Decreto-Lei n.º 10/88, de 15 de Janeiro de 1988
Decreto-Lei n.º 10/88 de 15 de Janeiro Os problemas que se põem ao sector farmacêutico adquirem cada vez maior acuidade, o que se traduz na procura de resposta à evolução tecnológica. O mesmo sucede no que respeita às ciências farmacêuticas, por força, designadamente, do aparecimento de novos princípios activos e melhor conhecimento no domínio das interacções medicamentosas, entre outros.
É, por isso, exigida às autoridades nacionais e internacionais uma atenção cada vez maior nos aspectos que se prendem com a produção, controle analítico, conservação e dispensa dos medicamentos.
Nesta perspectiva, e seguindo na esteira da legislação comunitária, não parece possível adiar por mais tempo uma providência legislativa no sentido de introduzir em todas as fases do circuito farmacêutico, nomeadamente na da distribuição por grosso, uma direcção técnica.
Visto que o artigo 102.º do Decreto-Lei n.º 48547, de 27 de Agosto de 1968, estabelece regras respeitantes à direcção técnica dos laboratórios de produtos farmacêuticos, torna-se necessário adaptar aquele dispositivo à nova realidade.
Assim: O Governo decreta, nos termos da alínea a) do n.º 1 do artigo 201.º da Constituição, o seguinte: Artigo 1.º O artigo 102.º do Decreto-Lei n.º 48547, de 27 de Agosto de 1968, passa a ter a seguinte redacção: Art. 102.º - 1 - As empresas produtoras, grossistas, importadoras e exportadoras de especialidades farmacêuticas para uso humano e ou para uso veterinário, e ou de outros produtos farmacêuticos, incluindo matérias-primas ou matérias subsidiárias, não podem exercer a sua actividade sem director técnico que, de forma efectiva e permanente, assuma e exerça a sua direcção técnica.
2 - A Direcção-Geral de Assuntos Farmacêuticos pode determinar que as empresas referidas no número anterior tenham um ou mais farmacêuticos para coadjuvar o director-técnico, sempre que a efectiva direcção das diferentes fases de manipulação e de controle das preparações nelas produzidas na armazenagem, conservação e distribuição das especialidades farmacêuticas e produtos farmacêuticos não possa ser eficazmente garantida pela actividade exclusiva do director...
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