Transfer certificate of GMP and Ownership of Products: What Companies Need to Know
The transfer of Good Manufacturing Practice Certificates (GMP) at Anvisa is a specific process, usually related to changes in certificate ownership due to corporate reorganization, such as mergers or acquisitions.
Integration of the Health Surveillance Fee into the Single Foreign Trade Portal: Timetable and Impacts for Brazilian Trade
Anvisa (the National Health Surveillance Agency), in partnership with the Foreign Trade Secretariat (Secex) and the Federal Revenue Service, has announced the integration of the payment of the Health Surveillance Fee into the Single Foreign Trade Portal (Siscomex). This change is part of a move to centralize and digitize foreign trade processes, offering more agility, transparency and simplicity for importers and exporters dealing with products subject to health surveillance.
QCC x GMP: How does the Quality Control Certificate relate to ANVISA’s Good Manufacturing Practices?
The QCC (Quality Control Certificate) is indeed associated with ANVISA’s Good Manufacturing Practices (GMP), but they are not exactly the same thing. ANVISA’s GMP (Good Manufacturing Practices) is a regulatory requirement that certifies that health product companies, such as medicines and medical devices, follow safe and effective manufacturing practices. QCC certification is a type of quality control documentation that can be used to certify compliance with ANVISA’s GMP standards, but QCC itself is more of a type of control certification and does not replace the formal GMP authorization issued by ANVISA
ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force
The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.
Gluten and Food Labeling: What You Need to Know
Gluten and Food Labeling: What You Need to Know
Discover That it is Possible to Import Dental Products.
Discover That it is Possible to Import Dental Products
“Discover the critical role that packaging plays in the development of cosmetic products.”
“Discover the critical role that packaging plays in the development of cosmetic products.”
Clone Drug Registration with ANVISA: Understand the Process
Clone Drug Registration with ANVISA: Understand the Process
How Product Registration Hosting Can Boost Your Business Success
How Product Registration Hosting Can Boost Your Business Success
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 country are regulated by the National Health Surveillance Agency (ANVISA). Against this backdrop, we explore the main types of medical devices and their specific applications within the Brazilian context. Introduction: […]