Pesticides: New decree improves legislation and adapts Brazilian rules to international regulations
According to information from ANVISA, Decree 10.833/2021 was published in the Federal Official Gazette (D.O.U.), on October 8, which amended Decree 4.074/2002 and presented updates to the Brazilian rules applied to pesticides, conjectured in Law 7802/1989. The legislation encompasses issues related to …
Pilot project migrates imports to the Single Foreign Trade Portal
According to information from Anvisa, the import of products for advanced therapies now belongs to the pilot project of petitioning the Single Foreign Trade Portal, through the application in the Import Licenses, Permissions, Certificates and Other Documents (LPCO) module. As of September …
In partnership with Inmetro, a Startup creates lung biotissues with the aim of studying their interaction with the new coronavirus
The startup Gcell Cultivo 3D is creating an automated platform to manufacture 3D biotissues from human lung cells, allowing for the study of their interaction with the new coronavirus. Gcell is part of Coppe’s Business Incubator (UFRJ) and uses the infrastructure of …
Phytosanitary treatments for quarantine purposes are regulated by Mapa
On August 27, the Ministry of Agriculture, Livestock and Supply (Mapa) published Ordinance No. 385, in the Official Gazette of the Federal Government, establishing the criteria and procedures for performing phytosanitary treatments with quarantine purposes. This measure is intended to meet the …
Even if not included on the package insert, the combination of drugs is not off-label
In short, according to Anvisa, even if not included on the package insert of one of the drugs, the combination is not considered off-label because, when required by one of the registration’s owners and if its use with other drugs was investigated, …
The importation of cannabis-derived products now has its own code
In the last 26th day of July, the Sanitary Surveillance Agency (ANVISA) informed that the application to import cannabis-derived products now has a unique subject code in cases of personal use by individuals. What are cannabis-derived products? “Cannabis” is the scientific …
Anvisa approves PC on Unique Identification of Medical Devices
The public consultancy for the regulation of the strategic project intends to unequivocally identify medical devices in the Brazilian market was approved in June by the National Health Surveillance Agency – ANVISA. What are medical devices? A medical device is an …
Managerial procedures required to obtain the Good Manufacture, Distribution, and Storage Practice Certificate
Anvisa issued the Resolution of the Collegiate Board of Directors (RDC) 497/2021, in which it establishes the managerial procedures required to obtain the Good Manufacture Practice Certificate and the Good Distribution and/or Storage Practice Certificate. The objective of this resolution is to …
How to add health product use instructions in Anvisa’s portal?
Anvisa requires the attachment of health product information during their registration in the regulating body’s portal. After the effectuation of the RDC no 431/2020, which enforces the upload of use instructions on Anvisa’s digital portal related to medical device notification or registration …
Anvisa’s Guidelines on Ultraviolet Light-Emitting Equipment
Anvisa issues a new technical note on ultraviolet light-emitting equipment, with clarifications and proof methodologies regarding its disinfectant effectiveness and the risks it may represent to human health. Get to know Anvisa’s guidelines, warnings and clarifications on the use of ultraviolet (UV) …