossociais no ambiente de trabalho;
• Implementação de medidas preventivas, como canais de denúncia, ações de capacitação anual e inclusão do tema nas atividades da CIPA;
• Monitoramento e avaliação da eficácia das ações adotadas.

Importante: A avaliação dos riscos deve focar os fatores internos do ambiente de trabalho e seguir uma abordagem coletiva e confidencial, resguardando a identidade dos colaboradores.

Adiamento das penalidades

De todo modo, em 24 de abril de 2025, o Governo Federal oficializou o adiamento do início das medidas de fiscalização contra as empresas que não estiverem cumprindo as novas regras.

Em resumo:

• As atualizações da NR-1 entram em vigor em 26 de maio de 2025;
• O Ministério do Trabalho e Emprego somente poderá aplicar multas a partir de maio de 2026 (após um ano);
• Até lá, as fiscalizações terão caráter exclusivamente educativo, com foco em orientar e permitir a adaptação dos processos internos.

Importante: Essa mudança não implica responsabilidade da empresa por situações pessoais dos trabalhadores, mas exige que fatores organizacionais que possam impactar a saúde mental sejam devidamente mapeados e tratados.

A equipe Trabalhista do Souto Correa segue acompanhando as atualizações sobre o tema e permanece à disposição para esclarecer dúvidas relativas ao processo de adequação às novas exigências.

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What happened?

The proposal to revise RDC 327/2019 includes significant changes, such as allowing the commercialization of cannabis-based products in compounding pharmacies. Anvisa suggests allowing the compounding of products containing exclusively the phytopharmaceutical CBD, provided it has at least 98% purity in an anhydrous base.

What was proposed?

Key points of the proposed changes include:

Why is this important?

In Brazil, products containing cannabis derivatives can be regulated in two distinct categories: as medicines, following the rules for proving quality, safety, and efficacy, or as cannabis-based products, with a simplified regularization process based on RDC 327/2019. Currently, there is only one approved cannabis medicine and 36 regulated cannabis-based products.

According to the current regulatory framework, the sanitary authorization for cannabis-based products has a non-renewable term of five years.

Therefore, the decision is significant, considering that the term of the first sanitary authorizations is ending.

The expectation is that Anvisa will publish a new regulatory framework for cannabis-based products later this year.

Comments from Anvisa’s Director-President

Romison Mota highlighted that the prohibition of dispensing industrialized cannabis-based products by compounding pharmacies is not technically justified.

Additionally, he clarified that the revision of RDC 327/2019 does not confuse with the recent decision issued by the Superior Court of Justice (“STJ”), which determined that Anvisa must create rules for the cultivation, industrialization, and commercialization of hemp by May 19.

RDC 660/2020

During the meeting, fifteen cannabis-based product importers, through the Institute for Connection and Regulation (ICR), presented a proposal to Anvisa to prevent what they call a market reserve for national manufacturers.

Previously, the Pharmaceutical Products Industry Association (Sindusfarma) defended the prevalence of RDC 327/2019, which regulates the manufacturing and commercialization of cannabis-based products in Brazil, arguing that this resolution guarantees the quality, safety, and efficacy of the products.

Sindusfarma argues that RDC 660/2020 – which deals with the exceptional importation by individuals for personal use – was created in an exceptional context and does not meet the safety criteria established by Anvisa. The entity suggests the revocation of RDC 660/2020, stating that the emergency situation that justified its creation has already been overcome.

Director Daniel Pereira also highlighted the need to review RDC 660/2020 to align with the current regulatory and market scenario.

What are the next steps?

DICOL unanimously decided to approve:

Industries, compounding pharmacies, medical entities, patient associations, and civil society will have 60 days to submit their contributions to Anvisa – from April 7th to June 6th.

Our Life Sciences & Healthcare team at Souto Correa is available for any questions about these topics and their possible developments through the email: lifesciences@soutocorrea.com.br.

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The normative instruction establishes that the request for approval to use Siscoaf is the responsibility of the betting operator agent and must be made on the Siscoaf website, according to the instructions in the manual prepared by Coaf.

In addition, the request for approval must be made within 10 (ten) days after the publication, in the Official Gazette of the Union, of the authorization for the betting operator agent to operate fixed-odds betting at the national level.

The normative instruction also states that the communication of non-occurrence of suspicious ML/FT transactions must be sent directly to the Secretariat of Prizes and Bets through the Betting Management System (Sigap), or through another channel created and informed by the Secretariat, by the last business day of January of the year following the year in which there were no occurrences.

Click here for the complete normative instruction.

The Gaming & Betting team at Souto Correa is available to provide more information on the subject.

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The law is structured as follows:

• Title I: General Provisions (Articles 1 to 88)
• Title II: Property Insurance (Articles 89 to 111)
• Title III: Life and Physical Integrity Insurance (Articles 112 to 124)
• Title IV: Mandatory Insurance (Article 125)
• Title V: Statute of Limitation (Articles 126 and 127)
• Title VI: Final and Transitional Provisions (Articles 128 to 134)

Among the main aspects addressed by the new law, we highlight the following:

• Risk Assessment and Allocation: The law includes definitions of limitation, elimination, significant aggravation, and significant reduction of the contracted risk, determining specific consequences for each of these hypotheses and creating obligations for both the insured and the insurer.
• Provision of Information: There are precise provisions on when and how information should be exchanged between the parties, establishing penalties for non-compliance.
• Contract Formation: New rules on the binding nature of proposals sent and received, as well as deadlines for acceptance. The law regulates cases of tacit agreement, which further demonstrates the necessity of revising the procedures that are currently employed in the insurance market.
• Types of Insurance: The existence of specific rules for property insurance, life and physical integrity insurance, and mandatory insurance. This brings aspects to be considered for existing and new contracts, such as new guidelines for apportionment, subrogation, and transfer.
• Claims Regulation and Settlement: This point regulates the procedures, deadlines, and even the consequences of non-compliance with such deadlines in the regulation phases, which aim to identify the causes and effects of the claim, and the settlement of amounts owed by the insurer (or replacement in kind).
• Statute of limitation: New specific limitation periods are established for certain insurance claims.
• Definition of Applicable Law, Jurisdiction, and Venue: The law that applies for the resolution of disputes related to insurance contracts executed in the country is the Brazilian law, with the absolute jurisdiction of the Brazilian courts. The venue will be the domicile of the insured or beneficiary, unless the insured or beneficiary files a lawsuit opting for the domicile of the insurer or its agent. In the case of lawsuits and arbitrations between the insurer, reinsurer, and retrocessionaire, the companies will respond in the forum of their domicile in Brazil.

The Legal Framework for Insurance will come into effect one year from the date of its publication, which occurred on December 10, 2024.

The Contracts team at Souto Correa is monitoring the developments of the new law and is available to provide further information on the subject.

O post Legal Framework for Insurance: Main Impacts apareceu primeiro em Souto Correa Advogados.

Previously, the INPI rejected trademarks containing advertising expressions based on a restrictive interpretation of item VII of Article 124 of the Brazilian Trademark Act. Under the new approach, only signs considered to be of common use and lacking originality—such as those that are purely descriptive, comparative, promotional, or laudatory—will remain ineligible for registration.

This change aligns Brazil with international trends. According to data from WIPO in 2004, only four out of 71 countries (Brazil, South Korea, China, and Japan) did not allow the registration of slogans as trademarks. More recently, China and Japan have revised their stance on this matter.

The INPI’s updated position modernizes Brazil’s trademark system and opens new opportunities for businesses to use slogans in their branding strategies.

Our Intellectual Property team is ready to provide further information on this topic.

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1. Suspension, throughout the national territory, of any reward advertising related to advance payment, anticipation, bonus, or prior advantage, even if merely for promotion, dissemination, or propaganda purposes, for the realization of bets;
2. Suspension, throughout the national territory, of any advertising of fixed-odds online betting games targeted at children and adolescents;
3. Presentation of a transparency report on the measures adopted to comply with the respective suspensions.

Order No. 2,344/2024 also refers to the reasons contained in Technical Note No. 6/2024/CMM/CGEMM/DPDC/SENACON/MJ, through which DPDC argued that the prohibition of granting, in any form, advance payment, anticipation, bonus, or prior advantage, even for the purpose of promotion, dissemination, or advertising, for the realization of bets, is provided for in Article 29, Item I, of Law No. 14,790 of 2023, so that all fixed-odds betting operations are already required to comply with this provision, regardless of the adjustment period. Additionally, DPDC has also identified news regarding child influencers who were promoting fixed-odds betting, which is also already prohibited by Law No. 14,790 of 2023, not depending on the end of the adjustment period.

These measures align with the recent decision issued by Justice Luiz Fux on November 12^th, 2024, and endorsed by the Plenary of the Supreme Federal Court on November 14^th, 2024, in the Direct Actions of Unconstitutionality (ADI) Nos. 7721 and 7723. In this decision, Justice Fux ordered the immediate implementation of actions to monitor and enforce compliance with the provisions of Ordinance SPA/MF No. 1,231/2024, regarding the prohibition of advertising and propaganda measures targeting children and adolescents.

Non-compliance with these measures may result in a daily fine of BRL 50,000, applicable from the date of non-compliance until full compliance with the measure is demonstrated.

The Gaming & Betting team at Souto Correa is closely monitoring developments and is available to provide further information on the matter.

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Why does this matter? 

If an exotic species acquires characteristics specific to Brazilian Biodiversity, all R&D activity involving that species will be regulated by the Biodiversity Law (Law No. 13,123/2015) and other related regulations. This means that companies must adjust their processes to ensure legal compliance to avoid the risk of sanctions.

Oversight 

With this new resolution, IBAMA (the Brazilian Institute of the Environment and Renewable Natural Resources) inspections will likely increase, targeting companies that conduct R&D involving exotic species that have acquired such characteristics.  Thus, this will require sectors such as food, agriculture, and agricultural Bio inputs to comply with the rules in said resolution.

Our Agribusiness, Environmental & Sustainability and Life Sciences & Healthcare team is currently working on projects to ensure compliance within the involved sectors. 

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The first guideline governs the format and content of patent applications. It enhances the process by streamlining electronic filings and providing greater transparency through clearer guidelines on specific requirements. This guideline addresses the formalities and content of patent applications, including provisions related to priority claims, grace periods, divisional applications, and the submission of amendments.

Significant changes were introduced for divisional applications, for instance, requiring a document that highlights the differences between the sets of claims in the divisional and original applications. In cases where there is an overlap in the scopes of protection of the two applications, the claims of the original application must be adjusted to exclude the subject matter claimed in the divisional application.

Additionally, for any amendments made to a pending patent application, a version showing the changes must be submitted, with additions underlined and deletions struck through. Alternatively, an extensive explanation that clearly identifies the changes can be submitted.

With respect to patent applications and granted patents, the second guideline facilitates changes such as name and address updates, and assignment of rights. The most significant modification is the removal of the requirement for certified translations of foreign documents, now allowing simple translations.

These new guidelines aim to give applicants more clarity, streamline the patent process, and demonstrate the BPTO’s commitment to improving Brazil’s intellectual property system.”

The Intellectual Property team of Souto Correa is available to provide more information and clarifications on the matter.

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As a consequence: 

• Companies that have not submitted the license application within that deadline will only be able to explore fixed quota betting activities after obtaining prior authorization from the Secretariat of Prizes and Betting. 

• Bettors who have placed bets with these companies will be able to withdraw their deposited funds until October 10, 2024, directly on the operators’ websites, without prejudice to their right to redeem these funds later. 

• Starting October 11, 2024, the SPA will begin the process of notifying operators in an irregular situation to proceed with the blocking and exclusion of applications that continue to offer fixed-quota betting in the national territory. 

In parallel, betting operators that have submitted their authorization request by September 17, 2024, will be allowed to continue operating in Brazil until December 31, 2024. 

For that, they must indicate the brands (up to 3 per authorization request) in operation and the respective internet domains where they will provide the service in the Brazilian territory until December 31, 2024. 

Said information must be provided by completing the form included in the Annex to SPA/MF Decree nº 1475 and sent to the email adequacao.spa@fazenda.gov.br by September 30, 2024. 

For further information, our Gaming & Betting team is at your disposal.  

O post Ordinance Prohibits Fixed-Odds Betting Without Authorization Request Starting October 1st apareceu primeiro em Souto Correa Advogados.