In the Licempre Blog you have access to the main information about company registration and product registration in agencies such as ANVISA, MAPA and INMETRO.
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 …
19
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 …
31
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 …
19
Which are the products that do not need to be regulated at Anvisa?
Did you know that some products do not need to be regulated at Anvisa? In our consultancy, we come across many customers who have this …
29
Less bureaucracy in the integration of consent for import licenses from INMETRO
INMETRO is integrating its license agreement process with Siscomex – Single Portal of the Integrated Foreign Trade System. The objective …
09
Sale of Products for the Treatment of COVID-19 unregistered with ANVISA
The resolution RDC 483/21 extraordinarily and temporarily provides the requirements for the importation of health products and drugs …
