Brazil’s ANVISA Extends the Validity Period of the Brazilian GMP Certificate
ANVISA has extended the validity period of the Good Manufacturing Practices Certificate to four years.
Blog – Understanding the Registration Process of Cosmetics with Brazil’s Anvisa
Before starting the registration process in Brazil, it is essential that the company complies with all regulatory requirements. This involves obtaining the Operating License/Authorization from the local health surveillance agency and the AFE/AE from Anvisa.
Exploring the Diversity of Medical Devices for Health Promotion in Brazil
Overview: Brazil stands out as the main market for medical devices in Latin America, with an established, albeit complex, regulatory system. Medical products in the
“Electronic Submission Now Available for Investigational New Drug Application (IND) Safety Reports”
The FDA has issued a reminder to drug sponsors and researchers regarding its recent publication of guidance outlining the process for electronically submitting investigational new drug application (IND) safety reports to the FDA Adverse Event Reporting System (FAERS). IND individual case safety reports (ICSRs) can now be submitted electronically through either the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal, with the FDA now accepting such submissions.
Health Product Labelling Requirements for Imported Products into Brazil
The import of Health products into Brazil is subject to various regulations, with proper labelling being a crucial part of this procedure. These regulations cover the current standards for labelling imported products, outlining the responsibilities of importers and the essential elements that must be included on labels.
Brazil’s Anvisa Updates the Labeling of Cosmetic Products – 2024
The Labeling of Cosmetics in Brazil’s regulations will start including INCI requirements in 2024.