{"id":61752,"date":"2023-12-04T11:22:59","date_gmt":"2023-12-04T02:22:59","guid":{"rendered":"https:\/\/monolith.law\/tr\/?p=61752"},"modified":"2024-01-17T16:50:56","modified_gmt":"2024-01-17T07:50:56","slug":"pharmaceuticals-law-revision","status":"publish","type":"post","link":"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision","title":{"rendered":"Reiwa'n\u0131n \u0130lk Y\u0131l\u0131nda (2019) Japon \u0130la\u00e7 Makinesi Yasas\u0131'nda Yap\u0131lan De\u011fi\u015fiklikler ~Eczaneler ve Eczac\u0131lar\u0131n Durumu, Para Cezas\u0131 Sistemi"},"content":{"rendered":"\n<p>Reiwa&#8217;n\u0131n ilk y\u0131l\u0131nda (2019) 4 Aral\u0131k&#8217;ta ilan edilen ve s\u0131ras\u0131yla uygulanmas\u0131 planlanan de\u011fi\u015fikliklerle &#8216;Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;, &#8216;Reiwa&#8217;n\u0131n B\u00fcy\u00fck De\u011fi\u015fiklik Yasas\u0131&#8217; olarak adland\u0131r\u0131ld\u0131 ve bir\u00e7ok alanda de\u011fi\u015fiklikler yap\u0131ld\u0131.<\/p>\n\n\n\n<p>Bu de\u011fi\u015fiklikler genel olarak, \u2460 ila\u00e7lar\u0131n geli\u015ftirilmesinden piyasaya s\u00fcr\u00fclmesine kadar olan s\u00fcrecin iyile\u015ftirilmesi, \u2461 eczac\u0131 ve eczanelerin durumunun g\u00f6zden ge\u00e7irilmesi, \u2462 g\u00fcvenin sa\u011flanmas\u0131 i\u00e7in yasalara uygunluk sisteminin geli\u015ftirilmesi olmak \u00fczere \u00fc\u00e7 ana noktaya odaklanmaktad\u0131r. \u00d6zellikle, \u2462 ile ilgili olarak, yeni bir sistemle birlikte, \u015firketlerin \u00f6nlemler almas\u0131 gerekmektedir.<\/p>\n\n\n\n<p>Bu makalede, \u2461 ve \u2462&#8217;\u00fcn ceza paras\u0131 sisteminin uygulanmas\u0131 hakk\u0131nda a\u00e7\u0131klama yapaca\u011f\u0131z.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_53 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Ilac_ve_Tibbi_Cihaz_Yasasi_Eski_Ilac_Yasasi_Nedir\" title=\"\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 (Eski \u0130la\u00e7 Yasas\u0131) Nedir?\">\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 (Eski \u0130la\u00e7 Yasas\u0131) Nedir?<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Ilac_Makinesi_Yasasi%E2%80%99nin_Amaci\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Amac\u0131\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Amac\u0131<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Ilac_ve_Tibbi_Cihaz_Kanunu%E2%80%99nun_Japanese_Pharmaceutical_and_Medical_Device_Act_Duzenleme_Kapsami\" title=\"\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun (Japanese Pharmaceutical and Medical Device Act) D\u00fczenleme Kapsam\u0131\">\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun (Japanese Pharmaceutical and Medical Device Act) D\u00fczenleme Kapsam\u0131<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Reklamlarla_Ilgili_Duzenlemeler\" title=\"Reklamlarla \u0130lgili D\u00fczenlemeler\">Reklamlarla \u0130lgili D\u00fczenlemeler<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Yaniltici_ve_Abartili_Reklamlarin_Yasaklanmasi\" title=\"Yan\u0131lt\u0131c\u0131 ve Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131\">Yan\u0131lt\u0131c\u0131 ve Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Belirli_Hastaliklar_Icin_Ilac_ve_Rejeneratif_Tip_Urunlerinin_Reklaminin_Sinirlanmasi\" title=\"Belirli Hastal\u0131klar \u0130\u00e7in \u0130la\u00e7 ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklam\u0131n\u0131n S\u0131n\u0131rlanmas\u0131\">Belirli Hastal\u0131klar \u0130\u00e7in \u0130la\u00e7 ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklam\u0131n\u0131n S\u0131n\u0131rlanmas\u0131<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Onaylanmamis_Ilaclarin_Reklaminin_Yasaklanmasi\" title=\"Onaylanmam\u0131\u015f \u0130la\u00e7lar\u0131n Reklam\u0131n\u0131n Yasaklanmas\u0131\">Onaylanmam\u0131\u015f \u0130la\u00e7lar\u0131n Reklam\u0131n\u0131n Yasaklanmas\u0131<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Eczaci_ve_Eczanelerin_Yeniden_Gozden_Gecirilmesi\" title=\"Eczac\u0131 ve Eczanelerin Yeniden G\u00f6zden Ge\u00e7irilmesi\">Eczac\u0131 ve Eczanelerin Yeniden G\u00f6zden Ge\u00e7irilmesi<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Eczaci_ve_Eczanelerin_Rolunun_Netlestirilmesi\" title=\"Eczac\u0131 ve Eczanelerin Rol\u00fcn\u00fcn Netle\u015ftirilmesi\">Eczac\u0131 ve Eczanelerin Rol\u00fcn\u00fcn Netle\u015ftirilmesi<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Sertifikali_Eczane_Sistemi\" title=\"Sertifikal\u0131 Eczane Sistemi\">Sertifikal\u0131 Eczane Sistemi<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Bolgesel_Isbirligi_Eczanesi_Nedir\" title=\"B\u00f6lgesel \u0130\u015fbirli\u011fi Eczanesi Nedir\">B\u00f6lgesel \u0130\u015fbirli\u011fi Eczanesi Nedir<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Uzmanlik_Saglik_Kurumu_Isbirligi_Eczanesi_Nedir\" title=\"Uzmanl\u0131k Sa\u011fl\u0131k Kurumu \u0130\u015fbirli\u011fi Eczanesi Nedir\">Uzmanl\u0131k Sa\u011fl\u0131k Kurumu \u0130\u015fbirli\u011fi Eczanesi Nedir<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Cevrimici_Ilac_Kullanimi_Danismanligi\" title=\"\u00c7evrimi\u00e7i \u0130la\u00e7 Kullan\u0131m\u0131 Dan\u0131\u015fmanl\u0131\u011f\u0131\">\u00c7evrimi\u00e7i \u0130la\u00e7 Kullan\u0131m\u0131 Dan\u0131\u015fmanl\u0131\u011f\u0131<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Ilac_Makinesi_Yasasi%E2%80%99ndaki_Degisiklikle_Eklenen_Idari_Para_Cezasi_Sistemi_Nedir\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fiklikle Eklenen \u0130dari Para Cezas\u0131 Sistemi Nedir?\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fiklikle Eklenen \u0130dari Para Cezas\u0131 Sistemi Nedir?<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Idari_Para_Cezasi_Satis_Miktarinin_45%E2%80%99i\" title=\"\u0130dari Para Cezas\u0131, Sat\u0131\u015f Miktar\u0131n\u0131n %4.5&#8217;i\">\u0130dari Para Cezas\u0131, Sat\u0131\u015f Miktar\u0131n\u0131n %4.5&#8217;i<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Duzenlemeye_Tabi_Kisiler\" title=\"D\u00fczenlemeye Tabi Ki\u015filer\">D\u00fczenlemeye Tabi Ki\u015filer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Ilac_Makinesi_Yasasi%E2%80%99ndaki_Degisiklikle_Tedbir_Emirleri_de_Eklendi\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fiklikle Tedbir Emirleri de Eklendi\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fiklikle Tedbir Emirleri de Eklendi<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Ilac_Makinesi_Yasasi_Degisikligi_Karsisinda_Sirketlerin_Almasi_Gereken_Onlemler\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131 De\u011fi\u015fikli\u011fi Kar\u015f\u0131s\u0131nda \u015eirketlerin Almas\u0131 Gereken \u00d6nlemler\">\u0130la\u00e7 Makinesi Yasas\u0131 De\u011fi\u015fikli\u011fi Kar\u015f\u0131s\u0131nda \u015eirketlerin Almas\u0131 Gereken \u00d6nlemler<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Kendi_Urunlerinizin_Reklamlarini_Tekrar_Kontrol_Edin\" title=\"Kendi \u00dcr\u00fcnlerinizin Reklamlar\u0131n\u0131 Tekrar Kontrol Edin\">Kendi \u00dcr\u00fcnlerinizin Reklamlar\u0131n\u0131 Tekrar Kontrol Edin<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Kendi_Yonergelerinizi_Olusturun_ve_Yayinlayin\" title=\"Kendi Y\u00f6nergelerinizi Olu\u015fturun ve Yay\u0131nlay\u0131n\">Kendi Y\u00f6nergelerinizi Olu\u015fturun ve Yay\u0131nlay\u0131n<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Ozet_Ilac_Makinesi_Yasasi%E2%80%99ndaki_Degisikliklerle_Ilgili_Belirsizlikler_Icin_Bir_Avukata_Danisin\" title=\"\u00d6zet: \u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fikliklerle \u0130lgili Belirsizlikler \u0130\u00e7in Bir Avukata Dan\u0131\u015f\u0131n\">\u00d6zet: \u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fikliklerle \u0130lgili Belirsizlikler \u0130\u00e7in Bir Avukata Dan\u0131\u015f\u0131n<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-revision\/#Buromuz_Tarafindan_Alinan_Onlemler\" title=\"B\u00fcromuz Taraf\u0131ndan Al\u0131nan \u00d6nlemler\">B\u00fcromuz Taraf\u0131ndan Al\u0131nan \u00d6nlemler<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_ve_Tibbi_Cihaz_Yasasi_Eski_Ilac_Yasasi_Nedir\"><\/span>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 (Eski \u0130la\u00e7 Yasas\u0131) Nedir?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/08\/shutterstock_1080775979.jpg\" alt=\"\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 (Eski \u0130la\u00e7 Yasas\u0131) Nedir?\" class=\"wp-image-50166\" \/><\/figure>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131, ila\u00e7lar\u0131n ve t\u0131bbi cihazlar\u0131n kalitesini, etkinli\u011fini ve g\u00fcvenli\u011fini sa\u011flamak ve halk sa\u011fl\u0131\u011f\u0131n\u0131 iyile\u015ftirmek amac\u0131yla y\u00fcr\u00fcrl\u00fc\u011fe konulan bir yasad\u0131r. Resmi ad\u0131 &#8220;\u0130la\u00e7lar\u0131n, T\u0131bbi Cihazlar\u0131n ve Di\u011fer \u00dcr\u00fcnlerin Kalitesinin, Etkinli\u011finin ve G\u00fcvenli\u011finin Sa\u011flanmas\u0131 Hakk\u0131nda Yasad\u0131r&#8221;.<\/p>\n\n\n\n<p>Daha \u00f6nce \u0130la\u00e7 Yasas\u0131 olarak adland\u0131r\u0131lan bu yasa, Heisei 26 y\u0131l\u0131nda (2014) \u2460 ila\u00e7lar\u0131n, t\u0131bbi cihazlar\u0131n ve di\u011fer \u00fcr\u00fcnlerin g\u00fcvenlik \u00f6nlemlerinin g\u00fc\u00e7lendirilmesi, \u2461 t\u0131bbi cihazlar\u0131n \u00f6zelliklerini dikkate alarak d\u00fczenlemelerin olu\u015fturulmas\u0131, \u2462 rejeneratif t\u0131p \u00fcr\u00fcnlerinin \u00f6zelliklerini dikkate alarak d\u00fczenlemelerin olu\u015fturulmas\u0131 ana hedefleriyle de\u011fi\u015ftirildi ve ayn\u0131 zamanda mevcut ad\u0131n\u0131 ald\u0131.<\/p>\n\n\n\n<p>Daha sonra, Reiwa 1 y\u0131l\u0131nda (2019) 4 Aral\u0131k&#8217;ta \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n bir k\u0131sm\u0131 de\u011fi\u015ftirildi ve yasa, prensip olarak Reiwa 2 y\u0131l\u0131nda (2020) 1 Eyl\u00fcl&#8217;de y\u00fcr\u00fcrl\u00fc\u011fe girdi. \u0130stisna olan maddeler de serpi\u015ftirilmi\u015f bir \u015fekilde y\u00fcr\u00fcrl\u00fc\u011fe girdi. Bu makalenin ikinci yar\u0131s\u0131nda tan\u0131t\u0131lacak olan para cezas\u0131 sistemi Reiwa 3 y\u0131l\u0131nda (2021) 1 A\u011fustos&#8217;ta y\u00fcr\u00fcrl\u00fc\u011fe girdi.<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/?p=49834\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 (Eski \u0130la\u00e7 Yasas\u0131) Nedir? Ama\u00e7lar\u0131, D\u00fczenlemeye Tabi Olanlar, Reklam D\u00fczenlemeleri A\u00e7\u0131klanm\u0131\u015ft\u0131r [ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99nin_Amaci\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Amac\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Ama\u00e7)<\/p>\n\n\n\n<p>Bu yasa, ila\u00e7lar, t\u0131bbi olmayan ila\u00e7lar, kozmetikler, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnleri (bundan b\u00f6yle &#8220;ila\u00e7lar vb.&#8221; olarak an\u0131lacakt\u0131r.) kalitesinin, etkinli\u011finin ve g\u00fcvenli\u011finin sa\u011flanmas\u0131 ve bu \u00fcr\u00fcnlerin kullan\u0131m\u0131ndan kaynaklanan sa\u011fl\u0131k ve hijyen tehlikelerinin olu\u015fumunu ve yay\u0131lmas\u0131n\u0131 \u00f6nlemek i\u00e7in gerekli d\u00fczenlemeleri yapmay\u0131, belirli ila\u00e7lar\u0131n d\u00fczenlenmesi ile ilgili \u00f6nlemleri almay\u0131 ve \u00f6zellikle t\u0131bbi a\u00e7\u0131dan gerekli olan ila\u00e7lar\u0131n, t\u0131bbi cihazlar\u0131n ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin ara\u015ft\u0131rma ve geli\u015ftirilmesini te\u015fvik etmek i\u00e7in gerekli \u00f6nlemleri almay\u0131 ama\u00e7lar. Bu, sa\u011fl\u0131k ve hijyenin iyile\u015ftirilmesini hedeflemektedir.<\/p>\n<cite><a href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Makinesi Yasas\u0131 Madde 1 [ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 1. maddesine g\u00f6re, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n amac\u0131;<\/p>\n\n\n\n<ul>\n<li>\u0130la\u00e7lar vb. kalitesinin, etkinli\u011finin ve g\u00fcvenli\u011finin sa\u011flanmas\u0131 i\u00e7in gerekli d\u00fczenlemeler<\/li>\n\n\n\n<li>\u0130la\u00e7lar vb. kullan\u0131m\u0131ndan kaynaklanan sa\u011fl\u0131k ve hijyen tehlikelerinin olu\u015fumunu ve yay\u0131lmas\u0131n\u0131 \u00f6nlemek i\u00e7in gerekli d\u00fczenlemeler<\/li>\n\n\n\n<li>Belirli ila\u00e7lar\u0131n d\u00fczenlenmesi ile ilgili \u00f6nlemler<\/li>\n\n\n\n<li>\u0130la\u00e7lar vb. ara\u015ft\u0131rma ve geli\u015ftirilmesini te\u015fvik etmek i\u00e7in gerekli \u00f6nlemler<\/li>\n<\/ul>\n\n\n\n<p>arac\u0131l\u0131\u011f\u0131yla, sa\u011fl\u0131k ve hijyenin iyile\u015ftirilmesini hedeflemektedir.<\/p>\n\n\n\n<p>\u0130la\u00e7lar vb. insan sa\u011fl\u0131\u011f\u0131na katk\u0131da bulunan \u015feyler olmas\u0131na ra\u011fmen, etkinlik veya g\u00fcvenlik sorunlar\u0131 oldu\u011funda kullan\u0131ld\u0131\u011f\u0131nda, sa\u011fl\u0131\u011fa zarar verebilir ve hayat gibi \u00f6nemli \u015feylere ciddi zararlar verebilir.<\/p>\n\n\n\n<p>Dolay\u0131s\u0131yla, \u0130la\u00e7 Makinesi Yasas\u0131, a\u015fa\u011f\u0131da belirtilecek olan abart\u0131l\u0131 reklam d\u00fczenlemeleri gibi s\u0131k\u0131 d\u00fczenlemeleri getirerek, insan v\u00fccuduna olan etkileri \u00f6nlemeyi ve halk\u0131n sa\u011fl\u0131\u011f\u0131n\u0131 ve g\u00fcvenli\u011fini korumay\u0131 ama\u00e7lamaktad\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_ve_Tibbi_Cihaz_Kanunu%E2%80%99nun_Japanese_Pharmaceutical_and_Medical_Device_Act_Duzenleme_Kapsami\"><\/span>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun (Japanese Pharmaceutical and Medical Device Act) D\u00fczenleme Kapsam\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun d\u00fczenleme kapsam\u0131na giren \u00fcr\u00fcnler a\u015fa\u011f\u0131daki 5 kategoriye ayr\u0131l\u0131r:<\/p>\n\n\n\n<ul>\n<li>\u0130la\u00e7lar: Re\u00e7eteli ila\u00e7lar, re\u00e7etesiz sat\u0131lan ila\u00e7lar, a\u015f\u0131lar vb.<\/li>\n\n\n\n<li>\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler: Gargara, b\u00f6cek \u00f6ld\u00fcr\u00fcc\u00fcler, sa\u00e7 boyalar\u0131, kontakt lens sol\u00fcsyonlar\u0131 vb.<\/li>\n\n\n\n<li>Kozmetik \u00dcr\u00fcnler: Sabunlar, v\u00fccut \u015fampuanlar\u0131, sa\u00e7 bak\u0131m \u00fcr\u00fcnleri, cilt bak\u0131m \u00fcr\u00fcnleri vb.<\/li>\n\n\n\n<li>T\u0131bbi Cihazlar: Kalp pili, yapay eklemler, termometreler, skalpel vb.<\/li>\n\n\n\n<li>Rejeneratif T\u0131p \u00dcr\u00fcnleri: H\u00fccre i\u015fleme \u00fcr\u00fcnleri (iPS h\u00fccreler vb.), gen tedavisi \u00fcr\u00fcnleri<\/li>\n<\/ul>\n\n\n\n<p>Peki, eczanelerde ve di\u011fer yerlerde s\u0131k\u00e7a g\u00f6rd\u00fc\u011f\u00fcm\u00fcz takviye edici g\u0131dalar nas\u0131l ele al\u0131n\u0131r?<\/p>\n\n\n\n<p>Takviye edici g\u0131dalar hakk\u0131nda \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nda belirli bir tan\u0131m bulunmamaktad\u0131r. Yiyecek ve i\u00e7ecekler, &#8220;g\u0131da&#8221; ve &#8220;ila\u00e7&#8221; olarak s\u0131n\u0131fland\u0131r\u0131l\u0131r (G\u0131da Hijyen Kanunu&#8217;nun 4. maddesi 1. f\u0131kras\u0131) ve bu nedenle takviye edici g\u0131dalar &#8220;g\u0131da&#8221; olarak s\u0131n\u0131fland\u0131r\u0131l\u0131r.<\/p>\n\n\n\n<p>Ancak, &#8220;ila\u00e7&#8221; olmayan bir \u00fcr\u00fcn\u00fcn, ila\u00e7 gibi etkinlik ve etkileri oldu\u011funu belirtmek, a\u015fa\u011f\u0131da belirtildi\u011fi gibi \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun 68. maddesine ayk\u0131r\u0131 olacakt\u0131r. Bu nedenle, &#8220;g\u0131da&#8221; i\u00e7in etkinlik ve etkileri belirtme sistemi olarak, sa\u011fl\u0131k fonksiyonel g\u0131da sistemi bulunmaktad\u0131r.<\/p>\n\n\n\n<p>Takviye edici g\u0131dalar, &#8220;g\u0131da&#8221; kategorisine girdi\u011fi i\u00e7in, genellikle \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun d\u00fczenleme kapsam\u0131na girmez.<\/p>\n\n\n\n<p>Takviye edici g\u0131dalar hakk\u0131nda daha fazla bilgi i\u00e7in, l\u00fctfen a\u015fa\u011f\u0131daki makaleye bak\u0131n\u0131z.<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/?p=49842\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun Reklam D\u00fczenlemeleri Nedir? Yasal \u0130fadelerle Reklam Olu\u015fturman\u0131n P\u00fcf Noktalar\u0131 [ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Reklamlarla_Ilgili_Duzenlemeler\"><\/span>Reklamlarla \u0130lgili D\u00fczenlemeler<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/08\/shutterstock_1217867398.png\" alt=\"Reklamlarla \u0130lgili D\u00fczenlemeler\" class=\"wp-image-49984\" \/><\/figure>\n\n\n\n<p>\u0130la\u00e7 Makineleri Yasas\u0131 (Japon \u0130la\u00e7 Makineleri Yasas\u0131) kapsam\u0131nda, ila\u00e7lar ve benzeri \u00fcr\u00fcnlerin reklamlar\u0131 s\u0131k\u0131 bir \u015fekilde d\u00fczenlenmektedir. Bu d\u00fczenlemeler genel olarak \u00fc\u00e7 ana ba\u015fl\u0131k alt\u0131nda toplanabilir.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Yaniltici_ve_Abartili_Reklamlarin_Yasaklanmasi\"><\/span>Yan\u0131lt\u0131c\u0131 ve Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical Affairs Law) 66. maddesi, ila\u00e7lar ve benzeri \u00fcr\u00fcnlerin yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklamlar\u0131n\u0131 yasaklamaktad\u0131r.<\/p>\n\n\n\n<p>Bir ila\u00e7 veya benzeri \u00fcr\u00fcn\u00fcn yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 bir ifade i\u00e7ermesi durumunda, bu ifadeye g\u00fcvenen kullan\u0131c\u0131lar\u0131n sa\u011fl\u0131\u011f\u0131na beklenmedik bir etki olabilece\u011fi d\u00fc\u015f\u00fcn\u00fclmektedir.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Abart\u0131l\u0131 Reklamlar vb.)<\/p>\n\n\n\n<p>1. Hi\u00e7 kimse, ila\u00e7lar, t\u0131bbi cihazlar, kozmetikler, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnlerinin ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda, a\u00e7\u0131k veya ima yoluyla, yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 makaleler yay\u0131nlamamal\u0131, tan\u0131mlamamal\u0131 veya yaymamal\u0131d\u0131r.<\/p>\n\n\n\n<p>2. \u0130la\u00e7lar, t\u0131bbi cihazlar, kozmetikler, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnlerinin etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda, bir doktor veya ba\u015fka bir ki\u015fi taraf\u0131ndan garanti edildi\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek makalelerin yay\u0131nlanmas\u0131, tan\u0131mlanmas\u0131 veya yay\u0131lmas\u0131, birinci f\u0131kra h\u00fckm\u00fcne tabidir.<\/p>\n\n\n\n<p>3. Hi\u00e7 kimse, ila\u00e7lar, t\u0131bbi cihazlar, kozmetikler, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnlerine ili\u015fkin k\u00fcrtaj\u0131 ima etmemeli veya m\u00fcstehcen belgeler veya \u00e7izimler kullanmamal\u0131d\u0131r.<\/p>\n<cite><a href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Makinesi Yasas\u0131 Madde 66 [ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>\u0130\u00e7inde bulunmayan bir etkinlik veya etkiyi g\u00f6stermek, re\u00e7etesiz sat\u0131lan ila\u00e7lar\u0131n ad\u0131n\u0131 taklit etmek ve hatta etkinlik veya etkiler do\u011fru olsa bile, bir doktor veya di\u011fer uzman\u0131n garantisinin oldu\u011fu yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek ifadeler de yasakt\u0131r. \u00d6rne\u011fin, bir ila\u00e7 veya t\u0131bbi cihaz olarak onaylanan veya bir kozmetik \u00fcr\u00fcn olan bir \u00fcr\u00fcn, kabul edilen etkinlik veya etkilerin \u00f6tesine ge\u00e7erek &#8220;leke veya \u00e7il \u00e7\u0131kar\u0131r&#8221; gibi reklamlar yaparsa, bu yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 bir reklam olarak kabul edilir.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Belirli_Hastaliklar_Icin_Ilac_ve_Rejeneratif_Tip_Urunlerinin_Reklaminin_Sinirlanmasi\"><\/span>Belirli Hastal\u0131klar \u0130\u00e7in \u0130la\u00e7 ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklam\u0131n\u0131n S\u0131n\u0131rlanmas\u0131<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n (Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131) 67. maddesi, belirli hastal\u0131klar i\u00e7in ila\u00e7lar ve benzeri \u00fcr\u00fcnler hakk\u0131nda, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n (Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131) gerekli \u00f6nlemleri belirlemesini \u00f6ng\u00f6rmektedir.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Belirli Hastal\u0131klar \u0130\u00e7in \u0130la\u00e7 ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklam\u0131n\u0131n S\u0131n\u0131rlanmas\u0131)<\/p>\n\n\n\n<p>1 Kanser ve di\u011fer \u00f6zel hastal\u0131klar\u0131n tedavisinde kullan\u0131lan ve bir doktor veya di\u015f hekimi g\u00f6zetiminde kullan\u0131lmad\u0131\u011f\u0131 takdirde \u00f6zellikle b\u00fcy\u00fck zarar riski ta\u015f\u0131yan ila\u00e7lar veya rejeneratif t\u0131p \u00fcr\u00fcnleri i\u00e7in, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131, ila\u00e7lar\u0131 veya rejeneratif t\u0131p \u00fcr\u00fcnlerini belirler ve bu ila\u00e7lar veya rejeneratif t\u0131p \u00fcr\u00fcnleri hakk\u0131ndaki reklamlar\u0131, genel halk\u0131 hedefleyen reklam y\u00f6ntemlerini s\u0131n\u0131rlar ve bu ila\u00e7lar\u0131n veya rejeneratif t\u0131p \u00fcr\u00fcnlerinin uygun kullan\u0131m\u0131n\u0131 sa\u011flamak i\u00e7in gerekli \u00f6nlemleri belirler.<\/p>\n\n\n\n<p>2 Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131, \u00f6zel hastal\u0131klar\u0131 belirleyen bu t\u00fcz\u00fc\u011f\u00fcn olu\u015fturulmas\u0131 veya kald\u0131r\u0131lmas\u0131 hakk\u0131nda bir kabine toplant\u0131s\u0131 talep etmeden \u00f6nce, \u0130la\u00e7 ve G\u0131da Hijyen Konseyi&#8217;nin (Japon \u0130la\u00e7 ve G\u0131da Hijyen Konseyi) g\u00f6r\u00fc\u015flerini almal\u0131d\u0131r. Ancak, \u0130la\u00e7 ve G\u0131da Hijyen Konseyi&#8217;nin \u00f6nemsiz bir konu olarak kabul etti\u011fi durumlar bu kural\u0131n d\u0131\u015f\u0131ndad\u0131r.<\/p>\n<cite><a href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131 Madde 67 [ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Bu maddeye g\u00f6re &#8220;\u00f6zel hastal\u0131klar&#8221;, &#8220;kanser&#8221;, &#8220;sarkom&#8221; ve &#8220;l\u00f6semi&#8221; olmak \u00fczere \u00fc\u00e7 hastal\u0131k belirlenmi\u015ftir. Bu hastal\u0131klarla ilgili ila\u00e7lar\u0131n ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin kullan\u0131m\u0131 y\u00fcksek d\u00fczeyde uzmanl\u0131k gerektirdi\u011finden, genel halk\u0131 hedefleyen reklamlar\u0131 s\u0131n\u0131rlamay\u0131 ama\u00e7layan bir h\u00fck\u00fcmd\u00fcr.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Onaylanmamis_Ilaclarin_Reklaminin_Yasaklanmasi\"><\/span>Onaylanmam\u0131\u015f \u0130la\u00e7lar\u0131n Reklam\u0131n\u0131n Yasaklanmas\u0131<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical Affairs Law) 68. maddesi, onay al\u0131nmam\u0131\u015f ila\u00e7lar hakk\u0131nda reklamlar\u0131 yasaklamaktad\u0131r.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Onay al\u0131nmam\u0131\u015f ila\u00e7lar, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklam\u0131n\u0131n yasaklanmas\u0131)<\/p>\n\n\n\n<p>Hi\u00e7 kimse, 14. maddenin 1. f\u0131kras\u0131, 23. maddenin 2. f\u0131kras\u0131n\u0131n 5. alt maddesi veya 23. maddenin 2. f\u0131kras\u0131n\u0131n 23. alt maddesi ile belirlenen ila\u00e7lar, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnleri hakk\u0131nda, hen\u00fcz 14. maddenin 1. f\u0131kras\u0131, 19. maddenin 2. f\u0131kras\u0131, 23. maddenin 2. f\u0131kras\u0131n\u0131n 5. alt maddesi, 23. maddenin 2. f\u0131kras\u0131n\u0131n 17. alt maddesi, 23. maddenin 25. f\u0131kras\u0131 veya 23. maddenin 37. f\u0131kras\u0131n\u0131n onay\u0131n\u0131 veya 23. maddenin 2. f\u0131kras\u0131n\u0131n 23. alt maddesinin sertifikas\u0131n\u0131 almadan, ad\u0131, \u00fcretim y\u00f6ntemi, etkinlik, etki veya performans hakk\u0131nda reklam yapamaz.<\/p>\n<cite><a href=\"https:\/\/elaws.e-gov.go.jp\/document?lawid=335AC0000000145\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Makinesi Yasas\u0131 Madde 68 [ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Bu maddenin ana noktas\u0131, onay (veya sertifika) al\u0131nmam\u0131\u015f ila\u00e7lar\u0131n etkinlik veya etkilerinin garanti edilmemesi nedeniyle, t\u00fcm reklamlar\u0131 yasaklayarak beklenmeyen sa\u011fl\u0131k risklerini \u00f6nlemektir.<\/p>\n\n\n\n<p>Onay veya sertifika al\u0131nmadan \u00f6nce ila\u00e7lar hakk\u0131nda, daha sonra ayn\u0131 i\u00e7eri\u011fe sahip olanlar\u0131n onay almas\u0131 durumunda bile, onay al\u0131nmam\u0131\u015f durumda isim, \u00fcretim y\u00f6ntemi, etkinlik, etki veya performans hakk\u0131nda reklam yap\u0131l\u0131rsa, bu maddeye ayk\u0131r\u0131 olaca\u011f\u0131 i\u00e7in dikkatli olunmal\u0131d\u0131r.<\/p>\n\n\n\n<p>Ayr\u0131ca, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenleme kapsam\u0131 d\u0131\u015f\u0131nda olan &#8216;g\u0131da&#8217; sat\u0131\u015f\u0131nda da dikkatli olunmal\u0131d\u0131r.<\/p>\n\n\n\n<p>\u00c7\u00fcnk\u00fc, s\u00f6zde sa\u011fl\u0131k g\u0131dalar\u0131 gibi &#8216;g\u0131dalar&#8217; bile, &#8216;kan bas\u0131nc\u0131n\u0131 d\u00fc\u015f\u00fcr\u00fcr&#8217; gibi etkinlik ve etkileri belirtmek i\u00e7in reklam yap\u0131l\u0131rsa, ila\u00e7 olarak kabul edilebilir.<\/p>\n\n\n\n<p>\u0130la\u00e7 olarak kabul edildi\u011fi takdirde, onay al\u0131nmadan reklam yapmak yasaklan\u0131r. Bu yasa\u011fa ayk\u0131r\u0131 olarak reklam yap\u0131l\u0131rsa, 2 y\u0131la kadar hapis veya 2 milyon yen&#8217;e kadar para cezas\u0131 uygulanabilir.<\/p>\n\n\n\n<p>Takviye edici g\u0131dalar\u0131n reklam\u0131nda dikkat edilmesi gereken noktalar\u0131 ayr\u0131nt\u0131l\u0131 olarak \u00f6\u011frenmek isteyenler, a\u015fa\u011f\u0131daki makalede detayl\u0131 olarak anlat\u0131lm\u0131\u015ft\u0131r, bu makale ile birlikte g\u00f6z atabilirsiniz.<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/corporate\/points-for-supplement-advertising\" target=\"_blank\" rel=\"noreferrer noopener\">Takviye Edici G\u0131dalar\u0131n Reklam\u0131nda Dikkat Edilmesi Gereken Noktalar [ja]<\/a><\/p>\n\n\n\n<p>Ayr\u0131ca, kozmetik ve sa\u011fl\u0131k g\u0131dalar\u0131n\u0131n reklam ifadeleri hakk\u0131nda dikkat edilmesi gereken noktalar\u0131 ayr\u0131nt\u0131l\u0131 olarak \u00f6\u011frenmek isteyenler, a\u015fa\u011f\u0131daki makalede detayl\u0131 olarak anlat\u0131lm\u0131\u015ft\u0131r, bu makale ile birlikte g\u00f6z atabilirsiniz.<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/corporate\/cosmetics-healthy-food-advertisement\" target=\"_blank\" rel=\"noreferrer noopener\">Kozmetik ve Sa\u011fl\u0131k G\u0131dalar\u0131n\u0131n Reklam \u0130fadeleri Hakk\u0131nda Dikkat Edilmesi Gereken Noktalar [ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Eczaci_ve_Eczanelerin_Yeniden_Gozden_Gecirilmesi\"><\/span>Eczac\u0131 ve Eczanelerin Yeniden G\u00f6zden Ge\u00e7irilmesi<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/tr\/wp-content\/uploads\/sites\/24\/2024\/01\/https___monolith-law.jp_wordpress_wp-admin_post.php_post50174actionedit-rewrite1-1.png\" alt=\"\" class=\"wp-image-62742\" srcset=\"https:\/\/monolith.law\/tr\/wp-content\/uploads\/sites\/24\/2024\/01\/https___monolith-law.jp_wordpress_wp-admin_post.php_post50174actionedit-rewrite1-1.png 735w, https:\/\/monolith.law\/tr\/wp-content\/uploads\/sites\/24\/2024\/01\/https___monolith-law.jp_wordpress_wp-admin_post.php_post50174actionedit-rewrite1-1-300x200.png 300w, https:\/\/monolith.law\/tr\/wp-content\/uploads\/sites\/24\/2024\/01\/https___monolith-law.jp_wordpress_wp-admin_post.php_post50174actionedit-rewrite1-1-250x167.png 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><\/figure>\n\n\n\n<p>Eczac\u0131lar ve eczaneler, t\u0131bbi kurulu\u015flardan gelen re\u00e7etelere dayanarak ila\u00e7lar\u0131 haz\u0131rlarlar. Bu \u015fekilde, muayene ve ila\u00e7 haz\u0131rlama i\u015flemlerinin ayr\u0131 ayr\u0131 yap\u0131lmas\u0131, eczac\u0131lar\u0131n ve eczanelerin hastan\u0131n durumunu ve kulland\u0131\u011f\u0131 ila\u00e7lar\u0131 anlamalar\u0131n\u0131 sa\u011flar. Bu, ila\u00e7 tedavisinin g\u00fcvenli\u011fi ve etkinli\u011fini garanti alt\u0131na al\u0131r.<\/p>\n\n\n\n<p>Ancak, ger\u00e7ekte, hastalar genellikle t\u0131bbi kurulu\u015flara yak\u0131n eczanelerde ila\u00e7lar\u0131n\u0131 haz\u0131rlat\u0131r ve eczac\u0131lar\u0131n ve eczanelerin hastan\u0131n durumunu ve kulland\u0131\u011f\u0131 ila\u00e7lar\u0131 s\u00fcrekli olarak anlamalar\u0131 zordur.<\/p>\n\n\n\n<p>Bu nedenle, Reiwa 1 y\u0131l\u0131nda (2019 y\u0131l\u0131nda) yap\u0131lan Japon \u0130la\u00e7 Kanunu&#8217;nda (Japanese Pharmaceutical Affairs Law) de\u011fi\u015fiklikler, hastalar\u0131n ya\u015fad\u0131klar\u0131 yerlerde g\u00fcvenle ila\u00e7 kullanabilmeleri i\u00e7in eczac\u0131lar ve eczaneler hakk\u0131nda yasal d\u00fczenlemeler yap\u0131lm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Eczaci_ve_Eczanelerin_Rolunun_Netlestirilmesi\"><\/span>Eczac\u0131 ve Eczanelerin Rol\u00fcn\u00fcn Netle\u015ftirilmesi<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Yenilenmi\u015f Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131&#8217;nda (\u85ac\u6a5f\u6cd5), eczaneler &#8220;eczac\u0131lar\u0131n sat\u0131\u015f veya da\u011f\u0131t\u0131m amac\u0131yla re\u00e7ete i\u015flemlerini ger\u00e7ekle\u015ftirdi\u011fi yerler&#8221; olarak tan\u0131mlanm\u0131\u015ft\u0131. Ancak, Reiwa d\u00f6neminin ilk y\u0131l\u0131nda (2019) yap\u0131lan de\u011fi\u015fiklikle, eczaneler &#8220;eczac\u0131lar\u0131n sat\u0131\u015f veya da\u011f\u0131t\u0131m amac\u0131yla re\u00e7ete i\u015flemlerini ger\u00e7ekle\u015ftirdi\u011fi ve ila\u00e7lar\u0131n ve t\u0131bbi \u00fcr\u00fcnlerin uygun kullan\u0131m\u0131 i\u00e7in gerekli bilgilerin sa\u011flanmas\u0131 ve eczac\u0131l\u0131k bilgisine dayal\u0131 y\u00f6nlendirmenin ger\u00e7ekle\u015ftirildi\u011fi yerler&#8221; olarak tan\u0131mlanm\u0131\u015ft\u0131r (Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n 2. maddesi, 12. f\u0131kra).<\/p>\n\n\n\n<p>Bu de\u011fi\u015fiklikle, eczaneler ve eczac\u0131lar, hastalara ila\u00e7lar hakk\u0131nda bilgi sa\u011flama ve y\u00f6nlendirme yapma konusunda uzman olduklar\u0131 a\u00e7\u0131k\u00e7a belirtilmi\u015ftir.<\/p>\n\n\n\n<p>Buna ba\u011fl\u0131 olarak, eczaneler ve eczac\u0131lar, sadece re\u00e7ete i\u015flemleri s\u0131ras\u0131nda de\u011fil, ayn\u0131 zamanda re\u00e7ete sonras\u0131 ila\u00e7 kullan\u0131m\u0131 y\u00f6nlendirmesi ve s\u00fcrekli ila\u00e7 kullan\u0131m durumunun takibi konusunda y\u00fck\u00fcml\u00fc k\u0131l\u0131nm\u0131\u015ft\u0131r. Ayr\u0131ca, hastalar\u0131n ila\u00e7 kullan\u0131m durumlar\u0131n\u0131 re\u00e7ete yazan doktora geri bildirme konusunda da \u00e7aba g\u00f6stermeleri gerekmektedir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Sertifikali_Eczane_Sistemi\"><\/span>Sertifikal\u0131 Eczane Sistemi<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Reiwa d\u00f6neminin ilk y\u0131l\u0131nda (2019) yap\u0131lan d\u00fczenleme ile &#8220;B\u00f6lgesel \u0130\u015fbirli\u011fi Eczanesi&#8221; ve &#8220;Uzmanl\u0131k Sa\u011fl\u0131k Kurumu \u0130\u015fbirli\u011fi Eczanesi&#8221; isimleri yeni olarak belirlenmi\u015ftir. Bunlar, eczanenin belirli bir i\u015flevi oldu\u011funu belirtmek i\u00e7in olu\u015fturulmu\u015ftur, b\u00f6ylece hastalar\u0131n kendilerine uygun eczaneyi se\u00e7meleri kolayla\u015fm\u0131\u015ft\u0131r. Bu durum, hastan\u0131n durumunun daha kolay anla\u015f\u0131labilmesini sa\u011flar, ki bu durum zaten uzun zamand\u0131r bekleniyordu.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bolgesel_Isbirligi_Eczanesi_Nedir\"><\/span>B\u00f6lgesel \u0130\u015fbirli\u011fi Eczanesi Nedir<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<figure class=\"wp-block-image is-resized\"><img decoding=\"async\" src=\"https:\/\/lh3.googleusercontent.com\/pcdPemdH4-kMLwQkMA9WSZwf-4ZUfYMowXvdm1jLr0JesPBG1BI3MwJNcoHvtUAgMhiTTRpT4qvPgBuGaE_BH5f6twZB0gPBJ9mhOu7Yyom72bMRCCZtVZrxJTb-XUqHHqf29dHCGfeSukci7dTq4e4\" alt=\"B\u00f6lgesel \u0130\u015fbirli\u011fi Eczanesi Nedir\" style=\"width:789px;height:468px\" \/><\/figure>\n\n\n\n<p class=\"has-text-align-right\"><a href=\"https:\/\/www.mhlw.go.jp\/content\/11121000\/000883897.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Japonya Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 &#8211; Eczac\u0131 E\u011fitimi ve Yetenek Geli\u015ftirme \u0130nceleme Toplant\u0131s\u0131 D\u00f6k\u00fcman\u0131 1 (20 Ocak Reiwa 4 y\u0131l\u0131 (2023)) [ja]<\/a><\/p>\n\n\n\n<p>B\u00f6lgesel \u0130\u015fbirli\u011fi Eczanesi (Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n 6.2 maddesi), di\u011fer sa\u011fl\u0131k hizmeti sa\u011flay\u0131c\u0131lar\u0131 ile i\u015fbirli\u011fi yaparak, hastalar\u0131n ila\u00e7 kullan\u0131m durumlar\u0131 gibi bilgileri merkezi bir \u015fekilde y\u00f6neten ve s\u00fcrekli i\u015fbirli\u011fi yapabilen eczaneyi ifade eder.<\/p>\n\n\n\n<p>B\u00f6lgesel \u0130\u015fbirli\u011fi Eczanesi&#8217;nin gereklilikleri aras\u0131nda, Japonya Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n belirledi\u011fi standartlara uygun olarak, bilgi payla\u015f\u0131m\u0131 ve gece\/hafta sonu hizmetleri dahil olmak \u00fczere re\u00e7ete d\u00fczenleme sistemi, evde sa\u011fl\u0131k hizmetlerine yan\u0131t verme gibi konular bulunmaktad\u0131r.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Uzmanlik_Saglik_Kurumu_Isbirligi_Eczanesi_Nedir\"><\/span>Uzmanl\u0131k Sa\u011fl\u0131k Kurumu \u0130\u015fbirli\u011fi Eczanesi Nedir<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh6.googleusercontent.com\/GvV25e9DI8Nkl4JfReuE5kDbK7TT6tb7Yt_s-M4ooT-6Fj4ZDXuY9gFf3E_er1uFkdBSDhEfu4gFfFwpf5Y_PsC9vdsyRRp73JSDy01u6YJV-fwrMgUudkFWWjlwO_ozrWDXES0UdMyr-UYTrAJIOwk\" alt=\"Uzmanl\u0131k Sa\u011fl\u0131k Kurumu \u0130\u015fbirli\u011fi Eczanesi Nedir\" \/><\/figure>\n\n\n\n<p class=\"has-text-align-right\"><a href=\"https:\/\/www.mhlw.go.jp\/content\/11121000\/000883897.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Japonya Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 &#8211; Eczac\u0131 E\u011fitimi ve Yetenek Geli\u015ftirme \u0130nceleme Toplant\u0131s\u0131 D\u00f6k\u00fcman\u0131 1 (20 Ocak Reiwa 4 y\u0131l\u0131 (2023)) [ja]<\/a><\/p>\n\n\n\n<p>Uzmanl\u0131k Sa\u011fl\u0131k Kurumu \u0130\u015fbirli\u011fi Eczanesi (Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n 6.3 maddesi), di\u011fer sa\u011fl\u0131k hizmeti sa\u011flay\u0131c\u0131lar\u0131 ile i\u015fbirli\u011fi yaparak, uzmanl\u0131k alan\u0131na dayal\u0131 farmas\u00f6tik bilgiye dayal\u0131 rehberlik sa\u011flayabilen bir eczaneyi ifade eder.<\/p>\n\n\n\n<p>Uzmanl\u0131k Sa\u011fl\u0131k Kurumu \u0130\u015fbirli\u011fi Eczanesi, uzmanl\u0131k rehberli\u011fi ve benzeri hizmetleri s\u00fcrekli olarak sa\u011flama gereklili\u011fi olan durumlarda, uzmanl\u0131k sa\u011fl\u0131k kurumlar\u0131 ile tedavi politikalar\u0131n\u0131 payla\u015f\u0131r ve evde bile uzmanl\u0131k gerektiren tedavilerin sa\u011flanabilmesi i\u00e7in kurulmu\u015ftur.<\/p>\n\n\n\n<p>\u015eu anda, sadece kanser hastalar\u0131 hedef al\u0131nmaktad\u0131r, ancak Japonya Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n belirledi\u011fi hastal\u0131k kategorilerine g\u00f6re sertifikaland\u0131rma yap\u0131l\u0131r, bu nedenle gelecekte hedef al\u0131nan hastal\u0131klar\u0131n geni\u015flemesi beklenmektedir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cevrimici_Ilac_Kullanimi_Danismanligi\"><\/span>\u00c7evrimi\u00e7i \u0130la\u00e7 Kullan\u0131m\u0131 Dan\u0131\u015fmanl\u0131\u011f\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Daha \u00f6nce, t\u0131bbi kurumlar taraf\u0131ndan \u00e7evrimi\u00e7i muayene yap\u0131lmas\u0131 m\u00fcmk\u00fcn olmu\u015f ve \u00e7evrimi\u00e7i muayenenin yayg\u0131nla\u015fmas\u0131n\u0131 hedefleyen politikalar uygulanm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<p>Ancak, eski Japon \u0130la\u00e7 Yasas\u0131&#8217;nda (Yakkihou), re\u00e7eteye dayal\u0131 ila\u00e7 haz\u0131rlama s\u0131ras\u0131nda y\u00fcz y\u00fcze ila\u00e7 kullan\u0131m\u0131 dan\u0131\u015fmanl\u0131\u011f\u0131 gerekti\u011fi belirtilmi\u015fti. Bu nedenle, \u00e7evrimi\u00e7i muayene yap\u0131lsa bile, hastalar\u0131n eczaneye gitmesi gerekiyordu ve \u00e7evrimi\u00e7i muayenenin avantajlar\u0131 tam olarak i\u015flevsel olam\u0131yordu.<\/p>\n\n\n\n<p>Bu nedenle, Reiwa 1 y\u0131l\u0131nda (2019) yap\u0131lan Japon \u0130la\u00e7 Yasas\u0131 de\u011fi\u015fikli\u011fi ile, belirli \u015fartlar\u0131 kar\u015f\u0131lad\u0131\u011f\u0131nda, \u00e7evrimi\u00e7i ila\u00e7 kullan\u0131m\u0131 dan\u0131\u015fmanl\u0131\u011f\u0131n\u0131n uygulanmas\u0131na izin verilmesi belirlenmi\u015ftir (Japon \u0130la\u00e7 Yasas\u0131 Madde 9-3, F\u0131kra 1).<\/p>\n\n\n\n<p>Y\u00fcz y\u00fcze ila\u00e7 kullan\u0131m\u0131 dan\u0131\u015fmanl\u0131\u011f\u0131n\u0131n gereklili\u011fi, kullan\u0131m talimatlar\u0131 ve yan etkiler hakk\u0131nda, uzman bilgisine sahip bir eczac\u0131n\u0131n a\u00e7\u0131klama yapmas\u0131 ve do\u011fru ila\u00e7 kullan\u0131m\u0131n\u0131 sa\u011flamak, g\u00fcvenli\u011fi ve etkinli\u011fi garanti etmek amac\u0131yla talep edilmi\u015ftir.<\/p>\n\n\n\n<p>Bu nedenle, \u00e7evrimi\u00e7i olarak da ayn\u0131 i\u015flevi yerine getirebilmek i\u00e7in, belirli \u015fartlar aras\u0131nda, \u00f6nceden y\u00fcz y\u00fcze ila\u00e7 kullan\u0131m\u0131 dan\u0131\u015fmanl\u0131\u011f\u0131 yap\u0131lm\u0131\u015f bir ila\u00e7 olmas\u0131, eczac\u0131 ve hastan\u0131n aras\u0131nda bir g\u00fcven ili\u015fkisi kurulmu\u015f olmas\u0131, hastan\u0131n onay\u0131n\u0131 al\u0131nm\u0131\u015f bir ila\u00e7 kullan\u0131m\u0131 dan\u0131\u015fmanl\u0131\u011f\u0131 plan\u0131n\u0131n olu\u015fturulmu\u015f olmas\u0131 ve bu plana dayal\u0131 ila\u00e7 kullan\u0131m\u0131 dan\u0131\u015fmanl\u0131\u011f\u0131 olmas\u0131 gerekmektedir.<\/p>\n\n\n\n<p>Ayr\u0131ca, Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 \u0130la\u00e7 ve Ya\u015fam Hijyeni B\u00fcrosu Ba\u015fkan\u0131&#8217;n\u0131n bildirisine g\u00f6re, \u00e7evrimi\u00e7i ila\u00e7 kullan\u0131m\u0131 dan\u0131\u015fmanl\u0131\u011f\u0131 uygulamas\u0131, gelecekteki \u00e7evrimi\u00e7i muayene ve \u00e7evrimi\u00e7i ila\u00e7 kullan\u0131m\u0131 dan\u0131\u015fmanl\u0131\u011f\u0131 yayg\u0131nla\u015fmas\u0131, teknolojik yenilikler ve di\u011fer durumlar g\u00f6z \u00f6n\u00fcnde bulundurularak d\u00fczenli olarak g\u00f6zden ge\u00e7irilecektir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99ndaki_Degisiklikle_Eklenen_Idari_Para_Cezasi_Sistemi_Nedir\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fiklikle Eklenen \u0130dari Para Cezas\u0131 Sistemi Nedir?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh5.googleusercontent.com\/boSWvu6tPOmogxdIQjoi0JYIkg0C0kkBSQZAkv_PcY-Wx02L01-7G5Ayw0tIdnWM5exaIgYUAWordimL2Ig5d1M1XEhMiGa-MypNhTRHQSId7Ed_aL3H6ZqTx--z3yJZ8uaQJy5XrD61sA0Nwa352dI\" alt=\"\u0130la\u00e7 Makinesi Yasas\u0131'ndaki De\u011fi\u015fiklikle Eklenen \u0130dari Para Cezas\u0131 Sistemi Nedir?\" \/><\/figure>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki \u00f6nceki d\u00fczenlemeye g\u00f6re, yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklamlar dahil olmak \u00fczere reklam d\u00fczenlemelerine ayk\u0131r\u0131 hareket eden ki\u015filere hapis ve para cezas\u0131 gibi cezai yapt\u0131r\u0131mlar uygulan\u0131yordu. Ancak, en y\u00fcksek para cezas\u0131 bile 2 milyon yen olup, reklam d\u00fczenlemelerine ayk\u0131r\u0131 hareket ederek elde edilen haks\u0131z kazan\u00e7la kar\u015f\u0131la\u015ft\u0131r\u0131ld\u0131\u011f\u0131nda d\u00fc\u015f\u00fck oldu\u011fu i\u00e7in cayd\u0131r\u0131c\u0131l\u0131\u011f\u0131 azd\u0131.<\/p>\n\n\n\n<p>Bu nedenle, Reiwa 1 y\u0131l\u0131nda (2019) yap\u0131lan \u0130la\u00e7 Makinesi Yasas\u0131 de\u011fi\u015fikli\u011fi ile &#8220;g\u00fcvenin sa\u011flanmas\u0131 i\u00e7in yasalara uygunluk sisteminin geli\u015ftirilmesi&#8221; kapsam\u0131nda idari para cezas\u0131 sistemi olu\u015fturulmu\u015ftur. \u0130dari para cezas\u0131 sistemi, ila\u00e7lar vb. hakk\u0131nda yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklam yapan ki\u015filere idari para cezas\u0131 \u00f6deme emri veren bir sistemdir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Idari_Para_Cezasi_Satis_Miktarinin_45%E2%80%99i\"><\/span>\u0130dari Para Cezas\u0131, Sat\u0131\u015f Miktar\u0131n\u0131n %4.5&#8217;i<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130dari para cezas\u0131n\u0131n miktar\u0131, yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklam yapt\u0131ktan sonraki belirli bir s\u00fcre i\u00e7inde ila\u00e7lar vb. sat\u0131\u015f miktar\u0131n\u0131n %4.5&#8217;i olarak belirlenmi\u015ftir. Dolay\u0131s\u0131yla, daha \u00f6nceki sabit para cezalar\u0131ndan farkl\u0131 olarak, yasad\u0131\u015f\u0131 eylemlerden elde edilen kazanca ba\u011fl\u0131 olarak miktar de\u011fi\u015fir, bu nedenle cayd\u0131r\u0131c\u0131l\u0131\u011f\u0131 y\u00fcksek oldu\u011fu d\u00fc\u015f\u00fcn\u00fclmektedir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Duzenlemeye_Tabi_Kisiler\"><\/span>D\u00fczenlemeye Tabi Ki\u015filer<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 66. maddesinin 1. f\u0131kras\u0131, yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklamlar\u0131 yasaklayan ki\u015fiyi &#8220;herkes&#8221; olarak belirler. Bu nedenle, ila\u00e7lar vb. satan i\u015fletmeler ve \u00fcreticiler gibi reklam verenlerin yan\u0131 s\u0131ra, reklam medyas\u0131, reklam ajanslar\u0131, reklamla ilgili afiliatlar ve influencerlar gibi ki\u015filer de idari para cezas\u0131na tabi olabilecek eylemleri ger\u00e7ekle\u015ftirebilir.<\/p>\n\n\n\n<p>Ancak, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131, idari para cezas\u0131 \u00f6deme emri kapsam\u0131ndaki &#8220;i\u015flemler&#8221; hakk\u0131nda \u015fu \u015fekilde a\u00e7\u0131klama yapm\u0131\u015ft\u0131r:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(\u0130dari Para Cezas\u0131 \u00d6deme Emri \u0130le \u0130lgili Toplam \u00dccretin Hesaplanma Y\u00f6ntemi Hakk\u0131nda S\u0131k\u00e7a Sorulan Sorular)<\/p>\n\n\n\n<p>\u00d6rne\u011fin, \u00fcretim ve sat\u0131\u015f i\u015fletmeleri, toptan sat\u0131\u015f i\u015fletmeleri, sat\u0131\u015f i\u015fletmeleri vb. taraf\u0131ndan yap\u0131lan i\u015flemlerdir. Ayr\u0131ca, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;na dayal\u0131 i\u015f izni alan ki\u015filer taraf\u0131ndan yap\u0131lan i\u015flemler s\u0131n\u0131rl\u0131 olmad\u0131\u011f\u0131ndan, \u00f6rne\u011fin, zaten piyasaya s\u00fcr\u00fclm\u00fc\u015f olan kozmetik \u00fcr\u00fcnler ve ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerin sat\u0131\u015f\u0131n\u0131 yapan ki\u015filer taraf\u0131ndan yap\u0131lan i\u015flemler de dahildir. Ancak, gazete \u015firketleri, dergi \u015firketleri, yay\u0131n i\u015fletmeleri, internet medya \u015firketleri vb. reklam medya i\u015fletmeleri ve bu reklam medya i\u015fletmelerine reklam arac\u0131l\u0131\u011f\u0131 ve devam\u0131 i\u015flemlerini yapan reklam ajanslar\u0131, hizmet sa\u011flay\u0131c\u0131lar vb. taraf\u0131ndan yap\u0131lan i\u015flemler dahil edilmez.<\/p>\n<cite><a href=\"https:\/\/www.mhlw.go.jp\/content\/000801630.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 \u0130la\u00e7 ve Ya\u015fam Hijyeni B\u00fcrosu \u0130\u015f \u0130leti\u015fimi 2021 Temmuz 6 [ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Bu \u015fekilde, idari para cezas\u0131 sistemi, ila\u00e7lar vb. ile do\u011frudan i\u015flem yapan \u00fcretim ve sat\u0131\u015f i\u015fletmeleri, toptan sat\u0131\u015f i\u015fletmeleri, sat\u0131\u015f i\u015fletmeleri vb. ki\u015fileri hedef al\u0131rken, reklam ajanslar\u0131, reklam medyas\u0131, ilgili afiliatlar ve influencerlar dahil edilmez.<\/p>\n\n\n\n<p>Ancak, Reiwa 1 y\u0131l\u0131ndaki de\u011fi\u015fiklikle, yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklam yapan ki\u015filere y\u00f6nelik cezai yapt\u0131r\u0131mlar ve tedbir emirleri eklenmi\u015ftir, bu nedenle ila\u00e7lar vb. hakk\u0131nda reklam yaparken daha \u00f6nce oldu\u011fundan daha dikkatli olunmas\u0131 gerekmektedir.<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/?p=49848\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n \u0130dari Para Cezas\u0131 Sistemi Nedir? Hedef Al\u0131nan Eylemler ve \u0130ndirim Uygulanan Durumlar A\u00e7\u0131klan\u0131yor [ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99ndaki_Degisiklikle_Tedbir_Emirleri_de_Eklendi\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fiklikle Tedbir Emirleri de Eklendi<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Yukar\u0131da belirtildi\u011fi gibi, Reiwa 1 y\u0131l\u0131ndaki \u0130la\u00e7 Makinesi Yasas\u0131 de\u011fi\u015fikli\u011fi ile yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklam yapan ki\u015filere y\u00f6nelik tedbir emirleri eklenmi\u015ftir. Tedbir emri, idari bir yapt\u0131r\u0131md\u0131r ve yasalara ayk\u0131r\u0131 hareket eden ki\u015filere, devlet veya yerel y\u00f6netimler taraf\u0131ndan yasad\u0131\u015f\u0131 eylemlerin durdurulmas\u0131 ve tekrar\u0131n\u0131n \u00f6nlenmesi i\u00e7in gerekli tedbirlerin al\u0131nmas\u0131 emredilir.<\/p>\n\n\n\n<p>Tedbir emirlerinin i\u00e7eri\u011fi a\u015fa\u011f\u0131daki 3 t\u00fcr olarak d\u00fczenlenebilir:<\/p>\n\n\n\n<ul>\n<li>Yasad\u0131\u015f\u0131 reklamlar\u0131n durdurulmas\u0131<\/li>\n\n\n\n<li>Yasad\u0131\u015f\u0131 eylemlerin tekrar\u0131n\u0131n \u00f6nlenmesi i\u00e7in gerekli hususlar veya bunlar\u0131n uygulanmas\u0131 ile ilgili halka a\u00e7\u0131k duyurular<\/li>\n\n\n\n<li>Halk sa\u011fl\u0131\u011f\u0131 \u00fczerindeki tehlikelerin \u00f6nlenmesi i\u00e7in gerekli tedbirler<\/li>\n<\/ul>\n\n\n\n<p>Bu arada, Reiwa 1 y\u0131l\u0131ndaki de\u011fi\u015fiklikle &#8220;halka a\u00e7\u0131k duyuru&#8221; eklenmi\u015f ve yasad\u0131\u015f\u0131 reklam yapan ki\u015filerin d\u0131\u015fa d\u00f6n\u00fck olarak belirtilmesi ile yasad\u0131\u015f\u0131 reklamlar\u0131n cayd\u0131r\u0131lmas\u0131 etkisi daha da art\u0131r\u0131lm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi_Degisikligi_Karsisinda_Sirketlerin_Almasi_Gereken_Onlemler\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131 De\u011fi\u015fikli\u011fi Kar\u015f\u0131s\u0131nda \u015eirketlerin Almas\u0131 Gereken \u00d6nlemler<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/tr\/wp-content\/uploads\/sites\/24\/2024\/01\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-1.png\" alt=\"\" class=\"wp-image-62743\" srcset=\"https:\/\/monolith.law\/tr\/wp-content\/uploads\/sites\/24\/2024\/01\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-1.png 735w, https:\/\/monolith.law\/tr\/wp-content\/uploads\/sites\/24\/2024\/01\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-1-300x200.png 300w, https:\/\/monolith.law\/tr\/wp-content\/uploads\/sites\/24\/2024\/01\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-1-250x167.png 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><\/figure>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 (Japon \u0130la\u00e7 Makinesi Yasas\u0131), insan sa\u011fl\u0131\u011f\u0131na ili\u015fkin bir\u00e7ok \u00fcr\u00fcnle ilgili bir yasad\u0131r, bu nedenle ilgili \u00fcr\u00fcnlerin i\u015fletmecileri, k\u00fc\u00e7\u00fck de\u011fi\u015fiklikler olsa bile bunlar\u0131 do\u011fru bir \u015fekilde anlamak zorundad\u0131r.<\/p>\n\n\n\n<p>E\u011fer bir \u0130la\u00e7 Makinesi Yasas\u0131 ihlali nedeniyle yakalan\u0131r ve i\u015f durdurma emri veya para cezas\u0131 \u00f6deme emri gibi emirler verilirse, sadece mali harcamalar de\u011fil, ayn\u0131 zamanda \u015firketin veya \u00fcr\u00fcn\u00fcn toplumsal itibar\u0131 ve imaj\u0131 da \u00f6nemli \u00f6l\u00e7\u00fcde zarar g\u00f6rebilir. Peki, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 olmamak i\u00e7in hangi \u00f6nlemleri almal\u0131y\u0131z?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Kendi_Urunlerinizin_Reklamlarini_Tekrar_Kontrol_Edin\"><\/span>Kendi \u00dcr\u00fcnlerinizin Reklamlar\u0131n\u0131 Tekrar Kontrol Edin<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u00d6ncelikle, kendi \u00fcr\u00fcn reklamlar\u0131n\u0131z\u0131n a\u015fa\u011f\u0131daki iki yasak maddesini ihlal edip etmedi\u011fini tekrar kontrol edin.<\/p>\n\n\n\n<ul>\n<li>Yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131<\/li>\n\n\n\n<li>Onaylanmam\u0131\u015f ila\u00e7lar\u0131n reklam\u0131n\u0131n yasaklanmas\u0131<\/li>\n<\/ul>\n\n\n\n<p>Bu s\u0131rada, \u0130la\u00e7 Makinesi Yasas\u0131 d\u0131\u015f\u0131nda, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n (Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131) olu\u015fturdu\u011fu y\u00f6nergeleri de kullanarak, reklamlarda yasad\u0131\u015f\u0131 i\u00e7erik olup olmad\u0131\u011f\u0131n\u0131 kontrol etmek iyi olacakt\u0131r.<\/p>\n\n\n\n<p>Dikkat etmeniz gereken nokta, reklam ifadelerinin a\u00e7\u0131k veya ima yoluyla yasad\u0131\u015f\u0131 reklam olabilece\u011fidir. Yani, do\u011frudan bir ifade olmasa bile, yasaklanan bir i\u00e7eri\u011fi ima ediyorsa, bu bir ihlal reklam\u0131 olabilir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Kendi_Yonergelerinizi_Olusturun_ve_Yayinlayin\"><\/span>Kendi Y\u00f6nergelerinizi Olu\u015fturun ve Yay\u0131nlay\u0131n<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u00dcr\u00fcn reklamlar\u0131, planlama ve \u00fcretimden medyada yay\u0131nlanmaya kadar bir\u00e7ok \u015firket ve ki\u015finin dahil oldu\u011fu bir s\u00fcre\u00e7tir, bu y\u00fczden sadece reklam verenin \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131 do\u011fru bir \u015fekilde anlamas\u0131, ihlalleri tamamen \u00f6nlemek i\u00e7in yeterli olmayabilir.<\/p>\n\n\n\n<p>Bu nedenle, kendi \u00fcr\u00fcnlerinizin reklamlar\u0131yla ilgili \u0130la\u00e7 Makinesi Yasas\u0131 h\u00fck\u00fcmleri ve y\u00f6nerge maddelerini i\u00e7eren kendi y\u00f6nergelerinizi olu\u015fturman\u0131z\u0131 ve bunlar\u0131 t\u00fcm ilgili taraflarla payla\u015fman\u0131z\u0131 \u00f6neririz.<\/p>\n\n\n\n<p>Ayr\u0131ca, reklam ajanslar\u0131na, onlar\u0131n arkas\u0131ndaki \u00fcretim \u015firketlerine, reklam yarat\u0131c\u0131lar\u0131na ve hatta ba\u011fl\u0131 kurulu\u015flara y\u00f6nergeleri yaymalar\u0131 konusunda rehberlik etmek de gereklidir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ozet_Ilac_Makinesi_Yasasi%E2%80%99ndaki_Degisikliklerle_Ilgili_Belirsizlikler_Icin_Bir_Avukata_Danisin\"><\/span>\u00d6zet: \u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki De\u011fi\u015fikliklerle \u0130lgili Belirsizlikler \u0130\u00e7in Bir Avukata Dan\u0131\u015f\u0131n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh3.googleusercontent.com\/NlUkUjIZjMHLiT44NCTF7kC51iWfXDmbpDdZ0Vulo8TtU5M47wEp-m8AtzejZqbp7gLm9wyFfdEbf1GnLgudeRGqSN71Ls76aR9DdadF0gV0IMJvVOd2c8wdLvmn342NJbUHDSD4atsuxNUpdxjn_Y4\" alt=\"\u00d6zet: \u0130la\u00e7 Makinesi Yasas\u0131'ndaki De\u011fi\u015fikliklerle \u0130lgili Belirsizlikler \u0130\u00e7in Bir Avukata Dan\u0131\u015f\u0131n\" \/><\/figure>\n\n\n\n<p>Buraya kadar, Reiwa&#8217;n\u0131n ilk y\u0131l\u0131nda (2019) Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki de\u011fi\u015fiklikler aras\u0131nda, eczaneler ve eczac\u0131lar\u0131n durumunun g\u00f6zden ge\u00e7irilmesi ve para cezas\u0131 sistemi hakk\u0131nda a\u00e7\u0131klamalar yapt\u0131k.<\/p>\n\n\n\n<p>\u00d6zellikle, para cezas\u0131 sistemi, ila\u00e7larla ilgilenen \u015firketler i\u00e7in b\u00fcy\u00fck bir risk olabilecek bir de\u011fi\u015fikliktir, bu y\u00fczden do\u011fru bir \u015fekilde anla\u015f\u0131lmas\u0131 gerekmektedir.<\/p>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 olmamak i\u00e7in, mevcut reklamlar\u0131n kontrol\u00fcn\u00fc ve \u00f6zg\u00fcn bir k\u0131lavuz olu\u015fturmay\u0131 ve bunu yaymay\u0131 \u00f6neriyoruz. Ancak, bir reklam\u0131n ifadesinin \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenlemelerine ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131n\u0131 belirlemek, bireysel olarak zor olabilir. Bu nedenle, reklamlar\u0131n kontrol\u00fc ve k\u0131lavuzun olu\u015fturulmas\u0131 konusunda, l\u00fctfen uzman bilgi ve deneyime sahip bir avukata dan\u0131\u015f\u0131n.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Buromuz_Tarafindan_Alinan_Onlemler\"><\/span>B\u00fcromuz Taraf\u0131ndan Al\u0131nan \u00d6nlemler<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Monolith Hukuk B\u00fcrosu, \u00f6zellikle IT ve hukuk alanlar\u0131nda y\u00fcksek uzmanl\u0131\u011fa sahip bir hukuk firmas\u0131d\u0131r. B\u00fcromuz, medya i\u015fletmecileri, inceleme sitesi i\u015fletmecileri, reklam ajanslar\u0131, D2C ve kozmetik \u00fcreticileri, klinikler, ASP i\u015fletmecileri gibi firmalara makale ve LP&#8217;nin hukuki kontrol\u00fc, y\u00f6nerge olu\u015fturma ve \u00f6rnekleme kontrol\u00fc gibi hizmetler sunmaktad\u0131r. Ayr\u0131nt\u0131lar a\u015fa\u011f\u0131daki makalede belirtilmi\u015ftir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Reiwa&#8217;n\u0131n ilk y\u0131l\u0131nda (2019) 4 Aral\u0131k&#8217;ta ilan edilen ve s\u0131ras\u0131yla uygulanmas\u0131 planlanan de\u011fi\u015fikliklerle &#8216;Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;, &#8216;Reiwa&#8217;n\u0131n B\u00fcy\u00fck De\u011fi\u015fiklik Ya [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":62741,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[30,24],"acf":[],"_links":{"self":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61752"}],"collection":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/comments?post=61752"}],"version-history":[{"count":2,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61752\/revisions"}],"predecessor-version":[{"id":62744,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61752\/revisions\/62744"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media\/62741"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media?parent=61752"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/categories?post=61752"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/tags?post=61752"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}