{"id":61747,"date":"2023-12-04T11:22:59","date_gmt":"2023-12-04T02:22:59","guid":{"rendered":"https:\/\/monolith.law\/tr\/?p=61747"},"modified":"2024-01-17T16:04:11","modified_gmt":"2024-01-17T07:04:11","slug":"quasi-drug-ads-regulation","status":"publish","type":"post","link":"https:\/\/monolith.law\/tr\/general-corporate\/quasi-drug-ads-regulation","title":{"rendered":"Farmas\u00f6tik Hukuku'nda (Japanese Pharmaceutical Affairs Law) \u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnlerin Tan\u0131m\u0131 Nedir? Reklamlarda \u0130fade Edilebilecek Etkinlik ve Etkiler Hakk\u0131nda"},"content":{"rendered":"\n<p>\u0130la\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerle ilgilenen \u00fcretici firmalar ve eczaneler gibi sat\u0131\u015f noktalar\u0131nda, Japon \u0130la\u00e7 Makinesi Yasas\u0131 (Pharmaceuticals and Medical Devices Act) kontrol\u00fc, g\u00fcnl\u00fck olarak ger\u00e7ekle\u015ftirilen risk y\u00f6netimi i\u015flemlerinden biridir. Ancak, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na g\u00f6re kabul edilebilir reklam g\u00f6sterim standartlar\u0131 belirsiz oldu\u011fu i\u00e7in bu konuda bir karar vermek zordur ve istemeden yasa d\u0131\u015f\u0131 durumlarla kar\u015f\u0131la\u015f\u0131labilmektedir.<\/p>\n\n\n\n<p>Bu makalede, bir avukat, istemeden Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131 ihlal etmeyi \u00f6nlemek i\u00e7in, ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerle ilgili ba\u015fvurular ve reklamlar a\u015famas\u0131nda talep edilen etkinlik ve etkilerin uygun ifadesi hakk\u0131nda a\u00e7\u0131klama yapacakt\u0131r.<\/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\/quasi-drug-ads-regulation\/#Ilac_Makinesi_Yasasi%E2%80%99na_Gore_Tibbi_Olmayan_Urunler_Nedir\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na G\u00f6re T\u0131bbi Olmayan \u00dcr\u00fcnler Nedir?\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na G\u00f6re T\u0131bbi Olmayan \u00dcr\u00fcnler Nedir?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/quasi-drug-ads-regulation\/#Ilac_Disi_Urunlerde_Ifade_Edilebilecek_Etkinlik_ve_Etkiler_Hakkinda\" title=\"\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnlerde \u0130fade Edilebilecek Etkinlik ve Etkiler Hakk\u0131nda\">\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnlerde \u0130fade Edilebilecek Etkinlik ve Etkiler Hakk\u0131nda<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/quasi-drug-ads-regulation\/#Genel_Kozmetikler_ve_Ilacli_Kozmetiklerde_Farkli_Etki_ve_Faydalarin_Ifadesi\" title=\"Genel Kozmetikler ve \u0130la\u00e7l\u0131 Kozmetiklerde Farkl\u0131 Etki ve Faydalar\u0131n \u0130fadesi\">Genel Kozmetikler ve \u0130la\u00e7l\u0131 Kozmetiklerde Farkl\u0131 Etki ve Faydalar\u0131n \u0130fadesi<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/quasi-drug-ads-regulation\/#Ilac_Makinesi_Yasasi_Ihlali_Olabilecek_Ifadelerin_Ornekleri\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlali Olabilecek \u0130fadelerin \u00d6rnekleri\">\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlali Olabilecek \u0130fadelerin \u00d6rnekleri<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/quasi-drug-ads-regulation\/#Ozet_Ilac_ve_Tibbi_Cihaz_Yasasi%E2%80%99nin_Hukuki_Kontrolu_Icin_Avukata_Basvurun\" title=\"\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n Hukuki Kontrol\u00fc \u0130\u00e7in Avukata Ba\u015fvurun\">\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n Hukuki Kontrol\u00fc \u0130\u00e7in Avukata Ba\u015fvurun<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/quasi-drug-ads-regulation\/#Buromuzun_Sundugu_Cozumler\" title=\"B\u00fcromuzun Sundu\u011fu \u00c7\u00f6z\u00fcmler\">B\u00fcromuzun Sundu\u011fu \u00c7\u00f6z\u00fcmler<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99na_Gore_Tibbi_Olmayan_Urunler_Nedir\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na G\u00f6re T\u0131bbi Olmayan \u00dcr\u00fcnler Nedir?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 (Japon \u0130la\u00e7, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenli\u011fi Hakk\u0131nda Kanun) Madde 2, F\u0131kra 2, &#8216;t\u0131bbi olmayan \u00fcr\u00fcnler&#8217; kavram\u0131n\u0131 a\u015fa\u011f\u0131daki gibi tan\u0131mlar:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Bu yasaya g\u00f6re &#8216;t\u0131bbi olmayan \u00fcr\u00fcnler&#8217;, a\u015fa\u011f\u0131da belirtilen maddeleri ve insan v\u00fccuduna olan etkileri hafif olanlar\u0131 ifade eder.<\/p>\n\n\n\n<p>1. A\u015fa\u011f\u0131daki (a) &#8211; (c) maddelerinde belirtilen ama\u00e7lar i\u00e7in kullan\u0131lan ve mekanik aletler vb. olmayan maddeler (bu kullan\u0131m ama\u00e7lar\u0131na ek olarak, ayn\u0131 zamanda \u00f6nceki f\u0131kran\u0131n ikinci veya \u00fc\u00e7\u00fcnc\u00fc maddesinde belirtilen ama\u00e7lar i\u00e7in kullan\u0131lanlar\u0131 hari\u00e7 tutar.)<\/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 d\u00f6kme<\/p>\n\n\n\n<p>2. \u0130nsan veya hayvan sa\u011fl\u0131\u011f\u0131 i\u00e7in, fareler, sinekler, sivrisinekler, bitler ve bunlar gibi canl\u0131lar\u0131n kontrol\u00fc amac\u0131yla kullan\u0131lan ve mekanik aletler vb. olmayan maddeler (bu kullan\u0131m ama\u00e7lar\u0131na ek olarak, ayn\u0131 zamanda \u00f6nceki f\u0131kran\u0131n ikinci veya \u00fc\u00e7\u00fcnc\u00fc maddesinde belirtilen ama\u00e7lar i\u00e7in kullan\u0131lanlar\u0131 hari\u00e7 tutar.)<\/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 ve (\u00f6nceki iki maddeyi hari\u00e7 tutan) Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 taraf\u0131ndan belirlenen maddeler.<\/p>\n<\/blockquote>\n\n\n\n<p>Yani, &#8216;t\u0131bbi olmayan \u00fcr\u00fcnler&#8217;, insan v\u00fccuduna olan etkileri a\u00e7\u0131s\u0131ndan &#8216;ila\u00e7lar&#8217; ve &#8216;kozmetikler&#8217; aras\u0131nda yer al\u0131r ve &#8216;ila\u00e7lara&#8217; k\u0131yasla insan v\u00fccuduna olan etkileri daha hafiftir. \u00d6rne\u011fin, t\u0131bbi kozmetikler, beslenme i\u00e7ecekleri, sa\u00e7 boyalar\u0131, t\u0131bbi di\u015f macunlar\u0131, ter \u00f6nleyici spreyler, sa\u00e7 b\u00fcy\u00fcme \u00fcr\u00fcnleri, b\u00f6cek \u00f6ld\u00fcr\u00fcc\u00fcler vb. &#8216;t\u0131bbi olmayan \u00fcr\u00fcnler&#8217; kapsam\u0131na girer.<\/p>\n\n\n\n<p>Not: Heisei 11 (1999) y\u0131l\u0131nda &#8216;\u0130la\u00e7 Uygulama Y\u00f6netmeli\u011fi&#8217; de\u011fi\u015fikli\u011fi ile &#8216;ila\u00e7lar&#8217; kategorisinden yeni &#8216;t\u0131bbi olmayan \u00fcr\u00fcnler&#8217; kategorisine ge\u00e7i\u015f yapan \u00fcr\u00fcnler &#8216;yeni belirlenmi\u015f t\u0131bbi olmayan \u00fcr\u00fcnler&#8217;, Heisei 16 (2004) y\u0131l\u0131ndaki de\u011fi\u015fiklikle ge\u00e7i\u015f yapanlar &#8216;yeni kapsam t\u0131bbi olmayan \u00fcr\u00fcnler&#8217; olarak adland\u0131r\u0131l\u0131r ve bunlar yukar\u0131daki \u0130la\u00e7 Makinesi Yasas\u0131 Madde 2, F\u0131kra 2, Madde 3&#8217;te belirtilen &#8216;belirlenmi\u015f t\u0131bbi olmayan \u00fcr\u00fcnler&#8217; kapsam\u0131na girer.<\/p>\n\n\n\n<p>&#8216;T\u0131bbi olmayan \u00fcr\u00fcnler&#8217;, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 taraf\u0131ndan belirlenen ve onaylanan etkin maddeleri belirli bir konsantrasyonda i\u00e7erir ve &#8216;tedavi&#8217; yerine genellikle &#8216;\u00f6nleme&#8217; amac\u0131yla \u00fcretilir. Ayr\u0131ca, &#8216;t\u0131bbi&#8217; ifadesi, ila\u00e7lardan daha hafif etkisi olan &#8216;t\u0131bbi olmayan \u00fcr\u00fcnler&#8217; i\u00e7in kabul edilir, bu nedenle &#8216;t\u0131bbi = t\u0131bbi olmayan \u00fcr\u00fcn&#8217; anlam\u0131na gelir.<\/p>\n\n\n\n<p>Ba\u011f\u0131ms\u0131z \u0130dari Kurulu\u015f \u0130la\u00e7 ve T\u0131bbi Cihaz Ajans\u0131 (PMDA), &#8216;t\u0131bbi olmayan \u00fcr\u00fcnler&#8217; kavram\u0131n\u0131n tan\u0131m\u0131n\u0131 ve \u00f6zelliklerini a\u015fa\u011f\u0131daki gibi a\u00e7\u0131klar:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>1. \u0130nsan v\u00fccuduna olan etkisi hafiftir. (\u0130la\u00e7 Makinesi Yasas\u0131 Madde 2, F\u0131kra 2)<\/p>\n\n\n\n<p>2. \u0130la\u00e7 de\u011fildir. (\u0130la\u00e7 Makinesi Yasas\u0131 Madde 2, F\u0131kra 1 ve F\u0131kra 2, Showa 37, 6 Eyl\u00fcl \u0130la\u00e7 Duyurusu No. 464 ve di\u011ferleri)<\/p>\n\n\n\n<p> \u2460 \u0130\u00e7erik ve miktar veya \u00f6z, t\u0131bbi olmayan \u00fcr\u00fcnler olarak kabul edilen kapsam\u0131 a\u015fanlar, etkinlik veya etkilerine bak\u0131lmaks\u0131z\u0131n, ila\u00e7 olarak ele al\u0131n\u0131r.<\/p>\n\n\n\n<p> \u2461 \u0130\u00e7erik ve miktar veya \u00f6z, t\u0131bbi olmayan \u00fcr\u00fcnler olarak kabul edilen kapsam dahilinde olanlar, ancak etkinlik veya etkileri veya kullan\u0131m \u015fekli ve dozu, t\u0131bbi olmayan \u00fcr\u00fcnler olarak kabul edilen kapsam\u0131 a\u015fanlar, ila\u00e7 olarak ele al\u0131n\u0131r.<\/p>\n\n\n\n<p>3. \u0130lgili \u00fcr\u00fcn\u00fcn a\u015fa\u011f\u0131dakilerden biri olmamas\u0131 gerekmektedir. (Showa 37, 6 Eyl\u00fcl \u0130la\u00e7 Duyurusu No. 464)<\/p>\n\n\n\n<p> a. Zehirli veya g\u00fc\u00e7l\u00fc ila\u00e7lara denk gelenler<\/p>\n\n\n\n<p> b. Saf \u00fcr\u00fcnler<\/p>\n\n\n\n<p>4. Ana kullan\u0131m amac\u0131 &#8220;\u00f6nleme&#8221;dir. (Showa 37, 6 Eyl\u00fcl \u0130la\u00e7 Duyurusu No. 464 ve di\u011ferleri)<\/p>\n\n\n\n<p> \u203b Yeni belirlenmi\u015f t\u0131bbi olmayan \u00fcr\u00fcnler ve yeni kapsam t\u0131bbi olmayan \u00fcr\u00fcnler i\u00e7in, ilgili duyurulara bak\u0131n\u0131z.<\/p>\n\n\n\n<p>5. G\u00fcnl\u00fck olarak s\u00fcrekli kullan\u0131m\u0131 \u00f6ng\u00f6r\u00fclen bir \u00fcr\u00fcnd\u00fcr.<\/p>\n\n\n\n<p>6. \u0130lkeler gere\u011fi, doktorlar veya eczac\u0131lar gibi sa\u011fl\u0131k profesyonellerinin denetimi alt\u0131nda kullan\u0131lmas\u0131 \u00f6ng\u00f6r\u00fclen bir \u00fcr\u00fcn de\u011fildir.<\/p>\n<cite><a href=\"https:\/\/www.pmda.go.jp\/files\/000245219.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;T\u0131bbi Olmayan \u00dcr\u00fcnlerin Onay Ba\u015fvurusunda Temel Dikkat Edilmesi Gereken Hususlar (Reiwa 3 Y\u0131l\u0131 Versiyonu)&#8221; [ja]<\/a><\/cite><\/blockquote>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na g\u00f6re ila\u00e7lar vb. s\u0131n\u0131fland\u0131rma kriterleri hakk\u0131nda daha ayr\u0131nt\u0131l\u0131 bilgi a\u015fa\u011f\u0131daki makalede bulunabilir.<\/p>\n\n\n\n<p>Referans Makale: <a href=\"https:\/\/monolith.law\/corporate\/pharmaceuticals-law\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;\u0130la\u00e7 Makinesi Yasas\u0131 (Eski \u0130la\u00e7 Yasas\u0131) Nedir? Ama\u00e7, D\u00fczenlenen Konular ve Reklam D\u00fczenlemeleri&#8221; [ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Disi_Urunlerde_Ifade_Edilebilecek_Etkinlik_ve_Etkiler_Hakkinda\"><\/span>\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnlerde \u0130fade Edilebilecek Etkinlik ve Etkiler Hakk\u0131nda<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2019\/03\/shutterstock_78062205702-1-1024x614.jpg\" alt=\"\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnlerde \u0130fade Edilebilecek Etkinlik ve Etkiler Hakk\u0131nda\" class=\"wp-image-233\" \/><\/figure>\n\n\n\n<p>&#8220;\u0130la\u00e7 D\u0131\u015f\u0131 \u00dcr\u00fcnler&#8221; durumunda, Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 taraf\u0131ndan, ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerin t\u00fcr\u00fcne g\u00f6re ifade edilebilecek etkinlik ve etkilerin kapsam\u0131 belirlenmi\u015ftir ve bu kapsam\u0131n d\u0131\u015f\u0131na \u00e7\u0131kan reklamlar, Japon \u0130la\u00e7 Makineleri Yasas\u0131&#8217;na (Pharmaceuticals and Medical Devices Act) ayk\u0131r\u0131 olacakt\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Genel_Kozmetikler_ve_Ilacli_Kozmetiklerde_Farkli_Etki_ve_Faydalarin_Ifadesi\"><\/span>Genel Kozmetikler ve \u0130la\u00e7l\u0131 Kozmetiklerde Farkl\u0131 Etki ve Faydalar\u0131n \u0130fadesi<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Daha \u00f6nce de belirtti\u011fimiz gibi, ila\u00e7l\u0131 kozmetikler olan &#8216;Japon Sa\u011fl\u0131k, \u0130\u015f\u00e7ilik ve Refah Bakanl\u0131\u011f\u0131&#8217; taraf\u0131ndan belirlenen etkin maddelerin etki ve faydalar\u0131na ek olarak, genel kozmetiklerde g\u00f6sterilebilecek 56 etki ve fayday\u0131 da ifade edebilir. Bu nedenle, genel kozmetiklere g\u00f6re daha etkili reklam ve tan\u0131t\u0131mlar yapabilirsiniz.<\/p>\n\n\n\n<p class=\"has-text-align-center\">\u3010Genel Kozmetikler ve \u0130la\u00e7l\u0131 Kozmetikler Aras\u0131ndaki Farklar\u3011<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\"><\/td><td class=\"has-text-align-center\" data-align=\"center\">Genel Kozmetikler<\/td><td class=\"has-text-align-center\" data-align=\"center\">\u0130la\u00e7l\u0131 Kozmetikler<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Etki ve Faydalar\u0131n Kapsam\u0131<\/td><td class=\"has-text-align-center\" data-align=\"center\">Sa\u011fl\u0131k, \u0130\u015f\u00e7ilik ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n belirledi\u011fi 56 etki<\/td><td class=\"has-text-align-center\" data-align=\"center\">Onaylanan etkiler + Genel Kozmetiklerin etkileri<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Etkin Madde \u0130\u00e7eri\u011fi<\/td><td class=\"has-text-align-center\" data-align=\"center\">Yok<\/td><td class=\"has-text-align-center\" data-align=\"center\">Var<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u0130la\u00e7l\u0131 kozmetiklerin, genel kozmetiklerin etki ve faydalar\u0131n\u0131 (Sa\u011fl\u0131k, \u0130\u015f\u00e7ilik ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n belirledi\u011fi 56 etki ve fayda) ifade ederken dikkat etmesi gereken \u00fc\u00e7 nokta a\u015fa\u011f\u0131daki gibidir:<\/p>\n\n\n\n<ol>\n<li>\u0130la\u00e7l\u0131 kozmeti\u011fin as\u0131l amac\u0131n\u0131n gizlenmemesi ve kozmetik oldu\u011fu yan\u0131lg\u0131s\u0131na yol a\u00e7mamas\u0131 gerekmektedir.<\/li>\n\n\n\n<li>Kozmetik ama\u00e7l\u0131 kullan\u0131m ve uygulama durumunda sa\u011fl\u0131k ve hijyen sorunlar\u0131na yol a\u00e7abilecek \u00fcr\u00fcnler (antiseptik i\u00e7eren \u015fampuanlar veya ila\u00e7l\u0131 sabunlar gibi) olmamal\u0131d\u0131r.<\/li>\n\n\n\n<li>Belirli bir etki veya faydan\u0131n, ila\u00e7l\u0131 kozmeti\u011fin etki ve faydas\u0131 olarak onayland\u0131\u011f\u0131 yan\u0131lg\u0131s\u0131na yol a\u00e7mamal\u0131d\u0131r.<\/li>\n<\/ol>\n\n\n\n<p>\u0130la\u00e7l\u0131 kozmetikler dahil olmak \u00fczere, ila\u00e7l\u0131 \u00fcr\u00fcnlerin reklamlar\u0131ndaki etki ve faydalar\u0131n ifadesinin, &#8216;Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;na (JPMDL) ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131na dair ayr\u0131nt\u0131l\u0131 de\u011ferlendirme kriterleri i\u00e7in, Sa\u011fl\u0131k, \u0130\u015f\u00e7ilik ve Refah Bakanl\u0131\u011f\u0131&#8217;n\u0131n <a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179263.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;\u0130la\u00e7lar ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam Standartlar\u0131na Dair A\u00e7\u0131klama ve Dikkat Edilmesi Gerekenler&#8221; [ja]<\/a> ve Japonya Kozmetik Sanayi Derne\u011fi&#8217;nin <a href=\"https:\/\/www.jcia.org\/user\/common\/download\/business\/advertising\/JCIA20200615_ADguide.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;Kozmetik ve Di\u011fer \u00dcr\u00fcnlerin Uygun Reklam K\u0131lavuzu&#8221; [ja]<\/a>na ba\u015fvurabilirsiniz.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi_Ihlali_Olabilecek_Ifadelerin_Ornekleri\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlali Olabilecek \u0130fadelerin \u00d6rnekleri<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>&#8220;Anti-Aging&#8221; ifadesi, \u0130la\u00e7 Makinesi Yasas\u0131 ve t\u0131bbi reklamlarla ilgili d\u00fczenlemelere ayk\u0131r\u0131 olabilecek anahtar kelimeler aras\u0131nda s\u0131k\u00e7a bilinir.<\/p>\n\n\n\n<p>Anti-Aging (\u0130ngilizce: <em>Anti-Aging<\/em>), &#8220;ya\u015flanma belirtilerinin \u00f6nlenmesi ve tedavisi, ya\u015flanmay\u0131 \u00f6nleme, anti-aging, anti-aging&#8221; anlam\u0131na gelen bir terimdir.<\/p>\n\n\n\n<p>Japonya Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131, <a href=\"https:\/\/www.mhlw.go.jp\/content\/10800000\/000927804.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;T\u0131bbi Reklam K\u0131lavuzu&#8221; [ja]<\/a> (Heisei 30 y\u0131l\u0131 (2018 y\u0131l\u0131) 8 May\u0131s tarihinde yay\u0131nlanm\u0131\u015ft\u0131r) i\u00e7erisinde &#8220;Anti-Aging&#8221; ifadesi hakk\u0131nda a\u015fa\u011f\u0131daki g\u00f6r\u00fc\u015f\u00fc belirtmi\u015ftir:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Anti-Aging klinikleri veya sadece Anti-Aging, bir t\u0131bbi b\u00f6l\u00fcm ad\u0131 olarak kabul edilmez ve ayr\u0131ca, kamu sa\u011fl\u0131k sigortas\u0131 kapsam\u0131nda veya \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 kapsam\u0131nda onaylanm\u0131\u015f ila\u00e7larla tedavi i\u00e7eri\u011fi de\u011fildir ve reklam olarak kabul edilmez.<\/p>\n<\/blockquote>\n\n\n\n<p>Ayr\u0131ca, Heisei 30 y\u0131l\u0131 Aral\u0131k ay\u0131nda ger\u00e7ekle\u015ftirilen <a href=\"https:\/\/www8.cao.go.jp\/kisei-kaikaku\/suishin\/meeting\/wg\/iryou\/20181220\/gijiroku1220.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;4. T\u0131bbi ve Bak\u0131m \u00c7al\u0131\u015fma Grubu Toplant\u0131 \u00d6zeti&#8221; [ja]<\/a>nda a\u015fa\u011f\u0131daki ifade yer almaktad\u0131r (bir k\u0131sm\u0131, i\u00e7eri\u011fe uygun olarak orijinal metinden de\u011fi\u015ftirilmi\u015ftir):<\/p>\n\n\n\n<p><em>&#8220;Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131, Anti-Aging ifadesine kar\u015f\u0131 tamamen olumsuz bir tutum sergilemiyor, sadece Anti-Aging oldu\u011funu belirterek \u00e7ekici hale getirme \u00e7abalar\u0131 genellikle kabul edilemez. Ancak, belirli ko\u015fullar\u0131 kar\u015f\u0131layan durumlar i\u00e7in, &#8220;reklam yap\u0131labilir konular&#8221; d\u0131\u015f\u0131ndaki konular hakk\u0131nda da bilgi sa\u011flanabilir.&#8221; <\/em><\/p>\n\n\n\n<p>Bunlar\u0131 g\u00f6z \u00f6n\u00fcnde bulundurdu\u011fumuzda, t\u0131bbi reklamlarda &#8220;Anti-Aging&#8221; ifadesinin kullan\u0131m\u0131 genellikle kabul edilemez, ancak T\u0131bbi Reklam K\u0131lavuzu&#8217;ndaki belirli kriterleri kar\u015f\u0131lad\u0131\u011f\u0131nda, t\u0131bbi uygulaman\u0131n i\u00e7eri\u011fini a\u00e7\u0131klamak amac\u0131yla, istisnai olarak kabul edilebilir. Ayr\u0131ca, &#8220;Anti-Aging&#8221;, ila\u00e7 etkisi ifade eden bir ifade oldu\u011fu i\u00e7in, ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerin reklamlar\u0131nda kullan\u0131lamaz.<\/p>\n\n\n\n<p>\u00d6te yandan, benzer ifadeler aras\u0131nda &#8220;Aging Care&#8221; ve &#8220;Aging Measures&#8221; bulunur, ancak bunlar &#8220;Anti-Aging&#8221;den farkl\u0131 olarak, t\u0131bbi uygulama ve ila\u00e7 etkisi ifade etmezler. Bu nedenle, onaylanm\u0131\u015f etkiler dahilinde, ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerde de kullan\u0131labilir.<\/p>\n\n\n\n<p>&#8220;Aging Care&#8221;, ya\u015fa uygun kozmetik vb. bak\u0131m\u0131 ifade eder. \u0130la\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerin reklamlar\u0131nda, hastal\u0131\u011f\u0131n &#8220;tedavisi&#8221; veya &#8220;iyile\u015ftirilmesi&#8221; gibi ila\u00e7 etkilerini ama\u00e7layan &#8220;Aging Care&#8221; ifadesini kullanamazs\u0131n\u0131z. \u00d6nceki ve sonraki ba\u011flam\u0131 g\u00f6z \u00f6n\u00fcnde bulundurarak, &#8220;ya\u015fa uygun cilt durumu bak\u0131m\u0131&#8221; anlam\u0131na geldi\u011fi yorumlanabilir durumlarda, kullan\u0131m\u0131na izin verilir.<\/p>\n\n\n\n<p>Bu \u015fekilde, &#8220;Anti-Aging&#8221;, t\u0131bbi uygulama ve ila\u00e7 etkisi ifade ederken, &#8220;Aging Care&#8221;, sadece &#8220;mevcut duruma uygun bak\u0131m&#8221; anlam\u0131na gelir ve bu nedenle kozmetik ve ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerle daha uyumlu oldu\u011funu s\u00f6yleyebiliriz.<\/p>\n\n\n\n<p>Ayr\u0131ca, &#8220;Beyazlatma&#8221; ve &#8220;Beyazlatma&#8221; ifadeleri de, belirli kurallara uygun olarak kullan\u0131ld\u0131\u011f\u0131nda, kullan\u0131labilir olabilir.<\/p>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 d\u00fczenlemeleri \u00e7er\u00e7evesinde, her ifadenin somut kullan\u0131m \u00f6rnekleri i\u00e7in, l\u00fctfen <a href=\"https:\/\/www.jcia.org\/user\/common\/download\/business\/advertising\/JCIA20200615_ADguide.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;Kozmetik ve Di\u011fer Uygun Reklam K\u0131lavuzu&#8221; [ja]<\/a>n\u0131 inceleyin.<\/p>\n\n\n\n<p>Referans makale: <a href=\"https:\/\/monolith.law\/corporate\/cosmetics-healthy-food-advertisement\" target=\"_blank\" rel=\"noreferrer noopener\">Kozmetik ve Sa\u011fl\u0131kl\u0131 G\u0131da Reklamlar\u0131nda Dikkat Edilmesi Gerekenler [ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ozet_Ilac_ve_Tibbi_Cihaz_Yasasi%E2%80%99nin_Hukuki_Kontrolu_Icin_Avukata_Basvurun\"><\/span>\u00d6zet: \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n Hukuki Kontrol\u00fc \u0130\u00e7in Avukata Ba\u015fvurun<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Reiwa&#8217;n\u0131n ilk y\u0131l\u0131nda (2019), \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;nda yap\u0131lan de\u011fi\u015fikliklerle, ila\u00e7lar ve benzeri \u00fcr\u00fcnlerin reklam d\u00fczenlemeleri kapsam\u0131nda, idari para cezas\u0131 sistemi kurulmu\u015f ve \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n reklam d\u00fczenlemelerine ayk\u0131r\u0131l\u0131klar daha a\u011f\u0131r cezaland\u0131r\u0131lmaya ba\u015flanm\u0131\u015ft\u0131r. \u0130la\u00e7lar ve benzeri \u00fcr\u00fcnlerin reklam y\u00f6nergeleri her y\u0131l g\u00fcncellenmekte olup, ila\u00e7 ve benzeri \u00fcr\u00fcnlerin reklamlar\u0131n\u0131n i\u015fletilmesi veya incelenmesiyle ilgilenen i\u015fletmeler, reklam ajanslar\u0131 ve di\u011fer ilgili ki\u015filerin dikkatli bir yakla\u015f\u0131m sergilemeleri gerekmektedir.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n yorumlanmas\u0131 ve reklamlardaki ifadelerin uygun olup olmad\u0131\u011f\u0131 konusunda kendi karar\u0131n\u0131z\u0131 vermek zor olabilir, bu nedenle endi\u015feleriniz varsa, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n hukuki kontrol\u00fc konusunda deneyimli bir avukata dan\u0131\u015fman\u0131z\u0131 \u00f6neririz.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 ve benzeri yasalar\u0131n hukuki kontrol\u00fc ve ifade de\u011fi\u015fikliklerinin \u00f6nerilmesi, olduk\u00e7a uzmanl\u0131k gerektiren bir aland\u0131r. Monolis Hukuk B\u00fcrosu, \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 Hukuk Ekibi&#8217;ni olu\u015fturmu\u015f olup, g\u0131da takviyelerinden ila\u00e7lara kadar \u00e7e\u015fitli \u00fcr\u00fcnlerin makale kontrollerini ger\u00e7ekle\u015ftirmektedir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Buromuzun_Sundugu_Cozumler\"><\/span>B\u00fcromuzun Sundu\u011fu \u00c7\u00f6z\u00fcmler<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Monolith Hukuk B\u00fcrosu, \u00f6zellikle IT ve hukuk alanlar\u0131nda geni\u015f deneyime 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 \u00e7e\u015fitli kurulu\u015flara 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>Monolith Hukuk B\u00fcrosu&#8217;nun hizmet alanlar\u0131: <a href=\"https:\/\/monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noreferrer noopener\">Makale ve LP&#8217;nin \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 Kontrol\u00fc [ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u0130la\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnlerle ilgilenen \u00fcretici firmalar ve eczaneler gibi sat\u0131\u015f noktalar\u0131nda, Japon \u0130la\u00e7 Makinesi Yasas\u0131 (Pharmaceuticals and Medical Devices Act) kontrol\u00fc, g\u00fcnl\u00fck olarak ger\u00e7ekle\u015ftirilen risk  [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":62714,"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\/61747"}],"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=61747"}],"version-history":[{"count":2,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61747\/revisions"}],"predecessor-version":[{"id":62715,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61747\/revisions\/62715"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media\/62714"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media?parent=61747"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/categories?post=61747"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/tags?post=61747"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}