In the Licempre Blog you have access to the main information about company registration and product registration in agencies such as ANVISA and INMETRO.
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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 …
08
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 …
27
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 …
10
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 …
11
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 …
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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 …
30
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 …
17
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 …
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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 …