{"id":13948,"date":"2016-10-27T10:59:07","date_gmt":"2016-10-27T09:59:07","guid":{"rendered":"https:\/\/faus-moliner.com\/ca\/?p=13948"},"modified":"2016-10-27T12:01:01","modified_gmt":"2016-10-27T11:01:01","slug":"importacion-paralela-de-productos-sanitarios-para-diagnostico-in-vitro","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/ca\/importacion-paralela-de-productos-sanitarios-para-diagnostico-in-vitro\/","title":{"rendered":"Importaci\u00f3n paralela de productos sanitarios para diagn\u00f3stico in vitro"},"content":{"rendered":"<p><strong>Antecedentes<\/strong><\/p>\n<p>Roche Diagnostics comercializa en Alemania productos sanitarios para diagn\u00f3stico <em>in vitro<\/em>. Servoprax adquir\u00eda dichos productos en el mercado del Reino Unido, donde tambi\u00e9n se comercializaban, les a\u00f1ad\u00eda una etiqueta e instrucciones en alem\u00e1n, y los vend\u00eda en este \u00faltimo pa\u00eds. En Alemania el etiquetado del producto hace referencia a dos unidades de medida (\u201cmmol\/l\u201d y \u201cmg\/dl\u201d), en tanto que en el Reino Unido el etiquetado recoge s\u00f3lo una (\u201cmmol\/l\u201d). Dado que las unidades que Servoprax distribu\u00eda en Alemania s\u00f3lo hac\u00edan referencia a esta \u00faltima (\u201cmmol\/l\u201d), Roche Diagnostics consider\u00f3 que Servoprax no pod\u00eda revenderlos en dicho pa\u00eds sin someterlos previamente a una evaluaci\u00f3n complementaria de conformidad. Servoprax someti\u00f3 los productos a dicha evaluaci\u00f3n en diciembre de 2010, pero Roche Diagnostics la demand\u00f3 igualmente por los supuestos perjuicios causados hasta entonces. El tribunal local, al entender que el caso depend\u00eda de la interpretaci\u00f3n de la Directiva 98\/79\/CE, decidi\u00f3 suspender el litigio principal y plantear la cuesti\u00f3n ante el TJUE.<\/p>\n<p><strong>La libertad de circulaci\u00f3n ampara la actuaci\u00f3n de Servoprax<\/strong><\/p>\n<p>Dado que de la Directiva 98\/79\/CE se desprende que los productos sanitarios para diagn\u00f3stico <em>in vitro<\/em> evaluados y con marcado CE deben poder beneficiarse de libre circulaci\u00f3n en la UE, y dado que las leyes alemanas no proh\u00edben su comercializaci\u00f3n cuando la informaci\u00f3n que los acompa\u00f1a se exprese \u00fanicamente con la unidad de medida \u201cmmol\/l\u201d, el TJUE concluy\u00f3 que no cabe exigir a Servoprax que someta a las unidades que revende en Alemania a una nueva evaluaci\u00f3n de conformidad. Recuerda, en este sentido, que la evaluaci\u00f3n de la conformidad del producto es una obligaci\u00f3n que compete al fabricante que lo pone por primera vez en circulaci\u00f3n en el territorio comunitario, y no al importador paralelo que lo adquiere en un Estado miembro para revenderlo posteriormente en otro. Ello es as\u00ed, concluye el tribunal, aun cuando la informaci\u00f3n que acompa\u00f1a al producto deba traducirse a la lengua oficial del pa\u00eds de importaci\u00f3n, tal como exige la Directiva 98\/79\/CE.<\/p>\n<p><strong>La inclusi\u00f3n de una etiqueta e instrucciones en alem\u00e1n no supone reacondicionar<\/strong><\/p>\n<p>Especialmente interesantes son las reflexiones del tribunal sobre la postura de la Comisi\u00f3n Europea, quien sosten\u00eda que el importador paralelo estaba obligado a comunicar la operaci\u00f3n al fabricante, por analog\u00eda con los criterios sentados por la jurisprudencia europea en el \u00e1mbito de los medicamentos. El TJUE, por el contrario, concluye que el mero hecho de incluir una etiqueta y unas instrucciones de uso traducidas a la lengua oficial del pa\u00eds de importaci\u00f3n, sin modificar el envase ni la presentaci\u00f3n del producto, no implica que \u00e9ste haya sido reacondicionado. Entiende, en consecuencia, que en estos casos no existe fundamento jur\u00eddico alguno que respalde una obligaci\u00f3n de notificar dicha operaci\u00f3n al fabricante.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Antecedentes Roche Diagnostics comercializa en Alemania productos sanitarios para diagn\u00f3stico in vitro. Servoprax adquir\u00eda dichos productos en el mercado del Reino Unido, donde tambi\u00e9n se comercializaban, les a\u00f1ad\u00eda una etiqueta e instrucciones en alem\u00e1n, y los vend\u00eda en este \u00faltimo pa\u00eds. En Alemania el etiquetado del producto hace referencia a dos unidades de medida (\u201cmmol\/l\u201d&#8230; <\/p>\n<div class=\"clear\"><\/div>\n<p><a href=\"https:\/\/faus-moliner.com\/ca\/importacion-paralela-de-productos-sanitarios-para-diagnostico-in-vitro\/\" class=\"excerpt-read-more\">M\u00e9s informaci\u00f3<\/a><\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[272,286,331,341,307],"tags":[],"coauthors":[],"class_list":["post-13948","post","type-post","status-publish","format-standard","hentry","category-capsulas-ca","category-dret-farmaceutic-i-life-sciences","category-dret-farmaceutic-i-life-sciences-ca","category-importacions-paralleles-ca","category-importacions-paralleles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Importaci\u00f3n paralela de productos sanitarios para diagn\u00f3stico in vitro - Faus Moliner<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/faus-moliner.com\/ca\/importacion-paralela-de-productos-sanitarios-para-diagnostico-in-vitro\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Importaci\u00f3n paralela de productos sanitarios para diagn\u00f3stico in vitro - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Antecedentes Roche Diagnostics comercializa en Alemania productos sanitarios para diagn\u00f3stico in vitro. 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