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Client Alert

06/09/2023

Anvisa’s public consultation is open until 10/25 to receive comments about the procedure to adopt reliance for medical devices

The National Health Surveillance Agency (Anvisa) has been striving to promote regulatory harmonization in recent years. In this regard, the Collegiate Board Resolution RDC 741/2022 has introduced authorization for optimized analysis through reliance mechanisms. However, RDC 741/2022 stipulates that each technical area of the Agency must define specific requirements for these optimized procedures, indicating the documents to …
Client Alert

06/09/2023

ANPD: Public Consultation on the preliminary study of legitimate interest

The National Data Protection Authority (ANPD) invites the general public to submit suggestions and comments on the Preliminary Study – Legitimate Interest (click here). The purpose of this consultation is to facilitate public discussion to assist in the future development of a Guidance Manual on the legal basis for the processing of personal data by the data …
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 …

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