Deliberação n.º 846/2006, de 29 de Junho de 2006
Deliberaçáo n.o 846/2006. - A empresa Laboratórios Azevedos - Indústria Farmacêutica, S. A., é titular da autorizaçáo de introduçáo no mercado (AIM) do medicamento:
Ciflan 250, 250 mg, cápsula consubstanciada na autorizaçáo com os registos n.os 4687794, 4687893, 2084697, concedida em 6 de Abril de 1992;
Ciflan 500, 500 mg, cápsula consubstanciada na autorizaçáo com o registos n.os 4687992, 4688099, 2084796, concedida em 6 de Abril de 1992.
O Decreto-Lei n.o 72/91, de 8 de Fevereiro, com a redacçáo que lhe foi dada pelo Decreto-Lei n.o 272/95, de 23 de Outubro, prevê no seu artigo 12.o que a AIM é válida por cinco anos, renováveis por iguais períodos, determinando o artigo 13.o, n.o 2, que o pedido de renovaçáo deve descrever a situaçáo respeitante aos dados de farmacovigilância do medicamento, e, quando for caso disso, ser acompanhado de documentaçáo actualizada que demonstre a adaptaçáo ao progresso técnico e científico do medicamento anteriormente autorizado.
No âmbito da avaliaçáo do pedido de renovaçáo da AIM dos medicamentos supracitados, o INFARMED concluiu que o processo náo cumpre o estipulado no artigo 11.o, n.o 1, alínea c), do Decreto-Lei n.o 72/91, de 8 de Fevereiro, com a redacçáo que lhe foi dada pelo Decreto-Lei n.o 272/95, de 23 de Outubro.
Nos termos e para os efeitos previstos nos artigos 100.o e 101.o do Código do Procedimento Administrativo, foi promovida a audiência prévia e escrita dos interessados, náo tendo, nesta sede, o titular de AIM apresentado fundamentaçáo para os motivos de indeferimento.
Assim, nos termos das...
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