Brazil issues first regulations covering medicinal gases
This article was originally published in SRA
Executive Summary
The Brazilian National Health Surveillance Agency, ANVISA, is to regulate for the first time gases sanctioned for medicinal use with the aim of ensuring that minimum requirements for quality assurance, safety and efficacy are met1. Under the new rules, manufacturers are required to submit to ANVISA “notifications” containing information about their products, though they do not need to obtain approval from the agency2.