Deliberação n.º 479/2006, de 12 de Abril de 2006
Deliberação n.º 479/2006. - Considerando que o fabrico de medicamentos de uso humano e de medicamentos veterinários está sujeito a autorização do conselho de administração do INFARMED, nos termos do artigo 54.º do Decreto-Lei n.º 72/91, de 8 de Fevereiro, e do artigo 27.º do Decreto-Lei n.º 184/97, de 26 de Julho, respectivamente; Considerando que a importação de medicamentos de uso humano e de medicamentos veterinários está sujeita a autorização do conselho de administração do INFARMED, nos termos do artigo 59.º do Decreto-Lei n.º 72/91, de 8 de Fevereiro, e do artigo 33.º do Decreto-Lei n.º 184/97, de 26 de Julho, respectivamente; Considerando que o fabrico e a importação de medicamentos experimentais estão sujeitos a autorização do conselho de administração do INFARMED, nos termos do artigo 29.º da Lei n.º 46/2004, de 19 de Agosto; Considerando que o artigo 40.º da Directiva n.º 2004/27/CE prevê a emissão de autorizações de fabrico e estabelece que os Estados membros devem introduzir as disposições necessárias para dar cumprimento à referida directiva; Considerando que os termos do artigo 47.º da Directiva n.º 2004/27/CE refere que a Comissão Europeia é a entidade responsável pela publicação das directrizes relativas à forma e ao conteúdo da autorização de fabrico e importação de medicamentos de uso humano e veterinário; Considerando que a directiva confere deste modo a necessária legitimidade aos documentos aprovados na Compilação de Procedimentos Comunitários, publicada pela Agência Europeia do Medicamento, sob mandato da Comissão Europeia; Considerando que a Directiva n.º 2004/27/CE introduz a obrigatoriedade da emissão de documentos harmonizados; Considerando que se reconhece a necessidade de emissão de um documento único para o fabrico, importação e exportação de medicamentos de uso humano e veterinário e...
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