Anvisa alters rules for exporting medicines from the ‘intubation kit’ – Prime Time Zone


Medicines such as fentanyl and midazolam may only be exported with prior authorization from the agency; resolution was published in the Federal Official Gazette

EVANDRO LEAL / FRAMAR / ESTADÃO CONTENT – 03/19/2021Vaccines against Covid-19 and medicinal oxygen are among the substances that need prior authorization from Anvisa

The National Health Surveillance Agency (Anvisa) determined this Wednesday, 31, that the remedies that make up the “intubation kit”Will need prior authorization from the Collegiate Board to be exported. The resolution was published in the Federal Official Gazette (DOU). The decision amends rules foreseen in a previous resolution on the export of raw materials, semi-finished products, bulk products or finished pharmaceutical products intended to combat Covid-19. Among the drugs used for intubation and which now need approval from Anvisa, are fantanil, midazolam, rocuronium and succinylcholine. Prior export authorization will be granted by the agency’s Collegiate Directorate.

Substances that require prior authorization from Anvisa for export:

  • Medicinal oxygen (O2);
  • Covid-19 vaccines;
  • Nitazoxanide, Chloroquine, Hydroxychloroquine, Azithromycin, and Ivermectin;
  • Fentanyl, midazolam, ethosuximide, propofol, pancuronium, vecuronium, rocuronium and succinylcholine, porcine sodium heparin, bovine sodium heparin, sodium enoxaparin and dexmedetomidine;
  • Active pharmaceutical ingredients (IFA), salts, ethers and esters of these substances;