{"id":10725,"date":"2014-01-21T15:59:35","date_gmt":"2014-01-21T14:59:35","guid":{"rendered":"https:\/\/faus-moliner.com\/en\/la-clasificacion-producto-sanitario-estado-miembro-no-obice-reclasificacion-medicamento\/"},"modified":"2016-03-23T18:09:57","modified_gmt":"2016-03-23T17:09:57","slug":"the-classification-as-a-medical-device-in-a-member-state-is-not-an-obstacle-for-it-to-be-reclassified-as-a-medicinal-product","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/the-classification-as-a-medical-device-in-a-member-state-is-not-an-obstacle-for-it-to-be-reclassified-as-a-medicinal-product\/","title":{"rendered":"The classification as a \u201cmedical device\u201d in a Member State is not an obstacle for it to be reclassified as a \u201cmedicinal product\u201d"},"content":{"rendered":"

Background<\/strong><\/p>\n

In 2008, the Finnish healthcare authority in Finland decided to reclassify \u201cGynocaps\u201d (vaginal capsule containing live lactobacilli and that is intended to restore balance to bacterial flora in the vagina) as a \u201cmedicinal product\u201d. Until then, such product had been marketed in Finland as \u201cmedical device\u201d bearing a CE marking. The Finnish authority based its decision on the fact that a similar product was being marketed in Finland as a \u201cmedicinal product\u201d. It also took into account the fact that the European Medicines Agency (EMA) has considered that a gynaecologic tampon containing live lactobaccili satisfied the conditions to be classified as \u201cmedicinal product\u201d on the basis of its intended use and effects.<\/p>\n

Subsequently, the decision of the Finnish authority was notified to the European Commission because it believed that until then the CE marking had been wrongly affixed. The manufacturer of Gynocaps challenged such decision claiming that the action performed by Gynocaps has no pharmacological effect and therefore it should not be classified as a \u201cmedicinal product\u201d, in accordance with the definition established in Directive 2001\/83.<\/p>\n

Position of the ECJ<\/strong><\/p>\n

The Supreme Administrative Court of Finland, \u00a0before which the appeal was heard, decided to stay the proceedings and to refer three questions to the ECJ.<\/p>\n

In its judgment, the ECJ decided as follows:<\/p>\n

    \n
  1. The classification as a \u201cmedical device\u201d in one Member State does not preclude the competent national authorities of another Member State from classifying the product concerned as a \u201cmedicinal product\u201d, on the basis of its pharmacological, immunological or metabolic effects. The classification of a product as a \u201cmedicinal product\u201d falls within the competence of national authorities after a case-by-case analysis.<\/li>\n<\/ol>\n
      \n
    1. National authorities that intend to reclassify as a \u201cmedicinal product\u201d a product that is being marketed as a \u201cmedical device\u201d must previously apply the procedure of \u201cwrongly affixed CE marking\u201d and, in case it is compromising the health and\/or the safety of the persons, they must follow the \u201csafeguard clause\u201d procedure according to the provisions of Directive 93\/42.<\/li>\n<\/ol>\n
        \n
      1. Finally, the ECJ highlights that in cases of doubt regarding whether to classify a product as a \u201cmedicinal product\u201d or as a \u201cmedical device\u201d, the vis atractiva<\/i> of the classification as \u201cmedicinal product\u201d must prevail according to article 2.2 of Directive 2001\/83.<\/li>\n<\/ol>\n

        Likewise, the ECJ declares that, in principle, within the same Member State a product cannot be marketed as a \u201cmedical device\u201d when there is another one classified as a \u201cmedicinal product\u201d if they both have in common an identical substance and the same mode of action, even if they are not strictly identical.<\/p>\n","protected":false},"excerpt":{"rendered":"

        Background In 2008, the Finnish healthcare authority in Finland decided to reclassify \u201cGynocaps\u201d (vaginal capsule containing live lactobacilli and that is intended to restore balance to bacterial flora in the vagina) as a \u201cmedicinal product\u201d. Until then, such product had been marketed in Finland as \u201cmedical device\u201d bearing a CE marking. The Finnish authority based… <\/p>\n

        <\/div>\n

        Read More<\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[72,217,86],"tags":[],"coauthors":[],"class_list":["post-10725","post","type-post","status-publish","format-standard","hentry","category-capsulas-en","category-pharmaceutical-and-life-sciences-law-2","category-pharmaceutical-and-life-sciences-law"],"acf":[],"yoast_head":"\nThe classification as a \u201cmedical device\u201d in a Member State is not an obstacle for it to be reclassified as a \u201cmedicinal product\u201d - 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\/en\/the-classification-as-a-medical-device-in-a-member-state-is-not-an-obstacle-for-it-to-be-reclassified-as-a-medicinal-product\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The classification as a \u201cmedical device\u201d in a Member State is not an obstacle for it to be reclassified as a \u201cmedicinal product\u201d - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Background In 2008, the Finnish healthcare authority in Finland decided to reclassify \u201cGynocaps\u201d (vaginal capsule containing live lactobacilli and that is intended to restore balance to bacterial flora in the vagina) as a \u201cmedicinal product\u201d. 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