Rdc 302008 api registry portuguese rdc 572009 api marketing authorization english rdc 452012 api stability studies english rdc 692014 api gmp portuguese normative instruction in 152009 list 1 of apis subject to marketing authorization english. During that period of time, anvisa delivered several related publications to make the. Collection of medicines according to the rdc n 55 of 2005. Seven types of technical deviations were found, and its characteristics. General overview of the brazilian regulatory framework 3. As established in subsection x of article 17 of decree no. Medicinal products regulation in brazil recent regulatory update and regulatory progress. But on december 4th 2015 anvisa revoked rdc 5820 and published instead an updated version of this resolution. After submitting the form, anvisa may approve the content and form of the alert message or may indicate needed corrections. Methodological proposal for validation of the disinfecting efficacy of. Esta resolucao altera as resolucoes da diretoria colegiada rdc n. A guide for importing medical equipment into brazil. O maior controle sobre esses medicamentos, estabelecido atraves da publicacao da rdc n.
Edificio minas rodovia papa joao paulo ii b serra verde, n. Brazilian health surveillance agency anvisa guidance on. Anvisa altera redacao da rdc sobre responsaveis por utis. Servico publico federal ministerio do desenvolvimento. Guidelines database portuguese re 8992003 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. In 2010, anvisa implemented the surveillance of primary bloodstream. Rdc 552010 marketing authorization of biological products. Auditing organizations may be used to issue anvisa gmp certificate rdc 1832017. Ouca e entenda as principais alteracoes estabelecidas pela anvisa. Adota a seguinte resolucao da diretoria colegiada e eu, diretorpresidente, determino sua publicacao. Forced degradation studies comparison between ich, ema. According to the deadline for the collegiate board resolution rdc, the resolution rdc 5820 was expected to come into force end of december 2015. A guide for importing medical equipment into brazil 1.