Acessem
http://portal.anvisa.gov.br/documents/10181/3422944/Guia8_versao2_out2018.pdf/34ebdc1f-802c-4be0-9d93-dcb6f635c19a?fbclid=IwAR1oy9A-itXaTC-n7zHuXdCd7lkEHypEqHFyPwEGtCEwVyBjlxQGR8uSEwM