{"id":61305,"date":"2023-12-04T11:20:31","date_gmt":"2023-12-04T02:20:31","guid":{"rendered":"https:\/\/monolith.law\/tr\/?p=61305"},"modified":"2024-03-20T00:57:02","modified_gmt":"2024-03-19T15:57:02","slug":"pmd-act-administrative-action","status":"publish","type":"post","link":"https:\/\/monolith.law\/tr\/general-corporate\/pmd-act-administrative-action","title":{"rendered":"\u0130la\u00e7 Makinesi Yasas\u0131'n\u0131n (Japanese Pharmaceutical and Medical Device Act) \u0130hlali Sonucu Y\u00f6netimsel Yapt\u0131r\u0131mlar\u0131n Durumu Nedir? \u00d6rneklerle A\u00e7\u0131klama"},"content":{"rendered":"\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda (Japanese Pharmaceutical Affairs Law), daha \u00f6nce ila\u00e7 vb. \u00fcretim ve sat\u0131\u015f i\u015fletmelerine y\u00f6nelik i\u015f iyile\u015ftirme emirleri ve \u00fcretim sat\u0131\u015f onay\u0131n\u0131n iptali gibi idari yapt\u0131r\u0131mlar belirlenmi\u015fti. Ancak, Reiwa&#8217;n\u0131n ilk y\u0131l\u0131nda (2019) yap\u0131lan de\u011fi\u015fiklikle, yeni para cezas\u0131 sistemi gibi sistemler getirildi.<\/p>\n\n\n\n<p>Bu makalede, yeni sistemlere de de\u011finirken, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical Affairs Law) ayk\u0131r\u0131l\u0131klara y\u00f6nelik idari yan\u0131tlar ve somut \u00f6rnekler hakk\u0131nda a\u00e7\u0131klamalar yapaca\u011f\u0131z.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_53 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pmd-act-administrative-action\/#Idari_Tedbirlerin_Iki_Turu_ve_Japon_Ilac_Hukuku%E2%80%99ndaki_Japanese_Pharmaceutical_Affairs_Law_Durum\" title=\"\u0130dari Tedbirlerin \u0130ki T\u00fcr\u00fc ve Japon \u0130la\u00e7 Hukuku&#8217;ndaki (Japanese Pharmaceutical Affairs Law) Durum\">\u0130dari Tedbirlerin \u0130ki T\u00fcr\u00fc ve Japon \u0130la\u00e7 Hukuku&#8217;ndaki (Japanese Pharmaceutical Affairs Law) Durum<\/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\/pmd-act-administrative-action\/#Idarenin_bireylere_hukuki_haklar_ve_yukumlulukler_yaratmasi\" title=\"\u0130darenin, bireylere hukuki haklar ve y\u00fck\u00fcml\u00fcl\u00fckler yaratmas\u0131\">\u0130darenin, bireylere hukuki haklar ve y\u00fck\u00fcml\u00fcl\u00fckler yaratmas\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\/pmd-act-administrative-action\/#Bireylere_Yuklenen_Yukumluluklerin_Yerine_Getirilmesini_Saglama_Araclari\" title=\"Bireylere Y\u00fcklenen Y\u00fck\u00fcml\u00fcl\u00fcklerin Yerine Getirilmesini Sa\u011flama Ara\u00e7lar\u0131\">Bireylere Y\u00fcklenen Y\u00fck\u00fcml\u00fcl\u00fcklerin Yerine Getirilmesini Sa\u011flama Ara\u00e7lar\u0131<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pmd-act-administrative-action\/#Ilac_Makinesi_Yasasi%E2%80%99nin_Japanese_Pharmaceutical_Affairs_Law_Idari_Para_Cezasi_Sistemi_Nedir\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical Affairs Law) \u0130dari Para Cezas\u0131 Sistemi Nedir?\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical Affairs Law) \u0130dari Para Cezas\u0131 Sistemi Nedir?<\/a><\/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\/pmd-act-administrative-action\/#Ilac_Makinesi_Yasasi_Ihlalleri_Sonucu_Yonetimsel_Yaptirim_Ornekleri\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlalleri Sonucu Y\u00f6netimsel Yapt\u0131r\u0131m \u00d6rnekleri\">\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlalleri Sonucu Y\u00f6netimsel Yapt\u0131r\u0131m \u00d6rnekleri<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pmd-act-administrative-action\/#Ornek_1_Pfizer_Inc\" title=\"\u00d6rnek 1: Pfizer Inc.\">\u00d6rnek 1: Pfizer Inc.<\/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\/pmd-act-administrative-action\/#Ornek_2_Kansai_Medico_Co_Ltd\" title=\"\u00d6rnek 2: Kansai Medico Co., Ltd.\">\u00d6rnek 2: Kansai Medico Co., Ltd.<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pmd-act-administrative-action\/#Ilac_Makinesi_Yasasi%E2%80%99na_Japanese_Pharmaceutical_and_Medical_Device_Act_Aykiri_Olmamak_Icin_Alinmasi_Gereken_Onlemler\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Olmamak \u0130\u00e7in Al\u0131nmas\u0131 Gereken \u00d6nlemler\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Olmamak \u0130\u00e7in Al\u0131nmas\u0131 Gereken \u00d6nlemler<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pmd-act-administrative-action\/#Sirket_Ici_Yonergeleri_Belirlemek\" title=\"\u015eirket \u0130\u00e7i Y\u00f6nergeleri Belirlemek\">\u015eirket \u0130\u00e7i Y\u00f6nergeleri Belirlemek<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pmd-act-administrative-action\/#Bir_Avukata_Danismak\" title=\"Bir Avukata Dan\u0131\u015fmak\">Bir Avukata Dan\u0131\u015fmak<\/a><\/li><\/ul><\/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\/pmd-act-administrative-action\/#Sonuc_Ilac_Makinesi_Yasasi%E2%80%99nin_Hukuki_Kontrolu_Icin_Bir_Avukata_Danisin\" title=\"Sonu\u00e7: \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Hukuki Kontrol\u00fc \u0130\u00e7in Bir Avukata Dan\u0131\u015f\u0131n\">Sonu\u00e7: \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Hukuki Kontrol\u00fc \u0130\u00e7in Bir Avukata Dan\u0131\u015f\u0131n<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/pmd-act-administrative-action\/#Hukuk_Buromuzun_Sundugu_Cozumler\" title=\"Hukuk B\u00fcromuzun Sundu\u011fu \u00c7\u00f6z\u00fcmler\">Hukuk B\u00fcromuzun Sundu\u011fu \u00c7\u00f6z\u00fcmler<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Idari_Tedbirlerin_Iki_Turu_ve_Japon_Ilac_Hukuku%E2%80%99ndaki_Japanese_Pharmaceutical_Affairs_Law_Durum\"><\/span>\u0130dari Tedbirlerin \u0130ki T\u00fcr\u00fc ve Japon \u0130la\u00e7 Hukuku&#8217;ndaki (Japanese Pharmaceutical Affairs Law) Durum<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Japon \u0130la\u00e7 Hukuku, sa\u011fl\u0131k ve hijyenin geli\u015ftirilmesini hedefleyerek, ila\u00e7lar\u0131n kalitesi, etkinli\u011fi ve g\u00fcvenli\u011finin sa\u011flanmas\u0131 ve sa\u011fl\u0131k ve hijyenle ilgili zararlar\u0131n olu\u015fumunun ve yay\u0131lmas\u0131n\u0131n \u00f6nlenmesi i\u00e7in gerekli d\u00fczenlemeleri ve tedbirleri uygulamaktad\u0131r (Japon \u0130la\u00e7 Hukuku Madde 1).<\/p>\n\n\n\n<p>Bu tedbirler genel olarak, \u2460 idarenin, bireylere hukuki etki olarak haklar ve y\u00fck\u00fcml\u00fcl\u00fckler yaratmas\u0131 ve \u2461\u2460&#8217;in eylemi ile y\u00fcklenen y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn yerine getirilmesini sa\u011flama ara\u00e7lar\u0131 olmak \u00fczere ikiye ayr\u0131l\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Idarenin_bireylere_hukuki_haklar_ve_yukumlulukler_yaratmasi\"><\/span>\u0130darenin, bireylere hukuki haklar ve y\u00fck\u00fcml\u00fcl\u00fckler yaratmas\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Bu eylem, daha da ayr\u0131nt\u0131l\u0131 olarak, bireylere eylem veya eylemsizlik emretme &#8220;emir eylemi&#8221;, bireylere hukuki durum olu\u015fturma &#8220;olu\u015fturma eylemi&#8221; ve bireylerle ilgili hukuki ili\u015fkileri belirleme &#8220;belirleme eylemi&#8221; olmak \u00fczere \u00fc\u00e7e ayr\u0131l\u0131r.<img decoding=\"async\" style=\"width: 735px\" src=\"https:\/\/lh4.googleusercontent.com\/mbTpbO66cqHaRY3tMUdG1ffRyskCEleqJ61clS663dkeldZ-oIiXXnZHUKp4L2LGUCIm1ysYzxl8zxQ4OFTWe4uI_5JDbAKHUgOSfNUAaMNbiURjq_4onSBDtKhWEMNcwrMx9C8EsK_IxA21mmPWeVU\"><\/p>\n\n\n\n<p>(Kaynak: <a href=\"https:\/\/www.mhlw.go.jp\/content\/10601000\/000477356.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">7 Haziran 2018 (Heisei 30) Tarihli 3. \u0130la\u00e7 ve T\u0131bbi Cihaz Sistemi Alt Komitesi Materyalleri 1[ja]<\/a>)<\/p>\n\n\n\n<p>Japon \u0130la\u00e7 Hukuku&#8217;nda, emir eylemi olarak, kalite ve g\u00fcvenlik y\u00f6netiminin iyile\u015ftirilmesi emri (Japon \u0130la\u00e7 Hukuku Madde 72, F\u0131kra 1), ihlal eylemlerinin durdurulmas\u0131 emri (Japon \u0130la\u00e7 Hukuku Madde 72-5, F\u0131kra 1), i\u015f durdurma emri (Japon \u0130la\u00e7 Hukuku Madde 72, F\u0131kra 1, Madde 75, F\u0131kra 1 vb.) gibi h\u00fck\u00fcmler bulunmaktad\u0131r.<\/p>\n\n\n\n<p>\u00d6zellikle, ihlal eylemlerinin durdurulmas\u0131 emri dahil olmak \u00fczere tedbir emirleri (Japon \u0130la\u00e7 Hukuku Madde 72-5) hakk\u0131nda, Reiwa 1 (2019) y\u0131l\u0131nda yap\u0131lan de\u011fi\u015fiklikle, hedef al\u0131nan ihlal eylemleri geni\u015fletilmi\u015ftir.<\/p>\n\n\n\n<p>Reiwa 1 (2019) y\u0131l\u0131nda yap\u0131lan Japon \u0130la\u00e7 Hukuku de\u011fi\u015fiklikleri hakk\u0131nda daha fazla bilgi i\u00e7in a\u015fa\u011f\u0131daki makaleye bak\u0131n\u0131z:<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/?p=49827\" target=\"_blank\" rel=\"noreferrer noopener\">Reiwa 1 (2019) Y\u0131l\u0131nda Japon \u0130la\u00e7 Hukuku De\u011fi\u015fiklikleri &#8211; Eczaneler ve Eczac\u0131lar\u0131n Durumu, \u0130dari Para Cezas\u0131 Sistemi[ja]<\/a><\/p>\n\n\n\n<p>Ayr\u0131ca, olu\u015fturma eylemi olarak, kay\u0131t onay kurulu\u015flar\u0131n\u0131n i\u015f prosed\u00fcrlerinin onay\u0131 (Japon \u0130la\u00e7 Hukuku Madde 23-10, F\u0131kra 1) ve \u00fcretim ve sat\u0131\u015f i\u015fletmelerinin izinlerinin iptali (Japon \u0130la\u00e7 Hukuku Madde 75, F\u0131kra 1) gibi h\u00fck\u00fcmler bulunmaktad\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bireylere_Yuklenen_Yukumluluklerin_Yerine_Getirilmesini_Saglama_Araclari\"><\/span>Bireylere Y\u00fcklenen Y\u00fck\u00fcml\u00fcl\u00fcklerin Yerine Getirilmesini Sa\u011flama Ara\u00e7lar\u0131<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Yukar\u0131da belirtilen eylemlerden bahsedersek, ila\u00e7 \u00fcreticilerine ve sat\u0131c\u0131lar\u0131na kalite ve g\u00fcvenlik y\u00f6netiminin iyile\u015ftirilmesi emri verilse bile, bu, kalite ve g\u00fcvenlik y\u00f6netiminin iyile\u015ftirilece\u011fi anlam\u0131na gelmez, emir verilen \u00fcretici ve sat\u0131c\u0131 ger\u00e7ekten iyile\u015ftirme eylemlerine ba\u015flamad\u0131k\u00e7a y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn yerine getirildi\u011fi s\u00f6ylenemez.<\/p>\n\n\n\n<p>Bu nedenle, bireylerin y\u00fck\u00fcml\u00fcl\u00fcklerini yerine getirmesini sa\u011flamak i\u00e7in, idarenin bireylere y\u00fck\u00fcml\u00fcl\u00fcklerin yerine getirilmesini zorlama y\u00f6ntemleri ve y\u00fck\u00fcml\u00fcl\u00fck ihlallerine kar\u015f\u0131 yapt\u0131r\u0131mlar hukuk taraf\u0131ndan belirlenmi\u015ftir.<\/p>\n\n\n\n<p>Japon \u0130la\u00e7 Hukuku&#8217;nda, geleneksel olarak hapis cezas\u0131 ve para cezas\u0131 (Japon \u0130la\u00e7 Hukuku Madde 83-6 ve a\u015fa\u011f\u0131s\u0131), idari para cezas\u0131 (Japon \u0130la\u00e7 Hukuku Madde 91) gibi h\u00fck\u00fcmler bulunmaktad\u0131r. Reiwa 1 (2019) y\u0131l\u0131nda yap\u0131lan de\u011fi\u015fiklikle yeni kurulan idari para cezas\u0131 sistemi (Japon \u0130la\u00e7 Hukuku Madde 75-5-2) de y\u00fck\u00fcml\u00fcl\u00fck ihlallerine kar\u015f\u0131 bir yapt\u0131r\u0131m olarak konumland\u0131r\u0131lm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99nin_Japanese_Pharmaceutical_Affairs_Law_Idari_Para_Cezasi_Sistemi_Nedir\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n (Japanese Pharmaceutical Affairs Law) \u0130dari Para Cezas\u0131 Sistemi Nedir?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0130dari para cezas\u0131, ihlal edenlere uygulanan mali y\u00fck\u00fcml\u00fcl\u00fckt\u00fcr. Benzer bir mali y\u00fck\u00fcml\u00fcl\u00fck olarak &#8220;para cezas\u0131&#8221; bulunmaktad\u0131r, ancak para cezas\u0131, ceza kanununda belirlenen bir t\u00fcr cezad\u0131r ve uyguland\u0131\u011f\u0131nda sab\u0131ka kayd\u0131 olu\u015fur. \u00d6te yandan, idari para cezas\u0131, idari ceza olarak konumland\u0131r\u0131lan bir \u015feydir ve \u00f6deme emri almak sab\u0131ka kayd\u0131 olu\u015fturmaz.<\/p>\n\n\n\n<p>\u0130dari para cezas\u0131 sisteminin uygulanmas\u0131n\u0131n bir nedeni olarak, geleneksel olarak belirlenen para cezas\u0131n\u0131n \u00fcst limitinin 2 milyon yen (yakla\u015f\u0131k 18.000 dolar) olarak belirlenmi\u015f olmas\u0131 ve \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical Affairs Law) ayk\u0131r\u0131 eylemlerden elde edilen sat\u0131\u015flara k\u0131yasla d\u00fc\u015f\u00fck olmas\u0131 g\u00f6sterilebilir.<\/p>\n\n\n\n<p>Bu t\u00fcr bir sistem hakk\u0131nda, ihlal eden eylemlere kar\u015f\u0131 cayd\u0131r\u0131c\u0131 etkinin yetersiz oldu\u011fu ve haks\u0131z kazan\u00e7lar\u0131n al\u0131nmas\u0131 gerekti\u011fi gibi ele\u015ftiriler vard\u0131. Bu nedenle, idari para cezas\u0131 sistemi, ihlal eden eylemlerden elde edilen sat\u0131\u015flar\u0131n %4.5&#8217;ini idari para cezas\u0131 olarak belirler ve ihlal eden eyleme g\u00f6re mali y\u00fck\u00fcml\u00fcl\u00fck uygulan\u0131r.<\/p>\n\n\n\n<p>Ayr\u0131ca, idari para cezas\u0131n\u0131n miktar\u0131 i\u00e7in bir \u00fcst limit belirlenmemi\u015ftir. Bu nedenle, yan\u0131lt\u0131c\u0131 ve abart\u0131l\u0131 reklamlar gibi yasad\u0131\u015f\u0131 reklamlar yaparak ila\u00e7lar\u0131 ve benzeri \u00fcr\u00fcnleri satan \u015firketler, b\u00fcy\u00fck mali y\u00fck\u00fcml\u00fcl\u00fcklerle kar\u015f\u0131 kar\u015f\u0131ya kalabilir, bu nedenle ila\u00e7lar ve benzeri \u00fcr\u00fcnlerin reklam\u0131n\u0131 yaparken, yasal d\u00fczenlemelere ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131na dikkatle dikkat etmek gerekmektedir.<\/p>\n\n\n\n<p>\u0130dari para cezas\u0131n\u0131n hesaplanma y\u00f6ntemi gibi daha ayr\u0131nt\u0131l\u0131 konular hakk\u0131nda, l\u00fctfen a\u015fa\u011f\u0131daki makaleye bak\u0131n\u0131z.<\/p>\n\n\n\n<p>\u0130lgili Makale: <a href=\"https:\/\/monolith.law\/?p=49848\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n \u0130dari Para Cezas\u0131 Sistemi Nedir? Hedef Al\u0131nan Eylemler ve \u0130ndirim Uygulanan Durumlar A\u00e7\u0131klanm\u0131\u015ft\u0131r[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi_Ihlalleri_Sonucu_Yonetimsel_Yaptirim_Ornekleri\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlalleri Sonucu Y\u00f6netimsel Yapt\u0131r\u0131m \u00d6rnekleri<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\/2023\/03\/Shutterstock_707565829.jpg\" alt=\"\u0130la\u00e7 Makinesi Yasas\u0131 \u0130hlalleri Sonucu Y\u00f6netimsel Yapt\u0131r\u0131m \u00d6rnekleri\" class=\"wp-image-60055\" \/><\/figure>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japon \u0130la\u00e7 Makinesi Yasas\u0131) ayk\u0131r\u0131 hareket eden \u015firketlere y\u00f6netimsel yapt\u0131r\u0131mlar uygulan\u0131r ve bu durumlar Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 gibi kurumlar taraf\u0131ndan bas\u0131n a\u00e7\u0131klamalar\u0131yla duyurulur. A\u015fa\u011f\u0131da, \u015firketlere uygulanan y\u00f6netimsel yapt\u0131r\u0131mlar\u0131n bir \u00f6rne\u011fini sunuyoruz.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ornek_1_Pfizer_Inc\"><\/span>\u00d6rnek 1: Pfizer Inc.<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>2015 Eyl\u00fcl&#8217;\u00fcnde (Heisei 27), Pfizer Inc.&#8217;e \u0130\u015fletme \u0130yile\u015ftirme Emri (Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 72. Maddesi&#8217;nin 4. F\u0131kras\u0131&#8217;n\u0131n 1. Paragraf\u0131) verildi.<\/p>\n\n\n\n<p>\u0130la\u00e7 ve benzeri \u00fcr\u00fcnlerin \u00fcreticileri ve sat\u0131c\u0131lar\u0131, yan etkilerin \u015f\u00fcpheli oldu\u011fu durumlar\u0131n ortaya \u00e7\u0131kmas\u0131 durumunda belirli bir s\u00fcre i\u00e7inde Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131&#8217;na bildirimde bulunma y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcne sahiptir (Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 68. Maddesi&#8217;nin 10. Paragraf\u0131, ayn\u0131 yasan\u0131n uygulama y\u00f6netmeli\u011fi 228. Madde&#8217;nin 20. Paragraf\u0131). Bu olayda, Pfizer Inc.&#8217;in \u00fcretti\u011fi ve satt\u0131\u011f\u0131 11 farkl\u0131 kanser ilac\u0131 i\u00e7in 212 yan etki vakas\u0131 tespit edilmi\u015f olmas\u0131na ra\u011fmen, belirlenen s\u00fcre i\u00e7inde bildirimde bulunulmamas\u0131 sorun olmu\u015ftur.<\/p>\n\n\n\n<p>Bu durum, yan etkileri bilen ila\u00e7 bilgi sorumlusunun bu bilgileri g\u00fcvenlik y\u00f6netim departman\u0131na bildirmemi\u015f olmas\u0131 gibi durumlar nedeniyle, \u0130\u015fletme \u0130yile\u015ftirme Emri&#8217;nin i\u00e7eri\u011fi olarak, g\u00fcvenlik y\u00f6netim i\u015flemlerinin revizyonu, \u00e7al\u0131\u015fanlara e\u011fitim ve d\u00fczeltici \u00f6nlemler ve tekrar\u0131n \u00f6nlenmesi i\u00e7in iyile\u015ftirme plan\u0131n\u0131n sunulmas\u0131 gibi hususlar belirtildi.<\/p>\n\n\n\n<p>Referans: <a href=\"https:\/\/www.mhlw.go.jp\/stf\/houdou\/0000094443.html\" target=\"_blank\" rel=\"noreferrer noopener\">\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 \u0130hlali \u0130\u015fletmelere Y\u00f6netimsel Yapt\u0131r\u0131mlar Hakk\u0131nda | Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ornek_2_Kansai_Medico_Co_Ltd\"><\/span>\u00d6rnek 2: Kansai Medico Co., Ltd.<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>2017 Mart&#8217;\u0131nda (Heisei 29), Kansai Medico Co., Ltd.&#8217;ye Nara \u0130li ve Nara \u015eehri taraf\u0131ndan \u0130\u015fletme \u0130yile\u015ftirme Tedbirleri Emri (Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 72. Maddesi&#8217;nin 4. F\u0131kras\u0131&#8217;n\u0131n 1. Paragraf\u0131) ve \u0130\u015fletme Durdurma Emri (Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 75. Maddesi&#8217;nin 1. Paragraf\u0131) verildi.<\/p>\n\n\n\n<p>Bu, C Tipi Hepatit tedavisi i\u00e7in kullan\u0131lan &#8220;Harvoni Kombine Tablet&#8221; adl\u0131 ilac\u0131n sahte versiyonunun eczanelerde da\u011f\u0131t\u0131ld\u0131\u011f\u0131 ve hastalara ula\u015ft\u0131\u011f\u0131 bir durumdur.<\/p>\n\n\n\n<p>Sahte \u00fcr\u00fcnleri tedarik eden ma\u011fazaya, sahte \u00fcr\u00fcnleri tedarik edip di\u011fer ma\u011fazalarda sat\u0131\u015f amac\u0131yla depolad\u0131\u011f\u0131 (Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 55. Maddesi&#8217;nin 2. F\u0131kras\u0131 ihlali), ila\u00e7 tedarik i\u015flemlerini ve da\u011f\u0131t\u0131m i\u015flemlerini bir y\u00f6neticiye y\u00f6nettirmedi\u011fi (Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 7. Maddesi&#8217;nin 2. F\u0131kras\u0131 ihlali), kutu ve ekli belgeler olmamas\u0131na ra\u011fmen ila\u00e7 testlerini ve denetimlerini bir y\u00f6neticiye yapt\u0131rmad\u0131\u011f\u0131 (Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 9. Maddesi&#8217;nin 1. F\u0131kras\u0131) gibi nedenlerle \u0130\u015fletme Durdurma Emri ve Y\u00f6netici De\u011fi\u015ftirme Emri (Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n 73. Maddesi) verildi.<\/p>\n\n\n\n<p>Ayr\u0131ca, tedarik\u00e7iden sahte \u00fcr\u00fcnler alan iki ma\u011fazaya, ila\u00e7 y\u00f6netim sistemi ve eczane kurucular\u0131n\u0131n denetim sistemi hakk\u0131nda \u0130\u015fletme \u0130yile\u015ftirme Emri verildi.<\/p>\n\n\n\n<p>Referans: <a href=\"https:\/\/www.mhlw.go.jp\/file\/04-Houdouhappyou-11126000-Iyakushokuhinkyoku-Kanshishidoumayakutaisakuka\/0000154073.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">C Tipi Hepatit Tedavi \u0130lac\u0131 &#8220;Harvoni\u00ae Kombine Tablet&#8221; Sahte \u00dcr\u00fcnlerine Y\u00f6nelik Tepki (5. Rapor) (Nara \u0130li Bas\u0131n A\u00e7\u0131klamas\u0131)[ja]<\/a><\/p>\n\n\n\n<p>Referans: <a href=\"https:\/\/www.mhlw.go.jp\/file\/04-Houdouhappyou-11126000-Iyakushokuhinkyoku-Kanshishidoumayakutaisakuka\/170316_press_nara.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">C Tipi Hepatit Tedavi \u0130lac\u0131 &#8220;Harvoni\u00ae Kombine Tablet&#8221; Sahte \u00dcr\u00fcnlerine Y\u00f6nelik Tepki (6. Rapor) (Nara \u0130li Bas\u0131n A\u00e7\u0131klamas\u0131)[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi%E2%80%99na_Japanese_Pharmaceutical_and_Medical_Device_Act_Aykiri_Olmamak_Icin_Alinmasi_Gereken_Onlemler\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na (Japanese Pharmaceutical and Medical Device Act) Ayk\u0131r\u0131 Olmamak \u0130\u00e7in Al\u0131nmas\u0131 Gereken \u00d6nlemler<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Bu zamana kadar belirtti\u011fimiz gibi, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 hareket etti\u011finizde, idari yapt\u0131r\u0131mlarla kar\u015f\u0131la\u015fabilirsiniz. Ayr\u0131ca, \u015firketinizin \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 hareket etti\u011fi ger\u00e7e\u011fi ve idari yapt\u0131r\u0131m\u0131n i\u00e7eri\u011fi gibi bilgilerin de kamuoyuna a\u00e7\u0131klanmas\u0131 durumu s\u00f6z konusu olabilir. Bu durum sadece maddi bir y\u00fck olu\u015fturmakla kalmaz, ayn\u0131 zamanda \u015firketinizin itibar\u0131n\u0131 da kaybetme riski ta\u015f\u0131r.<\/p>\n\n\n\n<p>Peki, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 hareket etmemek i\u00e7in hangi \u00f6nlemleri almal\u0131y\u0131z?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Sirket_Ici_Yonergeleri_Belirlemek\"><\/span>\u015eirket \u0130\u00e7i Y\u00f6nergeleri Belirlemek<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Al\u0131nabilecek \u00f6nlemlerden biri, \u015firket i\u00e7i y\u00f6nergelerin belirlenmesidir. Hangi eylemlerin \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 oldu\u011funu anlamak i\u00e7in yasa maddelerini ve Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131 taraf\u0131ndan yay\u0131nlanan \u00e7e\u015fitli y\u00f6nergeleri ve bildirimleri incelemek gerekmektedir. Ancak, bu bilgiler aras\u0131ndan gerekenleri anlamak zaman al\u0131c\u0131 olabilir.<\/p>\n\n\n\n<p>Bu nedenle, \u015firketinizin i\u015flemleri aras\u0131nda \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 olabilecek noktalar hakk\u0131nda, i\u015flemlerin nas\u0131l y\u00fcr\u00fct\u00fclece\u011fini belirleyerek bunlar\u0131 \u015firket i\u00e7i y\u00f6nerge olarak t\u00fcm \u00e7al\u0131\u015fanlarla payla\u015fabilirsiniz. Bu sayede, her bir \u00e7al\u0131\u015fan\u0131n \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 hareket etme konusunda dikkatli olmas\u0131 sa\u011flanabilir.<\/p>\n\n\n\n<p>\u00d6zellikle ila\u00e7 reklamlar\u0131 konusunda, sadece \u00fcretim ve sat\u0131\u015f \u015firketlerinin de\u011fil, reklam ajanslar\u0131n\u0131n da \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 hareket etmemeleri gerekti\u011fi i\u00e7in, i\u015f ortaklar\u0131n\u0131za da dikkat etmeleri gereken noktalar\u0131 aktarabiliyor olman\u0131z, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 hareket etme riskinizi daha da azaltacakt\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bir_Avukata_Danismak\"><\/span>Bir Avukata Dan\u0131\u015fmak<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Y\u00f6nergeleri belirlerken, hangi bilgilere ba\u015fvurman\u0131z gerekti\u011fi veya belirledi\u011finiz y\u00f6nergelerin yeterli olup olmad\u0131\u011f\u0131 konusunda endi\u015feleriniz varsa, \u0130la\u00e7 Makinesi Yasas\u0131 konusunda deneyimli bir avukata dan\u0131\u015fmak da \u00f6nemlidir. \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n d\u00fczenlemelerinin hangi eylemleri kapsad\u0131\u011f\u0131 konusunda kesin bir karar vermek zor olabilir, ancak ge\u00e7mi\u015f deneyimlere dayanarak bir avukat\u0131n hukuki bak\u0131\u015f a\u00e7\u0131s\u0131ndan alabilece\u011finiz tavsiyeler beklenebilir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Sonuc_Ilac_Makinesi_Yasasi%E2%80%99nin_Hukuki_Kontrolu_Icin_Bir_Avukata_Danisin\"><\/span>Sonu\u00e7: \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n Hukuki Kontrol\u00fc \u0130\u00e7in Bir Avukata Dan\u0131\u015f\u0131n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2023\/03\/Shutterstock_2129385929.jpg\" alt=\"Sonu\u00e7: \u0130la\u00e7 Makinesi Yasas\u0131 sorunlar\u0131yla kar\u015f\u0131la\u015f\u0131yorsan\u0131z bir avukata dan\u0131\u015f\u0131n\" class=\"wp-image-60056\" \/><\/figure>\n\n\n\n<p>Hangi eylemlerin \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 oldu\u011funu belirlemek, baz\u0131 \u015firketler i\u00e7in a\u00e7\u0131k bir \u015fekilde belirlenebilirken, baz\u0131 durumlarda ise yasal ya da yasad\u0131\u015f\u0131 olarak g\u00f6r\u00fclebilecek \u015fekilde karar vermek zor olabilir. Sadece y\u00f6nergelerin olu\u015fturulmas\u0131 de\u011fil, ayn\u0131 zamanda mevcut i\u015flerinizin veya gelecekte yapmay\u0131 planlad\u0131\u011f\u0131n\u0131z i\u015flerinizin \u0130la\u00e7 Makinesi Yasas\u0131&#8217;na ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131 konusunda endi\u015feleniyorsan\u0131z, bir avukata dan\u0131\u015f\u0131n.<\/p>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 ve benzeri yasalar\u0131n hukuki kontrol\u00fc ve yeniden ifade \u00f6nerileri, olduk\u00e7a uzmanl\u0131k gerektiren bir aland\u0131r. Monolith Hukuk B\u00fcrosu, bir \u0130la\u00e7 Makinesi Yasas\u0131 Hukuk Ekibi olu\u015fturmu\u015ftur ve 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=\"Hukuk_Buromuzun_Sundugu_Cozumler\"><\/span>Hukuk 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 Makinesi Yasas\u0131 Kontrol\u00fc[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;nda (Japanese Pharmaceutical Affairs Law), daha \u00f6nce ila\u00e7 vb. \u00fcretim ve sat\u0131\u015f i\u015fletmelerine y\u00f6nelik i\u015f iyile\u015ftirme emirleri ve \u00fcretim sat\u0131\u015f onay\u0131n\u0131n iptali gibi idari yapt\u0131r [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":64773,"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\/61305"}],"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=61305"}],"version-history":[{"count":3,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61305\/revisions"}],"predecessor-version":[{"id":64774,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61305\/revisions\/64774"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media\/64773"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media?parent=61305"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/categories?post=61305"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/tags?post=61305"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}