Rdc 48 2009 anvisa pdf files

May 23, 2015 this article describes regulatory approaches for approval of generic orally inhaled drug products oidps in the united states, european union, brazil, china and india. Jul 06, 2016 on july 4th, anvisa published the document named questions and answers of the resolution rdc 532015 and guide n. Good manufacturing practices, as a regulatory requirement from anvisa, apply to companies that manufacture drugs, medical devices, personal hygiene products, cosmetics and fragrances, sanitizing products, food and active pharmaceutical ingredients apis, located either on national territory or abroad. Comprehensive list of medical device regulations for medical devices sold in brazil. Mapping of applicable technical regulations, conformity assessment. Meiruze freitas, superintendent of medicines, anvisa pmda. Guidance document degradation profiles of drug products portuguese faq rdc 732016 portuguese guidance. Brazilian health surveillance agency anvisa guidance on. Ausraa australias regulatory process for medical devices. Feb 04, 2014 similarities and differences of international guidelines for bioequivalence.

Anvisa has also presented its official application to pics. We also can help you register your medical devices with anvisa. The brazilian health surveillance agency anvisa south. Pharmaceutical equivalence studies and comparative dissolution profile. This evaluation will impact the process of drugs prequalification of paho, as well as it will help guide regional cooperation in the field of health surveillance. Regulatory considerations for approval of generic inhalation. Table 2 list of anvisa resolutions on pesticides resolution of the board of directors rdc n. This is a working document, and hence it represents research in progress. To start a process of cooperation with identification of regulatory asymmetries and convergences.

Technovigilance requirements for registration holders, en pt, rdc 67 2009, 2009. Rdc 482009 postapproval changes of drug products portuguese revoked. Brazil medical device regulations anvisa guidelines emergo. The brazilian health surveillance agency anvisa south south. Diacetyl in beer pdf free solidcam cours francaisadds. Resolution rdc 2120, which altered resolution rdc 452008, regulates anvisas prior consent of pharmaceutical process and product patent applications. Rdc 482009 postapproval changes of drug products portuguese revoked rdc 172010 drug product gmp. Rdc 452012 api stability studies english rdc 692014 api gmp portuguese normative instruction in 15 2009 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. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Rdc 2552018 anvisa statute portuguese rdc 2832019 nitrosamines portuguese. This resolution is the result of a public consultation 29 issued by anvisa. Rdc 4499anvisa boas praticas em farmacias e drogarias by.

Faq apis english pdf guidance document degradation profiles of drug. Brazilian rules updating for pharmaceutical excipients. Information about api used drug master file dcb common. Rdc 48 2009 postapproval changes of drug products portuguese revoked rdc 172010 drug product gmp portuguese. Rdc n 602014 homeopathic drug rdc n 262007 herbal medicines rdc n 262014 biological drug rdc n 552010 specific drugs rdc n. The collegiate board of directors of the brazilian national health surveillance agency, in the exercise of the powers vested by article 11, subsection iv, of anvisa. The document brings 47 questions and answers about degradation. Similarities and differences of international guidelines for. Revokes resolution of the board of directors rdc no. Attenuation of paraquatinduced motor behavior and neurochemical disturbances by lvaline in vivo. The 1st braziljapan seminar on pharmaceuticals and medical. Rdc 37 2009 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 os 582019 simplified procedure for apis portuguese. Who region of the americas clinical investigation clinical investigation controls.

This will strength the relation among anvisa and the main. While registration of a generic oidp in any given market may require some documentation of the formulation and device similarity to the original product as well as comparative testing of in vitro characteristics and. Technovigilance requirements for registration holders, en pt, rdc 672009, 2009. Brazil medical device regulations anvisa guidelines. Mapping of applicable technical regulations, conformity. Rdc 102015 details clinical trial controls, including applications for permission to conduct. Rdc 52 2009 dedetizadora embalagem e rotulagem publicidade. Brazilian health surveillance agency anvisa technical note. The resolution of the collegiate board of directors of anvisa. Anvisa questions and answers of the resolution rdc 532015.

All documents listed below were published by anvisa in portuguese and translated by. 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. Os procedimentos operacionais padrao pops devem ser discutidos com a equipe, aprovados, assinados e datados pelo farmaceutico responsavel tecnico. These topic pages provide a quick overview and easy access to all content that can be found on ace for any give topic of interest weather encyclopaedia files, electoral materials, comparative data, consolidated replies, case studies, or other. Paho issued anvisa with the high level qualification. The collegiate board of the national health surveillance agency, in the exercise of the attributions granted by.