{"id":61315,"date":"2023-12-04T11:20:31","date_gmt":"2023-12-04T02:20:31","guid":{"rendered":"https:\/\/monolith.law\/tr\/?p=61315"},"modified":"2024-03-19T22:38:49","modified_gmt":"2024-03-19T13:38:49","slug":"pharmaceuticals-law-penalties","status":"publish","type":"post","link":"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties","title":{"rendered":"Japon \u0130la\u00e7 Makinesi Yasas\u0131'ndaki (Japanese Pharmaceutical Affairs Law) Cezalar ve Tutuklama Ko\u015fullar\u0131 Nelerdir? Ka\u00e7\u0131nma Noktalar\u0131 da A\u00e7\u0131klan\u0131yor"},"content":{"rendered":"\n<p>\u0130la\u00e7lar gibi \u00fcr\u00fcnlerle u\u011fra\u015fan \u00fcretim \u015firketleri ve eczaneler gibi yerlerde, Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131 (JPMDL) kontrol\u00fc rutin olarak ger\u00e7ekle\u015ftirilir. Ancak, JPMDL&#8217;nin d\u00fczenlemeleri sadece bu i\u015fletmelerle s\u0131n\u0131rl\u0131 de\u011fildir. D\u00fczenlemelerin kapsam\u0131 geni\u015f oldu\u011fu i\u00e7in, d\u00fczenlemeye tabi oldu\u011funu bilmeyen ve bu y\u00fczden JPMDL&#8217;ye ayk\u0131r\u0131 hareket eden durumlar\u0131 da g\u00f6rmekteyiz.<\/p>\n\n\n\n<p>Bu makalede, beklenmedik bir \u015fekilde JPMDL&#8217;ye ayk\u0131r\u0131 duruma d\u00fc\u015fmemek i\u00e7in, ihlal durumunda uygulanan cezalar ve ihlali \u00f6nleme noktalar\u0131n\u0131 ayr\u0131nt\u0131l\u0131 olarak a\u00e7\u0131kl\u0131yoruz.<\/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-penalties\/#Ilac_ve_Tibbi_Cihaz_Yasasi_Nedir\" title=\"\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 Nedir?\">\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 Nedir?<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Ilac_ve_Tibbi_Cihaz_Yasasi%E2%80%99nin_Amaci\" title=\"\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n Amac\u0131\">\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n Amac\u0131<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Dikkat_Edilmesi_Gereken_Duzenlemeler_Satis_ve_Reklam\" title=\"Dikkat Edilmesi Gereken D\u00fczenlemeler: Sat\u0131\u015f ve Reklam\">Dikkat Edilmesi Gereken D\u00fczenlemeler: Sat\u0131\u015f ve Reklam<\/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-penalties\/#Ilac_Makinesi_Yasasi%E2%80%99na_Japanese_Pharmaceutical_and_Medical_Device_Act_Aykiri_Davranislar\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Davran\u0131\u015flar\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Davran\u0131\u015flar<\/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-penalties\/#Duzenlemeye_Tabi_Olanlar\" title=\"D\u00fczenlemeye Tabi Olanlar\">D\u00fczenlemeye Tabi Olanlar<\/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-penalties\/#Ilac_Makinesi_Yasasi%E2%80%99nin_Satis_Duzenlemeleri\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Sat\u0131\u015f D\u00fczenlemeleri\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Sat\u0131\u015f D\u00fczenlemeleri<\/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-penalties\/#Ilac_Makinesi_Yasasi%E2%80%99nin_Reklam_Duzenlemeleri\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Reklam D\u00fczenlemeleri\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Reklam D\u00fczenlemeleri<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Reklamlarin_Ihlal_Olup_Olmadiginin_Degerlendirilme_Kriterleri\" title=\"Reklamlar\u0131n \u0130hlal Olup Olmad\u0131\u011f\u0131n\u0131n De\u011ferlendirilme Kriterleri\">Reklamlar\u0131n \u0130hlal Olup Olmad\u0131\u011f\u0131n\u0131n De\u011ferlendirilme Kriterleri<\/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\/pharmaceuticals-law-penalties\/#Ilac_Makinesi_Yasasi%E2%80%99na_Japon_Ilac_Makinesi_Yasasi_Aykiri_Olarak_Kabul_Edilen_Reklam_Ornekleri\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japon \u0130la\u00e7 Makinesi Yasas\u0131) Ayk\u0131r\u0131 Olarak Kabul Edilen Reklam \u00d6rnekleri\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japon \u0130la\u00e7 Makinesi Yasas\u0131) Ayk\u0131r\u0131 Olarak Kabul Edilen Reklam \u00d6rnekleri<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Ornek_1_Kozmetik_Urunler\" title=\"\u00d6rnek 1: Kozmetik \u00dcr\u00fcnler\">\u00d6rnek 1: Kozmetik \u00dcr\u00fcnler<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Ornek_2_Gida\" title=\"\u00d6rnek 2: G\u0131da\">\u00d6rnek 2: G\u0131da<\/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-12\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Ilac_Makinesi_Yasasi%E2%80%99na_Japanese_Pharmaceutical_and_Medical_Device_Act_Aykiri_Davranisin_Cezalari_ve_Tutuklama_Sartlari\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Davran\u0131\u015f\u0131n Cezalar\u0131 ve Tutuklama \u015eartlar\u0131\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Davran\u0131\u015f\u0131n Cezalar\u0131 ve Tutuklama \u015eartlar\u0131<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Cezalar\" title=\"Cezalar\">Cezalar<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Tutuklama_Sartlari\" title=\"Tutuklama \u015eartlar\u0131\">Tutuklama \u015eartlar\u0131<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#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><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Ozet_Ilac_ve_Tibbi_Cihaz_Kanunu%E2%80%99na_Japanese_Pharmaceutical_and_Medical_Device_Act_Aykirilik_Endisesi_Yasiyorsaniz_Bir_Avukata_Danisin\" title=\"\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131l\u0131k Endi\u015fesi Ya\u015f\u0131yorsan\u0131z Bir Avukata Dan\u0131\u015f\u0131n\">\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131l\u0131k Endi\u015fesi Ya\u015f\u0131yorsan\u0131z Bir Avukata Dan\u0131\u015f\u0131n<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pharmaceuticals-law-penalties\/#Buromuz_Tarafindan_Alinan_Onlemler\" title=\"B\u00fcromuz Taraf\u0131ndan Al\u0131nan \u00d6nlemler\">B\u00fcromuz Taraf\u0131ndan Al\u0131nan \u00d6nlemler<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_ve_Tibbi_Cihaz_Yasasi_Nedir\"><\/span>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 Nedir?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131, ila\u00e7lar, t\u0131bbi cihazlar vb. hakk\u0131nda gerekli d\u00fczenlemeleri belirleyen bir yasad\u0131r ve resmi ad\u0131 &#8220;\u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Yasa&#8221;d\u0131r.<\/p>\n\n\n\n<p>Eskiden &#8220;\u0130la\u00e7 \u0130\u015fleri Yasas\u0131&#8221; olarak uygulan\u0131yordu, ancak 2013 (Heisei 25) y\u0131l\u0131nda de\u011fi\u015ftirildi (2014 (Heisei 26) y\u0131l\u0131nda y\u00fcr\u00fcrl\u00fc\u011fe girdi) ve ad\u0131 &#8220;\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8221; olarak de\u011fi\u015ftirildi. Ayr\u0131ca &#8220;\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8221; olarak da an\u0131l\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_ve_Tibbi_Cihaz_Yasasi%E2%80%99nin_Amaci\"><\/span>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n Amac\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>&#8220;\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8221;n\u0131n amac\u0131, Madde 1&#8217;de a\u015fa\u011f\u0131daki gibi belirlenmi\u015ftir:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Madde 1 (Ama\u00e7)<\/p>\n\n\n\n<p>Bu yasa, ila\u00e7lar, t\u0131bbi cihazlar, kozmetikler ve rejeneratif t\u0131p \u00fcr\u00fcnlerinin (bundan b\u00f6yle &#8220;ila\u00e7lar vb.&#8221; olarak an\u0131lacakt\u0131r) kalitesinin, etkinli\u011finin ve g\u00fcvenli\u011finin sa\u011flanmas\u0131 ve bu \u00fcr\u00fcnlerin kullan\u0131m\u0131ndan kaynaklanan sa\u011fl\u0131k ve hijyen tehlikelerinin \u00f6nlenmesi i\u00e7in gerekli d\u00fczenlemeleri yapmay\u0131 ve belirli ila\u00e7lar\u0131n d\u00fczenlenmesi ile ilgili \u00f6nlemler almay\u0131 ama\u00e7lar. Ayr\u0131ca, 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 almay\u0131 ama\u00e7lar.<\/p>\n<cite>\u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Yasa Madde 1<\/cite><\/blockquote>\n\n\n\n<p>K\u0131sacas\u0131, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131, ila\u00e7lar vb. kalite, etkinlik ve g\u00fcvenli\u011fin sa\u011flanmas\u0131 i\u00e7in gerekli d\u00fczenlemeleri belirlemeyi ama\u00e7lar. Bu amac\u0131 ger\u00e7ekle\u015ftirmek i\u00e7in, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131, ila\u00e7lar vb. hakk\u0131nda \u00fcretim, y\u00f6netim, sat\u0131\u015f, reklam vb. a\u015famalarda \u00e7e\u015fitli d\u00fczenlemeler belirler.<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/?p=49834\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 (Eski \u0130la\u00e7 \u0130\u015fleri Yasas\u0131) Nedir? Ama\u00e7, D\u00fczenlenen Konular, Reklam D\u00fczenlemeleri[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Dikkat_Edilmesi_Gereken_Duzenlemeler_Satis_ve_Reklam\"><\/span>Dikkat Edilmesi Gereken D\u00fczenlemeler: Sat\u0131\u015f ve Reklam<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 taraf\u0131ndan belirlenen d\u00fczenlemeler aras\u0131nda, \u00f6zellikle dikkat edilmesi gerekenler sat\u0131\u015f ve reklam d\u00fczenlemeleridir.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;na ayk\u0131r\u0131l\u0131k nedeniyle ceza davas\u0131 a\u00e7\u0131lan durumlar\u0131n \u00e7o\u011fu, sat\u0131\u015f ve reklamla ilgili ihlalleri i\u00e7erir.<\/p>\n\n\n\n<p>Japonya Polis Te\u015fkilat\u0131&#8217;n\u0131n su\u00e7 istatistiklerine g\u00f6re, 2020 (Reiwa 2) y\u0131l\u0131ndaki su\u00e7lar\u0131n aras\u0131nda, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;na ayk\u0131r\u0131 olarak tutuklanan vakalar 63 olup, bir \u00f6nceki y\u0131la g\u00f6re 15 artm\u0131\u015ft\u0131r. Bu vakalar\u0131n 14&#8217;\u00fc yeni tip koronavir\u00fcs enfeksiyonu ile ilgili \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ihlalleriydi. (Japonya Polis Te\u015fkilat\u0131 Ya\u015fam G\u00fcvenli\u011fi B\u00fcrosu &#8220;<a href=\"https:\/\/www.npa.go.jp\/publications\/statistics\/safetylife\/seikeikan\/R02_seikatsukeizaijihan.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Reiwa 2 Y\u0131l\u0131nda Ya\u015fam Ekonomisi Su\u00e7lar\u0131n\u0131n Tutuklama Durumu[ja]<\/a>&#8220;)<\/p>\n\n\n\n<p>Ayr\u0131ca, 2021 (Reiwa 3) y\u0131l\u0131ndaki su\u00e7lar\u0131n aras\u0131nda, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;na ayk\u0131r\u0131 olarak tutuklanan vakalar 46 olup, bunlar\u0131n 7&#8217;si yeni tip koronavir\u00fcs enfeksiyonu ile ilgili \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ihlalleriydi. (Japonya Polis Te\u015fkilat\u0131 Ya\u015fam G\u00fcvenli\u011fi B\u00fcrosu &#8220;<a href=\"https:\/\/www.npa.go.jp\/safetylife\/seikeikan\/R03_seikatsukeizaijihan.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Reiwa 3 Y\u0131l\u0131nda Ya\u015fam Ekonomisi Su\u00e7lar\u0131n\u0131n Tutuklama Durumu[ja]<\/a>&#8220;)<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ihlallerinin i\u00e7eri\u011fi hakk\u0131nda, <a href=\"https:\/\/www.keishicho.metro.tokyo.lg.jp\/about_mpd\/jokyo_tokei\/tokei\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">Tokyo Metropolitan Polis Departman\u0131 istatistiklerine[ja]<\/a> g\u00f6re, durum a\u015fa\u011f\u0131daki gibidir:<\/p>\n\n\n\n<p>2018&#8217;de Tokyo&#8217;da meydana gelen \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ihlalleri 34 olup, bunlar\u0131n 15&#8217;i sat\u0131\u015fla ilgili, 10&#8217;u reklamla ilgili ihlallerdi. (Tokyo Metropolitan Polis Departman\u0131 &#8220;<a href=\"https:\/\/www.keishicho.metro.tokyo.lg.jp\/about_mpd\/jokyo_tokei\/tokei\/k_tokei30.html\" target=\"_blank\" rel=\"noreferrer noopener\">Tokyo Metropolitan Polis Departman\u0131 \u0130statistikleri (2018)[ja]<\/a>&#8220;)<\/p>\n\n\n\n<p>2019&#8217;da (Heisei 31 \/ Reiwa 1) Tokyo&#8217;da meydana gelen \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ihlalleri 12 olup, bunlar\u0131n 5&#8217;i sat\u0131\u015fla ilgili, 1&#8217;i reklamla ilgili ihlallerdi. (Tokyo Metropolitan Polis Departman\u0131 &#8220;<a href=\"https:\/\/www.keishicho.metro.tokyo.lg.jp\/about_mpd\/jokyo_tokei\/tokei\/k_tokei31.files\/ktd083.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Tokyo Metropolitan Polis Departman\u0131 \u0130statistikleri (Heisei 31 \/ Reiwa 1)[ja]<\/a>&#8220;)<\/p>\n\n\n\n<p>2020&#8217;de (Reiwa 2) Tokyo&#8217;da meydana gelen \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ihlalleri 24 olup, bunlar\u0131n 12&#8217;si sat\u0131\u015fla ilgili, 10&#8217;u reklamla ilgili ihlallerdi. (Tokyo Metropolitan Polis Departman\u0131 &#8220;<a href=\"https:\/\/www.keishicho.metro.tokyo.lg.jp\/about_mpd\/jokyo_tokei\/tokei\/k_tokei02.files\/ktd083.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Tokyo Metropolitan Polis Departman\u0131 \u0130statistikleri (Reiwa 2)[ja]<\/a>&#8220;)<\/p>\n\n\n\n<p>Bu istatistiklerden, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ihlallerinin \u00e7o\u011funun sat\u0131\u015f ve reklamla ilgili d\u00fczenlemelere ayk\u0131r\u0131 oldu\u011fu anla\u015f\u0131lmaktad\u0131r. Bu nedenle, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ihlallerinden ka\u00e7\u0131nmak i\u00e7in, sat\u0131\u015f ve reklamla ilgili d\u00fczenlemeleri do\u011fru bir \u015fekilde anlamak \u00f6zellikle \u00f6nemlidir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99na_Japanese_Pharmaceutical_and_Medical_Device_Act_Aykiri_Davranislar\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Davran\u0131\u015flar<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Burada, cezai yapt\u0131r\u0131mlar ve tutuklama ko\u015fullar\u0131n\u0131 a\u00e7\u0131klamadan \u00f6nce, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical and Medical Device Act) belirledi\u011fi d\u00fczenlemeler hakk\u0131nda bilgi veriyoruz.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Duzenlemeye_Tabi_Olanlar\"><\/span>D\u00fczenlemeye Tabi Olanlar<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p> Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n (\u85ac\u6a5f\u6cd5) ana d\u00fczenlemeye tabi olanlar, madde 1&#8217;de belirtildi\u011fi gibi, ila\u00e7lar, t\u0131bbi olmayan ila\u00e7lar, kozmetikler, t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnleridir (ilac vb.).<\/p>\n\n\n\n<p> &#8220;\u0130la\u00e7lar&#8221;, basit\u00e7e, hastal\u0131klar\u0131n ve yaralanmalar\u0131n te\u015fhis, tedavi ve \u00f6nlenmesinde kullan\u0131lan veya insan v\u00fccuduna ve i\u015flevlerine etki eden \u015feyler anlam\u0131na gelir (Madde 2, F\u0131kra 1). \u00d6rnek olarak, antijen belirleme test kitleri ve do\u011fum kontrol haplar\u0131 verilebilir.<\/p>\n\n\n\n<p> &#8220;T\u0131bbi olmayan ila\u00e7lar&#8221;, basit\u00e7e, insan v\u00fccuduna etkisi olan ancak ila\u00e7lara k\u0131yasla daha hafif etkisi olan \u015feyler anlam\u0131na gelir (Madde 2, F\u0131kra 2). \u00d6rnek olarak, a\u011f\u0131z spreyi, b\u00f6cek \u00f6ld\u00fcr\u00fcc\u00fcler ve kontakt lens temizleyiciler verilebilir.<\/p>\n\n\n\n<p> &#8220;Kozmetikler&#8221;, basit\u00e7e, t\u0131bbi olmayan ila\u00e7lara k\u0131yasla insan v\u00fccuduna daha hafif etkisi olan ve insan v\u00fccudunu temiz tutmak, cildi ve sa\u00e7\u0131 sa\u011fl\u0131kl\u0131 tutmak i\u00e7in v\u00fccuda s\u00fcr\u00fclen \u015feyler anlam\u0131na gelir (Madde 2, F\u0131kra 3). \u00d6rnek olarak, genel kozmetik \u00fcr\u00fcnler, \u015fampuanlar, di\u015f macunlar\u0131, cilt bak\u0131m \u00fcr\u00fcnleri ve v\u00fccut losyonlar\u0131 verilebilir.<\/p>\n\n\n\n<p> &#8220;T\u0131bbi cihazlar&#8221;, basit\u00e7e, v\u00fccut yap\u0131s\u0131na veya i\u015flevine etki eden veya te\u015fhis, tedavi ve \u00f6nleme ama\u00e7l\u0131 makineler ve aletler anlam\u0131na gelir (Madde 2, F\u0131kra 4). \u00d6rnek olarak, termometreler, diki\u015f ipleri, do\u011fum kontrol ara\u00e7lar\u0131, hastal\u0131k te\u015fhis programlar\u0131 verilebilir.<\/p>\n\n\n\n<p> &#8220;Rejeneratif t\u0131p \u00fcr\u00fcnleri&#8221;, h\u00fccrelere k\u00fclt\u00fcr gibi i\u015flemler uygulanan veya tedavi ama\u00e7l\u0131 h\u00fccrelere tan\u0131t\u0131lan ve v\u00fccutta ifade edilen genleri i\u00e7eren \u015feyler anlam\u0131na gelir (Madde 2, F\u0131kra 9). \u00d6rnek olarak, travmatik k\u0131k\u0131rdak defektlerine nakledilen k\u0131k\u0131rdak dokusu verilebilir.<\/p>\n\n\n\n<p> \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131, esas olarak yukar\u0131daki be\u015f \u015feyi d\u00fczenler ve sat\u0131\u015f ve reklamlarla ilgili k\u0131s\u0131tlamalar getirir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99nin_Satis_Duzenlemeleri\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Sat\u0131\u015f D\u00fczenlemeleri<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act), ila\u00e7lar ve benzeri \u00fcr\u00fcnlerle ilgili sat\u0131\u015f d\u00fczenlemeleri getirir.<\/p>\n\n\n\n<p>\u0130la\u00e7lar, y\u00fcksek d\u00fczeyde y\u00f6netilen t\u0131bbi cihazlar ve rejeneratif t\u0131p \u00fcr\u00fcnleri gibi \u00fcr\u00fcnlerin sat\u0131\u015f\u0131n\u0131 yapabilmek i\u00e7in Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131&#8217;n\u0131n izni olmas\u0131 gerekmektedir (Madde 24). Ayr\u0131ca, y\u00f6netilen t\u0131bbi cihazlar\u0131n sat\u0131\u015f\u0131 i\u00e7in bildirimde bulunulmas\u0131 gerekmektedir (Madde 29-3).<\/p>\n\n\n\n<p>Bu d\u00fczenlemeler, sat\u0131\u015f\u0131n &#8220;ticari&#8221; olarak yap\u0131lmas\u0131 durumunda ge\u00e7erlidir. &#8220;Ticari&#8221; ifadesi, tekrarlayan ve s\u00fcrekli bir dizi eylemin, bir i\u015fletmenin y\u00fcr\u00fct\u00fclmesi olarak de\u011ferlendirilebilece\u011fi durumlar\u0131 ifade eder. Toptan ve perakende sat\u0131\u015flar kadar, bireysel yeniden sat\u0131\u015flar da bu kapsama girebilir, bu nedenle dikkatli olunmal\u0131d\u0131r.<\/p>\n\n\n\n<p>Ayr\u0131ca, gerekli onaylar\u0131 veya izinleri almayan ila\u00e7lar ve benzeri \u00fcr\u00fcnlerin (onays\u0131z ve izinsiz ila\u00e7lar) sat\u0131\u015f\u0131 da yasakt\u0131r (Madde 55-2, Madde 60, Madde 62, Madde 64, Madde 65-4). \u00d6zellikle dikkat edilmesi gereken nokta, sat\u0131lan \u00fcr\u00fcnlerin g\u0131da vb. olmas\u0131 durumunda bile, &#8220;ila\u00e7&#8221; olarak kabul edilebilece\u011fi ve bu durumda onays\u0131z ve izinsiz ila\u00e7 olarak sat\u0131\u015f\u0131n\u0131n yasad\u0131\u015f\u0131 olaca\u011f\u0131d\u0131r.<\/p>\n\n\n\n<p>&#8220;\u0130la\u00e7&#8221;\u0131n uygulanabilirli\u011fi hakk\u0131nda, yarg\u0131 kararlar\u0131na g\u00f6re, a\u015fa\u011f\u0131daki kriterlerle karar verilir:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u00dcr\u00fcn\u00fcn bile\u015fenleri, \u015fekli, ad\u0131, \u00fcr\u00fcn \u00fczerinde belirtilen kullan\u0131m amac\u0131, etkinlik ve dozaj, sat\u0131\u015f y\u00f6ntemi ve bu s\u0131rada yap\u0131lan a\u00e7\u0131klamalar ve reklamlar gibi fakt\u00f6rlerin t\u00fcm\u00fc dikkate al\u0131narak, \u00fcr\u00fcn\u00fcn genel anlamda &#8220;insan veya hayvan hastal\u0131klar\u0131n\u0131n te\u015fhisi, tedavisi veya \u00f6nlenmesi amac\u0131yla kullan\u0131lmas\u0131&#8221; olarak kabul edilir ve bu, \u00fcr\u00fcn\u00fcn objektif olarak farmakolojik etkiye sahip olup olmad\u0131\u011f\u0131n\u0131 sorgulamaz.<\/p>\n<cite>En Y\u00fcksek Mahkeme Karar\u0131, Showa 57 (1982) 28 Eyl\u00fcl, Ceza Toplant\u0131s\u0131 36 Cilt 8 Say\u0131 787 Sayfa<\/cite><\/blockquote>\n\n\n\n<p>G\u0131da olarak sat\u0131lan \u00fcr\u00fcnler bile, \u015fekil ve etkinlik yan\u0131 s\u0131ra, sat\u0131\u015f y\u00f6ntemi ve reklamlar gibi fakt\u00f6rlerin t\u00fcm\u00fc dikkate al\u0131narak &#8220;ila\u00e7&#8221; olarak kabul edilip edilmeyece\u011fi belirlenir.<\/p>\n\n\n\n<p>Ayr\u0131ca, Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n &#8220;<a href=\"https:\/\/www.mhlw.go.jp\/content\/000658257.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7lar\u0131n Kapsam\u0131na \u0130li\u015fkin Standartlar\u0131n Bir K\u0131sm\u0131n\u0131n De\u011fi\u015ftirilmesi Hakk\u0131nda (Reiwa 2 (2020) 31 Mart, \u0130la\u00e7 Ya\u015fam Duyurusu 0331 No 33)[ja]<\/a>&#8221; belgesinde, ila\u00e7 benzeri etkinliklerin belirtildi\u011fi durumlarda \u00fcr\u00fcn\u00fcn &#8220;ila\u00e7&#8221; olarak kabul edilece\u011fi belirtilmi\u015ftir.<\/p>\n\n\n\n<p>Bu nedenle, sat\u0131\u015f y\u00f6ntemi veya reklam i\u00e7eri\u011fine ba\u011fl\u0131 olarak, &#8220;ila\u00e7&#8221; olarak kabul edilen bir \u00fcr\u00fcn\u00fcn sat\u0131\u015f\u0131 yasad\u0131\u015f\u0131 olabilir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99nin_Reklam_Duzenlemeleri\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Reklam D\u00fczenlemeleri<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131, 66. maddeden 68. maddeye kadar reklamlarla ilgili d\u00fczenlemeler getirir. Bu d\u00fczenlemeler aras\u0131nda, \u00f6zellikle \u00f6nemli olan 66. ve 68. maddelerin d\u00fczenlemelerini a\u00e7\u0131kl\u0131yoruz.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>66. Madde (Abart\u0131l\u0131 Reklamlar vb.)<\/p>\n\n\n\n<p>Hi\u00e7 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 bilgileri reklam yapmak, yazmak veya yaymak i\u00e7in kullanamaz.<\/p>\n\n\n\n<p>2. Bir doktorun veya ba\u015fka bir ki\u015finin ila\u00e7lar\u0131n, t\u0131bbi cihazlar\u0131n veya rejeneratif t\u0131p \u00fcr\u00fcnlerinin etkinli\u011fini, etkisini veya performans\u0131n\u0131 garanti etti\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek bilgilerin reklam\u0131n\u0131 yapmak, yazmak veya yaymak, birinci f\u0131kran\u0131n kapsam\u0131na girer.<\/p>\n\n\n\n<p>3. Hi\u00e7 kimse, ila\u00e7lar, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnleri hakk\u0131nda k\u00fcrtaj\u0131 ima eden veya m\u00fcstehcen belgeler veya \u00e7izimler kullanamaz.<\/p>\n<cite>\u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fin Sa\u011flanmas\u0131 Hakk\u0131nda Kanun 66. Madde<\/cite><\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>68. Madde (Onay Al\u0131nmam\u0131\u015f \u0130la\u00e7, T\u0131bbi Cihaz ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklam\u0131n\u0131n Yasaklanmas\u0131)<\/p>\n\n\n\n<p>Hi\u00e7 kimse, hen\u00fcz onay al\u0131nmam\u0131\u015f olan ve 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, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnleri hakk\u0131nda, 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 68. Madde<\/cite><\/blockquote>\n\n\n\n<p>66. ve 68. maddelerin h\u00fck\u00fcmlerini \u00f6zetlersek, a\u015fa\u011f\u0131daki reklamlar\u0131n yasakland\u0131\u011f\u0131n\u0131 s\u00f6yleyebiliriz:<\/p>\n\n\n\n<ol>\n<li>Yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklamlar<\/li>\n\n\n\n<li>Doktorlar\u0131n vb. etkinli\u011fi ve etkisini garanti etti\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7an reklamlar<\/li>\n\n\n\n<li>K\u00fcrtaj\u0131 ima eden veya m\u00fcstehcen belge ve \u00e7izimlerin kullan\u0131ld\u0131\u011f\u0131 reklamlar<\/li>\n\n\n\n<li>Onay al\u0131nmam\u0131\u015f ila\u00e7, t\u0131bbi cihaz vb. reklamlar\u0131<\/li>\n<\/ol>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n &#8220;reklam&#8221; tan\u0131m\u0131, 1998 (Heisei 10) y\u0131l\u0131nda (Gregorian takvimine g\u00f6re 1998) 29 Eyl\u00fcl tarihli Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 \u0130la\u00e7 G\u00fcvenli\u011fi B\u00fcrosu G\u00f6zetim ve Rehberlik \u015eube M\u00fcd\u00fcr\u00fc Bildirisi (<a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Yasas\u0131&#8217;nda \u0130la\u00e7 Reklamlar\u0131n\u0131n Uygunlu\u011fu Hakk\u0131nda[ja]<\/a>) ile a\u00e7\u0131klanm\u0131\u015ft\u0131r. Buna g\u00f6re, a\u015fa\u011f\u0131daki \u00fc\u00e7 gereklilik kar\u015f\u0131land\u0131\u011f\u0131nda &#8220;reklam&#8221; olarak kabul edilir:<\/p>\n\n\n\n<ul>\n<li>M\u00fc\u015fteriyi \u00e7ekme (sat\u0131n alma iste\u011fini art\u0131rma) niyeti a\u00e7\u0131k olmal\u0131d\u0131r (te\u015fvik edicilik)<\/li>\n\n\n\n<li>Belirli bir ila\u00e7 vb. \u00fcr\u00fcn\u00fcn ad\u0131 a\u00e7\u0131k\u00e7a belirtilmi\u015f olmal\u0131d\u0131r (belirlilik)<\/li>\n\n\n\n<li>Genel halk\u0131n fark\u0131nda olabilece\u011fi bir durumda olmal\u0131d\u0131r (fark\u0131ndal\u0131k)<\/li>\n<\/ul>\n\n\n\n<p>66. ve 68. maddelerin reklam d\u00fczenlemeleri, &#8220;herkes&#8221; ifadesiyle, t\u00fcm ki\u015filere uygulan\u0131r ve d\u00fczenlenen ki\u015filerle s\u0131n\u0131rl\u0131 de\u011fildir. Sadece sa\u011fl\u0131k \u00e7al\u0131\u015fanlar\u0131 ve reklam talep edenler de\u011fil, reklam ajanslar\u0131, ba\u011fl\u0131 kurulu\u015flar, influencerlar vb. de d\u00fczenlemeye tabidir ve t\u00fczel ki\u015filer ve bireyler aras\u0131nda ayr\u0131m yap\u0131lmaz.<\/p>\n\n\n\n<p>Ayr\u0131ca, reklam medyas\u0131yla ilgili bir s\u0131n\u0131rlama da yoktur, bu nedenle bro\u015f\u00fcrler, dergiler vb. ka\u011f\u0131t medya ve web siteleri yan\u0131 s\u0131ra ki\u015fisel SNS&#8217;ler de d\u00fczenlemeye tabidir.<\/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<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Reklamlarin_Ihlal_Olup_Olmadiginin_Degerlendirilme_Kriterleri\"><\/span>Reklamlar\u0131n \u0130hlal Olup Olmad\u0131\u011f\u0131n\u0131n De\u011ferlendirilme Kriterleri<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Reklamlar\u0131n, Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n (\u85ac\u6a5f\u6cd5) reklam d\u00fczenlemelerine ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131n\u0131n de\u011ferlendirilmesi, Japonya Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n bildirisi olan &#8216;<a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_c.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7lar ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131 Hakk\u0131nda[ja]<\/a>&#8216; ve &#8216;<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179263.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7lar ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131n\u0131n A\u00e7\u0131klamas\u0131 ve Dikkat Edilmesi Gereken Hususlar Hakk\u0131nda[ja]<\/a>&#8216;na dayanarak yap\u0131lmaktad\u0131r.<\/p>\n\n\n\n<p>\u0130la\u00e7lar ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131, a\u015fa\u011f\u0131daki 14 kriteri belirtmektedir:<\/p>\n\n\n\n<ol>\n<li>\u0130simle ilgili<\/li>\n\n\n\n<li>\u00dcretim y\u00f6ntemiyle ilgili<\/li>\n\n\n\n<li>Etkinlik, performans ve g\u00fcvenlikle ilgili<\/li>\n\n\n\n<li>A\u015f\u0131r\u0131 t\u00fcketimi veya k\u00f6t\u00fcye kullan\u0131m\u0131 te\u015fvik edebilecek reklamlar\u0131n k\u0131s\u0131tlanmas\u0131<\/li>\n\n\n\n<li>T\u0131bbi ila\u00e7lar\u0131n reklamlar\u0131n\u0131n k\u0131s\u0131tlanmas\u0131<\/li>\n\n\n\n<li>Genel reklamlarda etkinlik ifadelerinin k\u0131s\u0131tlanmas\u0131<\/li>\n\n\n\n<li>Al\u0131\u015fkanl\u0131k yap\u0131c\u0131 ila\u00e7lar\u0131n reklamlar\u0131nda belirtilmesi veya eklenmesi gereken hususlar<\/li>\n\n\n\n<li>Kullan\u0131m ve i\u015flemle ilgili dikkat edilmesi gereken hususlar\u0131n ila\u00e7 reklamlar\u0131nda belirtilmesi veya eklenmesi gereken hususlar<\/li>\n\n\n\n<li>Ba\u015fka bir \u015firketin \u00fcr\u00fcnlerine kar\u015f\u0131 iftira i\u00e7eren reklamlar\u0131n k\u0131s\u0131tlanmas\u0131<\/li>\n\n\n\n<li>T\u0131bbi profesyonellerin \u00f6nerileri<\/li>\n\n\n\n<li>\u00d6d\u00fcl, hediye vb. reklamlar\u0131n k\u0131s\u0131tlanmas\u0131<\/li>\n\n\n\n<li>Rahats\u0131zl\u0131k, rahats\u0131zl\u0131k, endi\u015fe veya korku yaratabilecek reklamlar\u0131n k\u0131s\u0131tlanmas\u0131<\/li>\n\n\n\n<li>Televizyon, radyo programlar\u0131 vb. reklamlar\u0131n i\u015flenmesi<\/li>\n\n\n\n<li>\u0130la\u00e7lar\u0131n kozmetik veya g\u0131da kullan\u0131m\u0131 veya t\u0131bbi cihazlar\u0131n g\u00fczellik veya sa\u011fl\u0131k ekipman\u0131 kullan\u0131m\u0131 hakk\u0131ndaki ifadelerin k\u0131s\u0131tlanmas\u0131<\/li>\n<\/ol>\n\n\n\n<p>Reklam ifadelerinin \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;na ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131, yukar\u0131daki kriterlere g\u00f6re de\u011ferlendirilir. \u00d6rne\u011fin, 3. maddede belirtilen etkinlik hakk\u0131nda, &#8220;Onay gerektiren ila\u00e7lar\u0131n etkinli\u011fi veya performans\u0131 hakk\u0131ndaki ifadeler, onaylanan etkinliklerin kapsam\u0131n\u0131 a\u015fmamal\u0131d\u0131r&#8221; denilmekte ve izin verilen kapsam\u0131n \u00f6tesinde ifadeler kullanan reklamlar \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;na ayk\u0131r\u0131 olacakt\u0131r.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99na_Japon_Ilac_Makinesi_Yasasi_Aykiri_Olarak_Kabul_Edilen_Reklam_Ornekleri\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japon \u0130la\u00e7 Makinesi Yasas\u0131) Ayk\u0131r\u0131 Olarak Kabul Edilen Reklam \u00d6rnekleri<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Peki, tam olarak hangi t\u00fcr reklam ifadeleri \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 olacakt\u0131r? \u00d6zellikle kozmetik ve g\u0131da \u00fcr\u00fcnleri ile ilgili olarak, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 kabul edilen reklam \u00f6rneklerini inceleyelim.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ornek_1_Kozmetik_Urunler\"><\/span>\u00d6rnek 1: Kozmetik \u00dcr\u00fcnler<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Kozmetik \u00fcr\u00fcnlerin reklamlar\u0131 hakk\u0131nda, &#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 Alan\u0131n\u0131n De\u011fi\u015ftirilmesi[ja]<\/a>&#8216; ile birlikte &#8216;Japon \u0130la\u00e7lar ve Di\u011fer Uygun Reklam Standartlar\u0131&#8217;na g\u00f6re de\u011ferlendirilir.<\/p>\n\n\n\n<p>Burada, kozmetik \u00fcr\u00fcnlerin 56 farkl\u0131 etkinlik ve etki ifadesinin kapsam\u0131 belirlenmi\u015ftir ve bu kapsam\u0131n d\u0131\u015f\u0131na \u00e7\u0131kan ifadeler ila\u00e7 yasalar\u0131n\u0131 ihlal eder.<\/p>\n\n\n\n<p>\u00d6zellikle, a\u015fa\u011f\u0131daki ifadeler, kozmetik \u00fcr\u00fcnlerin kabul edilen etkinlik ve etki kapsam\u0131n\u0131 a\u015far ve ila\u00e7 yasalar\u0131n\u0131 ihlal eder:<\/p>\n\n\n\n<ul>\n<li>&#8216;Cildin yorgunlu\u011funu almak istiyorsan&#8217;<\/li>\n\n\n\n<li>&#8216;Cildin derinliklerine ula\u015f\u0131r&#8217;<\/li>\n\n\n\n<li>&#8216;K\u0131r\u0131\u015f\u0131kl\u0131klar\u0131 \u00f6nler&#8217;<\/li>\n\n\n\n<li>&#8216;\u25cb\u25cb tedavi eder&#8217;<\/li>\n\n\n\n<li>&#8216;\u25cb\u25cb&#8217;yi yeniden olu\u015fturur&#8217;<\/li>\n\n\n\n<li>&#8216;H\u00fccre k\u00f6kenli g\u00fc\u00e7&#8217;<\/li>\n\n\n\n<li>&#8216;En iyi detoks&#8217;<\/li>\n\n\n\n<li>&#8216;Sa\u00e7\u0131 yeniden olu\u015fturur ve temelden iyile\u015ftirir&#8217;<\/li>\n\n\n\n<li>&#8216;Ya\u015flanma kar\u015f\u0131t\u0131 bak\u0131mla gen\u00e7le\u015fir&#8217;<\/li>\n\n\n\n<li>&#8216;Cilt tipini iyile\u015ftiren ya\u015flanma kar\u015f\u0131t\u0131 bak\u0131m&#8217;<\/li>\n\n\n\n<li>&#8216;Bunu kullanmaya ba\u015flad\u0131\u011f\u0131mdan beri ince \u00e7izgiler olu\u015fmuyor!&#8217;<\/li>\n\n\n\n<li>&#8216;En iyi kozmetik \u00fcr\u00fcn&#8217;<\/li>\n\n\n\n<li>&#8216;H\u0131zl\u0131 etki eder&#8217;<\/li>\n\n\n\n<li>&#8216;Kesin garanti&#8217;<\/li>\n<\/ul>\n\n\n<p><!-- \/wp:paragraph --><br \/><!-- wp:heading {\"level\":4} --><\/p>\n<h4><span class=\"ez-toc-section\" id=\"Ornek_2_Gida\"><\/span>\u00d6rnek 2: G\u0131da<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><!-- \/wp:heading --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>\u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;nda (Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131) g\u0131da ile ilgili bir h\u00fck\u00fcm bulunmamaktad\u0131r. Bu nedenle, g\u0131da ile ilgili her t\u00fcrl\u00fc reklam\u0131n \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;na ayk\u0131r\u0131 olmayaca\u011f\u0131n\u0131 d\u00fc\u015f\u00fcnenler olabilir.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Ancak, bir g\u0131da \u00fcr\u00fcn\u00fcn\u00fcn etiketi veya reklam i\u00e7eri\u011fi, bir ila\u00e7m\u0131\u015f gibi etkinlik ve etkileri \u00f6ne s\u00fcrerse, bu \u00fcr\u00fcn bir ila\u00e7 olarak kabul edilir.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Ve bir ila\u00e7 olarak kabul edildi\u011finde, ila\u00e7 olarak onay al\u0131nmad\u0131\u011f\u0131 s\u00fcrece, 68. maddeye g\u00f6re reklam \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;na ayk\u0131r\u0131 olur.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Yani, asl\u0131nda \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n d\u00fczenlemesine tabi olmayan bir \u00fcr\u00fcn bile, bir ila\u00e7m\u0131\u015f gibi etkinlik ve etkileri \u00f6ne s\u00fcren bir reklam yapmak, \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;na ayk\u0131r\u0131 olacakt\u0131r.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Ancak, &#8220;Sa\u011fl\u0131k Fonksiyonel G\u0131da Sistemi&#8221; (Japon Sa\u011fl\u0131k Fonksiyonel G\u0131da Sistemi) sayesinde, baz\u0131 g\u0131dalar\u0131n devlet taraf\u0131ndan onaylanan fonksiyonlar\u0131n\u0131 g\u00f6stermelerine izin verilir. &#8220;Sa\u011fl\u0131k Fonksiyonel G\u0131dalar&#8221; aras\u0131nda, \u2460Fonksiyonel G\u0131dalar, \u2461Besin Fonksiyonel G\u0131dalar, \u2462Belirli Sa\u011fl\u0131k G\u0131dalar\u0131 bulunmaktad\u0131r.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>\u00d6rne\u011fin, besin bile\u015feninin ad\u0131 potasyum olan bir Besin Fonksiyonel G\u0131das\u0131, &#8220;Potasyum, normal kan bas\u0131nc\u0131n\u0131 korumak i\u00e7in gereken bir besin maddesidir&#8221; etkisini g\u00f6sterebilir.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Referans: T\u00fcketici Ajans\u0131 &#8220;Sa\u011fl\u0131k ve Beslenme ile \u0130lgili G\u0131da Etiketleme Sistemleri&#8221;<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Ayr\u0131ca, g\u0131da \u00fcr\u00fcnleri i\u00e7in Sa\u011fl\u0131k Geli\u015ftirme Yasas\u0131 (Japon Sa\u011fl\u0131k Geli\u015ftirme Yasas\u0131) uygulanmaktad\u0131r. Bu yasan\u0131n 65. maddesinin 1. f\u0131kras\u0131, g\u0131da \u00fcr\u00fcnleri hakk\u0131nda yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 ifadeler kullanmay\u0131 yasaklar.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>G\u0131da reklamlar\u0131 yaparken, \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;na ek olarak, Sa\u011fl\u0131k Geli\u015ftirme Yasas\u0131&#8217;na da ayk\u0131r\u0131 olmamaya dikkat etmek gereklidir.<\/p>\n<p><!-- \/wp:paragraph --><br \/><!-- wp:heading --><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99na_Japanese_Pharmaceutical_and_Medical_Device_Act_Aykiri_Davranisin_Cezalari_ve_Tutuklama_Sartlari\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Davran\u0131\u015f\u0131n Cezalar\u0131 ve Tutuklama \u015eartlar\u0131<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><!-- \/wp:heading --><\/p>\n<p><!-- wp:image {\"id\":50197,\"sizeSlug\":\"full\",\"linkDestination\":\"none\"} --><\/p>\n<p><!-- \/wp:image --><\/p>\n<p><!-- wp:heading {\"level\":3} --><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Cezalar\"><\/span>Cezalar<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><!-- \/wp:heading --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Gerekli izin al\u0131nmadan ila\u00e7 sat\u0131\u015f\u0131 yap\u0131lmas\u0131 (24. Madde ihlali) veya onaylanmam\u0131\u015f ila\u00e7lar\u0131n sat\u0131\u015f\u0131 (55. Madde 2. F\u0131kra ihlali) durumunda, 3 y\u0131la kadar hapis cezas\u0131 ve\/veya 3 milyon yen&#8217;e kadar para cezas\u0131 uygulanabilir (84. Madde 9. ve 18. F\u0131kra).<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Peki ya reklam d\u00fczenlemelerine ayk\u0131r\u0131 davran\u0131ld\u0131\u011f\u0131nda ne olur? \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na g\u00f6re reklam d\u00fczenlemelerine ayk\u0131r\u0131 davran\u0131lmas\u0131 durumunda, 2 y\u0131la kadar hapis cezas\u0131 ve\/veya 2 milyon yen&#8217;e kadar para cezas\u0131 uygulanabilir (85. Madde 4. ve 5. F\u0131kra).<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Ayr\u0131ca, Reiwa 1 y\u0131l\u0131nda (2019) \u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda yap\u0131lan de\u011fi\u015fiklikle idari para cezas\u0131 sistemi getirilmi\u015ftir.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Bu nedenle, yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 reklam yap\u0131ld\u0131\u011f\u0131nda (66. Madde 1. F\u0131kra ihlali), y\u00fcksek miktarda idari para cezas\u0131 (ihlal edilen d\u00f6nemin sat\u0131\u015flar\u0131 \u00fczerinden hesaplanan %4.5&#8217;lik bir miktar) uygulanabilir.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Referans: <a title=\"\u0130la\u00e7 Makinesi Yasas\u0131'n\u0131n \u0130dari Para Cezas\u0131 Sistemi Nedir? Hedef Al\u0131nan Eylemler ve \u0130ndirim Uygulanan Durumlar\" href=\"https:\/\/monolith.law\/corporate\/pharmaceuticals-law-surcharge\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n \u0130dari Para Cezas\u0131 Sistemi Nedir? Hedef Al\u0131nan Eylemler ve \u0130ndirim Uygulanan Durumlar[ja]<\/a><\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Di\u011fer yandan, sat\u0131\u015f d\u00fczenlemelerine veya reklam d\u00fczenlemelerine ayk\u0131r\u0131 davran\u0131ld\u0131\u011f\u0131nda, i\u015flemi durdurma emri veya i\u015fletme izninin iptali gibi idari yapt\u0131r\u0131mlar uygulanabilir.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:heading {\"level\":3} --><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Tutuklama_Sartlari\"><\/span>Tutuklama \u015eartlar\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><!-- \/wp:heading --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Peki, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenlemelerine ayk\u0131r\u0131 davran\u0131ld\u0131\u011f\u0131nda tutuklanma olas\u0131l\u0131\u011f\u0131 var m\u0131d\u0131r?<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Tutuklama \u015fartlar\u0131, tutuklama sebebi ve tutuklaman\u0131n gereklili\u011fi olmak \u00fczere iki unsura dayan\u0131r. Tutuklama sebebi, basit\u00e7e ifade etmek gerekirse, cezai yapt\u0131r\u0131m\u0131n hedefi olan bir eylemin varl\u0131\u011f\u0131d\u0131r.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Tutuklaman\u0131n gereklili\u011fi, ka\u00e7ma riski gibi durumlar\u0131 i\u00e7erir, ancak genellikle tutuklaman\u0131n gereksiz oldu\u011funa karar verilmez.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Daha \u00f6nce de belirtildi\u011fi gibi, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na g\u00f6re sat\u0131\u015f d\u00fczenlemelerine ve reklam d\u00fczenlemelerine ayk\u0131r\u0131 davranmak cezai yapt\u0131r\u0131m\u0131n hedefi olabilir. Bu nedenle, bu d\u00fczenlemelere ayk\u0131r\u0131 davran\u0131ld\u0131\u011f\u0131nda, tutuklama sebebi oldu\u011fu i\u00e7in tutuklanma olas\u0131l\u0131\u011f\u0131 vard\u0131r.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>\u00d6zellikle reklam d\u00fczenlemeleri, &#8220;herkesi&#8221; kapsayan d\u00fczenlemelerdir. Bu nedenle, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 bir reklam yay\u0131nlad\u0131\u011f\u0131n\u0131zda, reklamla ilgili herhangi bir ki\u015fi, su\u00e7 olu\u015ftu\u011fu i\u00e7in tutuklanabilir.<\/p>\n<p><!-- \/wp:paragraph --><br \/><!-- wp:heading --><\/p>\n<h2><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<p><!-- \/wp:heading --><\/p>\n<p><!-- wp:image {\"id\":50199,\"sizeSlug\":\"full\",\"linkDestination\":\"none\"} --><\/p>\n<p><!-- \/wp:image --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 ihlallerinden ka\u00e7\u0131nma noktalar\u0131, genellikle a\u015fa\u011f\u0131daki iki ana noktada toplanmaktad\u0131r:<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:list --><\/p>\n<ul>\n<li style=\"list-style-type: none\">\n<ul><!-- wp:list-item -->\n<li>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n maddelerini, y\u00f6netmelikler, k\u0131lavuzlar, bildirimler, yarg\u0131 kararlar\u0131 ve idari y\u00f6nlendirmeler gibi sadece yasa metnini de\u011fil, ayn\u0131 zamanda ilgili t\u00fcm belgeleri dikkatlice inceleyerek ve \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n kurallar\u0131n\u0131 do\u011fru bir \u015fekilde anlayarak<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --><!-- wp:list-item --><\/p>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li>Bu bilgileri \u015firket i\u00e7inde payla\u015farak ve risk y\u00f6netimi sistemini tam anlam\u0131yla olu\u015fturarak<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- \/wp:list --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Yine de, \u0130la\u00e7 Makinesi Yasas\u0131 ile ilgili y\u00f6netmelikler ve yarg\u0131 kararlar\u0131 gibi belgeler geni\u015f bir yelpazeyi kapsar ve t\u00fcm\u00fcn\u00fc anlamak olduk\u00e7a zordur.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>\u00d6zellikle, \u0130la\u00e7 Makinesi Yasas\u0131 ile ilk kez kar\u015f\u0131la\u015fanlar i\u00e7in, kurallar\u0131 yanl\u0131\u015f anlama olas\u0131l\u0131\u011f\u0131 y\u00fcksektir. Reklam ifadelerinin veya s\u00f6zle\u015fme i\u00e7eriklerinin hukuki kontrol\u00fcn\u00fc bir avukata b\u0131rakarak hem zaman hem de emek tasarrufu sa\u011flanabilir.<\/p>\n<p><!-- \/wp:paragraph --><br \/><!-- wp:heading --><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Ozet_Ilac_ve_Tibbi_Cihaz_Kanunu%E2%80%99na_Japanese_Pharmaceutical_and_Medical_Device_Act_Aykirilik_Endisesi_Yasiyorsaniz_Bir_Avukata_Danisin\"><\/span>\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131l\u0131k Endi\u015fesi Ya\u015f\u0131yorsan\u0131z Bir Avukata Dan\u0131\u015f\u0131n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><!-- \/wp:heading --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Kanunu&#8217;nun (Japanese Pharmaceutical and Medical Device Act) d\u00fczenlemeleri geni\u015f bir alana yay\u0131lm\u0131\u015ft\u0131r ve fark\u0131nda olmadan bu kanuna ayk\u0131r\u0131 hareket edebilirsiniz. Kendi kendinize bu kanuna uyup uymad\u0131\u011f\u0131n\u0131z\u0131 belirlemek zor olabilir, bu y\u00fczden en ufak bir endi\u015feniz bile olsa, bu konuda uzman olan bir avukata dan\u0131\u015fman\u0131z\u0131 \u00f6neririz.<\/p>\n<p><!-- \/wp:paragraph --><br \/><!-- wp:heading --><\/p>\n<h2><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<p><!-- \/wp:heading --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Monolis Hukuk B\u00fcrosu, \u00f6zellikle IT ve hukuk alanlar\u0131nda y\u00fcksek uzmanl\u0131\u011fa sahip bir hukuk b\u00fcrosudur. 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<p><!-- \/wp:paragraph --><\/p>\n<figure class=\"is-type-wp-embed\">\n<div><a href=\"https:\/\/monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noopener\">https:\/\/monolith.law\/operationofmedia[ja]<\/a><\/div>\n<\/figure>","protected":false},"excerpt":{"rendered":"<p>\u0130la\u00e7lar gibi \u00fcr\u00fcnlerle u\u011fra\u015fan \u00fcretim \u015firketleri ve eczaneler gibi yerlerde, Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131 (JPMDL) kontrol\u00fc rutin olarak ger\u00e7ekle\u015ftirilir. Ancak, JPMDL&#8217;nin d\u00fczenlemeleri sa [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":64700,"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\/61315"}],"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=61315"}],"version-history":[{"count":4,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61315\/revisions"}],"predecessor-version":[{"id":64702,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61315\/revisions\/64702"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media\/64700"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media?parent=61315"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/categories?post=61315"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/tags?post=61315"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}