ORBIS Compliance

Brazil's ANVISA Detects Batches of Counterfeit Critical Medicines

Published /Effective /Brazil

On June 3, 2025, Brazil's National Health Surveillance Agency (ANVISA) issued two resolutions ordering the seizure of batches of counterfeit medicines.

The measure specifically affects the products Rybelsus and Ofev, whose respective batches were not recognized by their legitimate manufacturers. This indicates that the medicines in question were not produced by these companies and are therefore considered counterfeit.

Rybelsus is an oral medication used in the treatment of type 2 diabetes, whose active ingredient is semaglutide. Ofev is indicated to treat and slow the progression of lung diseases such as idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSID), also known as scleroderma.

WHOM DOES THIS IMPACT?

The direct impact is on patients, healthcare professionals, legitimate pharmaceutical companies, and the regulatory and healthcare system.

CONCLUSION:

The impact is high because it directly compromises the health and lives of patients, challenges the credibility of the healthcare system, and represents a serious problem involving multiple stakeholders in the fields of public health and pharmaceutical safety.

Regulatory Authority

ANVISA

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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