Medida Provisória nº 69 de 26/09/2002. DISPÕE SOBRE A PROTEÇÃO DE INFORMAÇÃO NÃO DIVULGADA SUBMETIDA PARA APROVAÇÃO DA COMERCIALIZAÇÃO DE PRODUTOS E DA OUTRAS PROVIDENCIAS.
MEDIDA PROVISÓRIA Nº 69, DE 26 DE SETEMBRO DE 2002
Dispõe sobre a proteção de informação não divulgada submetida para aprovação da comercialização de produtos e dá outras providências
O PRESIDENTE DA REPÚBLICA, no uso da atribuição que lhe confere o art. 62 da Constituição, adota a seguinte Medida Provisória, com força de lei:
Esta Medida Provisória regula a proteção, contra o uso comercial desleal, de informações relativas aos resultados de testes ou outros dados não divulgados apresentados às autoridades competentes como condição para aprovar ou manter o registro para a comercialização de produtos farmacêuticos de uso humano e veterinário, fertilizantes, agrotóxicos seus componentes e afins.
Parágrafo único. As informações protegidas serão aquelas cuja elaboração envolva esforço considerável e que tenham valor comercial enquanto não divulgadas.
Consideram-se não divulgadas as informações que, até a data da solicitação do registro:
I - não sejam facilmente acessíveis a pessoas que normalmente lidam com o tipo de informação em questão, seja como um todo, seja na configuração e montagem específicas de seus componentes; e
II - tenham sido objeto de precauções eficazes para manutenção da sua confidencialidade pela pessoa legalmente responsável pelo seu controle.
Parágrafo único. Atendido o disposto nos incisos I e II, presumem-se não divulgadas as informações apresentadas sob declaração de confidencialidade.
A proteção das informações, definidas na forma dos arts. 1º e 2º e...
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