{"id":15891,"date":"2009-04-08T00:00:00","date_gmt":"2009-04-08T04:00:00","guid":{"rendered":"http:\/\/www.farmchemicalsinternational.com\/2009\/04\/08\/brazil-registration-challenges\/"},"modified":"2019-09-16T13:47:14","modified_gmt":"2019-09-16T17:47:14","slug":"brazil-registration-challenges","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/pt\/industry-news\/brazil-registration-challenges\/","title":{"rendered":"Brasil: Desafios do Registro"},"content":{"rendered":"<p>O acesso aos maiores mercados de pesticidas do mundo (em valores de vendas) \u00e9 restrito e custoso devido \u00e0s dificuldades em obter registro de produtos e compensa\u00e7\u00e3o de dados. Na dire\u00e7\u00e3o oposta, existem alguns mercados (em volumes de vendas) onde o acesso \u00e9 quase irrestrito, com registro simplificado e sem compensa\u00e7\u00e3o de dados. Mas essas raz\u00f5es s\u00e3o as mesmas que permitiram uma competi\u00e7\u00e3o predat\u00f3ria com margens m\u00ednimas de vendas. Nesse ambiente, qualquer instabilidade \u2014 seja clim\u00e1tica, pol\u00edtica ou financeira \u2014 leva a grandes perdas econ\u00f4micas em toda a cadeia de suprimentos.<\/p>\n<p>Com um dos procedimentos de registro mais trabalhosos e complexos do mundo, o Brasil manteve alguns dos maiores players da China e da \u00cdndia longe por causa das dificuldades em obter registros de produtos. Tornou-se um exemplo cl\u00e1ssico de barreira involunt\u00e1ria ao acesso ao mercado. Essas dificuldades se tornaram t\u00e3o cr\u00edticas que os registros de produtos custam entre US$ $1 milh\u00e3o a $1,5 milh\u00e3o e, na maioria dos casos, os pacotes de dados que suportavam esses registros tamb\u00e9m tiveram que ser atualizados. Al\u00e9m disso, h\u00e1 exemplos de empresas que foram incorporadas e seus ativos mais valiosos eram seus registros de produtos.<\/p>\n<p>Desde a nova regulamenta\u00e7\u00e3o que simplifica o processo para produtos pesticidas equivalentes ou registros me-too, os mercados brasileiros t\u00eam sofrido uma das maiores transforma\u00e7\u00f5es dos \u00faltimos 20 anos. Desde 2006, as ag\u00eancias reguladoras aprovaram 88 produtos equivalentes de grau t\u00e9cnico e 59 formula\u00e7\u00f5es para produtos equivalentes de grau t\u00e9cnico.<\/p>\n<p>Considerando o fato de que pelo menos uma formula\u00e7\u00e3o \u00e9 registrada para cada produto de grau t\u00e9cnico, h\u00e1 cerca de 30 novas submiss\u00f5es de formula\u00e7\u00f5es sob an\u00e1lise. Esses produtos devem estar dispon\u00edveis no mercado este ano. Estima-se que muitos outros registros de produtos formulados ser\u00e3o aplicados porque \u00e9 poss\u00edvel usar um \u00fanico registro de produto t\u00e9cnico para obter in\u00fameros registros de formula\u00e7\u00e3o, geralmente chamados de clones. Estima-se que 60 a 80 submiss\u00f5es de produtos t\u00e9cnicos equivalentes foram aplicadas at\u00e9 o final de 2008 e ser\u00e3o avaliadas durante 2009.<\/p>\n<p>Se nos pr\u00f3ximos dois a tr\u00eas anos a pol\u00edtica governamental permitir a promo\u00e7\u00e3o de competi\u00e7\u00e3o que possibilite a entrada de novos players no mercado por meio de novos registros, ent\u00e3o estima-se que fabricantes e comerciantes de m\u00e9dio e grande porte \u2014 que at\u00e9 agora s\u00f3 fornecem para distribuidores locais \u2014 ir\u00e3o proliferar no Brasil. No entanto, as abordagens das empresas estrangeiras podem n\u00e3o ser suficientes considerando o tamanho do mercado. Como principal fabricante de pesticidas do mundo, a China tem poucos representantes acessando-a diretamente, em contraste com as empresas da \u00cdndia, onde os relacionamentos est\u00e3o mais avan\u00e7ados.<\/p>\n<p>Independentemente do pa\u00eds de origem dos novos participantes, eles t\u00eam v\u00e1rios desafios a resolver, como: <br \/> \u00e2\u2013 Compreens\u00e3o da legisla\u00e7\u00e3o e dos procedimentos de registro de produtos;<br \/> \u00e2\u2013 Sistemas tribut\u00e1rios federais, estaduais e municipais e direitos trabalhistas;<br \/> \u00e2\u2013 Fatores que atrasam qualquer poss\u00edvel investimento e dificultam a elabora\u00e7\u00e3o da estrat\u00e9gia al\u00e9m de induzir estrat\u00e9gias erradas, o que j\u00e1 aconteceu em alguns casos nos \u00faltimos anos.<\/p>\n<p>Peculiaridades de uma legisla\u00e7\u00e3o diferente de qualquer outra no mundo permitem que autoridades brasileiras rejeitem ou aceitem com condi\u00e7\u00f5es muitos dos relat\u00f3rios de estudos laboratoriais realizados em outros pa\u00edses e rotineiramente aceitos em pa\u00edses da OCDE, EUA e Jap\u00e3o. N\u00e3o \u00e9 incomum que relat\u00f3rios escritos por renomados laborat\u00f3rios internacionais sejam rejeitados por ag\u00eancias reguladoras por n\u00e3o atenderem aos requisitos.<\/p>\n<p>Ao contr\u00e1rio do que tem sido notado por alguns setores da m\u00eddia, o processo de registro se tornou mais complexo e trabalhoso apesar da rapidez das an\u00e1lises por parte das ag\u00eancias reguladoras. Devido ao grande n\u00famero de submiss\u00f5es j\u00e1 avaliadas e ainda a serem avaliadas, os agentes reguladores adquiriram mais experi\u00eancia para acelerar as avalia\u00e7\u00f5es que, hoje, duram entre oito e 18 meses para produtos t\u00e9cnicos e mais tr\u00eas a quatro meses para formula\u00e7\u00f5es.<\/p>\n<p>Nos \u00faltimos anos, os registros de produtos equivalentes mais comuns foram concedidos para os ingredientes ativos em:<br \/> \u00e2\u2013 Herbicidas\/dessecantes: 2,4-D, glifosato, dicloreto de paraquate, picloram, tebutiurom; <br \/> \u00e2\u2013 Fungicidas: carbendazim, mancozeb, tebuconazol; <br \/> \u00e2\u2013 Inseticidas\/acaricidas: abamectina, imidacloprida.<\/p>\n<p>A tend\u00eancia para os pr\u00f3ximos anos \u00e9 o aumento de pedidos de registro de produtos cujas patentes expiram de 2010 a 2012, com destaque especial para azoxi-strobina e fipronil.<\/p>\n<p>Os produtos de glifosato, imidacloprido e dicloreto de paraquate devem manter altos n\u00fameros de pedidos de registro como nos anos anteriores, mas o mercado deve diminuir devido \u00e0 satura\u00e7\u00e3o de alguns desses produtos, especialmente considerando o aumento no n\u00famero de participantes em rela\u00e7\u00e3o ao tamanho e crescimento do mercado.<\/p>","protected":false},"excerpt":{"rendered":"<p>O acesso aos maiores mercados de pesticidas do mundo (em valores de vendas) \u00e9 restrito e custoso devido \u00e0s dificuldades em\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":[489],"tags":[],"class_list":["post-15891","post","type-post","status-publish","format-standard","hentry","category-industry-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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