Digital medication package inserts begin to be regulated by Anvisa.
Nowadays, it is the Resolution 47 of Anvisa’s Board of Directors (RDC), from September 8, 2009, that establishes the rules for the development, standardization, updating, publication and provision of medication package inserts. However, this year, the Act no. 14,338 from 2022 was …
Understand the amendments to nutrition labeling rules.
On October 13, corrections were published that contribute to ensuring clarity, objectivity, and consistency of the Resolution of the Collegiate Board of Directors (RCBD) [Resolução da Diretoria Colegiada – RDC] 429/2020 and Normative Instruction 75/2020. In the meantime, the General Management of …
Check the updated version of the Cadifa Manual of Administrative Procedures.
Anvisa has just published the third version of the Cadifa Manual on administrative procedures. The document was updated due to the migration of the petition of matters related to Cadifa (Adequacy Letter of Active Pharmaceutical Input Dossier) to the Solicita System, following …
Do I need a Company Operation Authorization (AFE, in Portuguese)?
If you own a company that operates in the health, cosmetics, sanitizing and pharmaceutical industries, the Company Operation Authorization (AFE) is one of the steps in your company’s regularization process. Among a series of norms and standards, it regulates safety in facilities, …
Solicita System receives migration of new subjects.
From now on, notifications of temporary and permanent discontinuation of manufacturing and reactivation of medicines manufacturing can be found in the Solicita System. Due to this migration, current requests should only be made electronically. Despite the change, the codes for electronic petitioning …
The new standard on the Certification of Good Manufacturing Practices for medical devices comes into force
On June 1st, according to Anvisa, Directors’ Collegiate Resolution (RDC) 687/2022 came into force, which brings the new criteria for granting or renewing the Certification of Good Manufacturing Practices (CBPF) for medical devices. The new standard arrives to replace the previous RDC …
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, …