Cycl2R, Here are two links, one a pdf download.
Post# of 148277
Here are two links, one a pdf download. Document in Portuguese. Google translate will work on sections.
https://www.gov.br/anvisa/pt-br/assuntos/medi...8.2021.pdf
https://www.gov.br/anvisa/pt-br/assuntos/medi...d.pdf/view
Page 21, items 103 & 104 I believe.
This is the screen shot of page 21.