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About Us
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In Focus
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In Focus

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Client Alerts
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Client Alert

01/09/2023

Procedure changes for prioritizing registration, post-registration, and prior consent for clinical research of medicines come into force

Published on August 21, Anvisa’s RDC No. 811/2023 comes into force today (September 1, 2023). The new resolution changed the following rules: Anvisa’s RDC No. 204/2017, which sets out the priority category for applications for registration, post-registration, and prior consent for clinical research of medicines; and Anvisa’s RDC No. 205/2017, which establishes a special procedure …
Client Alert

25/08/2023

New law requires “SUS” to publish stocks of medicines in public pharmacies

On August 24, 2023, the Acting President of the Republic, Geraldo Alckmin, sanctioned Law N°. 14.654/2023, which adds a provision to the Organic Health Law (Law N°. 8.080/1990). The new law mandates various levels of the Unified Health System (“SUS”) to disclose on their websites the stocks of medicines in public pharmacies under their management. …
Client Alert

23/08/2023

ANVISA promotes changes in the Regulatory Framework for medical devices that aim to bring legal certainty to importers

The advent of RDC 751/2022 was important for the medical devices sector, as it updated Brazil’s regulatory framework after 2 (two) decades of validity. However, despite all the discussion that headed its publication, the Brazilian Health Regulatory Agency (Anvisa) needed to update it quickly to bring more legal certainty to the regulated sector, as well as to …
Client Alert

08/08/2023

ANVISA approves rule that includes Singlie Import Declaration (DUIMP) in imports subject to Health Surveillance

Duimp integrates updating and harmonization of customs procedures subject to sanitary inspection. The Collegiate Board (DICOL) of the Brazilian Health Regulatory Agency (Anvisa), approved during the 11th Ordinary Public Meeting (ROP 11), held on August 2, 2023, a Resolution proposal that aims to regulate the importation through Duimp of goods and products subject to health …
Client Alert

07/08/2023

ANATEL: Subsidies on use of Code 0304 for calls related to charges open

ANATEL Subsidy Call No. 22/2023 on Code 0304 for Debt Collection Calls Aims to gather impressions on the implementation of 0304 to identify debt collection calls, just as 0303 already identifies active telemarketing. Code 0304 will affect all sectors that collect by phone call, for example: stores, companies, banks, offices, hospitals, health plans, telecom service …
Client Alert

28/07/2023

Brazilian Federal Revenue Service regulates the Conformity Shipment Program (“Programa Remessa Conforme”) for e-commerce companies

On July 26th, 2023, the COANA (General Customs Administration Coordination) Ordinance n° 130/2023 was published to regulate the Conformity Shipment Program (“Programa Remessa Conforme” – PRC) for e-commerce companies. Joining in PRC is voluntary, but, according to the Federal Revenue, it will provide faster and more economical customs treatment for e-commerce companies. It is worth …
Client Alert

21/07/2023

Anvisa prohibits importation of cannabis in natura, even if it is for medicinal use

The discussion about the use of CBD products continues to be strong around the world and in Brazil it would be no different. In a nutshell, the Brazilian framework related to the CBD products is: RDC 327/2019, which sets forth the procedures for granting Sanitary Authorization for manufacturing and importation, as well as establishing requirements …
Client Alert

28/06/2023

Federal District regulates take-back system of packaging

The Federal District published on June 12th, 2023 State Decree nº 44.607/2023 (Portuguese only), which sets forth the guidelines for the implementation, structuring and operationalization of the take-back system of packaging in general. Also, the Decree establishes the Certificate of Credit Recycling – RECICLADF in the Federal District. The Decree applies to all manufacturers, importers, distributors, and …
Newsletter

13/06/2023

[News] Data Protection

Since it was established, the National Data Protection Authority (“ANPD”) has adopted measures and promulgated regulations and recommendations regarding the General Data Protection LAW. Listed below are the main news on the subject, released in April and May 2023: ANPD releases technical note on personal data treatment in the pharmaceutical sector Technical Note No. 4/2022/CGTP/ANPD brings …
Client Alert

09/06/2023

IBAMA’s Normative Ruling establishes a preventive embargo on indigenous lands and other public areas of the legal Amazon

IBAMA’s Normative Ruling No. 15/2023 was published on June 6th, 2023 regulating the general preventive and remote embargo of areas with irregular suppression of vegetation, forest exploitation and use of fire in Indigenous Lands and other public areas within the Legal Amazon. Such Normative Ruling provides for the procedures and conditions for the embargo, and the request …

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About Us
Practice Areas
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In Focus
Carrers
Contact

São Paulo | SP

Dr. Ruth Cardoso Avenue, 8501,
17th Floor, Pinheiros District
Postal Code 05425-070
Phone +55 11 3530 8400

Rio de Janeiro | RJ

Visconde de Pirajá Street, 250,
7th Floor, Ipanema District
Postal Code 22410-000
Phone + 55 21 3590 6901

Porto Alegre | RS

Carlos Gomes Avenue, 700,
13th Floor, Auxiliadora District
Postal Code 90480-000
Phone + 55 51 3018 0500

Brasília | DF

SHIS, QL 08, Block 02,
House 01, Lago Sul District
Postal Code 71620-225
Phone + 55 61 3574 7808

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