Decreto-Lei n.º 100/94, de 19 de Abril de 1994
Decreto-Lei n.° 100/94 de 19 de Abril O Decreto-Lei n.° 72/91, de 8 de Fevereiro, estabeleceu, entre outras, as regras que disciplinam a publicidade dos medicamentos para uso humano, substituindo a regulamentação introduzida nesta matéria pelo Decreto-Lei n.° 48 547, de 27 de Agosto de 1968, por disposições mais consentâneas com as actuais necessidades.
Com o presente diploma, para além de se prosseguir o aperfeiçoamento da disciplina publicitária em matéria de medicamentos, visa-se também adaptar aquela à ordem jurídica comunitária, designadamente à Directiva n.° 92/28/CEE, do Conselho, de 31 de Março de 1992.
Foram ouvidas a Ordem dos Médicos e a Ordem dos Farmacêuticos.
Assim: Nos termos da alínea a) do n.° 1 do artigo 201.° da Constituição, o Governo decreta o seguinte: Artigo 1.° Objecto e âmbito 1 - O presente diploma transpõe para a ordem jurídica interna a Directiva n.° 92/28/CEE, do Conselho, de 31 de Março, e estabelece o regime jurídico da publicidade dos medicamentos para uso humano.
2 - Estão excluídos do âmbito do presente decreto-lei: a) A rotulagem e o folheto informativo que acompanham os medicamentos para uso humano; b) A correspondência, eventualmente acompanhada de qualquer documento não publicitário, necessária para dar resposta a uma pergunta específica sobre determinado medicamento; c) As informações concretas e os documentos de referência relativos às alterações de embalagem, às advertências sobre os efeitos adversos no âmbito da farmacovigilância, bem como aos catálogos de venda e às listas de preços, desde que não contenham informação sobre o medicamento; d) As informações relativas à saúde humana ou a doenças humanas, desde que não façam referência, ainda que indirecta, a um medicamento.
Artigo 2.° Definição Considera-se publicidade de medicamentos, para efeitos do presente diploma, qualquer forma de comunicação, de informação, de prospecção ou de incentivo que directa ou indirectamente promova a sua prescrição, dispensa, venda, aquisição ou consumo.
Artigo 3.° Princípios gerais 1 - É proibida a publicidade de medicamentos para os quais não tenha sido concedida uma autorização de introdução no mercado.
2 - A publicidade dos medicamentos: a) Deve promover o uso racional dos medicamentos, fazendo-o de forma objectiva e sem exagerar as suas propriedades; b) Deve ser concebida de maneira que a mensagem publicitária apareça claramente expressa, indicando tratar-se de um medicamento; c) Não pode divergir das informações constantes do resumo das características do medicamento, tal como foi autorizado; d) Não pode ser enganosa; 3 - Os medicamentos cuja dispensa depende obrigatoriamente de receita médica só podem ser anunciados ou publicitados em publicações técnicas ou suportes de informação destinados exclusivamente a médicos e outros profissionais de saúde.
Artigo 4.° Publicidade junto do público A publicidade junto do público deve conter as seguintes informações: a) O nome do medicamento, bem como a denominação comum, caso o...
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