Rdc 71 2009 anvisa pdf

Rdc 71 embalagens embalagem e rotulagem receita medica. On 16 june 2011, anvisa published resolution rdc n 262011, which suspends the requirements for the adaptation period of drug labelling rules established by resolution rdc n 71, 22 december 2009. The provisions in this regulation must ensure reading by electronic data capture mechanisms and must be legibly inscribed to the human eye, throughout the pharma supply chain and within the validity of the product. It addresses technovigilance rules applicable to registration. Rdc 552010 marketing authorization rdc 462000 blood products rdc 3232003 probiotics rdc 502011 stability rdc 472009 rdc 602012 package insert rdc 71 2009 rdc 612012 labelling rdc 172010 gmp rdc 1942017 allergenics rdc 1872017 hyperimmune sera law 6. Brazil medical device regulations anvisa guidelines. Generic medicines regulation in brazil request pdf. We also can help you register your medical devices with anvisa. Comprehensive list of medical device regulations for medical devices sold in brazil.

Os documentos eletronicos deverao permitir busca textual. We use cookies to offer you a better experience, personalize content, tailor advertising, provide social media features, and better understand the use of our services. Regulatory considerations for biological products in brazil. Anexo iii, com seus respectivos apendices i e ii da resolucao n. Rdc 71 2009 rdc 612012 import rdc 812008 quality control rdc 2342005 good manufacturing pratices rdc 172010 blood products rdc 462000 allergenics rdc 2332005 probiotics. Rdc 552010 marketing authorization of biological products. It addresses technovigilance rules applicable to registration holders for health products in brazil. Anvisa rdc 552010 i new biological product is the biological medicine containing a molecule with a known biological activity, still not licensed in brazil, and that. O artigo 76 da resolucao da diretoria colegiada rdc n. Anvisa grants permission for clinical trials to be conducted in accord.