{"id":61311,"date":"2023-12-04T11:20:31","date_gmt":"2023-12-04T02:20:31","guid":{"rendered":"https:\/\/monolith.law\/tr\/?p=61311"},"modified":"2024-03-19T22:46:56","modified_gmt":"2024-03-19T13:46:56","slug":"pharmaceuticals-law","status":"publish","type":"post","link":"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law","title":{"rendered":"Eczac\u0131l\u0131k Kanunu (eski ad\u0131yla \u0130la\u00e7 \u0130\u015fleri Kanunu) nedir? Amac\u0131n, d\u00fczenleyici hedeflerin ve reklam d\u00fczenlemelerinin a\u00e7\u0131klanmas\u0131"},"content":{"rendered":"\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) duydu\u011funuzda, &#8220;\u0130la\u00e7la ilgili bir yasa&#8221; veya &#8220;Eczaneler ve sa\u011fl\u0131k kurulu\u015flar\u0131yla ilgili bir yasa&#8221; oldu\u011funu d\u00fc\u015f\u00fcnen bir\u00e7ok ki\u015fi olabilir. Ancak, ger\u00e7ekte, \u00e7ok geni\u015f bir kapsama alan\u0131na sahip bir yasad\u0131r ve \u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda, \u00e7e\u015fitli sekt\u00f6rlerdeki i\u015fletmelerin uymas\u0131 gereken bir\u00e7ok kural bulunmaktad\u0131r.<\/p>\n\n\n\n<p>Bilmeden \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131 ihlal etmemek i\u00e7in, \u0130la\u00e7 Makinesi Yasas\u0131 hakk\u0131nda iyi bir bilgiye sahip olman\u0131z gerekmektedir.<\/p>\n\n\n\n<p>Bu makalede, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n amac\u0131, d\u00fczenlemeye tabi olanlar ve reklam d\u00fczenlemeleri hakk\u0131nda bilgi verilmektedir.<\/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\/#Ilac_ve_Tibbi_Cihaz_Kanunu_Eski_Ilac_Kanunu_Nedir\" title=\"\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu (Eski \u0130la\u00e7 Kanunu) Nedir?\">\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu (Eski \u0130la\u00e7 Kanunu) 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\/#Ilac_Kanunu%E2%80%99ndan_Ilac_ve_Tibbi_Cihaz_Kanunu%E2%80%99na\" title=\"\u0130la\u00e7 Kanunu&#8217;ndan \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na\">\u0130la\u00e7 Kanunu&#8217;ndan \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na<\/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\/#Ilac_ve_Tibbi_Cihaz_Kanunu%E2%80%99nun_Amaci\" title=\"\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun Amac\u0131\">\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun Amac\u0131<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Ilac_Makinesi_Yasasi%E2%80%99nin_Japanese_Pharmaceutical_and_Medical_Device_Act_Ana_Duzenleme_Konulari_ve_Tanimlari\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical and Medical Device Act) Ana D\u00fczenleme Konular\u0131 ve Tan\u0131mlar\u0131\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical and Medical Device Act) Ana D\u00fczenleme Konular\u0131 ve Tan\u0131mlar\u0131<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Ilaclar\" title=\"\u0130la\u00e7lar\">\u0130la\u00e7lar<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Ilac_Disi_Urunler\" title=\"\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler\">\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Kozmetik_Urunler\" title=\"Kozmetik \u00dcr\u00fcnler\">Kozmetik \u00dcr\u00fcnler<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Tibbi_Cihazlar\" title=\"T\u0131bbi Cihazlar\">T\u0131bbi Cihazlar<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Rejeneratif_Tip_Urunleri\" title=\"Rejeneratif T\u0131p \u00dcr\u00fcnleri\">Rejeneratif T\u0131p \u00dcr\u00fcnleri<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Ilac_Makinesi_Yasasi_Kapsamindaki_Reklam_Duzenlemeleri\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131 Kapsam\u0131ndaki Reklam D\u00fczenlemeleri\">\u0130la\u00e7 Makinesi Yasas\u0131 Kapsam\u0131ndaki Reklam D\u00fczenlemeleri<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#%E2%80%9CAbarti%E2%80%9D_Olup_Olmadigi_Japon_Ilac_ve_Diger_Urunlerin_Uygun_Reklam_Standartlarina_Gore_Belirlenir\" title=\"&#8220;Abart\u0131&#8221; Olup Olmad\u0131\u011f\u0131 Japon \u0130la\u00e7 ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131na G\u00f6re Belirlenir\">&#8220;Abart\u0131&#8221; Olup Olmad\u0131\u011f\u0131 Japon \u0130la\u00e7 ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131na G\u00f6re Belirlenir<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Ilac_Makinesi_Yasasi%E2%80%99nin_Duzenlemeye_Tabi_Olmayan_Urunler\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n D\u00fczenlemeye Tabi Olmayan \u00dcr\u00fcnler\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n D\u00fczenlemeye Tabi Olmayan \u00dcr\u00fcnler<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Ilac_Makinesi_Yasasi%E2%80%99na_Aykiri_Davranisin_Cezalari\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na Ayk\u0131r\u0131 Davran\u0131\u015f\u0131n Cezalar\u0131\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na Ayk\u0131r\u0131 Davran\u0131\u015f\u0131n Cezalar\u0131<\/a><\/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\/#Ilac_Makinesi_Yasasi_Ihlallerinden_Kacinma_Noktalari\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlallerinden Ka\u00e7\u0131nma Noktalar\u0131\">\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlallerinden Ka\u00e7\u0131nma Noktalar\u0131<\/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\/#Yonergeleri_Dogru_Anlama\" title=\"Y\u00f6nergeleri Do\u011fru Anlama\">Y\u00f6nergeleri Do\u011fru Anlama<\/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\/#Sirket_Icinde_Paylasim\" title=\"\u015eirket \u0130\u00e7inde Payla\u015f\u0131m\">\u015eirket \u0130\u00e7inde Payla\u015f\u0131m<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#Ilac_Makinesi_Yasasi_Japanese_Pharmaceutical_and_Medical_Device_Act_ve_Fiyat_Indikasyon_Yasasi_Japanese_Price_Indication_Act_Arasindaki_Farklar_Nelerdir\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) ve Fiyat \u0130ndikasyon Yasas\u0131 (Japanese Price Indication Act) Aras\u0131ndaki Farklar Nelerdir?\">\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) ve Fiyat \u0130ndikasyon Yasas\u0131 (Japanese Price Indication Act) Aras\u0131ndaki Farklar Nelerdir?<\/a><\/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\/#Ozet_Ilac_ve_Tibbi_Cihaz_Kanunu_Japanese_Pharmaceutical_and_Medical_Device_Act_ile_ilgili_sorunlariniz_icin_avukata_danisin\" title=\"\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu (Japanese Pharmaceutical and Medical Device Act) ile ilgili sorunlar\u0131n\u0131z i\u00e7in avukata dan\u0131\u015f\u0131n\">\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu (Japanese Pharmaceutical and Medical Device Act) ile ilgili sorunlar\u0131n\u0131z i\u00e7in 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-19\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law\/#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_Kanunu_Eski_Ilac_Kanunu_Nedir\"><\/span>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu (Eski \u0130la\u00e7 Kanunu) Nedir?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Kanunu%E2%80%99ndan_Ilac_ve_Tibbi_Cihaz_Kanunu%E2%80%99na\"><\/span>\u0130la\u00e7 Kanunu&#8217;ndan \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu, ila\u00e7lar, t\u0131bbi cihazlar vb. hakk\u0131nda, \u00fcretim, etiketleme, sat\u0131\u015f, da\u011f\u0131t\u0131m, reklam gibi a\u015famalarda gereken d\u00fczenlemeleri belirleyen bir yasad\u0131r. Resmi ad\u0131 &#8220;\u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun&#8221;dur.<\/p>\n\n\n\n<p>Eski ad\u0131 &#8220;\u0130la\u00e7 Kanunu&#8221; idi ancak t\u0131p, eczac\u0131l\u0131k, elektronik m\u00fchendisli\u011fi gibi alanlardaki ilerlemelere uyum sa\u011flamak i\u00e7in Heisei 25 (2013) y\u0131l\u0131nda de\u011fi\u015fiklik yap\u0131ld\u0131 (Heisei 26 y\u0131l\u0131nda y\u00fcr\u00fcrl\u00fc\u011fe girdi) ve ad\u0131 &#8220;\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8221; olarak de\u011fi\u015ftirildi.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu, ila\u00e7lar\u0131 vb. d\u00fczenler, ancak eczaneler veya ila\u00e7 sat\u0131c\u0131lar\u0131 gibi ila\u00e7 sat\u0131\u015f i\u015fletmeleri olmasa bile, \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun d\u00fczenlemeleri genellikle ge\u00e7erlidir. \u00d6rne\u011fin, bir termometre &#8220;t\u0131bbi cihaz&#8221; olarak kabul edildi\u011fi i\u00e7in \u00fcretim ve reklam a\u015famalar\u0131nda d\u00fczenlemeler ge\u00e7erlidir. Ayr\u0131ca, kozmetik veya g\u0131da \u00fcr\u00fcnlerini tan\u0131t\u0131rken, hastal\u0131klar\u0131n \u00f6nlenmesine yard\u0131mc\u0131 olabilecek ifadeler kullan\u0131l\u0131rsa, herkes \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na ayk\u0131r\u0131 olabilir.<\/p>\n\n\n\n<p>Bu \u015fekilde, \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun d\u00fczenlemeleri geni\u015f kapsaml\u0131d\u0131r ve d\u00fczenlemelerin kapsam\u0131n\u0131 ve i\u00e7eri\u011fini do\u011fru bir \u015fekilde anlamazsan\u0131z, beklenmedik bir \u015fekilde \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na ayk\u0131r\u0131 olabilirsiniz.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_ve_Tibbi_Cihaz_Kanunu%E2%80%99nun_Amaci\"><\/span>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun Amac\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun amac\u0131, Madde 1&#8217;de belirtilmi\u015ftir.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Bu kanun, ila\u00e7lar, ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler, kozmetikler, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnleri (bundan sonra &#8220;ila\u00e7lar vb.&#8221; olarak an\u0131lacakt\u0131r.) kalite, etkinlik 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 yapmak, belirli ila\u00e7lar\u0131n (tehlikeli ila\u00e7lar) d\u00fczenlenmesi ve t\u0131bbi gereklili\u011fi y\u00fcksek olan ila\u00e7lar, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin ara\u015ft\u0131rma ve geli\u015ftirilmesini te\u015fvik etmek i\u00e7in gerekli \u00f6nlemleri almak amac\u0131yla, sa\u011fl\u0131k ve hijyenin iyile\u015ftirilmesini hedeflemektedir.<\/p>\n<cite>\u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun Madde 1<\/cite><\/blockquote>\n\n\n\n<p>Madde 1&#8217;in h\u00fck\u00fcmlerini d\u00fczenlersek, a\u015fa\u011f\u0131daki gibi olur:<\/p>\n\n\n\n<ol>\n<li>\u0130la\u00e7lar, ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler, kozmetikler, t\u0131bbi cihazlar, rejeneratif t\u0131p \u00fcr\u00fcnleri olmak \u00fczere 5 kategori (ila\u00e7lar vb.) i\u00e7in g\u00fcvenlik d\u00fczenlemeleri yapmak<\/li>\n\n\n\n<li>&#8220;Belirli ila\u00e7lar&#8221; (tehlikeli ila\u00e7lar) hakk\u0131nda d\u00fczenlemeler yapmak<\/li>\n\n\n\n<li>\u0130la\u00e7lar, t\u0131bbi cihazlar, rejeneratif t\u0131p \u00fcr\u00fcnlerinin ara\u015ft\u0131rma ve geli\u015ftirilmesini te\u015fvik etmek<\/li>\n<\/ol>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu, bu \u00fc\u00e7 amaca uygun d\u00fczenlemeleri belirler.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99nin_Japanese_Pharmaceutical_and_Medical_Device_Act_Ana_Duzenleme_Konulari_ve_Tanimlari\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical and Medical Device Act) Ana D\u00fczenleme Konular\u0131 ve Tan\u0131mlar\u0131<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) ayk\u0131r\u0131 hareket etmemek i\u00e7in, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenleme konular\u0131n\u0131 do\u011fru bir \u015fekilde anlamak gereklidir.<\/p>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical and Medical Device Act) ana d\u00fczenleme konular\u0131, 1. maddede belirtildi\u011fi gibi, ila\u00e7lar, t\u0131bbi olmayan ila\u00e7lar, kozmetik \u00fcr\u00fcnler, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnleridir. Her birinin tan\u0131m\u0131n\u0131 g\u00f6zden ge\u00e7irelim.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilaclar\"><\/span>\u0130la\u00e7lar<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>&#8220;\u0130la\u00e7&#8221; denildi\u011finde, \u00e7o\u011fu ki\u015finin akl\u0131na eczaneden al\u0131nan re\u00e7eteli ila\u00e7lar veya a\u011fr\u0131 kesiciler gibi \u00fcr\u00fcnler gelir. Ancak, ger\u00e7ekte &#8220;ila\u00e7&#8221; kapsam\u0131na giren bir\u00e7ok ba\u015fka \u00fcr\u00fcn de bulunmaktad\u0131r.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu (Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu), ila\u00e7lar\u0131 Madde 2, F\u0131kra 1&#8217;de tan\u0131mlamaktad\u0131r.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Bu kanuna g\u00f6re &#8220;ila\u00e7&#8221;, a\u015fa\u011f\u0131daki maddeleri ifade eder:<\/p>\n\n\n\n<p>Bir &#8211; Japon Eczac\u0131l\u0131k Standartlar\u0131&#8217;nda (Japanese Pharmacopoeia) yer alan maddeler<\/p>\n\n\n\n<p>\u0130ki &#8211; \u0130nsan veya hayvan hastal\u0131klar\u0131n\u0131n te\u015fhisi, tedavisi veya \u00f6nlenmesi amac\u0131yla kullan\u0131lan ve makine, alet vb. (makine, alet, di\u015f malzemeleri, t\u0131bbi malzemeler, hijyen \u00fcr\u00fcnleri ve programlar (elektronik bilgisayarlara y\u00f6nelik talimatlar olup, bir sonu\u00e7 elde edebilmek i\u00e7in bir araya getirilmi\u015f olanlar\u0131 ifade eder. A\u015fa\u011f\u0131da ayn\u0131.) ve bunlar\u0131 kaydeden kay\u0131t medyas\u0131n\u0131 ifade eder. A\u015fa\u011f\u0131da ayn\u0131.) olmayan maddeler (ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler ve rejeneratif t\u0131p \u00fcr\u00fcnleri hari\u00e7.)<\/p>\n\n\n\n<p>\u00dc\u00e7 &#8211; \u0130nsan veya hayvan v\u00fccut yap\u0131s\u0131 veya i\u015flevine etki etme amac\u0131yla kullan\u0131lan ve makine, alet vb. olmayan maddeler (ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler, kozmetikler ve rejeneratif t\u0131p \u00fcr\u00fcnleri hari\u00e7.)<\/p>\n<cite>\u0130la\u00e7, T\u0131bbi Cihaz vb. Kalite, Etkinlik ve G\u00fcvenlik Sa\u011flama Kanunu Madde 2, F\u0131kra 1<\/cite><\/blockquote>\n\n\n\n<p>1 numaral\u0131 &#8220;Japon Eczac\u0131l\u0131k Standartlar\u0131&#8221;, devlet taraf\u0131ndan belirlenen ila\u00e7 kalite standartlar\u0131d\u0131r. Bu standartlar aras\u0131nda, sadece kimyasal ila\u00e7lar de\u011fil, zeytinya\u011f\u0131 ve bal gibi maddeler de yer al\u0131r. Bu maddeler, ama\u00e7lar\u0131 g\u0131da kullan\u0131m\u0131 gibi belirli bir ama\u00e7la s\u0131n\u0131rl\u0131 olmad\u0131k\u00e7a, &#8220;ila\u00e7&#8221; olarak kabul edilir.<\/p>\n\n\n\n<p>2 numaral\u0131 madde, hastal\u0131klar\u0131n veya yaralanmalar\u0131n te\u015fhisi, tedavisi veya \u00f6nlenmesi amac\u0131yla kullan\u0131lan maddeleri tan\u0131mlar. \u00d6rnek olarak, a\u015f\u0131lar ve antijen test kitleri verilebilir.<\/p>\n\n\n\n<p>3 numaral\u0131 madde, insan v\u00fccudu veya i\u015flevlerine etki etme amac\u0131yla kullan\u0131lan maddeleri tan\u0131mlar. \u00d6rnek olarak, do\u011fum kontrol haplar\u0131 verilebilir.<\/p>\n\n\n\n<p>Dikkat edilmesi gereken nokta, \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun ama\u00e7 d\u00fczenlemesi yapt\u0131\u011f\u0131d\u0131r. Yani, bir \u00fcr\u00fcn\u00fcn ger\u00e7ekte hastal\u0131k veya yaralanman\u0131n te\u015fhisi, tedavisi veya \u00f6nlenmesinde etkili olup olmad\u0131\u011f\u0131na bak\u0131lmaks\u0131z\u0131n, bu ama\u00e7la sat\u0131l\u0131yorsa, &#8220;ila\u00e7&#8221; olarak d\u00fczenlenir. \u00d6rne\u011fin, bir \u00fcr\u00fcn g\u0131da olarak sat\u0131l\u0131yor olsa bile, &#8220;kan\u0131 temizler&#8221; gibi bir ifade kullan\u0131l\u0131yorsa, bu, ila\u00e7 etkisi oldu\u011funu belirtti\u011fi i\u00e7in, &#8220;ila\u00e7&#8221; olarak kabul edilir.<\/p>\n\n\n\n<p>\u0130la\u00e7lara y\u00f6nelik ana d\u00fczenlemeler, basit\u00e7e ifade edilecek olursa, \u00fcretim ve sat\u0131\u015fla ilgili izinlerdir. Yani, idari makamlardan izin al\u0131nmad\u0131k\u00e7a, ila\u00e7 \u00fcretmek veya satmak m\u00fcmk\u00fcn de\u011fildir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Disi_Urunler\"><\/span>\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u300c\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler\u300d hakk\u0131nda do\u011fru bir anlay\u0131\u015fa sahip olan ki\u015fi say\u0131s\u0131 azd\u0131r. Genel olarak, \u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler, insan v\u00fccuduna etkisi olan ancak ila\u00e7lara k\u0131yasla daha hafif etkisi olan \u00fcr\u00fcnleri ifade eder ve ila\u00e7lardan daha hafif d\u00fczenlemelere tabidir.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131, \u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler&#8217;i Madde 2, F\u0131kra 2&#8217;de tan\u0131mlar.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Bu yasada &#8220;\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler&#8221;, a\u015fa\u011f\u0131da belirtilen ve insan v\u00fccuduna hafif etkisi olan maddeleri ifade eder.<\/p>\n\n\n\n<p>1. A\u015fa\u011f\u0131da A&#8217;dan C&#8217;ye kadar belirtilen ama\u00e7lar i\u00e7in kullan\u0131lan maddeler (bu kullan\u0131m ama\u00e7lar\u0131n\u0131n yan\u0131 s\u0131ra, ayn\u0131 zamanda \u00f6nceki f\u0131kran\u0131n ikinci veya \u00fc\u00e7\u00fcnc\u00fc maddesinde belirtilen ama\u00e7lar i\u00e7in kullan\u0131lan maddeler hari\u00e7) ve mekanik aletler vb. olmayanlar<\/p>\n\n\n\n<p>A. Mide bulant\u0131s\u0131 ve di\u011fer rahats\u0131zl\u0131klar\u0131n veya a\u011f\u0131z veya v\u00fccut kokusunun \u00f6nlenmesi<\/p>\n\n\n\n<p>B. Pi\u015fik, tahri\u015f vb. \u00f6nlenmesi<\/p>\n\n\n\n<p>C. Sa\u00e7 d\u00f6k\u00fclmesinin \u00f6nlenmesi, sa\u00e7 b\u00fcy\u00fcmesi veya t\u00fcy alma<\/p>\n\n\n\n<p>2. \u0130nsan veya hayvan sa\u011fl\u0131\u011f\u0131 i\u00e7in fare, sinek, sivrisinek, pire ve bunlara benzer canl\u0131lar\u0131n kontrol\u00fc amac\u0131yla kullan\u0131lan maddeler (bu kullan\u0131m ama\u00e7lar\u0131n\u0131n yan\u0131 s\u0131ra, ayn\u0131 zamanda \u00f6nceki f\u0131kran\u0131n ikinci veya \u00fc\u00e7\u00fcnc\u00fc maddesinde belirtilen ama\u00e7lar i\u00e7in kullan\u0131lan maddeler hari\u00e7) ve mekanik aletler vb. olmayanlar<\/p>\n\n\n\n<p>3. \u00d6nceki f\u0131kran\u0131n ikinci veya \u00fc\u00e7\u00fcnc\u00fc maddesinde belirtilen ama\u00e7lar i\u00e7in kullan\u0131lan maddeler (\u00f6nceki iki maddeye dahil olmayanlar) aras\u0131ndan, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 taraf\u0131ndan belirlenenler<\/p>\n<cite>\u0130la\u00e7, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenliklerinin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun Madde 2, F\u0131kra 2<\/cite><\/blockquote>\n\n\n\n<p>Yukar\u0131daki h\u00fck\u00fcmlere bak\u0131ld\u0131\u011f\u0131nda, insan v\u00fccuduna hafif etkisi olan ve \u2460 mide bulant\u0131s\u0131 vb. i\u00e7in kullan\u0131lanlar, \u2461 fare vb. kontrol\u00fc i\u00e7in kullan\u0131lanlar, \u2462 Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 taraf\u0131ndan belirlenenler, \u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler kapsam\u0131na girdi\u011fi anla\u015f\u0131lmaktad\u0131r.<\/p>\n\n\n\n<p>\u2460 kapsam\u0131na giren \u00f6rnekler aras\u0131nda a\u011f\u0131z spreyi, gargara, t\u0131ra\u015f yan\u0131\u011f\u0131 \u00f6nleyici krem, sa\u00e7 b\u00fcy\u00fct\u00fcc\u00fc, t\u00fcy d\u00f6k\u00fcc\u00fc vb. bulunmaktad\u0131r.<\/p>\n\n\n\n<p>\u2461 kapsam\u0131na giren \u00f6rnekler aras\u0131nda sinek kovucu t\u00fcts\u00fc, fare kapan\u0131, b\u00f6cek ilac\u0131 vb. bulunmaktad\u0131r.<\/p>\n\n\n\n<p>\u2462, asl\u0131nda &#8220;ila\u00e7&#8221; kapsam\u0131na giren ancak Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 taraf\u0131ndan belirlenenlerin &#8220;\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler&#8221; kapsam\u0131na girdi\u011fini belirleyen bir h\u00fck\u00fcmd\u00fcr. Bu, etkisinin hafif oldu\u011fu ve genel perakende ma\u011fazalar\u0131nda bile sat\u0131ld\u0131\u011f\u0131nda halk\u0131n sa\u011fl\u0131\u011f\u0131na etkisi olmayaca\u011f\u0131 d\u00fc\u015f\u00fcn\u00fclen \u00fcr\u00fcnlerin da\u011f\u0131t\u0131m\u0131n\u0131 te\u015fvik etmek amac\u0131yla olu\u015fturulmu\u015f bir h\u00fck\u00fcmd\u00fcr.<\/p>\n\n\n\n<p>\u2462&#8217;\u00fcn somut \u00f6rnekleri aras\u0131nda kontakt lens dezenfektan\u0131, antiseptik dezenfektan, ba\u011f\u0131rsak d\u00fczenleyici, sa\u00e7 boyas\u0131 vb. bulunmaktad\u0131r.<\/p>\n\n\n\n<p>\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler, ila\u00e7lar gibi, insan v\u00fccuduna belirli bir etkisi olan \u00fcr\u00fcnlerdir, ancak ila\u00e7lara k\u0131yasla, bu etkinin &#8220;hafif&#8221; oldu\u011fu \u00f6zelli\u011fi vard\u0131r. \u00d6rne\u011fin, \u2461&#8217;nin bir \u00f6rne\u011fi olarak b\u00f6cek ilac\u0131n\u0131 belirttik, ancak e\u011fer insan v\u00fccuduna olduk\u00e7a \u015fiddetli bir etkisi olan bir bile\u015fen i\u00e7eriyorsa, bu &#8220;\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcn&#8221; de\u011fil, &#8220;ila\u00e7&#8221; kapsam\u0131na girer.<\/p>\n\n\n\n<p>\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler&#8217;e y\u00f6nelik ana d\u00fczenlemeler, basit\u00e7e ifade edilirse, \u00fcretimle ilgili izinlerdir. Di\u011fer yandan, sat\u0131\u015fla ilgili olarak izin almak gerekli de\u011fildir. Yani, \u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler, genel perakende ma\u011fazalar\u0131nda serbest\u00e7e sat\u0131labilir. Ancak, daha sonra belirtildi\u011fi gibi, reklamla ilgili d\u00fczenlemeler ge\u00e7erlidir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Kozmetik_Urunler\"><\/span>Kozmetik \u00dcr\u00fcnler<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Kozmetik denildi\u011finde, \u00e7o\u011fu ki\u015fi kad\u0131nlar\u0131n \u015f\u0131kl\u0131k i\u00e7in kulland\u0131\u011f\u0131 \u00fcr\u00fcnleri d\u00fc\u015f\u00fcn\u00fcr. Ancak, Japonca&#8217;daki &#8216;Kozmetik \u00dcr\u00fcnler&#8217; ifadesi, &#8216;Farmas\u00f6tik ve T\u0131bbi Cihazlar Yasas\u0131&#8217;nda (\u85ac\u6a5f\u6cd5) daha geni\u015f bir kapsam\u0131 ifade eder.<\/p>\n\n\n\n<p>Farmas\u00f6tik ve T\u0131bbi Cihazlar Yasas\u0131, kozmetik \u00fcr\u00fcnleri Madde 2, F\u0131kra 3&#8217;te tan\u0131mlar.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p> Bu yasaya g\u00f6re &#8216;kozmetik \u00fcr\u00fcnler&#8217;, insan v\u00fccudunu temizlemek, g\u00fczelle\u015ftirmek, \u00e7ekicili\u011fi art\u0131rmak, g\u00f6r\u00fcn\u00fcm\u00fc de\u011fi\u015ftirmek veya cildi veya sa\u00e7\u0131 sa\u011fl\u0131kl\u0131 tutmak i\u00e7in v\u00fccuda s\u00fcr\u00fclen, p\u00fcsk\u00fcrt\u00fclen veya benzeri y\u00f6ntemlerle kullan\u0131lan \u00fcr\u00fcnleri ifade eder. Ancak, bu \u00fcr\u00fcnlerin etkisi hafiftir. Bunun yan\u0131 s\u0131ra, bu kullan\u0131m amac\u0131n\u0131n yan\u0131 s\u0131ra, Madde 1, F\u0131kra 2 veya F\u0131kra 3&#8217;te belirtilen ama\u00e7larla da kullan\u0131lan \u00fcr\u00fcnler ve t\u0131bbi cihazlar hari\u00e7tir.<\/p>\n<cite>Farmas\u00f6tik ve T\u0131bbi Cihazlar Yasas\u0131 Madde 2, F\u0131kra 3<\/cite><\/blockquote>\n\n\n\n<p>Yukar\u0131daki h\u00fck\u00fcmleri okudu\u011fumuzda, kad\u0131nlar\u0131n genel kozmetik \u00fcr\u00fcnleri gibi &#8216;g\u00fczelle\u015ftirici, \u00e7ekicili\u011fi art\u0131r\u0131c\u0131, g\u00f6r\u00fcn\u00fcm\u00fc de\u011fi\u015ftirici&#8217; \u00fcr\u00fcnlerin yan\u0131 s\u0131ra, \u015fampuan veya di\u015f macunu gibi &#8216;insan v\u00fccudunu temizleyici&#8217; \u00fcr\u00fcnler ve cilt bak\u0131m \u00fcr\u00fcnleri veya v\u00fccut losyonlar\u0131 gibi &#8216;cildi ve sa\u00e7\u0131 sa\u011fl\u0131kl\u0131 tutan&#8217; \u00fcr\u00fcnlerin de kozmetik \u00fcr\u00fcnler kapsam\u0131na girdi\u011fini g\u00f6r\u00fcyoruz.<\/p>\n\n\n\n<p>Ayr\u0131ca, kozmetik \u00fcr\u00fcnlerin insan v\u00fccudu \u00fczerinde belirli bir etkisi vard\u0131r, ancak bu etki ila\u00e7 veya antibakteriyel etki i\u00e7ermez. \u00d6rne\u011fin, sadece kirleri temizlemek i\u00e7in kullan\u0131lan di\u015f macunu bir kozmetik \u00fcr\u00fcn olarak kabul edilirken, di\u015f eti hastal\u0131\u011f\u0131n\u0131 \u00f6nlemeyi vaat eden di\u015f macunu, ila\u00e7 etkisi beklenen bir \u00fcr\u00fcn oldu\u011fu i\u00e7in, t\u0131bbi cihaz veya ila\u00e7 olarak kabul edilebilir.<\/p>\n\n\n\n<p>Ek olarak, kozmetik \u00fcr\u00fcnler sadece v\u00fccuda s\u00fcr\u00fclen \u00fcr\u00fcnlerle s\u0131n\u0131rl\u0131d\u0131r, bu nedenle i\u00e7ilen veya v\u00fccuda enjekte edilen \u00fcr\u00fcnler kozmetik \u00fcr\u00fcn olarak kabul edilmez.<\/p>\n\n\n\n<p>Kozmetik \u00fcr\u00fcnlerle ilgili ana d\u00fczenlemeler, \u00fcretimle ilgili izin ve bildirimlerde bulunur ve t\u0131bbi cihazlardan daha hafif d\u00fczenlemelerle kar\u015f\u0131la\u015f\u0131r. Kozmetik \u00fcr\u00fcnler, genel perakende ma\u011fazalar\u0131nda serbest\u00e7e sat\u0131labilir. Ancak, a\u015fa\u011f\u0131da belirtildi\u011fi gibi, reklamla ilgili d\u00fczenlemeler ge\u00e7erlidir. Ayr\u0131ca, kozmetik \u00fcr\u00fcn olarak belirtilebilecek etkinlik ve etki ifadelerinin kapsam\u0131 da s\u0131n\u0131rl\u0131d\u0131r.<\/p>\n\n\n\n<p>Referans: 21 Temmuz 2011 (Heisei 23) Tarihli \u0130la\u00e7 ve G\u0131da Dairesi Ba\u015fkan\u0131 Bildirisi No: 0721-1 &#8216;<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/kesyouhin_hanni_20111.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Kozmetik \u00dcr\u00fcnlerin Etkinlik Kapsam\u0131n\u0131n De\u011fi\u015ftirilmesi Hakk\u0131nda[ja]<\/a>&#8216;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tibbi_Cihazlar\"><\/span>T\u0131bbi Cihazlar<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>T\u0131bbi cihazlar genellikle cerrahi b\u0131\u00e7aklar veya enjekt\u00f6rler gibi t\u0131bbi malzemeleri i\u00e7erir, ancak bunlarla s\u0131n\u0131rl\u0131 de\u011fildir.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu (Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu), t\u0131bbi cihazlar\u0131 Madde 2, Paragraf 4&#8217;te tan\u0131mlar.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Bu kanuna g\u00f6re &#8220;t\u0131bbi cihaz&#8221;, insan veya hayvan hastal\u0131klar\u0131n\u0131n te\u015fhisi, tedavisi veya \u00f6nlenmesi i\u00e7in kullan\u0131lan veya insan veya hayvan v\u00fccudunun yap\u0131s\u0131 veya i\u015flevini etkileme amac\u0131 g\u00fcden makine ve aletler (yeniden olu\u015fturucu t\u0131p \u00fcr\u00fcnleri hari\u00e7.) olup, h\u00fck\u00fcmet kararnamesi ile belirlenenlerdir.<\/p>\n<cite>\u0130la\u00e7, T\u0131bbi Cihaz vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun Madde 2, Paragraf 4<\/cite><\/blockquote>\n\n\n\n<p>Yukar\u0131daki h\u00fck\u00fcmleri okudu\u011fumuzda, \u2460 v\u00fccut yap\u0131s\u0131n\u0131 veya i\u015flevini etkileme amac\u0131 g\u00fcden &#8220;makine ve aletler&#8221; veya \u2461 te\u015fhis, tedavi veya \u00f6nleme amac\u0131 g\u00fcden &#8220;makine ve aletler&#8221; ve h\u00fck\u00fcmet kararnamesi ile belirlenenlerin t\u0131bbi cihazlara dahil oldu\u011funu anlar\u0131z.<\/p>\n\n\n\n<p>&#8220;Makine ve aletler&#8221; tan\u0131m\u0131, Madde 2, Paragraf 1, Madde 2&#8217;de a\u015fa\u011f\u0131daki \u015fekilde belirtilmi\u015ftir.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Makine ve aletler, di\u015f malzemeleri, t\u0131bbi malzemeler, hijyen malzemeleri ve programlar (bir sonu\u00e7 elde edebilmek i\u00e7in birle\u015ftirilmi\u015f olan ve bir bilgisayara y\u00f6nelik talimatlar\u0131 i\u00e7erir. A\u015fa\u011f\u0131da ayn\u0131 \u015fekilde.) ve bunlar\u0131n kaydedildi\u011fi kay\u0131t ortamlar\u0131n\u0131 ifade eder.<\/p>\n<cite>\u0130la\u00e7, T\u0131bbi Cihaz vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun Madde 2, Paragraf 1, Madde 2<\/cite><\/blockquote>\n\n\n\n<p>\u00d6rne\u011fin, kas geli\u015ftirme ekipmanlar\u0131, kas geli\u015ftirme amac\u0131 g\u00fctt\u00fc\u011f\u00fc i\u00e7in &#8220;v\u00fccut yap\u0131s\u0131n\u0131 veya i\u015flevini etkileme amac\u0131&#8221;na sahiptir, ancak &#8220;makine ve aletler&#8221; ve h\u00fck\u00fcmet kararnamesi ile belirlenenler aras\u0131nda yer almad\u0131\u011f\u0131 i\u00e7in t\u0131bbi cihaz olarak kabul edilmez. \u00d6te yandan, bir masaj aleti, &#8220;v\u00fccut yap\u0131s\u0131n\u0131 veya i\u015flevini etkileme amac\u0131&#8221;na sahip olan ve h\u00fck\u00fcmet kararnamesi ile belirlenen &#8220;makine ve aletler&#8221; aras\u0131nda yer ald\u0131\u011f\u0131 i\u00e7in t\u0131bbi cihaz olarak kabul edilir.<\/p>\n\n\n\n<p>Di\u011fer t\u0131bbi cihaz \u00f6rnekleri aras\u0131nda termometreler, diki\u015f ipleri, do\u011fum kontrol \u00fcr\u00fcnleri ve bula\u015f\u0131c\u0131 hastal\u0131k te\u015fhis programlar\u0131 bulunmaktad\u0131r.<\/p>\n\n\n\n<p>T\u0131bbi cihazlar, risk seviyesi ve kullan\u0131m amac\u0131na g\u00f6re &#8220;Genel T\u0131bbi Cihazlar&#8221;, &#8220;Y\u00f6netilen T\u0131bbi Cihazlar&#8221; ve &#8220;Y\u00fcksek Derecede Y\u00f6netilen T\u0131bbi Cihazlar&#8221; olmak \u00fczere s\u0131n\u0131fland\u0131r\u0131l\u0131r.<\/p>\n\n\n\n<p>T\u0131bbi cihazlara y\u00f6nelik ana d\u00fczenlemeler, basit\u00e7e ifade edilirse, \u00fcretim ve sat\u0131\u015f, kiralama ve tamir ile ilgili izin ve bildirimlerdir. D\u00fczenlemelerin derecesi, t\u0131bbi cihaz\u0131n s\u0131n\u0131fland\u0131r\u0131lmas\u0131na ba\u011fl\u0131 olarak de\u011fi\u015fir. \u00d6rne\u011fin, &#8220;Y\u00fcksek Derecede Y\u00f6netilen T\u0131bbi Cihazlar&#8221; i\u00e7in sat\u0131\u015f s\u0131ras\u0131nda izin gereklidir, ancak &#8220;Genel T\u0131bbi Cihazlar&#8221; i\u00e7in sat\u0131\u015f s\u0131ras\u0131nda izin veya bildirim gerekmez ve serbest\u00e7e sat\u0131labilirler.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Rejeneratif_Tip_Urunleri\"><\/span>Rejeneratif T\u0131p \u00dcr\u00fcnleri<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Rejeneratif t\u0131p \u00fcr\u00fcnlerinin d\u00fczenlenmesi, 2014 y\u0131l\u0131nda (Gregorian takvimine g\u00f6re) yap\u0131lan de\u011fi\u015fiklikle olu\u015fturulan bir sistemdir. Profes\u00f6r Shinya Yamanaka&#8217;n\u0131n iPS h\u00fccrelerinin geli\u015ftirilmesi gibi, rejeneratif t\u0131p alan\u0131ndaki ilerlemeler dikkat \u00e7ekici olmas\u0131na ra\u011fmen, riskler hakk\u0131nda hala bilinmeyen \u00e7ok \u015fey var. Bu nedenle, g\u00fcvenli\u011fi sa\u011flarken ilerlemeyi te\u015fvik etmek i\u00e7in yeni bir sistem getirdik.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131 (Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131), rejeneratif t\u0131p \u00fcr\u00fcnlerini Madde 2, Paragraf 9&#8217;da tan\u0131mlamaktad\u0131r.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Bu yasada &#8220;rejeneratif t\u0131p \u00fcr\u00fcnleri&#8221;, a\u015fa\u011f\u0131da belirtilen maddeleri (t\u0131bbi olmayan \u00fcr\u00fcnler ve kozmetikler hari\u00e7) ifade eder ve bunlar h\u00fck\u00fcmet kararnamesi ile belirlenir.<\/p>\n\n\n\n<p>Birincisi, a\u015fa\u011f\u0131da belirtilen t\u0131bbi veya veteriner ama\u00e7l\u0131 kullan\u0131lan maddelerden, insan veya hayvan h\u00fccrelerine k\u00fclt\u00fcr veya di\u011fer i\u015flemler uygulananlar<\/p>\n\n\n\n<p>\u0130kincisi, insan veya hayvan v\u00fccudunun yap\u0131s\u0131n\u0131n veya i\u015flevinin yeniden olu\u015fturulmas\u0131, onar\u0131lmas\u0131 veya \u015fekillendirilmesi<\/p>\n\n\n\n<p>\u00dc\u00e7\u00fcnc\u00fcs\u00fc, insan veya hayvan hastal\u0131klar\u0131n\u0131n tedavisi veya \u00f6nlenmesi<\/p>\n\n\n\n<p>D\u00f6rd\u00fcnc\u00fcs\u00fc, insan veya hayvan hastal\u0131klar\u0131n\u0131n tedavisi i\u00e7in kullan\u0131lan maddelerden, insan veya hayvan h\u00fccrelerine tan\u0131t\u0131lan ve bu h\u00fccrelerin i\u00e7inde ifade edilen genleri i\u00e7erenler<\/p>\n<cite>\u0130la\u00e7, T\u0131bbi Cihazlar ve Di\u011fer \u00dcr\u00fcnlerin Kalite, Etkinlik ve G\u00fcvenli\u011finin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun Madde 2, Paragraf 9<\/cite><\/blockquote>\n\n\n\n<p>Yukar\u0131daki h\u00fck\u00fcmlere bak\u0131ld\u0131\u011f\u0131nda, rejeneratif t\u0131p \u00fcr\u00fcnlerinin genel olarak iki t\u00fcr oldu\u011funu g\u00f6rebiliriz. Birincisi, &#8220;insan veya hayvan h\u00fccrelerine k\u00fclt\u00fcr veya di\u011fer i\u015flemler uygulananlar&#8221;. \u0130kincisi, &#8220;insan veya hayvan h\u00fccrelerine tan\u0131t\u0131lan ve bu h\u00fccrelerin i\u00e7inde ifade edilen genleri i\u00e7erenler&#8221;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi_Kapsamindaki_Reklam_Duzenlemeleri\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131 Kapsam\u0131ndaki Reklam D\u00fczenlemeleri<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Burada, bir\u00e7ok ki\u015finin dikkat etmesi gereken bir d\u00fczenlemeyi, \u0130la\u00e7 Makinesi Yasas\u0131 kapsam\u0131ndaki reklam d\u00fczenlemelerini a\u00e7\u0131kl\u0131yoruz.<\/p>\n\n\n\n<p>\u0130la\u00e7lar hakk\u0131ndaki reklamlar, halka bilgi sa\u011flama y\u00f6n\u00fcne sahipken, a\u015f\u0131r\u0131 reklam ifadeleri artarsa, kalitesiz \u00fcr\u00fcnlerin da\u011f\u0131t\u0131m\u0131 ve g\u00fcvenlikle ilgili yan\u0131lg\u0131lar\u0131n ortaya \u00e7\u0131kmas\u0131 gibi, halk\u0131n sa\u011fl\u0131\u011f\u0131na zarar verebilecek durumlar ortaya \u00e7\u0131kabilir. Bu nedenle, \u0130la\u00e7 Makinesi Yasas\u0131, 66. maddeden 68. maddeye kadar, ila\u00e7lar hakk\u0131ndaki reklamlar\u0131 d\u00fczenler.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Hi\u00e7 kimse, ila\u00e7lar, t\u0131bbi cihazlar, kozmetikler 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 ifadeleri reklam yaparak, tan\u0131mlayarak veya yaymayamaz.<\/p>\n\n\n\n<p>2. Bir doktorun veya ba\u015fka bir ki\u015finin ila\u00e7lar\u0131n, t\u0131bbi cihazlar\u0131n, kozmetiklerin veya rejeneratif t\u0131p \u00fcr\u00fcnlerinin etkinli\u011fini, etkisini veya performans\u0131n\u0131 garanti etti\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek ifadeleri reklam yapmak, tan\u0131mlamak veya yaymak, birinci f\u0131krada belirtilen durumlar\u0131 kapsar.<\/p>\n\n\n\n<p>3. Hi\u00e7 kimse, ila\u00e7lar, t\u0131bbi cihazlar, kozmetikler veya rejeneratif t\u0131p \u00fcr\u00fcnlerine ili\u015fkin k\u00fcrtaj\u0131 ima etmek veya m\u00fcstehcen belgeler veya \u00e7izimler kullanmak suretiyle hareket edemez.<\/p>\n<cite>\u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun Madde 66<\/cite><\/blockquote>\n\n\n\n<p>Madde 66&#8217;n\u0131n birinci f\u0131kras\u0131, ila\u00e7lar\u0131n ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 reklamlar\u0131 yasaklayan bir h\u00fck\u00fcmd\u00fcr. Etkinli\u011fi ve etkisini abart\u0131l\u0131 bir \u015fekilde reklam yapmak, yanl\u0131\u015f kullan\u0131m\u0131n yay\u0131lmas\u0131na ve hastal\u0131\u011f\u0131n k\u00f6t\u00fcle\u015fmesine yol a\u00e7abilir. Bu t\u00fcr reklamlar\u0131 d\u00fczenleyen Madde 66&#8217;n\u0131n birinci f\u0131kras\u0131d\u0131r.<\/p>\n\n\n\n<p>Burada &#8220;reklam&#8221; dedi\u011fimiz \u015fey, a\u015fa\u011f\u0131daki \u00fc\u00e7 gereksinimi kar\u015f\u0131layan \u015feydir. (Referans: 29 Eyl\u00fcl 1999 (Heisei 11) tarihli \u0130la\u00e7 Denetim No. 148, Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 \u0130la\u00e7 G\u00fcvenli\u011fi B\u00fcrosu Denetim ve Rehberlik B\u00f6l\u00fcm\u00fc Bildirisi &#8220;<a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Yasas\u0131 Kapsam\u0131nda \u0130la\u00e7 Reklamlar\u0131n\u0131n Uygunlu\u011fu[ja]<\/a>&#8220;)<\/p>\n\n\n\n<ol>\n<li>M\u00fc\u015fteriyi \u00e7ekme (m\u00fc\u015fterinin sat\u0131n alma iste\u011fini art\u0131rma) niyetinin a\u00e7\u0131k olmas\u0131<\/li>\n\n\n\n<li>Belirli bir ilac\u0131n \u00fcr\u00fcn ad\u0131n\u0131n a\u00e7\u0131k\u00e7a belirtilmi\u015f olmas\u0131<\/li>\n\n\n\n<li>Genel halk\u0131n fark\u0131nda olabilece\u011fi bir durumda olmas\u0131<\/li>\n<\/ol>\n\n\n\n<p>Madde 66&#8217;n\u0131n ikinci f\u0131kras\u0131, bir doktorun veya ba\u015fka bir ki\u015finin ila\u00e7lar\u0131n etkinli\u011fini, etkisini veya performans\u0131n\u0131 garanti etti\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek ifadeleri reklam yapman\u0131n yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 reklamlara dahil oldu\u011funu belirtir.<\/p>\n\n\n\n<p>Madde 66&#8217;n\u0131n \u00fc\u00e7\u00fcnc\u00fc f\u0131kras\u0131, ila\u00e7lar hakk\u0131nda k\u00fcrtaj\u0131 ima etmek veya m\u00fcstehcen ifadeler kullanman\u0131n yasakland\u0131\u011f\u0131n\u0131 belirtir.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Kanser veya di\u011fer \u00f6zel hastal\u0131klar\u0131n tedavisinde kullan\u0131lmas\u0131 ama\u00e7lanan ila\u00e7lar veya rejeneratif t\u0131p \u00fcr\u00fcnleri hakk\u0131nda, bir doktor veya di\u015f hekimi g\u00f6zetiminde kullan\u0131lmad\u0131\u011f\u0131 takdirde \u00f6zellikle b\u00fcy\u00fck zararlar do\u011furabilecek olanlar hakk\u0131nda, 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 reklamlarla ilgili olarak, genel halk d\u0131\u015f\u0131ndaki t\u0131bbi profesyonellere y\u00f6nelik 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 kraliyet kararnamesi hakk\u0131nda, bu kararnamenin olu\u015fturulmas\u0131 veya kald\u0131r\u0131lmas\u0131 hakk\u0131nda kabine toplant\u0131s\u0131 talep etmeden \u00f6nce, \u0130la\u00e7 ve G\u0131da Hijyen Konseyi&#8217;nin 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 kapsam d\u0131\u015f\u0131ndad\u0131r.<\/p>\n<cite>\u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun Madde 67<\/cite><\/blockquote>\n\n\n\n<p>Madde 67, \u00f6zel hastal\u0131klar\u0131n tedavisinde kullan\u0131lmas\u0131 ama\u00e7lanan ila\u00e7lar hakk\u0131nda, devletin reklam y\u00f6ntemlerinin s\u0131n\u0131rlanmas\u0131 gibi \u00f6nlemleri belirleyebilece\u011fini belirten bir h\u00fck\u00fcmd\u00fcr. Ger\u00e7ekten de, kanser, sarkom, l\u00f6semi i\u00e7in kullan\u0131lan ila\u00e7lar\u0131n reklamlar\u0131 yasaklanm\u0131\u015ft\u0131r (\u0130la\u00e7 Makinesi Yasas\u0131 Uygulama Y\u00f6netmeli\u011fi Madde 228-10, Ek Tablo Be\u015f).<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Hi\u00e7 kimse, 14. maddenin birinci f\u0131kras\u0131, 23. maddenin be\u015finci f\u0131kras\u0131 veya 23. maddenin yirmi \u00fc\u00e7\u00fcnc\u00fc f\u0131kras\u0131n\u0131n birinci f\u0131kras\u0131nda belirtilen ila\u00e7lar veya t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnleri hakk\u0131nda, hen\u00fcz 14. maddenin birinci f\u0131kras\u0131, 19. maddenin ikinci f\u0131kras\u0131, 23. maddenin be\u015finci f\u0131kras\u0131, 23. maddenin on yedinci f\u0131kras\u0131, 23. maddenin yirmi be\u015finci f\u0131kras\u0131 veya 23. maddenin otuz yedinci f\u0131kras\u0131n\u0131n onay\u0131n\u0131 veya 23. maddenin yirmi \u00fc\u00e7\u00fcnc\u00fc f\u0131kras\u0131n\u0131n birinci f\u0131kras\u0131n\u0131n sertifikas\u0131n\u0131 almadan, bu ila\u00e7lar\u0131n, t\u0131bbi cihazlar\u0131n veya rejeneratif t\u0131p \u00fcr\u00fcnlerinin ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda reklam yapamaz.<\/p>\n<cite>\u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun Madde 68<\/cite><\/blockquote>\n\n\n\n<p>Madde 68, onaylanmam\u0131\u015f ila\u00e7lar, t\u0131bbi cihazlar, rejeneratif t\u0131p \u00fcr\u00fcnleri hakk\u0131nda reklam yapmay\u0131 yasaklayan bir h\u00fck\u00fcmd\u00fcr. Etkinlik ve etkiler, onayland\u0131ktan sonra halka a\u00e7\u0131k\u00e7a kabul edilir, bu nedenle onaydan \u00f6nce etkinlik ve etkileri belirtmek, kafa kar\u0131\u015f\u0131kl\u0131\u011f\u0131na yol a\u00e7ar. Bu t\u00fcr reklamlar\u0131 d\u00fczenleyen Madde 68&#8217;dir.<\/p>\n\n\n\n<p>\u00d6zellikle dikkat edilmesi gereken nokta, yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131 (Madde 66) ve onaylanmam\u0131\u015f ila\u00e7lar\u0131n reklamlar\u0131n\u0131n yasaklanmas\u0131 (Madde 68) hakk\u0131ndaki d\u00fczenlemelerin, d\u00fczenlemeye tabi olanlar\u0131n &#8220;herkes&#8221; olmas\u0131d\u0131r.<\/p>\n\n\n\n<p>Bu d\u00fczenlemeler &#8220;herkes&#8221;, yani &#8220;t\u00fcm ki\u015filer&#8221;i kapsar. Sadece ila\u00e7 \u00fcreticileri veya sat\u0131c\u0131lar\u0131 de\u011fil, ayn\u0131 zamanda reklam yapma talebini alan ki\u015filer de bu d\u00fczenlemelere tabidir.<\/p>\n\n\n\n<p>Bu nedenle, televizyon, gazete gibi kitle ileti\u015fim ara\u00e7lar\u0131, reklam ajanslar\u0131, ba\u011fl\u0131 pazarlamac\u0131lar, influencerlar gibi ki\u015filer de ila\u00e7lar\u0131 veya kozmetikleri tan\u0131t\u0131rken, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 olmamak i\u00e7in dikkatli olmal\u0131d\u0131rlar.<\/p>\n\n\n\n<p>Ayr\u0131ca, asl\u0131nda \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenleme kapsam\u0131na girmeyen \u00fcr\u00fcnler hakk\u0131nda bile, ifade i\u00e7eri\u011fine ba\u011fl\u0131 olarak, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenleme kapsam\u0131na girebilece\u011fi bir olas\u0131l\u0131k vard\u0131r. Bu konuyu, &#8220;\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n D\u00fczenleme Kapsam\u0131na Girmeyen \u00dcr\u00fcnler&#8221; b\u00f6l\u00fcm\u00fcnde a\u00e7\u0131kl\u0131yoruz.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E2%80%9CAbarti%E2%80%9D_Olup_Olmadigi_Japon_Ilac_ve_Diger_Urunlerin_Uygun_Reklam_Standartlarina_Gore_Belirlenir\"><\/span>&#8220;Abart\u0131&#8221; Olup Olmad\u0131\u011f\u0131 Japon \u0130la\u00e7 ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131na G\u00f6re Belirlenir<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>&#8220;Yan\u0131lt\u0131c\u0131&#8221; ifadesi, ger\u00e7eklerden farkl\u0131 olan\u0131, &#8220;abart\u0131&#8221; ifadesi ise en \u00fcst d\u00fczeydeki ifadeyi kullanmay\u0131 ifade eder. &#8220;Yan\u0131lt\u0131c\u0131 veya abart\u0131&#8221; kavram\u0131n\u0131n belirlenmesi i\u00e7in, Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 taraf\u0131ndan belirlenen &#8220;<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179264.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Japon \u0130la\u00e7 ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131[ja]<\/a>&#8221; ve &#8220;<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179263.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Japon \u0130la\u00e7 ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131na Dair A\u00e7\u0131klamalar ve Dikkat Edilmesi Gereken Hususlar[ja]<\/a>&#8221; belgelerinde belirtilmi\u015ftir.<\/p>\n\n\n\n<p>\u00d6rne\u011fin, isimlendirme konusunda, Japon Eczac\u0131l\u0131k Standartlar\u0131&#8217;nda belirlenen isimler veya bildirilen isimler d\u0131\u015f\u0131nda bir isim kullan\u0131lmamas\u0131 gerekti\u011fi belirtilmi\u015ftir.<\/p>\n\n\n\n<p>Daha spesifik olarak, onay gerektiren ila\u00e7lar\u0131n isimleri hakk\u0131nda, kanji karakterlerinin hiragana veya alfabeye \u00e7evrilmemesi gerekti\u011fi ve etkinlik ve etkiler hakk\u0131nda onaylanan kapsam\u0131n \u00f6tesinde bir ifade kullan\u0131lmamas\u0131 gerekti\u011fi belirtilmi\u015ftir.<\/p>\n\n\n\n<p>Di\u011fer yandan, \u00f6rne\u011fin, bir ila\u00e7 \u015fampuan\u0131nda &#8220;sa\u00e7 ve sa\u00e7 derisini sa\u011fl\u0131kl\u0131 tutar&#8221; ifadesi ile &#8220;sa\u00e7lar\u0131 yumu\u015fat\u0131r&#8221; ifadesinin ayn\u0131 anda kullan\u0131lamayaca\u011f\u0131 gibi, \u00fcr\u00fcn t\u00fcr\u00fcne g\u00f6re belirli standartlar belirlenmi\u015ftir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99nin_Duzenlemeye_Tabi_Olmayan_Urunler\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n D\u00fczenlemeye Tabi Olmayan \u00dcr\u00fcnler<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenlemeye tabi oldu\u011fu \u00fcr\u00fcnler, yukar\u0131da belirtilen &#8220;ila\u00e7lar vb.&#8221;dir. Bu nedenle, &#8220;ila\u00e7lar vb.&#8221; kapsam\u0131na girmeyen \u00fcr\u00fcnlerin, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131 dikkate almadan sat\u0131\u015f ve reklam yapabilece\u011fi d\u00fc\u015f\u00fcn\u00fclebilir.<\/p>\n\n\n\n<p>Ancak, asl\u0131nda &#8220;ila\u00e7lar vb.&#8221; kapsam\u0131na girmeyen bir \u00fcr\u00fcn olsa bile, e\u011fer etiketleme veya reklam i\u00e7eri\u011fi ila\u00e7 gibi bir etki veya etkinlik \u00f6neriyorsa, bir ila\u00e7 olarak kabul edilebilir.<\/p>\n\n\n\n<p>Ve e\u011fer bir ila\u00e7 olarak kabul edilirse, ila\u00e7 olarak onay al\u0131nmad\u0131\u011f\u0131 s\u00fcrece, Madde 68 uyar\u0131nca reklam yapmak yasaklan\u0131r.<\/p>\n\n\n\n<p>Yani, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenlemeye tabi olmayan bir \u00fcr\u00fcn olsa bile, ila\u00e7 benzeri bir etki veya etkinlik \u00f6neren bir reklam yapmak, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 olacakt\u0131r.<\/p>\n\n\n\n<p>Bu durumda, sa\u011fl\u0131\u011f\u0131 destekleyen sa\u011fl\u0131k g\u0131dalar\u0131 ve takviyeler, &#8220;ila\u00e7lar vb.&#8221; de\u011fil, sadece g\u0131da olduklar\u0131 i\u00e7in, ila\u00e7 benzeri bir etki veya etkinlik \u00f6neremezler. Sa\u011fl\u0131k g\u0131dalar\u0131 ve takviyeler hakk\u0131nda &#8220;kanseri \u00f6nler&#8221;, &#8220;ya\u015flanmay\u0131 \u00f6nler&#8221; gibi reklamlar \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131d\u0131r.<\/p>\n\n\n\n<p>Ancak, belirli bir sa\u011fl\u0131k g\u0131das\u0131, ger\u00e7ekten sa\u011fl\u0131kl\u0131 olmas\u0131na ra\u011fmen, bu t\u00fcr bir ifadenin kabul edilemez oldu\u011fu d\u00fc\u015f\u00fcn\u00fcl\u00fcrse, bu, gereksiz yere \u00fcr\u00fcn ve bilgi ak\u0131\u015f\u0131n\u0131 engeller.<\/p>\n\n\n\n<p>Bu nedenle, devletin g\u00fcvenli\u011fi ve etkinli\u011fi inceleyip onaylad\u0131\u011f\u0131 baz\u0131 g\u0131dalar, &#8220;sa\u011fl\u0131k fonksiyonel g\u0131dalar&#8221; olarak, devletin kabul etti\u011fi \u00f6l\u00e7\u00fcde etki ve etkinlik g\u00f6sterme izni verilmi\u015ftir.<\/p>\n\n\n\n<p>&#8220;Sa\u011fl\u0131k Fonksiyonel G\u0131dalar&#8221; aras\u0131nda,<\/p>\n\n\n\n<ol>\n<li>Fonksiyonel G\u0131dalar<\/li>\n\n\n\n<li>Beslenme Fonksiyonel G\u0131dalar\u0131<\/li>\n\n\n\n<li>Belirli Sa\u011fl\u0131k G\u0131dalar\u0131<\/li>\n<\/ol>\n\n\n\n<p>bulunmaktad\u0131r.<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/?p=49842\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Reklam D\u00fczenlemeleri Nedir? Yasal \u0130fadelerle Reklam Olu\u015fturman\u0131n P\u00fcf Noktalar\u0131[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99na_Aykiri_Davranisin_Cezalari\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na Ayk\u0131r\u0131 Davran\u0131\u015f\u0131n Cezalar\u0131<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japon \u0130la\u00e7 Makinesi Yasas\u0131) ayk\u0131r\u0131 davran\u0131\u015f durumunda, cezai yapt\u0131r\u0131mlar uygulan\u0131r. Ayr\u0131ca, 2021&#8217;de (Reiwa 1 (2019) y\u0131l\u0131nda) y\u00fcr\u00fcrl\u00fc\u011fe giren \u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda, yeni bir para cezas\u0131 sistemi getirilmi\u015ftir.<\/p>\n\n\n\n<p>Para cezas\u0131 sistemi, ila\u00e7lar vb. hakk\u0131nda yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 reklamlar yapan ki\u015filere para \u00f6deme emri veren bir sistemdir. Para cezas\u0131n\u0131n miktar\u0131, belirli bir d\u00f6nemin sat\u0131\u015flar\u0131n\u0131n %4.5&#8217;i olarak belirlenmi\u015ftir (Madde 75&#8217;in 5&#8217;inin 2&#8217;nin 1. f\u0131kras\u0131).<\/p>\n\n\n\n<p>Para cezas\u0131 sistemi hakk\u0131nda daha fazla bilgi i\u00e7in a\u015fa\u011f\u0131daki makaleye g\u00f6z atabilirsiniz.<\/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 Para Cezas\u0131 Sistemi Nedir? Hedeflenen Davran\u0131\u015flar ve \u0130ndirim Uygulanan Durumlar[ja]<\/a><\/p>\n\n\n\n<p>\u00d6zetlemek gerekirse, yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 reklamlar yapan ki\u015filer, cezai yapt\u0131r\u0131mlar\u0131n yan\u0131 s\u0131ra, para cezas\u0131 nedeniyle maddi zarar riskiyle kar\u015f\u0131 kar\u015f\u0131ya kalabilirler.<\/p>\n\n\n\n<p>Ayr\u0131ca, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 davranma ger\u00e7e\u011fi, sadece hukuki sorunlara yol a\u00e7makla kalmaz, ayn\u0131 zamanda faillerin itibar\u0131n\u0131n kaybolmas\u0131 gibi b\u00fcy\u00fck bir riski de beraberinde getirir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi_Ihlallerinden_Kacinma_Noktalari\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlallerinden Ka\u00e7\u0131nma Noktalar\u0131<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act), eczaneler ve di\u011fer sa\u011fl\u0131k sekt\u00f6rleri d\u0131\u015f\u0131nda, \u00e7e\u015fitli sekt\u00f6rlerdeki \u015firketlere de uygulan\u0131r. \u0130la\u00e7 Makinesi Yasas\u0131 ihlallerinden ka\u00e7\u0131nmak i\u00e7in a\u015fa\u011f\u0131daki iki noktay\u0131 kontrol edelim.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Yonergeleri_Dogru_Anlama\"><\/span>Y\u00f6nergeleri Do\u011fru Anlama<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 ihlallerinden ka\u00e7\u0131nmak i\u00e7in, \u015firketinizin \u00fcr\u00fcnlerinin \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n kapsam\u0131na girip girmedi\u011fini, \u00fcretim, sat\u0131\u015f, reklam gibi s\u00fcre\u00e7lerde hangi d\u00fczenlemelerin uygulanaca\u011f\u0131n\u0131 do\u011fru bir \u015fekilde anlamak gereklidir.<\/p>\n\n\n\n<p>Bunun i\u00e7in, ilgili yasalar\u0131n yan\u0131 s\u0131ra, Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n belirledi\u011fi y\u00f6nergelerin i\u00e7eri\u011fini kontrol etmek gereklidir.<\/p>\n\n\n\n<p>Ancak, yasalar\u0131, y\u00f6nergeleri, yarg\u0131 kararlar\u0131n\u0131 ve idari y\u00f6nlendirmeleri kapsaml\u0131 bir \u015fekilde anlamak olduk\u00e7a zordur. Bu nedenle, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131na karar veremiyorsan\u0131z, bir avukata dan\u0131\u015fman\u0131z\u0131 \u00f6neririz.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Sirket_Icinde_Paylasim\"><\/span>\u015eirket \u0130\u00e7inde Payla\u015f\u0131m<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 ihlallerinden ka\u00e7\u0131nmak i\u00e7in, \u015firketinizin \u00fcr\u00fcnlerinin \u00f6zelliklerine g\u00f6re, \u0130la\u00e7 Makinesi Yasas\u0131 d\u00fczenlemeleriyle \u00e7at\u0131\u015fabilecek noktalar\u0131 belirlemek ve bir kontrol listesi olu\u015fturarak bunlar\u0131 \u015firket i\u00e7inde payla\u015fmak \u00f6nemlidir.<\/p>\n\n\n\n<p>\u00d6zellikle, reklam d\u00fczenlemeleri &#8220;herkese&#8221; uygulan\u0131r, bu nedenle, ta\u015feronlar\u0131n\u0131z\u0131n \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 reklam yapmamas\u0131n\u0131 sa\u011flamak i\u00e7in bir kontrol mekanizmas\u0131 olu\u015fturman\u0131z gereklidir.<\/p>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 d\u00fczenlemeleri hakk\u0131ndaki noktalar\u0131 t\u00fcm \u00e7al\u0131\u015fanlar\u0131n kontrol edebilece\u011fi bir sistem olu\u015fturarak, \u0130la\u00e7 Makinesi Yasas\u0131 ihlallerinden ka\u00e7\u0131nabilirsiniz.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi_Japanese_Pharmaceutical_and_Medical_Device_Act_ve_Fiyat_Indikasyon_Yasasi_Japanese_Price_Indication_Act_Arasindaki_Farklar_Nelerdir\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) ve Fiyat \u0130ndikasyon Yasas\u0131 (Japanese Price Indication Act) Aras\u0131ndaki Farklar Nelerdir?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u015eimdiye kadar \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenlemeleri hakk\u0131nda a\u00e7\u0131klamalar yapt\u0131k, \u00f6zellikle dikkat edilmesi gereken nokta, t\u00fcm ki\u015filere uygulanan reklam d\u00fczenlemeleriydi. Son olarak, \u0130la\u00e7 Makinesi Yasas\u0131 gibi reklam d\u00fczenlemeleri yapan Fiyat \u0130ndikasyon Yasas\u0131&#8217;n\u0131 ele alaca\u011f\u0131z ve bu iki yasan\u0131n reklam d\u00fczenlemeleri aras\u0131ndaki farklar\u0131 a\u00e7\u0131klayaca\u011f\u0131z.<\/p>\n\n\n\n<p>Fiyat \u0130ndikasyon Yasas\u0131&#8217;n\u0131n amac\u0131, genel t\u00fcketicilerin \u00f6zg\u00fcr ve mant\u0131kl\u0131 se\u00e7imlerini engellemeyi \u00f6nlemektir. Bu nedenle, d\u00fczenlemenin hedefi t\u00fcm \u00fcr\u00fcnlerdir. \u00d6te yandan, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenleme hedefi &#8220;ila\u00e7lar vb.&#8221; idi.<\/p>\n\n\n\n<p>Fiyat \u0130ndikasyon Yasas\u0131&#8217;n\u0131n d\u00fczenlemeleri, \u00fcr\u00fcn veya hizmet sa\u011flayan i\u015fletmelerle s\u0131n\u0131rl\u0131d\u0131r. \u00d6te yandan, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na g\u00f6re reklam d\u00fczenlemeleri &#8220;herkese&#8221;, yani t\u00fcm ki\u015filere uygulan\u0131r.<\/p>\n\n\n\n<p>Ayr\u0131ca, Fiyat \u0130ndikasyon Yasas\u0131&#8217;nda da para cezas\u0131 sistemi belirlenmi\u015ftir. Ancak, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na g\u00f6re para cezas\u0131 miktar\u0131 sat\u0131\u015f miktar\u0131n\u0131n %4.5&#8217;i iken, Fiyat \u0130ndikasyon Yasas\u0131&#8217;na g\u00f6re para cezas\u0131 miktar\u0131 sat\u0131\u015f miktar\u0131n\u0131n %3&#8217;\u00fc olarak belirlenmi\u015ftir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ozet_Ilac_ve_Tibbi_Cihaz_Kanunu_Japanese_Pharmaceutical_and_Medical_Device_Act_ile_ilgili_sorunlariniz_icin_avukata_danisin\"><\/span>\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu (Japanese Pharmaceutical and Medical Device Act) ile ilgili sorunlar\u0131n\u0131z i\u00e7in avukata dan\u0131\u015f\u0131n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun d\u00fczenlemeye tabi konular\u0131 ve d\u00fczenleme i\u00e7eriklerini a\u00e7\u0131klad\u0131k.<\/p>\n\n\n\n<p>Tekrarlamak gerekirse, \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun d\u00fczenlemeye tabi oldu\u011fu maddeler geni\u015f bir yelpazeyi kapsar ve g\u00fcnl\u00fck ya\u015fam\u0131m\u0131zdaki nesneler bile bu kanunun d\u00fczenlemelerine tabi olabilir.<\/p>\n\n\n\n<p>Ayr\u0131ca, d\u00fczenlemeye tabi olmayan \u00fcr\u00fcnler bile, reklam d\u00fczenlemeleri gibi &#8220;herkesin&#8221; uymas\u0131 gereken d\u00fczenlemeleri i\u00e7erir. Reklamlarla ilgili olarak, \u00fcr\u00fcn\u00fcn sat\u0131\u015f noktas\u0131n\u0131n yan\u0131 s\u0131ra, reklam ajanslar\u0131, ba\u011fl\u0131 kurulu\u015flar ve influencerlar gibi ki\u015filere de d\u00fczenlemelerin uygulanabilece\u011fini unutmamak \u00f6nemlidir.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na ayk\u0131r\u0131 bir durumun olup olmad\u0131\u011f\u0131 konusunda endi\u015feleriniz varsa, uzman 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\n\n\n<p><a href=\"https:\/\/monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/operationofmedia[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) duydu\u011funuzda, &#8220;\u0130la\u00e7la ilgili bir yasa&#8221; veya &#8220;Eczaneler ve sa\u011fl\u0131k kurulu\u015flar\u0131yla ilgili bir yasa&#8221; oldu\u011funu  [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":64703,"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\/61311"}],"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=61311"}],"version-history":[{"count":3,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61311\/revisions"}],"predecessor-version":[{"id":64704,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61311\/revisions\/64704"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media\/64703"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media?parent=61311"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/categories?post=61311"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/tags?post=61311"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}