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 …
Inmetro announces the Regulatory Agenda for Legal Metrology for the first time
Inmetro’s Legal Metrology Board (Dimel) announced in an unprecedented way its Regulatory Agenda for the years 2022 and 2023, as stated in the Federal Official Gazette. This publication had great popular participation and designates the main topics for the period, reviewing metrological …
Anvisa updates the codes of its Contingency Plan
Recently, Anvisa announced that it identified the need to include and change the subject codes for the Import Licensing petition, through the Request System, originating from the registration of LPCO – Licenses, Permissions, Certificates and Other Documents, in the Single Foreign Trade …
Inmetro makes two patent applications internationally protected
According to a statement from Inmetro (National Institute of Metrology, Quality and Technology), two of its patents, which already had deposits in Brazil, are now also protected abroad. Potential innovations are in the area of telecommunications and biotechnology. The first concerns data …
Norm on imports of medicines and medical devices reaches the end of its validity, according to Anvisa
With the emergence of the pandemic, Brazil needed to supply itself with essential products to face Covid-19 in hospital environments. For this, the RDC 483/2021 was created as an emergency, which aimed to supply the national market in order to meet all …
Change simplifies the provision of Inmetro’s identification seals
Previously, you had to obtain an approval in advance with Inmetro. Nowadays, though, the printers were authorized to provide the seals. All you need to do is request the file with the safety specifications for the necessary purpose. These seals’ issuance …
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 …