{"id":10145,"date":"2021-06-27T23:07:45","date_gmt":"2021-06-27T21:07:45","guid":{"rendered":"https:\/\/www.laffineur.com\/legislacao-farmaceutica\/"},"modified":"2021-06-28T14:56:24","modified_gmt":"2021-06-28T12:56:24","slug":"legislacao-farmaceutica","status":"publish","type":"page","link":"https:\/\/www.laffineur.com\/pt-pt\/o-mercado-interno-da-ue-direito-regulatorio-lobby\/legislacao-farmaceutica\/","title":{"rendered":"Legisla\u00e7\u00e3o farmac\u00eautica"},"content":{"rendered":"

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LEGISLA\u00c7\u00c3O FARMAC\u00caUTICA<\/h1>\n\t\t\t\t\t<\/div>[vc_column_text]O quadro jur\u00eddico do direito farmac\u00eautico europeu assenta em dois diplomas legais: a Diretiva 2001\/83, que estabelece um c\u00f3digo comunit\u00e1rio relativo aos medicamentos para uso humano e o Regulamento 726\/2004, que estabelece procedimentos comunit\u00e1rios de autoriza\u00e7\u00e3o e de fiscaliza\u00e7\u00e3o de medicamentos para uso humano e veterin\u00e1rio e que institui uma Ag\u00eancia Europeia de Medicamentos (EMA) sediada em Londres. Para al\u00e9m destes dois textos legislativos, h\u00e1 uma ampla gama de normas espec\u00edficas como a legisla\u00e7\u00e3o sobre os ensaios cl\u00ednicos ou textos n\u00e3o vinculativos como a \u201cComunica\u00e7\u00e3o da Comiss\u00e3o relativa \u00e0s importa\u00e7\u00f5es paralelas de medicamentos cuja coloca\u00e7\u00e3o no mercado foi\u00a0 autorizada\u201d.\u00a0\u00a0<\/span><\/p>\n

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O nosso escrit\u00f3rio possui uma ampla experi\u00eancia em prestar<\/span> aconselhamento a empresas fabricantes de produtos farmac\u00eauticos.<\/a><\/span><\/p>\n

Fomos ainda ampliando a nossa experiencia nas seguintes \u00e1reas:<\/span><\/p>\n

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