{"id":1379,"date":"2021-04-09T10:39:07","date_gmt":"2021-04-09T08:39:07","guid":{"rendered":"https:\/\/pharmavalue.it\/?p=1379"},"modified":"2021-04-21T10:51:17","modified_gmt":"2021-04-21T08:51:17","slug":"modification-of-national-requirements-in-the-blue-box-for-medicinal-products","status":"publish","type":"post","link":"https:\/\/pharmavalue.it\/en\/modification-of-national-requirements-in-the-blue-box-for-medicinal-products\/","title":{"rendered":"Modification of national requirements in the blue box for medicines"},"content":{"rendered":"<p>AIFA has published a communication on the update of the national requirements to be included in the Blue Box. There is an important impact on the regulatory activities of companies as the part concerning price information has been changed.<br \/>\nFOR ALL PROCEDURES: MUTUAL RECOGNISATION, DECENTRALISED, CENTRALISED the price to be entered is the one given in the AIFA determination published in the Official Journal, <strong>applying the reductions provided for in the AIFA determinations of 3 July 2006 and 27 September 2006<\/strong>i.e. the statutory temporary reductions -5%, -5%;<\/p>\n<p>The price previously indicated was the public price.<\/p>\n<p>Given the onerousness of the change, who knows if the trade associations will not confront the regulatory agency to modify these demands.<\/p>\n<p>Here is the communication from AIFA: <a href=\"https:\/\/lnkd.in\/dvWMXNz\">https:\/\/lnkd.in\/dvWMXNz<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>AIFA ha pubblicato una comunicazione sull&#8217;aggiornamento circa i requisiti nazionali da inserire in Blue Box. C&#8217;\u00e8 un impatto importante sulle attivit\u00e0 regolatorie delle aziende in quanto \u00e8 stata modificata la parte relativa alle informazioni sui prezzi. PER TUTTE LE PROCEDURE: MUTUO RICONOSCIMENTO, DECENTRATA, CENTRALIZZATA il prezzo da inserire \u00e8 quello riportato nella determinazione AIFA pubblicata [&hellip;]<\/p>\n","protected":false},"author":314,"featured_media":1381,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","_seopress_titles_title":"Modifica dei requisiti nazionali nella blue box dei medicinali","_seopress_titles_desc":"Impatto importante sulle attivit\u00e0 regolatorie delle aziende, \u00e8 stata modificata la parte relativa alle informazioni sui prezzi.","_seopress_robots_index":"","footnotes":""},"categories":[38,9],"tags":[39,40,41],"class_list":["post-1379","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-analisi-di-scenario","category-appunti","tag-attivita-regolatorie","tag-blue-blox","tag-prezzi"],"_links":{"self":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts\/1379","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=1379"}],"version-history":[{"count":0,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts\/1379\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/media\/1381"}],"wp:attachment":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/media?parent=1379"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/categories?post=1379"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/tags?post=1379"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}