Ficam revogadas as disposicoes em contrario, em especial as resolucoes n. Medicamento rdc 6014 principio ativo rdc 45 2012 estabilidade excipientes embalagem rdc 7109 rotulagem rdc 4709 bula estudos in vitro rdc 3110 eqfar re 012005 estabilidade rdc 89903 validacao rdc 58 impurezas nt 03 dissolucao estudos in vivo re 0915 ddcm re 1170 be bpf rdc 1710 27. Requirements for proof of gmp for registration processes of healthcare products en en pt. The resolution of the collegiate board of directors of anvisa. O maior controle sobre esses medicamentos, estabelecido atraves da publicacao da rdc n. Benetoli duran intradermica endovenoso o cateter pode ter um unico ou multiplos lumens. Guidelines database portuguese re 8992003 analytical validation portuguese rdc 372009 officially recognized compendia portuguese rdc. Re 899 2003 analytical validation portuguese rdc 372009 officially recognized compendia portuguese rdc 2552018 anvisa statute portuguese rdc 2832019 nitrosamines portuguese rdc 1662017 analytical validation portuguese os 220 clarifications about api stability studies portuguese. Requirements for economic information report en en pt.
Anvisa will then issue their decision, consenting, or not, on the granting. Main reasons for registration application refusal of generic and. Medical device manufacturers participation in the medical. Rdc 45 2012 api stability studies english rdc 692014 api gmp portuguese normative instruction in 152009 list 1 of apis subject to marketing authorization english normative instruction in 320 list 2 of apis subject to marketing authorization english technical note nt 62015 coinscoifa starting material portuguese. Rdc 52 2009 dedetizadora embalagem e rotulagem publicidade. Resoluo rdc n o 45 pdf documento assinado digitalmente conforme mp no 2. Yes, please send the documentation in a searchable and indexed pdf file. Brazil medical device regulations anvisa guidelines. Brazil, the largest country in south america, has become the second largest pharmaceutical market in the emerging world.