Decreto-Lei n.º 314/2009, de 28 de Outubro de 2009
Decreto-Lei n. 314/2009
de 28 de Outubro
O Decreto -Lei n. 148/2008, de 29 de Julho, transpôs, parcialmente, para a ordem jurídica interna as Directivas n.os 2001/82/CE, do Parlamento Europeu e do Conselho, de 6 de Novembro, que estabelece um código comunitário relativo aos medicamentos veterinários, 2004/28/CE, do Parlamento Europeu e do Conselho, de 31 de Março, que altera a Directiva n. 2001/82/CE, e 2006/130/CE, da Comissáo, de 11 de Dezembro, que determina os critérios de isençáo da receita médico -veterinária para determinados medicamentos veterinários aplicáveis a produtores de alimentos para consumo humano, bem como a Directiva n. 91/412/CEE, da Comissáo, de 23 de Julho, que estabelece princípios e normas de boas práticas de fabrico.
Aquele decreto -lei visou, igualmente, assegurar a execuçáo e garantir o cumprimento, no ordenamento jurídico nacional, das obrigaçóes decorrentes do Regulamento (CE)
n. 1084/2003, da Comissáo, de 3 de Junho, relativo à análise da alteraçáo dos termos das autorizaçóes de introduçáo no mercado de medicamentos para uso humano e medicamentos veterinários, concedidas pelas autoridades competentes dos Estados membros, na parte relativa aos medicamentos veterinários.
Com a publicaçáo da Directiva n. 2009/9/CE, da Comissáo, de 10 de Fevereiro, foram introduzidas alteraçóes à Directiva n. 2001/82/CE, nomeadamente no que diz respeito aos requisitos específicos científicos e técnicos pormenorizados em matéria de ensaios de medicamentos veterinários, com base nos quais deve ser avaliada a qualidade, segurança e eficácia destes medicamentos, bem como as instruçóes relativas à apresentaçáo e ao conteúdo do processo de pedido de autorizaçáo de introduçáo no mercado.
Por outro lado, aproveita -se o presente diploma para se clarificar algumas normas cujo sentido e alcance têm...
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