{"id":29562,"date":"2017-01-24T11:14:28","date_gmt":"2017-01-24T10:14:28","guid":{"rendered":"http:\/\/www.fedaiisf.it\/?p=29562"},"modified":"2017-01-24T11:14:28","modified_gmt":"2017-01-24T10:14:28","slug":"aifa-consultazione-pubblica-lista-farmaci-pericolosi-la-guida","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/aifa-consultazione-pubblica-lista-farmaci-pericolosi-la-guida\/","title":{"rendered":"AIFA. Public consultation on the list of drugs dangerous for driving"},"content":{"rendered":"<h1 id=\"page-title\">Public consultation on the list of dangerous drugs for driving pursuant to art. 55 of law 120\/2010<\/h1>\n<p>The Italian Medicines Agency (AIFA) has decided to open a public consultation, pursuant to law 241\/90 and subsequent amendments, on the attached document, containing the list of dangerous drugs for driving and classified according to the criteria established by the integrated project of the <a class=\"ext\" href=\"http:\/\/www.druid-project.eu\/Druid\/EN\/Home\/home_node.html\" target=\"_blank\" rel=\"noopener\">European Commission DRUID<\/a> (Driving under the Influence of Drugs, Alcohol and Medicines) (<strong><em><a href=\"http:\/\/www.agenziafarmaco.gov.it\/sites\/default\/files\/all1_Lista_farmaci_pericolosi_guida.pdf\" target=\"_blank\" rel=\"noopener\">attachment 1<\/a><\/em><\/strong>). This document will be incorporated as a technical attachment to a Ministerial Decree to be issued by the Ministry of Health. The explanation of the risk categories is given in <em><strong><a href=\"http:\/\/www.agenziafarmaco.gov.it\/sites\/default\/files\/all2_Pittogramma_Guida.pdf\" target=\"_blank\" rel=\"noopener\">attachment 2<\/a><\/strong><\/em>.<\/p>\n<p>With this consultation initiative, AIFA intends to collect the comments and proposals of the owners <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/it\/glossary\/term\/1432\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Marketing authorization for a drug. It is granted by AIFA after a group of experts has evaluated its safety and effectiveness. It constitutes the &quot;identity card&quot; of the medicinal product since it indicates the essential characteristics that identify it.\">AIC<\/dfn><\/a> in order to draw up a list as exhaustive and updated as possible of the principles <img loading=\"lazy\" decoding=\"async\" class=\"alignright\" src=\"http:\/\/pinkitalia.it\/wp-content\/uploads\/2015\/03\/Incidenti-stradali-da-colpi-di-sonno-il-decalogo-per-vincerli-con-dieta2.jpg\" alt=\"Risultati immagini per colpo di sonno in auto\" width=\"377\" height=\"196\" \/>active ingredients that may affect the ability to drive and operate machinery.<\/p>\n<p>All holders of medicinal products that contain warnings on the ability to drive and operate machinery in the printouts, and which are not included in the attached list, are invited to notify them to the following email address <a class=\"mailto\" href=\"mailto:farmacovigilanza@aifa.gov.it\" target=\"_blank\">farmacovigilanza@aifa.gov.it<\/a>, together with a classification proposal using the same format as the attached list.<\/p>\n<p>Likewise, proposals for justified modifications of the classification of substances already included in the attached list may be sent, always to the same email address, using the same format.<\/p>\n<p>The public consultation will end on the ninetieth day from the date of publication on the AIFA web portal.<\/p>\n<p><a href=\"http:\/\/www.agenziafarmaco.gov.it\/it\/content\/consultazione-pubblica-su-lista-farmaci-pericolosi-la-guida-ai-sensi-dell%E2%80%99ex-art-55-della-le\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #0000ff;\">AIFA. Notice to Companies \u2013 23\/01\/2017<\/span><\/a><\/p>\n<div class=\"field-item odd\">\n<div class=\"filefield-file\"><img decoding=\"async\" class=\"filefield-icon field-icon-application-pdf\" src=\"http:\/\/www.aifa.gov.it\/sites\/all\/modules\/filefield\/icons\/application-pdf.png\" alt=\"application\/pdf icon\" \/><a class=\"ext\" title=\"all1_List_drugs_dangerous_guide.pdf\" href=\"http:\/\/www.aifa.gov.it\/sites\/default\/files\/all1_Lista_farmaci_pericolosi_guida.pdf\" target=\"_blank\" type=\"application\/pdf; length=537404\" rel=\"noopener\">Annex 1 - List of drugs dangerous for driving<\/a><\/div>\n<\/div>\n<div class=\"field-item even\">\n<div class=\"filefield-file\"><img decoding=\"async\" class=\"filefield-icon field-icon-application-pdf\" src=\"http:\/\/www.aifa.gov.it\/sites\/all\/modules\/filefield\/icons\/application-pdf.png\" alt=\"application\/pdf icon\" \/><a class=\"ext\" title=\"all2_Pictogram_Guide.pdf\" href=\"http:\/\/www.aifa.gov.it\/sites\/default\/files\/all2_Pittogramma_Guida.pdf\" target=\"_blank\" type=\"application\/pdf; length=1596426\" rel=\"noopener\">Annex 2 \u2013 Guide<\/a><\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Consultazione pubblica su lista farmaci pericolosi per la guida ai sensi dell\u2019ex art. 55 della legge 120\/2010 L&#8217;Agenzia Italiana del Farmaco (AIFA) ha deciso di aprire una consultazione pubblica, ai sensi della legge 241\/90 e s.m.i, \u00a0sul documento allegato, recante la lista dei farmaci pericolosi per la guida e classificati secondo i criteri stabiliti dal &hellip;<\/p>","protected":false},"author":4,"featured_media":6102,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[49],"class_list":["post-29562","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizie","tag-aifa"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/29562","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=29562"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/29562\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/6102"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=29562"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=29562"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=29562"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}