{"id":61080,"date":"2023-12-04T11:08:45","date_gmt":"2023-12-04T02:08:45","guid":{"rendered":"https:\/\/monolith.law\/tr\/?p=61080"},"modified":"2024-03-19T15:32:14","modified_gmt":"2024-03-19T06:32:14","slug":"medical-supplies-law","status":"publish","type":"post","link":"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law","title":{"rendered":"\u0130la\u00e7 Reklamlar\u0131n\u0131n Yasal D\u00fczenlemeleri: Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131'n\u0131 (JPMDL) A\u00e7\u0131kl\u0131yoruz"},"content":{"rendered":"\n<p>2014 y\u0131l\u0131nda (12 Haziran 2014) Japon \u0130la\u00e7 Yasas\u0131 (\u015fimdiki ad\u0131yla Japon \u0130la\u00e7, T\u0131bbi Cihazlar ve Di\u011fer \u00dcr\u00fcnlerin Kalitesi, Etkinli\u011fi ve G\u00fcvenli\u011finin Sa\u011flanmas\u0131 Hakk\u0131nda Yasas\u0131, bundan sonra &#8216;\u0130la\u00e7 ve Cihaz Yasas\u0131&#8217; olarak an\u0131lacakt\u0131r.) k\u0131smen de\u011fi\u015ftirildi ve baz\u0131 ila\u00e7lar hari\u00e7 olmak \u00fczere, internet \u00fczerinden ila\u00e7 sat\u0131\u015f\u0131 m\u00fcmk\u00fcn hale geldi.<\/p>\n\n\n\n<p>Bu durumla birlikte, internet \u00fczerinden ila\u00e7 reklamlar\u0131n\u0131 g\u00f6rmek daha s\u0131k hale geldi, ancak ila\u00e7 reklamlar\u0131 aras\u0131nda hukuki a\u00e7\u0131dan sorunlu olan reklamlar da az de\u011fil.<\/p>\n\n\n\n<p>Dolay\u0131s\u0131yla, bu makalede, ila\u00e7 reklamlar\u0131n\u0131 yay\u0131nlamay\u0131 d\u00fc\u015f\u00fcnen i\u015fletme sahiplerine y\u00f6nelik olarak, ila\u00e7 reklamlar\u0131yla ilgili yasal d\u00fczenlemeleri tan\u0131taca\u011f\u0131z.<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/corporate\/quasi-drug-advertisement-guidelines\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/corporate\/quasi-drug-advertisement-guidelines[ja]<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/corporate\/supplement-advertisement\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/corporate\/supplement-advertisement[ja]<\/a><\/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\/medical-supplies-law\/#Ilac_Makinesi_Yasasi%E2%80%99na_Gore_Reklam_Duzenlemeleri\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na G\u00f6re Reklam D\u00fczenlemeleri\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na G\u00f6re 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-2\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#Ilaclarin_Hukuki_Tanimi\" title=\"\u0130la\u00e7lar\u0131n Hukuki Tan\u0131m\u0131\">\u0130la\u00e7lar\u0131n Hukuki Tan\u0131m\u0131<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#Ilac_Reklamlarinin_Duzenlenmesi\" title=\"\u0130la\u00e7 Reklamlar\u0131n\u0131n D\u00fczenlenmesi\">\u0130la\u00e7 Reklamlar\u0131n\u0131n D\u00fczenlenmesi<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#%E2%80%9CReklam%E2%80%9Din_Tanimi\" title=\"&#8220;Reklam&#8221;\u0131n Tan\u0131m\u0131\">&#8220;Reklam&#8221;\u0131n Tan\u0131m\u0131<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#%E3%80%8CReklam%E3%80%8Din_Duzenlendigi_Ozneler\" title=\"\u300cReklam\u300d\u0131n D\u00fczenlendi\u011fi \u00d6zneler\">\u300cReklam\u300d\u0131n D\u00fczenlendi\u011fi \u00d6zneler<\/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\/medical-supplies-law\/#Hangi_Ifadelerin_Duzenlemeye_Tabi_Oldugu\" title=\"Hangi \u0130fadelerin D\u00fczenlemeye Tabi Oldu\u011fu\">Hangi \u0130fadelerin D\u00fczenlemeye Tabi Oldu\u011fu<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#Abartili_Reklamlarin_Yasaklanmasi_Madde_66\" title=\"Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131 (Madde 66)\">Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131 (Madde 66)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#Belirli_Hastaliklar_Icin_Ilaclar_ve_Rejeneratif_Tip_Urunlerinin_Reklamlarinin_Sinirlanmasi_Madde_67\" title=\"Belirli Hastal\u0131klar \u0130\u00e7in \u0130la\u00e7lar ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklamlar\u0131n\u0131n S\u0131n\u0131rlanmas\u0131 (Madde 67)\">Belirli Hastal\u0131klar \u0130\u00e7in \u0130la\u00e7lar ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklamlar\u0131n\u0131n S\u0131n\u0131rlanmas\u0131 (Madde 67)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#Onaylanmamis_Ilaclar_Tibbi_Cihazlar_ve_Rejeneratif_Tip_Urunlerinin_Reklamlarinin_Yasaklanmasi_Madde_68\" title=\"Onaylanmam\u0131\u015f \u0130la\u00e7lar, T\u0131bbi Cihazlar ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklamlar\u0131n\u0131n Yasaklanmas\u0131 (Madde 68)\">Onaylanmam\u0131\u015f \u0130la\u00e7lar, T\u0131bbi Cihazlar ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklamlar\u0131n\u0131n Yasaklanmas\u0131 (Madde 68)<\/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-10\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#Ozet\" title=\"\u00d6zet\">\u00d6zet<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-supplies-law\/#Ofisimiz_Tarafindan_Alinan_Onlemler\" title=\"Ofisimiz Taraf\u0131ndan Al\u0131nan \u00d6nlemler\">Ofisimiz Taraf\u0131ndan Al\u0131nan \u00d6nlemler<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99na_Gore_Reklam_Duzenlemeleri\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na G\u00f6re Reklam D\u00fczenlemeleri<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\/04\/medical-supplies-law4.jpg\" alt=\"\" class=\"wp-image-44115\" \/><\/figure>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131, ila\u00e7lar\u0131n kalitesi, etkinli\u011fi ve g\u00fcvenli\u011finin sa\u011flanmas\u0131 ve ila\u00e7lar\u0131n kullan\u0131m\u0131ndan kaynaklanan sa\u011fl\u0131k ve hijyen tehlikelerinin olu\u015fmas\u0131n\u0131 ve yay\u0131lmas\u0131n\u0131 \u00f6nlemek i\u00e7in a\u015fa\u011f\u0131daki gibi d\u00fczenlemeler yapmaktad\u0131r.<\/p>\n\n\n\n<ul>\n<li>A\u015f\u0131r\u0131 reklamlar\u0131n yasaklanmas\u0131 (Madde 66)<\/li>\n\n\n\n<li>Belirli hastal\u0131klar i\u00e7in ila\u00e7 ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklam\u0131n\u0131n s\u0131n\u0131rlanmas\u0131 (Madde 67)<\/li>\n\n\n\n<li>Onay al\u0131nmam\u0131\u015f ila\u00e7lar, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklam\u0131n\u0131n yasaklanmas\u0131 (Madde 68)<\/li>\n<\/ul>\n\n\n\n<p>Yukar\u0131daki h\u00fck\u00fcmlere ayk\u0131r\u0131 hareket edilmesi durumunda, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 veya prefekt\u00fcr valisi taraf\u0131ndan, ayk\u0131r\u0131 eylemin durdurulmas\u0131, ayk\u0131r\u0131 eylemin tekrar ger\u00e7ekle\u015fmesini \u00f6nlemek i\u00e7in gerekli hususlar veya bunlar\u0131n uygulanmas\u0131yla ilgili olarak halk sa\u011fl\u0131\u011f\u0131 \u00fczerindeki tehlikelerin olu\u015fmas\u0131n\u0131 \u00f6nlemek i\u00e7in yeterli \u00f6nlemlerin al\u0131nmas\u0131 emredilebilir.<\/p>\n\n\n\n<p>Ayr\u0131ca, ila\u00e7lar hakk\u0131nda yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 makaleler yay\u0131nlama, tan\u0131mlama veya yayma durumunda, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131&#8217;ndan, idari para cezas\u0131 \u00f6deme emri alabilirsiniz.<\/p>\n\n\n\n<p>A\u015fa\u011f\u0131da, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na g\u00f6re reklam d\u00fczenlemeleri hakk\u0131nda daha ayr\u0131nt\u0131l\u0131 bilgi verilmektedir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilaclarin_Hukuki_Tanimi\"><\/span>\u0130la\u00e7lar\u0131n Hukuki Tan\u0131m\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>T\u00fcm ila\u00e7lar &#8220;ila\u00e7&#8221; olarak kabul edilmez, sadece \u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda belirlenen tan\u0131ma uyan durumlarda, &#8220;ila\u00e7&#8221; olarak kabul edilir.<\/p>\n\n\n\n<p>&#8220;\u0130la\u00e7&#8221;\u0131n tan\u0131m\u0131, a\u015fa\u011f\u0131daki \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 2. maddesinin 1. f\u0131kras\u0131nda belirtilmi\u015ftir.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Tan\u0131m)<br>Madde 2 Bu yasada &#8220;ila\u00e7&#8221;, a\u015fa\u011f\u0131daki maddeleri ifade eder.<br>1. Japon Eczac\u0131l\u0131k Standartlar\u0131&#8217;nda belirtilen maddeler<br>2. \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 malzemeleri ve programlar (bir bilgisayara y\u00f6nelik talimatlar olup, bir sonu\u00e7 elde etmek i\u00e7in birle\u015ftirilmi\u015f olanlar\u0131 ifade eder. A\u015fa\u011f\u0131da ayn\u0131.) ve bunlar\u0131 kaydeden kay\u0131t ortamlar\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.)<br>3. \u0130nsan veya hayvan v\u00fccudunun yap\u0131s\u0131n\u0131 veya i\u015flevini etkileme amac\u0131yla kullan\u0131lan ve makine, alet vb. olmayan maddeler (ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler, kozmetik \u00fcr\u00fcnler ve rejeneratif t\u0131p \u00fcr\u00fcnleri hari\u00e7.)<\/p>\n<\/blockquote>\n\n\n\n<p>Japon Eczac\u0131l\u0131k Standartlar\u0131 hakk\u0131nda hi\u00e7 duymam\u0131\u015f olanlar\u0131n\u0131z olabilir.<\/p>\n\n\n\n<p>Japon Eczac\u0131l\u0131k Standartlar\u0131 hakk\u0131nda, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n web sitesinde a\u015fa\u011f\u0131daki gibi tan\u0131t\u0131lmaktad\u0131r.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Japon Eczac\u0131l\u0131k Standartlar\u0131, ila\u00e7lar\u0131n, t\u0131bbi cihazlar\u0131n vb. kalitesi, etkinli\u011fi ve g\u00fcvenli\u011finin sa\u011flanmas\u0131 hakk\u0131ndaki yasa&#8217;n\u0131n 41. maddesi uyar\u0131nca, ila\u00e7lar\u0131n nitelikleri ve kalitesinin uygunlu\u011funu sa\u011flamak amac\u0131yla, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131&#8217;n\u0131n \u0130la\u00e7 ve G\u0131da Hijyen Konseyi&#8217;nin g\u00f6r\u00fc\u015flerini alarak belirledi\u011fi ila\u00e7 standartlar\u0131 kitab\u0131d\u0131r.<\/p>\n<cite><a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000066530.html\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000066530.html[ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>Bu Japon Eczac\u0131l\u0131k Standartlar\u0131&#8217;nda belirtilen maddeler, yukar\u0131daki 2. maddenin 1. f\u0131kras\u0131n\u0131n 1. bendi uyar\u0131nca, &#8220;ila\u00e7&#8221; olarak kabul edilir.<\/p>\n\n\n\n<p>Ayr\u0131ca, Japon Eczac\u0131l\u0131k Standartlar\u0131&#8217;nda belirtilmeyen maddeler bile, insan veya hayvan hastal\u0131klar\u0131n\u0131n te\u015fhisi, tedavisi veya \u00f6nlenmesi amac\u0131yla kullan\u0131lan veya insan veya hayvan v\u00fccudunun yap\u0131s\u0131n\u0131 veya i\u015flevini etkileme amac\u0131yla kullan\u0131lan ve makine, alet vb. olmayan ve \u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda belirtilen ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler vb. olmayan maddeler, yukar\u0131daki 2. maddenin 1. f\u0131kras\u0131n\u0131n 2. ve 3. bendi uyar\u0131nca, &#8220;ila\u00e7&#8221; olarak kabul edilir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Reklamlarinin_Duzenlenmesi\"><\/span>\u0130la\u00e7 Reklamlar\u0131n\u0131n D\u00fczenlenmesi<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\/04\/medical-supplies-law1.jpg\" alt=\"\" class=\"wp-image-44114\" \/><\/figure>\n\n\n\n<p>\u0130la\u00e7 reklamlar\u0131n\u0131n d\u00fczenlenmesi hakk\u0131nda, daha \u00f6nce belirtildi\u011fi gibi, abart\u0131l\u0131 reklamlar, belirli hastal\u0131klar i\u00e7in ila\u00e7lar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklamlar\u0131 ile onay \u00f6ncesi ila\u00e7lar, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklamlar\u0131 hedef al\u0131nmaktad\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E2%80%9CReklam%E2%80%9Din_Tanimi\"><\/span>&#8220;Reklam&#8221;\u0131n Tan\u0131m\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda &#8220;reklam&#8221; terimi ge\u00e7mektedir, ancak \u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda &#8220;reklam&#8221;\u0131n tan\u0131m\u0131 hakk\u0131nda bir h\u00fck\u00fcm bulunmamaktad\u0131r.<\/p>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki &#8220;reklam&#8221; hakk\u0131nda, a\u015fa\u011f\u0131daki &#8220;\u0130la\u00e7 Yasas\u0131&#8217;nda \u0130la\u00e7lar vb. Reklamlar\u0131n\u0131n Uygunlu\u011fu Hakk\u0131nda&#8221;<\/p>\n\n\n\n<p>(Heisei 10 (1998) 29 Eyl\u00fcl T\u0131bbi G\u00f6zetim No. 148 \u0130l Sa\u011fl\u0131k M\u00fcd\u00fcrl\u00fc\u011f\u00fc (Daire) Ba\u015fkan\u0131&#8217;na Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 T\u0131bbi G\u00fcvenlik B\u00fcrosu G\u00f6zetim ve Rehberlik \u015eube M\u00fcd\u00fcr\u00fc Bildirisi) i\u00e7erisinde, 3 gereklilik belirtilmi\u015ftir.<\/p>\n\n\n\n<ul>\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 ila\u00e7 vb. \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<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf[ja]<\/a><\/p>\n\n\n\n<p>Belirli bir ifade eylemi ger\u00e7ekle\u015ftirildi\u011finde ve yukar\u0131daki 3 gereklilikten herhangi birine uygun oldu\u011funda, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;ndaki &#8220;reklam&#8221; olarak kabul edilir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%80%8CReklam%E3%80%8Din_Duzenlendigi_Ozneler\"><\/span>\u300cReklam\u300d\u0131n D\u00fczenlendi\u011fi \u00d6zneler<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Reklam\u0131n d\u00fczenlendi\u011fi \u00f6zneler olarak, sadece hedeflenen ila\u00e7lar\u0131 satan i\u015fletmelerin oldu\u011funu d\u00fc\u015f\u00fcnenler olabilir.<\/p>\n\n\n\n<p>Ancak, Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n (Pharmaceuticals and Medical Devices Act) amac\u0131, daha \u00f6nce belirtildi\u011fi gibi, ila\u00e7lar\u0131n ve di\u011fer t\u0131bbi \u00fcr\u00fcnlerin kalitesini, etkinli\u011fini ve g\u00fcvenli\u011fini sa\u011flamak ve bu \u00fcr\u00fcnlerin kullan\u0131m\u0131ndan kaynaklanan sa\u011fl\u0131k ve hijyen tehlikelerinin ortaya \u00e7\u0131kmas\u0131n\u0131 ve yay\u0131lmas\u0131n\u0131 \u00f6nlemektir.<\/p>\n\n\n\n<p>Bu ama\u00e7larla ili\u015fkili olarak, sadece hedeflenen ila\u00e7lar\u0131 satan i\u015fletmeler de\u011fil, di\u011fer ki\u015filerin de reklam yapmas\u0131 durumunda, d\u00fczenlemeler yap\u0131lmas\u0131 gerekmektedir, aksi takdirde ama\u00e7lar\u0131na ula\u015famazlar.<\/p>\n\n\n\n<p>Bu nedenle, Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131&#8217;nda, reklam\u0131n d\u00fczenlendi\u011fi \u00f6znelerle ilgili bir s\u0131n\u0131rlama yoktur, genel halk veya ila\u00e7 satmayan i\u015fletmeler bile, ila\u00e7larla ilgili reklam yapt\u0131klar\u0131nda, Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n d\u00fczenlemelerine tabi olurlar.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Hangi_Ifadelerin_Duzenlemeye_Tabi_Oldugu\"><\/span>Hangi \u0130fadelerin D\u00fczenlemeye Tabi Oldu\u011fu<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Yukar\u0131da belirtildi\u011fi gibi, Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 (\u85ac\u6a5f\u6cd5) kapsam\u0131nda d\u00fczenlemeye tabi olanlar, abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131 (Madde 66), belirli hastal\u0131klar i\u00e7in ila\u00e7lar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklamlar\u0131n\u0131n s\u0131n\u0131rlanmas\u0131 (Madde 67) ve onaylanmam\u0131\u015f ila\u00e7lar, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklamlar\u0131n\u0131n yasaklanmas\u0131d\u0131r (Madde 68).<\/p>\n\n\n\n<p>Bu nedenle, a\u015fa\u011f\u0131da her bir d\u00fczenlemeyi a\u00e7\u0131kl\u0131yoruz.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Abartili_Reklamlarin_Yasaklanmasi_Madde_66\"><\/span>Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131 (Madde 66)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131 hakk\u0131nda, Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n 66. maddesi a\u015fa\u011f\u0131daki gibi h\u00fck\u00fcm getirir:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Abart\u0131l\u0131 Reklamlar)<br>Madde 66 &#8211; Kimse, ila\u00e7lar, 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 ifadeleri reklam yapmak, yazmak veya yaymak i\u00e7in kullanamaz.<br>2 &#8211; Bir doktor veya ba\u015fka bir ki\u015finin bu \u00fcr\u00fcnlerin etkinli\u011fini, etkisini veya performans\u0131n\u0131 garanti etti\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek ifadelerin reklam\u0131n\u0131 yapmak, yazmak veya yaymak, birinci f\u0131kra h\u00fckm\u00fcne tabidir.<br>3 &#8211; Kimse, ila\u00e7lar, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnlerine ili\u015fkin k\u00fcrtaj\u0131 ima etmek veya m\u00fcstehcen belgeler veya \u00e7izimler kullanmak i\u00e7in kullanamaz.<\/p>\n<\/blockquote>\n\n\n\n<p>Abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131 hakk\u0131nda \u00f6zetle \u015funlar s\u00f6ylenebilir:<\/p>\n\n\n\n<ul>\n<li>\u0130la\u00e7lar, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnlerinin ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 ifadelerin reklam\u0131n\u0131 yapmak, yazmak veya yaymak yasakt\u0131r.<\/li>\n\n\n\n<li>Bir doktor veya ba\u015fka bir ki\u015finin bu \u00fcr\u00fcnlerin etkinli\u011fini, etkisini veya performans\u0131n\u0131 garanti etti\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek ifadelerin reklam\u0131n\u0131 yapmak, yazmak veya yaymak yasakt\u0131r.<\/li>\n\n\n\n<li>K\u00fcrtaj\u0131 ima etmek veya m\u00fcstehcen belgeler veya \u00e7izimler kullanmak yasakt\u0131r.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Belirli_Hastaliklar_Icin_Ilaclar_ve_Rejeneratif_Tip_Urunlerinin_Reklamlarinin_Sinirlanmasi_Madde_67\"><\/span>Belirli Hastal\u0131klar \u0130\u00e7in \u0130la\u00e7lar ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklamlar\u0131n\u0131n S\u0131n\u0131rlanmas\u0131 (Madde 67)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Belirli hastal\u0131klar i\u00e7in ila\u00e7lar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklamlar\u0131n\u0131n s\u0131n\u0131rlanmas\u0131 hakk\u0131nda, Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n 67. maddesi a\u015fa\u011f\u0131daki gibi h\u00fck\u00fcm getirir:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Belirli Hastal\u0131klar \u0130\u00e7in \u0130la\u00e7lar ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklamlar\u0131n\u0131n S\u0131n\u0131rlanmas\u0131)<br>Madde 67 &#8211; 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 zararlar do\u011furabilecek ila\u00e7lar veya rejeneratif t\u0131p \u00fcr\u00fcnleri hakk\u0131nda, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131, bu 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 hedef alan 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 alabilir.<br>2 &#8211; Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131, \u00f6zel hastal\u0131klar\u0131 belirleyen h\u00fck\u00fcmet 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 h\u00fckme tabi de\u011fildir.<\/p>\n<\/blockquote>\n\n\n\n<p>Belirli hastal\u0131klar i\u00e7in ila\u00e7lar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklamlar\u0131n\u0131n s\u0131n\u0131rlanmas\u0131 hakk\u0131nda, kullan\u0131m\u0131nda y\u00fcksek d\u00fczeyde uzmanl\u0131k gerektiren kanser, sarkom ve l\u00f6semi ila\u00e7lar\u0131n\u0131n genel halk\u0131 hedef alan reklamlar\u0131 s\u0131n\u0131rlaman\u0131n hedefi olmaktad\u0131r.<\/p>\n\n\n\n<p>Bu nedenle, t\u0131bbi profesyonelleri hedef al\u0131yorsan\u0131z, bu d\u00fczenlemeye tabi olmayacaks\u0131n\u0131z.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Onaylanmamis_Ilaclar_Tibbi_Cihazlar_ve_Rejeneratif_Tip_Urunlerinin_Reklamlarinin_Yasaklanmasi_Madde_68\"><\/span>Onaylanmam\u0131\u015f \u0130la\u00e7lar, T\u0131bbi Cihazlar ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklamlar\u0131n\u0131n Yasaklanmas\u0131 (Madde 68)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Onaylanmam\u0131\u015f ila\u00e7lar, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklamlar\u0131n\u0131n yasaklanmas\u0131 hakk\u0131nda, Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n 68. maddesi a\u015fa\u011f\u0131daki gibi h\u00fck\u00fcm getirir:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Onaylanmam\u0131\u015f \u0130la\u00e7lar, T\u0131bbi Cihazlar ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklamlar\u0131n\u0131n Yasaklanmas\u0131)<br>Madde 68 &#8211; Kimse, hen\u00fcz onay (veya sertifikasyon) al\u0131nmam\u0131\u015f ila\u00e7lar veya t\u0131bbi cihazlar hakk\u0131nda, bu \u00fcr\u00fcnlerin ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda reklam yapamaz.<\/p>\n<\/blockquote>\n\n\n\n<p>Onaylanmam\u0131\u015f ila\u00e7lar, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin reklamlar\u0131n\u0131n yasaklanmas\u0131 hakk\u0131nda, onay (veya sertifikasyon) al\u0131nmam\u0131\u015f ila\u00e7lar veya t\u0131bbi cihazlar hakk\u0131nda, bu \u00fcr\u00fcnlerin ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda reklam yapmak yasaklanm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ozet\"><\/span>\u00d6zet<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\/04\/medical-supplies-law2.jpg\" alt=\"\" class=\"wp-image-44116\" \/><\/figure>\n\n\n\n<p>Yukar\u0131da, ila\u00e7 reklamlar\u0131n\u0131 d\u00fc\u015f\u00fcnen i\u015fletme sahiplerine y\u00f6nelik olarak, ila\u00e7 reklamlar\u0131 hakk\u0131ndaki yasal d\u00fczenlemeleri tan\u0131tt\u0131k.<\/p>\n\n\n\n<p>\u0130la\u00e7 reklamlar\u0131 hakk\u0131nda yeterince ara\u015ft\u0131rma yapmadan hareket ederseniz, yasay\u0131 ihlal etme olas\u0131l\u0131\u011f\u0131n\u0131z vard\u0131r.<\/p>\n\n\n\n<p>\u00d6zellikle abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131 gibi durumlarla \u00e7eli\u015fen durumlar yayg\u0131n olabilir, bu nedenle ila\u00e7 reklamlar\u0131 yapmay\u0131 d\u00fc\u015f\u00fcnen i\u015fletme sahiplerinin dikkatli olmas\u0131 gerekmektedir.<\/p>\n\n\n\n<p>\u0130la\u00e7 reklam\u0131 d\u00fczenlemelerine ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131, yay\u0131nlamay\u0131 d\u00fc\u015f\u00fcnd\u00fc\u011f\u00fcn\u00fcz reklam\u0131n i\u00e7eri\u011fi ile ili\u015fkili olarak, somut bir de\u011ferlendirme yapman\u0131z gerekmektedir. Bu nedenle, ila\u00e7 reklamlar\u0131 yay\u0131nlamay\u0131 d\u00fc\u015f\u00fcnen i\u015fletme sahiplerinin, uzman bilgisi olan bir avukata dan\u0131\u015fmalar\u0131n\u0131 \u00f6neririz.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ofisimiz_Tarafindan_Alinan_Onlemler\"><\/span>Ofisimiz 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 internet hukuku olmak \u00fczere, hukukun \u00e7e\u015fitli alanlar\u0131nda y\u00fcksek uzmanl\u0131\u011fa sahip bir hukuk b\u00fcrosudur. Son y\u0131llarda, internet reklamlar\u0131 etraf\u0131nda d\u00f6nen yan\u0131lt\u0131c\u0131 reklamc\u0131l\u0131k gibi Japon \u00d6d\u00fcl G\u00f6sterim Yasas\u0131&#8217;n\u0131n (Keihin Hy\u014dji H\u014d) ihlalleri b\u00fcy\u00fck bir sorun haline gelmi\u015ftir ve hukuki denetim ihtiyac\u0131 giderek artmaktad\u0131r. B\u00fcromuz, \u00e7e\u015fitli Japon yasalar\u0131n\u0131n d\u00fczenlemelerini g\u00f6z \u00f6n\u00fcnde bulundurarak, mevcut veya planlanan i\u015fletmelerin hukuki risklerini analiz eder ve i\u015fletmeyi durdurmadan m\u00fcmk\u00fcn oldu\u011funca yasal hale getirmeye \u00e7al\u0131\u015f\u0131r. Ayr\u0131nt\u0131lar a\u015fa\u011f\u0131daki makalede belirtilmi\u015ftir.<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/practices\/corporate\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/practices\/corporate[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>2014 y\u0131l\u0131nda (12 Haziran 2014) Japon \u0130la\u00e7 Yasas\u0131 (\u015fimdiki ad\u0131yla Japon \u0130la\u00e7, T\u0131bbi Cihazlar ve Di\u011fer \u00dcr\u00fcnlerin Kalitesi, Etkinli\u011fi ve G\u00fcvenli\u011finin Sa\u011flanmas\u0131 Hakk\u0131nda Yasas\u0131, bundan sonra &#8216;\u0130la\u00e7  [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":64644,"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\/61080"}],"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=61080"}],"version-history":[{"count":3,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61080\/revisions"}],"predecessor-version":[{"id":64645,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61080\/revisions\/64645"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media\/64644"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media?parent=61080"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/categories?post=61080"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/tags?post=61080"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}