Know the numbers of ANVISA’s post-market monitoring of products in 2021.
Last year, 216,406 notifications were received by Anvisa’s monitoring area regarding adverse events, technical complaints and deviations in product quality, as well as reports of intoxications. Of these notifications, 124,523 were divided by the agency into specific surveillance, namely pharmacovigilance, techno vigilance , …
VigiMed has now new features.
As part of the improvement in pharmacovigilance, Anvisa announces that the VigiMed system has received new functionalities. The most awaited news is the Medical Dictionary for Regulatory Activities (MedDRA), which has been incorporated into the manual data entry module. This new measure …
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 …
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 …
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 question, and in this blog post, you will understand better about the regulation of products and which …
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 identified as a priority for use in health services, due to the health urgency during the pandemic. According to the regulation of products and …
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