{"id":14815,"date":"2008-12-22T00:00:00","date_gmt":"2008-12-22T05:00:00","guid":{"rendered":"http:\/\/www.farmchemicalsinternational.com\/2008\/12\/22\/me-too-fast-track\/"},"modified":"2019-09-16T13:48:12","modified_gmt":"2019-09-16T17:48:12","slug":"me-too-fast-track","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/markets\/me-too-fast-track\/","title":{"rendered":"Eu tamb\u00e9m via r\u00e1pida"},"content":{"rendered":"<p>O mercado brasileiro de defensivos agr\u00edcolas \u00e9 conhecido mundialmente como muito atrativo, devido aos altos volumes de vendas (US$ 1,4 bilh\u00e3o em 2005 no n\u00edvel de distribuidor), altas margens de vendas (uma das mais altas do mundo) e dif\u00edcil acesso ao mercado causado por legisla\u00e7\u00e3o regulat\u00f3ria muito complexa, custos elevados e muita burocracia. <\/p>\n<p> Desde 2002, quando foi editado o Decreto n.\u00ba 4.072\/2002 para instituir o Registro de Equival\u00eancia, poucos produtos foram efetivamente registrados. Apesar de os avan\u00e7os no registro de produtos gen\u00e9ricos terem proporcionado uma redu\u00e7\u00e3o consider\u00e1vel de custos, o longo tempo para obten\u00e7\u00e3o da autoriza\u00e7\u00e3o de mercado desestimulou v\u00e1rios novos participantes, especialmente porque n\u00e3o h\u00e1 um prazo estipulado realista para a concess\u00e3o dessas licen\u00e7as. Sens\u00edvel a alguns segmentos da sociedade, principalmente aqueles ligados a grandes produtores rurais em contato pr\u00f3ximo com a classe pol\u00edtica, o governo federal publicou em 7 de dezembro o Decreto Presidencial n.\u00ba 5.981, que pretende agilizar, simplificar e reduzir o tempo de an\u00e1lise e concess\u00e3o de licen\u00e7as de registro, notadamente para produtos definidos como \u201cme-too\u201d. <\/p>\n<p> Algumas altera\u00e7\u00f5es importantes quando comparadas \u00e0 legisla\u00e7\u00e3o anterior envolvem o registro de produtos t\u00e9cnicos. Entre elas: <br \/> &nbsp;<\/p>\n<ul>\n<li>Simplifica\u00e7\u00e3o dos testes obrigat\u00f3rios<\/li>\n<\/ul>\n<ul>\n<li>Estabelecimento de etapas para submiss\u00e3o de testes, a serem seguidas caso n\u00e3o seja poss\u00edvel demonstrar equival\u00eancia ao produto de refer\u00eancia&nbsp;<\/li>\n<\/ul>\n<ul>\n<li>A possibilidade de que os registos de produtos cancelados possam servir como produtos de refer\u00eancia para registo de equival\u00eancia<\/li>\n<\/ul>\n<ul>\n<li>Comunica\u00e7\u00e3o da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria, ANVISA, respons\u00e1vel pela regula\u00e7\u00e3o sanit\u00e1ria no Brasil, que informar\u00e1 ao requerente do registro de equival\u00eancia quais produtos registrados servir\u00e3o como produtos de refer\u00eancia.<\/li>\n<\/ul>\n<p>Com esses novos par\u00e2metros \u00e9 poss\u00edvel estimar uma redu\u00e7\u00e3o no tempo de execu\u00e7\u00e3o dos testes necess\u00e1rios. O teste de hidr\u00f3lise, por exemplo, que era exigido pela legisla\u00e7\u00e3o anterior, pode levar at\u00e9 oito meses para ser executado. Para mol\u00e9culas consideradas inst\u00e1veis, como o fipronil, \u00e9 necess\u00e1rio realizar o teste com compostos radiomarcados (C14) que podem custar at\u00e9 US$ $50.000.<\/p>\n<p class=\"subhead\">Lei de Formula\u00e7\u00e3o Reformulada<\/p>\n<p>Para produtos formulados, os avan\u00e7os na legisla\u00e7\u00e3o podem ser considerados ainda mais ben\u00e9ficos. No entanto, deve-se levar em conta que, no Brasil, al\u00e9m do registro em n\u00edvel federal, \u00e9 obrigat\u00f3rio o registro em n\u00edvel estadual, o que em alguns casos \u00e9 mais restritivo e complexo do que as regras de registro em n\u00edvel federal. <\/p>\n<p> Algumas altera\u00e7\u00f5es importantes em rela\u00e7\u00e3o \u00e0 legisla\u00e7\u00e3o anterior referente a produtos formulados incluem:<\/p>\n<ul>\n<li>A submiss\u00e3o de testes de efic\u00e1cia n\u00e3o \u00e9 obrigat\u00f3ria, em alguns casos<\/li>\n<\/ul>\n<ul>\n<li>Em alguns casos, a apresenta\u00e7\u00e3o de testes de res\u00edduos n\u00e3o \u00e9 obrigat\u00f3ria.<\/li>\n<\/ul>\n<p>Apesar dessa flexibilidade adicional, o novo Decreto determina que \u00e9 obrigat\u00f3ria a apresenta\u00e7\u00e3o de informa\u00e7\u00f5es sobre a fitotoxicidade do produto sobre as culturas tratadas. Isso pode levar \u00e0 necessidade de realiza\u00e7\u00e3o de testes de efic\u00e1cia para demonstrar a inocuidade do produto sobre as culturas. Outro ponto relevante a ser considerado \u00e9 a Permiss\u00e3o de Uso Experimental (PEU). Desde que se tornou obrigat\u00f3ria, o n\u00famero de solicita\u00e7\u00f5es vem aumentando significativamente a cada ano. Solicita\u00e7\u00f5es de amostras de 500 gramas para importa\u00e7\u00e3o necess\u00e1rias para realiza\u00e7\u00e3o de testes laboratoriais podem levar mais de 12 meses para serem deferidas, o que tem atrasado cronogramas experimentais e registros de produtos.<\/p>\n<p> De acordo com o novo Decreto, a concess\u00e3o de tais EUPs pode ser autom\u00e1tica em alguns casos espec\u00edficos. Para abordar esse t\u00f3pico, uma nova legisla\u00e7\u00e3o regulat\u00f3ria espec\u00edfica ser\u00e1 publicada no futuro. Infelizmente, as implementa\u00e7\u00f5es desses novos procedimentos podem levar v\u00e1rios meses. As autoridades reguladoras n\u00e3o preveem mudan\u00e7as nos procedimentos relativos a EUPs at\u00e9 abril de 2007, e o conselho \u00e0s empresas \u00e9 que todas devem proceder de acordo com a legisla\u00e7\u00e3o anterior por enquanto. <\/p>\n<p> Recomenda-se cautela \u00e0s empresas ao determinar or\u00e7amentos para assuntos regulat\u00f3rios. Apesar do que foi divulgado na imprensa, os custos n\u00e3o devem ser reduzidos t\u00e3o drasticamente quanto indicado, pois outras despesas devem ser levadas em conta, como os registros estaduais, sem os quais n\u00e3o \u00e9 permitido transportar e comercializar pesticidas no Brasil. \u00c9 o caso do estado do Paran\u00e1, que \u00e9 respons\u00e1vel por quase 30% da produtividade agr\u00edcola brasileira e possui um alto n\u00edvel tecnol\u00f3gico de produ\u00e7\u00e3o. Para registrar pesticidas neste estado, \u00e9 necess\u00e1rio apresentar relat\u00f3rios de testes de efic\u00e1cia e estudos de res\u00edduos.<\/p>\n<p> Os avan\u00e7os regulat\u00f3rios apresentados neste novo Decreto promovem um passo importante para acesso mais r\u00e1pido ao mercado de pesticidas. As autoridades reguladoras declararam que seu principal objetivo \u00e9 diminuir o per\u00edodo declarado de concess\u00f5es de registro para novos produtos para menos de 6 meses.<\/p>","protected":false},"excerpt":{"rendered":"<p>O mercado brasileiro de defensivos agr\u00edcolas \u00e9 conhecido mundialmente como muito atrativo, devido aos altos volumes de vendas (US$ 1,4 bilh\u00e3o em 2005\u2026<\/p>","protected":false},"author":110,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-14815","post","type-post","status-publish","format-standard","hentry","category-markets"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Me-Too Fast Track - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"The Brazilian pesticide market is known worldwide as very attractive, due to high sales volumes (US $4.2 billion in 2005 at the distributor level), high\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.agribusinessglobal.com\/pt\/markets\/me-too-fast-track\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Me-Too Fast Track - 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