{"id":1482,"date":"2021-03-30T13:31:38","date_gmt":"2021-03-30T11:31:38","guid":{"rendered":"https:\/\/pharmavalue.it\/?p=1482"},"modified":"2021-04-27T15:46:50","modified_gmt":"2021-04-27T13:46:50","slug":"new-application-form-for-listing-of-medicines-under-law-648-96","status":"publish","type":"post","link":"https:\/\/pharmavalue.it\/en\/new-application-form-for-listing-of-medicines-under-law-648-96\/","title":{"rendered":"New application form for listing of medicines under Law 648\/96"},"content":{"rendered":"<p>AIFA has published a new application form for the inclusion of medicines in the list pursuant to Law 648\/96; there are some changes compared to the previous form<\/p>\n<p>Here is the extra information required:<\/p>\n<ul style=\"list-style-type: disc;\">\n<li>Authorisation status of the medicinal product in Italy and abroad;<\/li>\n<li>Reimbursement scheme for the medicine in Italy;<\/li>\n<li>Specify whether it is a rare disease or an orphan drug for the indication or for a different indication;<\/li>\n<li>Willingness of the pharmaceutical company to provide the medicine free of charge pursuant to the Ministerial Decree of 7 September 2017 (mandatory)<\/li>\n<\/ul>\n<p>In general, the instructions provided for compilation are much more precise and require more specific information. Delivery of the hard copy of the dossier to AIFA is no longer necessary<\/p>\n<p>There are still no clarifications regarding the procedural modalities for the 648 negotiations under the Interministerial Decree of 2 August 2019. Authorised applicants remain those foreseen by 648: Patient Associations, Scientific Societies, Health Authorities, Universities, clinicians or upon indication of AIFA's CTS.<\/p>\n<div class=\"_df_book df-lite\" id=\"df_1484\"  _slug=\"nuovo-modulo-per-la-richiesta-di-inserimento-di-medicinali-nellelenco-ai-sensi-della-legge-648-96\" data-title=\"nuovo-modulo-per-la-richiesta-di-inserimento-di-medicinali-nellelenco-ai-sensi-della-legge-648-96\" wpoptions=\"true\" thumbtype=\"\" ><\/div><script class=\"df-shortcode-script\" nowprocket type=\"application\/javascript\">window.option_df_1484 = {\"outline\":[],\"backgroundColor\":\"#eeeeee\",\"duration\":\"500\",\"autoEnableOutline\":\"false\",\"autoEnableThumbnail\":\"false\",\"overwritePDFOutline\":\"false\",\"enableDownload\":\"true\",\"direction\":\"1\",\"pageSize\":\"0\",\"soundEnable\":\"false\",\"source\":\"https:\\\/\\\/pharmavalue.it\\\/wp-content\\\/uploads\\\/2021\\\/04\\\/Nuovo-modulo-per-la-richiesta-di-inserimento-di-medicinali-nellelenco-ai-sensi-della-legge-648_96.pdf\",\"wpOptions\":\"true\"}; if(window.DFLIP && window.DFLIP.parseBooks){window.DFLIP.parseBooks();}<\/script>","protected":false},"excerpt":{"rendered":"<p>AIFA ha pubblicato un nuovo modulo per la richiesta di inserimento di medicinali nell&#8217;elenco ai sensi della legge 648\/96; si evincono alcune novit\u00e0 rispetto a quello precedente Ecco le informazioni richieste in pi\u00f9: Stato autorizzativo del medicinale in Italia e all&#8217;estero; Regime di rimborsabilit\u00e0 del medicinale in Italia; Specificare se si tratta di una malattia [&hellip;]<\/p>\n","protected":false},"author":314,"featured_media":1488,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[9],"tags":[57,46,59,58],"class_list":["post-1482","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-appunti","tag-648-96","tag-aifa","tag-early-access","tag-farmaci"],"_links":{"self":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts\/1482","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/users\/314"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/comments?post=1482"}],"version-history":[{"count":0,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts\/1482\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/media\/1488"}],"wp:attachment":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/media?parent=1482"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/categories?post=1482"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/tags?post=1482"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}