{"id":59551,"date":"2023-10-27T15:44:01","date_gmt":"2023-10-27T06:44:01","guid":{"rendered":"https:\/\/monolith.law\/vi\/?p=59551"},"modified":"2023-11-09T20:48:12","modified_gmt":"2023-11-09T11:48:12","slug":"pmd-act-administrative-action","status":"publish","type":"post","link":"https:\/\/monolith.law\/vi\/general-corporate\/pmd-act-administrative-action","title":{"rendered":"Ph\u1ea3n \u1ee9ng tr\u01b0\u1edbc c\u00e1c bi\u1ec7n ph\u00e1p h\u00e0nh ch\u00ednh do vi ph\u1ea1m &#8216;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8217;? Gi\u1ea3i th\u00edch k\u00e8m theo c\u00e1c v\u00ed d\u1ee5"},"content":{"rendered":"\n<p>Trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, t\u1eeb tr\u01b0\u1edbc \u0111\u1ebfn nay \u0111\u00e3 quy \u0111\u1ecbnh c\u00e1c bi\u1ec7n ph\u00e1p h\u00e0nh ch\u00ednh nh\u01b0 l\u1ec7nh c\u1ea3i thi\u1ec7n c\u00f4ng vi\u1ec7c \u0111\u1ed1i v\u1edbi nh\u1eefng ng\u01b0\u1eddi kinh doanh s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m, ho\u1eb7c vi\u1ec7c h\u1ee7y b\u1ecf s\u1ef1 ch\u1ea5p thu\u1eadn s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng. Tuy nhi\u00ean, do s\u1eeda \u0111\u1ed5i v\u00e0o n\u0103m \u0111\u1ea7u Reiwa (n\u0103m 2019), h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n ph\u1ea1t m\u1edbi \u0111\u00e3 \u0111\u01b0\u1ee3c gi\u1edbi thi\u1ec7u.<\/p>\n\n\n\n<p>B\u00e0i vi\u1ebft n\u00e0y s\u1ebd gi\u1ea3i th\u00edch v\u1ec1 ph\u1ea3n \u1ee9ng c\u1ee7a ch\u00ednh quy\u1ec1n \u0111\u1ed1i v\u1edbi vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, c\u0169ng nh\u01b0 c\u00e1c v\u00ed d\u1ee5 c\u1ee5 th\u1ec3, \u0111\u1ed3ng th\u1eddi c\u0169ng \u0111\u1ec1 c\u1eadp \u0111\u1ebfn h\u1ec7 th\u1ed1ng m\u1edbi.<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Hai_loai_bien_phap_hanh_chinh_va_tinh_hinh_ung_pho_trong_Luat_Duoc_pham_va_Thiet_bi_y_te_cua_Nhat_Ban\" title=\"Hai lo\u1ea1i bi\u1ec7n ph\u00e1p h\u00e0nh ch\u00ednh v\u00e0 t\u00ecnh h\u00ecnh \u1ee9ng ph\u00f3 trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n\">Hai lo\u1ea1i bi\u1ec7n ph\u00e1p h\u00e0nh ch\u00ednh v\u00e0 t\u00ecnh h\u00ecnh \u1ee9ng ph\u00f3 trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Hanh_dong_cua_chinh_quyen_tao_ra_quyen_loi_va_nghia_vu_phap_ly_cho_ca_nhan\" title=\"H\u00e0nh \u0111\u1ed9ng c\u1ee7a ch\u00ednh quy\u1ec1n t\u1ea1o ra quy\u1ec1n l\u1ee3i v\u00e0 ngh\u0129a v\u1ee5 ph\u00e1p l\u00fd cho c\u00e1 nh\u00e2n\">H\u00e0nh \u0111\u1ed9ng c\u1ee7a ch\u00ednh quy\u1ec1n t\u1ea1o ra quy\u1ec1n l\u1ee3i v\u00e0 ngh\u0129a v\u1ee5 ph\u00e1p l\u00fd cho c\u00e1 nh\u00e2n<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Cac_bien_phap_de_dam_bao_viec_thuc_hien_nghia_vu_duoc_gan_cho_ca_nhan\" title=\"C\u00e1c bi\u1ec7n ph\u00e1p \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o vi\u1ec7c th\u1ef1c hi\u1ec7n ngh\u0129a v\u1ee5 \u0111\u01b0\u1ee3c g\u00e1n cho c\u00e1 nh\u00e2n\">C\u00e1c bi\u1ec7n ph\u00e1p \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o vi\u1ec7c th\u1ef1c hi\u1ec7n ngh\u0129a v\u1ee5 \u0111\u01b0\u1ee3c g\u00e1n cho c\u00e1 nh\u00e2n<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#He_thong_phat_tien_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban_la_gi\" title=\"H\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n l\u00e0 g\u00ec?\">H\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n l\u00e0 g\u00ec?<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Cac_vi_du_ve_hinh_phat_hanh_chinh_do_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"C\u00e1c v\u00ed d\u1ee5 v\u1ec1 h\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh do vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\">C\u00e1c v\u00ed d\u1ee5 v\u1ec1 h\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh do vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Vi_du_1_Cong_ty_co_phan_Pfizer_Nhat_Ban\" title=\"V\u00ed d\u1ee5 1: C\u00f4ng ty c\u1ed5 ph\u1ea7n Pfizer Nh\u1eadt B\u1ea3n\">V\u00ed d\u1ee5 1: C\u00f4ng ty c\u1ed5 ph\u1ea7n Pfizer Nh\u1eadt B\u1ea3n<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Vi_du_2_Cong_ty_co_phan_Kansai_Medico\" title=\"V\u00ed d\u1ee5 2: C\u00f4ng ty c\u1ed5 ph\u1ea7n Kansai Medico\">V\u00ed d\u1ee5 2: C\u00f4ng ty c\u1ed5 ph\u1ea7n Kansai Medico<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Bien_phap_de_khong_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"Bi\u1ec7n ph\u00e1p \u0111\u1ec3 kh\u00f4ng vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\">Bi\u1ec7n ph\u00e1p \u0111\u1ec3 kh\u00f4ng vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Xay_dung_huong_dan_noi_bo_cua_cong_ty\" title=\"X\u00e2y d\u1ef1ng h\u01b0\u1edbng d\u1eabn n\u1ed9i b\u1ed9 c\u1ee7a c\u00f4ng ty\">X\u00e2y d\u1ef1ng h\u01b0\u1edbng d\u1eabn n\u1ed9i b\u1ed9 c\u1ee7a c\u00f4ng ty<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Tham_van_voi_luat_su\" title=\"Tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0\">Tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Tom_tat_Hay_thao_luan_voi_luat_su_ve_viec_kiem_tra_phap_ly_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_cua_Nhat_Ban_Japanese_Pharmaceutical_and_Medical_Device_Law\" title=\"T\u00f3m t\u1eaft: H\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0 v\u1ec1 vi\u1ec7c ki\u1ec3m tra ph\u00e1p l\u00fd theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Law)\">T\u00f3m t\u1eaft: H\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0 v\u1ec1 vi\u1ec7c ki\u1ec3m tra ph\u00e1p l\u00fd theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Law)<\/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\/vi\/general-corporate\/pmd-act-administrative-action\/#Gioi_thieu_ve_cac_bien_phap_cua_van_phong_luat_su_cua_chung_toi\" title=\"Gi\u1edbi thi\u1ec7u v\u1ec1 c\u00e1c bi\u1ec7n ph\u00e1p c\u1ee7a v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u1ee7a ch\u00fang t\u00f4i\">Gi\u1edbi thi\u1ec7u v\u1ec1 c\u00e1c bi\u1ec7n ph\u00e1p c\u1ee7a v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u1ee7a ch\u00fang t\u00f4i<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Hai_loai_bien_phap_hanh_chinh_va_tinh_hinh_ung_pho_trong_Luat_Duoc_pham_va_Thiet_bi_y_te_cua_Nhat_Ban\"><\/span>Hai lo\u1ea1i bi\u1ec7n ph\u00e1p h\u00e0nh ch\u00ednh v\u00e0 t\u00ecnh h\u00ecnh \u1ee9ng ph\u00f3 trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Act) nh\u1eb1m m\u1ee5c \u0111\u00edch c\u1ea3i thi\u1ec7n s\u1ee9c kh\u1ecfe c\u00f4ng c\u1ed9ng th\u00f4ng qua vi\u1ec7c \u0111\u01b0a ra c\u00e1c quy \u0111\u1ecbnh v\u00e0 bi\u1ec7n ph\u00e1p c\u1ea7n thi\u1ebft \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m, ng\u0103n ch\u1eb7n s\u1ef1 ph\u00e1t sinh v\u00e0 lan r\u1ed9ng c\u1ee7a c\u00e1c r\u1ee7i ro v\u1ec1 s\u1ee9c kh\u1ecfe c\u00f4ng c\u1ed9ng (\u0110i\u1ec1u 1 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n).<\/p>\n\n\n\n<p>C\u00e1c bi\u1ec7n ph\u00e1p n\u00e0y, n\u00f3i chung, c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c chia th\u00e0nh hai lo\u1ea1i: \u2460 h\u00e0nh \u0111\u1ed9ng c\u1ee7a ch\u00ednh quy\u1ec1n t\u1ea1o ra quy\u1ec1n l\u1ee3i v\u00e0 ngh\u0129a v\u1ee5 cho c\u00e1 nh\u00e2n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u00e0 \u2461 c\u00e1c bi\u1ec7n ph\u00e1p \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o vi\u1ec7c th\u1ef1c hi\u1ec7n ngh\u0129a v\u1ee5 \u0111\u01b0\u1ee3c g\u00e1n b\u1edfi h\u00e0nh \u0111\u1ed9ng \u2460.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Hanh_dong_cua_chinh_quyen_tao_ra_quyen_loi_va_nghia_vu_phap_ly_cho_ca_nhan\"><\/span>H\u00e0nh \u0111\u1ed9ng c\u1ee7a ch\u00ednh quy\u1ec1n t\u1ea1o ra quy\u1ec1n l\u1ee3i v\u00e0 ngh\u0129a v\u1ee5 ph\u00e1p l\u00fd cho c\u00e1 nh\u00e2n<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>H\u00e0nh \u0111\u1ed9ng n\u00e0y c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i th\u00e0nh &#8220;h\u00e0nh \u0111\u1ed9ng ra l\u1ec7nh&#8221; y\u00eau c\u1ea7u c\u00e1 nh\u00e2n h\u00e0nh \u0111\u1ed9ng ho\u1eb7c kh\u00f4ng h\u00e0nh \u0111\u1ed9ng, &#8220;h\u00e0nh \u0111\u1ed9ng h\u00ecnh th\u00e0nh&#8221; thi\u1ebft l\u1eadp v\u1ecb tr\u00ed ph\u00e1p l\u00fd cho c\u00e1 nh\u00e2n, v\u00e0 &#8220;h\u00e0nh \u0111\u1ed9ng x\u00e1c \u0111\u1ecbnh&#8221; x\u00e1c \u0111\u1ecbnh m\u1ed1i quan h\u1ec7 ph\u00e1p l\u00fd li\u00ean quan \u0111\u1ebfn c\u00e1 nh\u00e2n.<img decoding=\"async\" style=\"width: 735px\" src=\"https:\/\/lh4.googleusercontent.com\/mbTpbO66cqHaRY3tMUdG1ffRyskCEleqJ61clS663dkeldZ-oIiXXnZHUKp4L2LGUCIm1ysYzxl8zxQ4OFTWe4uI_5JDbAKHUgOSfNUAaMNbiURjq_4onSBDtKhWEMNcwrMx9C8EsK_IxA21mmPWeVU\"><\/p>\n\n\n\n<p>(Ngu\u1ed3n: <a href=\"https:\/\/www.mhlw.go.jp\/content\/10601000\/000477356.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">T\u00e0i li\u1ec7u 1 c\u1ee7a H\u1ed9i \u0111\u1ed3ng Qu\u1ea3n l\u00fd D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf l\u1ea7n th\u1ee9 3 ng\u00e0y 7 th\u00e1ng 6 n\u0103m 2018 (Heisei 30)[ja]<\/a>)<\/p>\n\n\n\n<p>Trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n, c\u00e1c h\u00e0nh \u0111\u1ed9ng ra l\u1ec7nh nh\u01b0 l\u1ec7nh c\u1ea3i thi\u1ec7n ph\u01b0\u01a1ng ph\u00e1p qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n (\u0110i\u1ec1u 72, Kho\u1ea3n 1), l\u1ec7nh d\u1eebng vi ph\u1ea1m (\u0110i\u1ec1u 72-5, Kho\u1ea3n 1), l\u1ec7nh d\u1eebng ho\u1ea1t \u0111\u1ed9ng kinh doanh (\u0110i\u1ec1u 72, Kho\u1ea3n 1 v\u00e0 \u0110i\u1ec1u 75, Kho\u1ea3n 1) v\u00e0 c\u00e1c h\u00e0nh \u0111\u1ed9ng kh\u00e1c \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh.<\/p>\n\n\n\n<p>\u0110\u1eb7c bi\u1ec7t, c\u00e1c bi\u1ec7n ph\u00e1p ra l\u1ec7nh nh\u01b0 l\u1ec7nh d\u1eebng vi ph\u1ea1m \u0111\u00e3 \u0111\u01b0\u1ee3c m\u1edf r\u1ed9ng \u0111\u1ed1i t\u01b0\u1ee3ng vi ph\u1ea1m \u00e1p d\u1ee5ng sau s\u1eeda \u0111\u1ed5i n\u0103m 2019 (Reiwa 1).<\/p>\n\n\n\n<p>V\u1ec1 s\u1eeda \u0111\u1ed5i Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n n\u0103m 2019 (Reiwa 1) bao g\u1ed3m c\u00e1c bi\u1ec7n ph\u00e1p ra l\u1ec7nh, vui l\u00f2ng tham kh\u1ea3o b\u00e0i vi\u1ebft sau.<\/p>\n\n\n\n<p>B\u00e0i vi\u1ebft li\u00ean quan: <a href=\"https:\/\/Monolith.law\/?p=49827\" target=\"_blank\" rel=\"noreferrer noopener\">N\u1ed9i dung s\u1eeda \u0111\u1ed5i Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n n\u0103m 2019 (Reiwa 1) &#8211; H\u01b0\u1edbng \u0111i c\u1ee7a c\u00e1c hi\u1ec7u thu\u1ed1c v\u00e0 d\u01b0\u1ee3c s\u0129, h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n[ja]<\/a><\/p>\n\n\n\n<p>Ngo\u00e0i ra, c\u00e1c h\u00e0nh \u0111\u1ed9ng h\u00ecnh th\u00e0nh bao g\u1ed3m vi\u1ec7c ph\u00ea duy\u1ec7t quy ch\u1ebf ho\u1ea1t \u0111\u1ed9ng c\u1ee7a c\u01a1 quan ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd (\u0110i\u1ec1u 23-10, Kho\u1ea3n 1) v\u00e0 vi\u1ec7c h\u1ee7y b\u1ecf gi\u1ea5y ph\u00e9p kinh doanh s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng (\u0110i\u1ec1u 75, Kho\u1ea3n 1).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cac_bien_phap_de_dam_bao_viec_thuc_hien_nghia_vu_duoc_gan_cho_ca_nhan\"><\/span>C\u00e1c bi\u1ec7n ph\u00e1p \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o vi\u1ec7c th\u1ef1c hi\u1ec7n ngh\u0129a v\u1ee5 \u0111\u01b0\u1ee3c g\u00e1n cho c\u00e1 nh\u00e2n<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>V\u1edbi c\u00e1c h\u00e0nh \u0111\u1ed9ng \u0111\u00e3 n\u00eau tr\u00ean, ngay c\u1ea3 khi ch\u00ednh quy\u1ec1n ra l\u1ec7nh cho c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i d\u01b0\u1ee3c ph\u1ea9m c\u1ea3i thi\u1ec7n ph\u01b0\u01a1ng ph\u00e1p qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n, \u0111i\u1ec1u \u0111\u00f3 kh\u00f4ng c\u00f3 ngh\u0129a l\u00e0 ph\u01b0\u01a1ng ph\u00e1p qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n s\u1ebd \u0111\u01b0\u1ee3c c\u1ea3i thi\u1ec7n. N\u1ebfu nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i kh\u00f4ng th\u1ef1c s\u1ef1 h\u00e0nh \u0111\u1ed9ng \u0111\u1ec3 c\u1ea3i thi\u1ec7n, h\u1ecd s\u1ebd kh\u00f4ng \u0111\u01b0\u1ee3c coi l\u00e0 \u0111\u00e3 th\u1ef1c hi\u1ec7n ngh\u0129a v\u1ee5 c\u1ee7a m\u00ecnh.<\/p>\n\n\n\n<p>Do \u0111\u00f3, \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o vi\u1ec7c th\u1ef1c hi\u1ec7n ngh\u0129a v\u1ee5 c\u1ee7a c\u00e1 nh\u00e2n, ph\u00e1p lu\u1eadt \u0111\u00e3 quy \u0111\u1ecbnh c\u00e1c ph\u01b0\u01a1ng ph\u00e1p m\u00e0 ch\u00ednh quy\u1ec1n c\u00f3 th\u1ec3 \u00e9p bu\u1ed9c c\u00e1 nh\u00e2n th\u1ef1c hi\u1ec7n ngh\u0129a v\u1ee5 c\u1ee7a m\u00ecnh v\u00e0 c\u00e1c h\u00ecnh ph\u1ea1t \u0111\u1ed1i v\u1edbi vi ph\u1ea1m ngh\u0129a v\u1ee5.<\/p>\n\n\n\n<p>Trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n, c\u00e1c h\u00ecnh ph\u1ea1t nh\u01b0 t\u00f9 giam, ph\u1ea1t ti\u1ec1n (\u0110i\u1ec1u 83-6 tr\u1edf xu\u1ed1ng), ph\u1ea1t ti\u1ec1n (\u0110i\u1ec1u 91) \u0111\u00e3 \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh t\u1eeb tr\u01b0\u1edbc. H\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n m\u1edbi \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp sau s\u1eeda \u0111\u1ed5i n\u0103m 2019 (Reiwa 1) (\u0110i\u1ec1u 75-5-2) c\u0169ng \u0111\u01b0\u1ee3c coi l\u00e0 h\u00ecnh ph\u1ea1t \u0111\u1ed1i v\u1edbi vi ph\u1ea1m ngh\u0129a v\u1ee5.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"He_thong_phat_tien_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban_la_gi\"><\/span>H\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n l\u00e0 g\u00ec?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ph\u1ea1t ti\u1ec1n l\u00e0 m\u1ed9t h\u00ecnh th\u1ee9c g\u00e1nh n\u1eb7ng t\u00e0i ch\u00ednh \u0111\u1ed1i v\u1edbi ng\u01b0\u1eddi vi ph\u1ea1m. C\u00f3 m\u1ed9t h\u00ecnh th\u1ee9c g\u00e1nh n\u1eb7ng t\u00e0i ch\u00ednh t\u01b0\u01a1ng t\u1ef1 l\u00e0 &#8220;ti\u1ec1n ph\u1ea1t&#8221;, nh\u01b0ng ti\u1ec1n ph\u1ea1t l\u00e0 m\u1ed9t lo\u1ea1i h\u00ecnh ph\u1ea1t \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong B\u1ed9 lu\u1eadt H\u00ecnh s\u1ef1 Nh\u1eadt B\u1ea3n, v\u00e0 n\u1ebfu b\u1ecb ph\u1ea1t th\u00ec s\u1ebd c\u00f3 ti\u1ec1n \u00e1n. Ng\u01b0\u1ee3c l\u1ea1i, ph\u1ea1t ti\u1ec1n \u0111\u01b0\u1ee3c xem l\u00e0 m\u1ed9t h\u00ecnh th\u1ee9c ph\u1ea1t h\u00e0nh ch\u00ednh, v\u00e0 vi\u1ec7c nh\u1eadn l\u1ec7nh n\u1ed9p ph\u1ea1t kh\u00f4ng t\u1ea1o ra ti\u1ec1n \u00e1n.<\/p>\n\n\n\n<p>M\u1ed9t trong nh\u1eefng l\u00fd do h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng l\u00e0 do m\u1ee9c ti\u1ec1n ph\u1ea1t t\u1ed1i \u0111a theo quy \u0111\u1ecbnh tr\u01b0\u1edbc \u0111\u00e2y l\u00e0 2 tri\u1ec7u y\u00ean (kho\u1ea3ng 432 tri\u1ec7u \u0111\u1ed3ng), so v\u1edbi doanh thu t\u1eeb h\u00e0nh vi vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, s\u1ed1 ti\u1ec1n n\u00e0y kh\u00e1 nh\u1ecf.<\/p>\n\n\n\n<p>\u0110\u1ed1i v\u1edbi h\u1ec7 th\u1ed1ng nh\u01b0 v\u1eady, \u0111\u00e3 c\u00f3 nh\u1eefng l\u1eddi ch\u1ec9 tr\u00edch r\u1eb1ng n\u00f3 kh\u00f4ng \u0111\u1ee7 \u0111\u1ec3 ng\u0103n ch\u1eb7n h\u00e0nh vi vi ph\u1ea1m, v\u00e0 n\u00ean t\u1ecbch thu l\u1ee3i nhu\u1eadn kh\u00f4ng c\u00f4ng b\u1eb1ng. Do \u0111\u00f3, trong h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n, s\u1ed1 ti\u1ec1n ph\u1ea1t \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh l\u00e0 4,5% doanh thu t\u1eeb h\u00e0nh vi vi ph\u1ea1m, v\u00e0 g\u00e1nh n\u1eb7ng t\u00e0i ch\u00ednh t\u01b0\u01a1ng \u1ee9ng v\u1edbi h\u00e0nh vi vi ph\u1ea1m s\u1ebd \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng.<\/p>\n\n\n\n<p>Ngo\u00e0i ra, kh\u00f4ng c\u00f3 gi\u1edbi h\u1ea1n cho s\u1ed1 ti\u1ec1n ph\u1ea1t. Do \u0111\u00f3, c\u00e1c c\u00f4ng ty \u0111\u00e3 ti\u1ebfn h\u00e0nh qu\u1ea3ng c\u00e1o b\u1ea5t h\u1ee3p ph\u00e1p nh\u01b0 qu\u1ea3ng c\u00e1o gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i \u0111\u1ec3 b\u00e1n d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1 c\u00f3 th\u1ec3 ph\u1ea3i ch\u1ecbu g\u00e1nh n\u1eb7ng t\u00e0i ch\u00ednh l\u1edbn, do \u0111\u00f3, khi qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1, c\u1ea7n ph\u1ea3i ch\u00fa \u00fd k\u1ef9 l\u01b0\u1ee1ng \u0111\u1ec3 kh\u00f4ng vi ph\u1ea1m quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt.<\/p>\n\n\n\n<p>\u0110\u1ed1i v\u1edbi c\u00e1ch t\u00ednh s\u1ed1 ti\u1ec1n ph\u1ea1t v\u00e0 n\u1ed9i dung chi ti\u1ebft h\u01a1n, vui l\u00f2ng tham kh\u1ea3o b\u00e0i vi\u1ebft d\u01b0\u1edbi \u0111\u00e2y.<\/p>\n\n\n\n<p>B\u00e0i vi\u1ebft li\u00ean quan: <a href=\"https:\/\/Monolith.law\/?p=49848\" target=\"_blank\" rel=\"noreferrer noopener\">H\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n l\u00e0 g\u00ec? Gi\u1ea3i th\u00edch v\u1ec1 h\u00e0nh vi \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng v\u00e0 c\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c gi\u1ea3m b\u1edbt[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Cac_vi_du_ve_hinh_phat_hanh_chinh_do_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>C\u00e1c v\u00ed d\u1ee5 v\u1ec1 h\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh do vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n<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=\"C\u00e1c v\u00ed d\u1ee5 v\u1ec1 h\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh do vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\" class=\"wp-image-60055\" \/><\/figure>\n\n\n\n<p>Khi c\u00e1c doanh nghi\u1ec7p vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, h\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh s\u1ebd \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng v\u00e0 B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i s\u1ebd c\u00f4ng b\u1ed1 th\u00f4ng tin v\u1ec1 vi\u1ec7c n\u00e0y. D\u01b0\u1edbi \u0111\u00e2y l\u00e0 m\u1ed9t s\u1ed1 v\u00ed d\u1ee5 v\u1ec1 h\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh \u0111\u00e3 \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng cho c\u00e1c doanh nghi\u1ec7p.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vi_du_1_Cong_ty_co_phan_Pfizer_Nhat_Ban\"><\/span>V\u00ed d\u1ee5 1: C\u00f4ng ty c\u1ed5 ph\u1ea7n Pfizer Nh\u1eadt B\u1ea3n<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>V\u00e0o th\u00e1ng 9 n\u0103m 2015, C\u00f4ng ty c\u1ed5 ph\u1ea7n Pfizer Nh\u1eadt B\u1ea3n \u0111\u00e3 nh\u1eadn l\u1ec7nh c\u1ea3i thi\u1ec7n ho\u1ea1t \u0111\u1ed9ng kinh doanh (\u0110i\u1ec1u 72-4, \u0110i\u1ec1u 1 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n).<\/p>\n\n\n\n<p>C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i d\u01b0\u1ee3c ph\u1ea9m c\u00f3 ngh\u0129a v\u1ee5 b\u00e1o c\u00e1o cho B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i trong m\u1ed9t kho\u1ea3ng th\u1eddi gian nh\u1ea5t \u0111\u1ecbnh n\u1ebfu ph\u00e1t hi\u1ec7n ra c\u00e1c tri\u1ec7u ch\u1ee9ng nghi ng\u1edd l\u00e0 t\u00e1c d\u1ee5ng ph\u1ee5 (\u0110i\u1ec1u 68-10 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, \u0110i\u1ec1u 228-20 c\u1ee7a Ph\u1ee5 l\u1ee5c Lu\u1eadt). Trong tr\u01b0\u1eddng h\u1ee3p n\u00e0y, v\u1ea5n \u0111\u1ec1 \u0111\u00e3 n\u1ea3y sinh l\u00e0 C\u00f4ng ty c\u1ed5 ph\u1ea7n Pfizer Nh\u1eadt B\u1ea3n \u0111\u00e3 kh\u00f4ng b\u00e1o c\u00e1o trong th\u1eddi gian quy \u0111\u1ecbnh d\u00f9 \u0111\u00e3 n\u1eafm b\u1eaft \u0111\u01b0\u1ee3c 212 tr\u01b0\u1eddng h\u1ee3p t\u00e1c d\u1ee5ng ph\u1ee5 c\u1ee7a 11 lo\u1ea1i thu\u1ed1c ch\u1ed1ng ung th\u01b0 v\u00e0 c\u00e1c lo\u1ea1i thu\u1ed1c kh\u00e1c m\u00e0 c\u00f4ng ty s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i.<\/p>\n\n\n\n<p>Do c\u00f3 t\u00ecnh hu\u1ed1ng m\u00e0 ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch th\u00f4ng tin y d\u01b0\u1ee3c \u0111\u00e3 n\u1eafm b\u1eaft \u0111\u01b0\u1ee3c t\u00e1c d\u1ee5ng ph\u1ee5 nh\u01b0ng kh\u00f4ng b\u00e1o c\u00e1o cho b\u1ed9 ph\u1eadn qu\u1ea3n l\u00fd an to\u00e0n, n\u00ean n\u1ed9i dung c\u1ee7a l\u1ec7nh c\u1ea3i thi\u1ec7n ho\u1ea1t \u0111\u1ed9ng kinh doanh bao g\u1ed3m vi\u1ec7c s\u1eeda \u0111\u1ed5i quy tr\u00ecnh l\u00e0m vi\u1ec7c qu\u1ea3n l\u00fd an to\u00e0n, \u0111\u00e0o t\u1ea1o nh\u00e2n vi\u00ean, n\u1ed9p k\u1ebf ho\u1ea1ch c\u1ea3i thi\u1ec7n li\u00ean quan \u0111\u1ebfn bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c v\u00e0 ng\u0103n ch\u1eb7n t\u00e1i ph\u00e1t.<\/p>\n\n\n\n<p>Tham kh\u1ea3o: <a href=\"https:\/\/www.mhlw.go.jp\/stf\/houdou\/0000094443.html\" target=\"_blank\" rel=\"noreferrer noopener\">H\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh \u0111\u1ed1i v\u1edbi nh\u1eefng ng\u01b0\u1eddi vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf | B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vi_du_2_Cong_ty_co_phan_Kansai_Medico\"><\/span>V\u00ed d\u1ee5 2: C\u00f4ng ty c\u1ed5 ph\u1ea7n Kansai Medico<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>V\u00e0o th\u00e1ng 3 n\u0103m 2017, C\u00f4ng ty c\u1ed5 ph\u1ea7n Kansai Medico \u0111\u00e3 nh\u1eadn l\u1ec7nh c\u1ea3i thi\u1ec7n ho\u1ea1t \u0111\u1ed9ng kinh doanh (\u0110i\u1ec1u 72-4, \u0110i\u1ec1u 1 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n) v\u00e0 l\u1ec7nh d\u1eebng ho\u1ea1t \u0111\u1ed9ng kinh doanh (\u0110i\u1ec1u 75, \u0110i\u1ec1u 1 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n) t\u1eeb t\u1ec9nh Nara v\u00e0 th\u00e0nh ph\u1ed1 Nara.<\/p>\n\n\n\n<p>\u0110\u00e2y l\u00e0 tr\u01b0\u1eddng h\u1ee3p thu\u1ed1c \u0111i\u1ec1u tr\u1ecb vi\u00eam gan C &#8220;Harvoni&#8221; gi\u1ea3 m\u1ea1o \u0111\u00e3 \u0111\u01b0\u1ee3c k\u00ea \u0111\u01a1n t\u1ea1i hi\u1ec7u thu\u1ed1c v\u00e0 l\u01b0u th\u00f4ng \u0111\u1ebfn b\u1ec7nh nh\u00e2n.<\/p>\n\n\n\n<p>\u0110\u1ed1i v\u1edbi c\u1eeda h\u00e0ng \u0111\u00e3 mua h\u00e0ng gi\u1ea3 m\u1ea1o, l\u1ec7nh d\u1eebng ho\u1ea1t \u0111\u1ed9ng kinh doanh v\u00e0 l\u1ec7nh thay \u0111\u1ed5i ng\u01b0\u1eddi qu\u1ea3n l\u00fd (\u0110i\u1ec1u 73 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n) \u0111\u00e3 \u0111\u01b0\u1ee3c ban h\u00e0nh v\u00ec l\u00fd do nh\u01b0 mua h\u00e0ng gi\u1ea3 m\u1ea1o, l\u01b0u tr\u1eef v\u1edbi m\u1ee5c \u0111\u00edch b\u00e1n cho c\u00e1c c\u1eeda h\u00e0ng kh\u00e1c (vi ph\u1ea1m \u0110i\u1ec1u 55, \u0110i\u1ec1u 2 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n), kh\u00f4ng \u0111\u1ec3 ng\u01b0\u1eddi qu\u1ea3n l\u00fd qu\u1ea3n l\u00fd c\u00f4ng vi\u1ec7c mua h\u00e0ng v\u00e0 ph\u00e2n ph\u1ed1i d\u01b0\u1ee3c ph\u1ea9m (vi ph\u1ea1m \u0110i\u1ec1u 7, \u0110i\u1ec1u 2 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n), kh\u00f4ng cho ng\u01b0\u1eddi qu\u1ea3n l\u00fd th\u1ef1c hi\u1ec7n ki\u1ec3m tra th\u1eed nghi\u1ec7m d\u01b0\u1ee3c ph\u1ea9m d\u00f9 kh\u00f4ng c\u00f3 h\u1ed9p v\u00e0 t\u00e0i li\u1ec7u \u0111\u00ednh k\u00e8m t\u1ea1i th\u1eddi \u0111i\u1ec3m mua h\u00e0ng (vi ph\u1ea1m \u0110i\u1ec1u 9, \u0110i\u1ec1u 1 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n).<\/p>\n\n\n\n<p>Ngo\u00e0i ra, l\u1ec7nh c\u1ea3i thi\u1ec7n ho\u1ea1t \u0111\u1ed9ng kinh doanh \u0111\u00e3 \u0111\u01b0\u1ee3c ban h\u00e0nh \u0111\u1ed1i v\u1edbi 2 c\u1eeda h\u00e0ng \u0111\u00e3 nh\u1eadn h\u00e0ng gi\u1ea3 m\u1ea1o t\u1eeb c\u1eeda h\u00e0ng mua h\u00e0ng, li\u00ean quan \u0111\u1ebfn h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd d\u01b0\u1ee3c ph\u1ea9m v\u00e0 h\u1ec7 th\u1ed1ng gi\u00e1m s\u00e1t c\u1ee7a ng\u01b0\u1eddi m\u1edf hi\u1ec7u thu\u1ed1c.<\/p>\n\n\n\n<p>Tham kh\u1ea3o: <a href=\"https:\/\/www.mhlw.go.jp\/file\/04-Houdouhappyou-11126000-Iyakushokuhinkyoku-Kanshishidoumayakutaisakuka\/0000154073.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Ph\u1ea3n \u1ee9ng \u0111\u1ed1i v\u1edbi thu\u1ed1c \u0111i\u1ec1u tr\u1ecb vi\u00eam gan C &#8220;Harvoni&#8221; gi\u1ea3 m\u1ea1o \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n trong t\u1ec9nh (B\u00e1o c\u00e1o th\u1ee9 5) (T\u00e0i li\u1ec7u c\u00f4ng b\u1ed1 b\u00e1o ch\u00ed c\u1ee7a t\u1ec9nh Nara)[ja]<\/a><\/p>\n\n\n\n<p>Tham kh\u1ea3o: <a href=\"https:\/\/www.mhlw.go.jp\/file\/04-Houdouhappyou-11126000-Iyakushokuhinkyoku-Kanshishidoumayakutaisakuka\/170316_press_nara.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Ph\u1ea3n \u1ee9ng \u0111\u1ed1i v\u1edbi thu\u1ed1c \u0111i\u1ec1u tr\u1ecb vi\u00eam gan C &#8220;Harvoni&#8221; gi\u1ea3 m\u1ea1o \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n trong t\u1ec9nh (B\u00e1o c\u00e1o th\u1ee9 6) (T\u00e0i li\u1ec7u c\u00f4ng b\u1ed1 b\u00e1o ch\u00ed c\u1ee7a t\u1ec9nh Nara)[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Bien_phap_de_khong_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>Bi\u1ec7n ph\u00e1p \u0111\u1ec3 kh\u00f4ng vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Nh\u01b0 \u0111\u00e3 gi\u1edbi thi\u1ec7u \u0111\u1ebfn nay, n\u1ebfu vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, b\u1ea1n c\u00f3 th\u1ec3 ph\u1ea3i ch\u1ecbu h\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh, v\u00e0 th\u1ef1c t\u1ebf vi ph\u1ea1m lu\u1eadt c\u1ee7a c\u00f4ng ty v\u00e0 n\u1ed9i dung c\u1ee7a h\u00ecnh ph\u1ea1t h\u00e0nh ch\u00ednh c\u0169ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c c\u00f4ng khai. \u0110i\u1ec1u n\u00e0y kh\u00f4ng ch\u1ec9 g\u00e2y g\u00e1nh n\u1eb7ng v\u1ec1 m\u1eb7t t\u00e0i ch\u00ednh m\u00e0 c\u00f2n c\u00f3 th\u1ec3 l\u00e0m m\u1ea5t uy t\u00edn c\u1ee7a c\u00f4ng ty.<\/p>\n\n\n\n<p>V\u1eady th\u00ec, ch\u00fang ta n\u00ean th\u1ef1c hi\u1ec7n nh\u1eefng bi\u1ec7n ph\u00e1p n\u00e0o \u0111\u1ec3 kh\u00f4ng vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n?<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Xay_dung_huong_dan_noi_bo_cua_cong_ty\"><\/span>X\u00e2y d\u1ef1ng h\u01b0\u1edbng d\u1eabn n\u1ed9i b\u1ed9 c\u1ee7a c\u00f4ng ty<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>M\u1ed9t trong nh\u1eefng bi\u1ec7n ph\u00e1p l\u00e0 x\u00e2y d\u1ef1ng h\u01b0\u1edbng d\u1eabn n\u1ed9i b\u1ed9 c\u1ee7a c\u00f4ng ty. Ngo\u00e0i vi\u1ec7c x\u00e1c nh\u1eadn c\u00e1c \u0111i\u1ec1u kho\u1ea3n \u0111\u1ec3 bi\u1ebft h\u00e0nh vi n\u00e0o vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, c\u0169ng c\u1ea7n n\u1eafm b\u1eaft n\u1ed9i dung c\u1ee7a c\u00e1c h\u01b0\u1edbng d\u1eabn v\u00e0 th\u00f4ng b\u00e1o kh\u00e1c \u0111\u01b0\u1ee3c ph\u00e1t h\u00e0nh b\u1edfi B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n, nh\u01b0ng vi\u1ec7c hi\u1ec3u th\u00f4ng tin c\u1ea7n thi\u1ebft t\u1eeb nh\u1eefng ngu\u1ed3n n\u00e0y c\u00f3 th\u1ec3 t\u1ed1n nhi\u1ec1u c\u00f4ng s\u1ee9c.<\/p>\n\n\n\n<p>Do \u0111\u00f3, trong c\u00f4ng vi\u1ec7c c\u1ee7a c\u00f4ng ty, v\u1ec1 c\u00e1c \u0111i\u1ec3m c\u00f3 th\u1ec3 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, chia s\u1ebb c\u00e1ch th\u1ef1c hi\u1ec7n c\u00f4ng vi\u1ec7c nh\u01b0 th\u1ebf n\u00e0o d\u01b0\u1edbi d\u1ea1ng h\u01b0\u1edbng d\u1eabn n\u1ed9i b\u1ed9 c\u1ee7a c\u00f4ng ty v\u1edbi to\u00e0n b\u1ed9 nh\u00e2n vi\u00ean c\u00f3 th\u1ec3 gi\u00fap c\u1ea3nh b\u00e1o m\u1ecdi ng\u01b0\u1eddi v\u1ec1 vi\u1ec7c vi ph\u1ea1m lu\u1eadt.<\/p>\n\n\n\n<p>\u0110\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi qu\u1ea3ng c\u00e1o cho c\u00e1c s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m, kh\u00f4ng ch\u1ec9 c\u00e1c c\u00f4ng ty s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng m\u00e0 c\u1ea3 c\u00e1c nh\u00e0 qu\u1ea3ng c\u00e1o c\u0169ng c\u1ea7n ch\u00fa \u00fd \u0111\u1ec3 kh\u00f4ng vi ph\u1ea1m lu\u1eadt. N\u1ebfu b\u1ea1n c\u00f3 th\u1ec3 truy\u1ec1n \u0111\u1ea1t nh\u1eefng \u0111i\u1ec3m c\u1ea7n ch\u00fa \u00fd \u0111\u1ebfn c\u00e1c \u0111\u1ed1i t\u00e1c, kh\u1ea3 n\u0103ng vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n s\u1ebd gi\u1ea3m \u0111i.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tham_van_voi_luat_su\"><\/span>Tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Khi x\u00e2y d\u1ef1ng h\u01b0\u1edbng d\u1eabn, n\u1ebfu b\u1ea1n c\u1ea3m th\u1ea5y lo l\u1eafng v\u1ec1 vi\u1ec7c l\u1ef1a ch\u1ecdn th\u00f4ng tin c\u1ea7n tham kh\u1ea3o ho\u1eb7c n\u1ebfu h\u01b0\u1edbng d\u1eabn \u0111\u00e3 x\u00e2y d\u1ef1ng c\u00f3 \u0111\u1ee7 n\u1ed9i dung hay kh\u00f4ng, vi\u1ec7c tham v\u1ea5n v\u1edbi m\u1ed9t lu\u1eadt s\u01b0 am hi\u1ec3u v\u1ec1 Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n c\u0169ng r\u1ea5t quan tr\u1ecdng. M\u1eb7c d\u00f9 vi\u1ec7c x\u00e1c \u0111\u1ecbnh li\u1ec7u h\u00e0nh vi c\u00f3 b\u1ecb quy \u0111\u1ecbnh b\u1edfi Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n hay kh\u00f4ng l\u00e0 kh\u00f3 kh\u0103n, nh\u01b0ng b\u1ea1n c\u00f3 th\u1ec3 mong \u0111\u1ee3i l\u1eddi khuy\u00ean t\u1eeb g\u00f3c nh\u00ecn ph\u00e1p l\u00fd c\u1ee7a m\u1ed9t lu\u1eadt s\u01b0 d\u1ef1a tr\u00ean kinh nghi\u1ec7m trong qu\u00e1 kh\u1ee9.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tom_tat_Hay_thao_luan_voi_luat_su_ve_viec_kiem_tra_phap_ly_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_cua_Nhat_Ban_Japanese_Pharmaceutical_and_Medical_Device_Law\"><\/span>T\u00f3m t\u1eaft: H\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0 v\u1ec1 vi\u1ec7c ki\u1ec3m tra ph\u00e1p l\u00fd theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Law)<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=\"T\u00f3m t\u1eaft: N\u1ebfu b\u1ea1n g\u1eb7p r\u1eafc r\u1ed1i v\u1edbi Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n, h\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0\" class=\"wp-image-60056\" \/><\/figure>\n\n\n\n<p>C\u00f3 nh\u1eefng h\u00e0nh vi vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh r\u00f5 r\u00e0ng t\u1ea1i t\u1eebng c\u00f4ng ty, nh\u01b0ng c\u0169ng c\u00f3 nh\u1eefng tr\u01b0\u1eddng h\u1ee3p kh\u00f3 x\u00e1c \u0111\u1ecbnh l\u00e0 h\u1ee3p ph\u00e1p hay vi ph\u1ea1m ph\u00e1p lu\u1eadt t\u00f9y thu\u1ed9c v\u00e0o c\u00e1ch nh\u00ecn nh\u1eadn. N\u1ebfu b\u1ea1n lo l\u1eafng v\u1ec1 vi\u1ec7c c\u00f4ng vi\u1ec7c hi\u1ec7n t\u1ea1i ho\u1eb7c d\u1ef1 \u0111\u1ecbnh th\u1ef1c hi\u1ec7n trong t\u01b0\u01a1ng lai c\u00f3 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n hay kh\u00f4ng, kh\u00f4ng ch\u1ec9 vi\u1ec7c thi\u1ebft l\u1eadp h\u01b0\u1edbng d\u1eabn, h\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0.<\/p>\n\n\n\n<p>Vi\u1ec7c ki\u1ec3m tra ph\u00e1p l\u00fd v\u00e0 \u0111\u1ec1 xu\u1ea5t bi\u1ec3u di\u1ec5n vi\u1ebft l\u1ea1i theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n v\u00e0 c\u00e1c lu\u1eadt li\u00ean quan l\u00e0 m\u1ed9t l\u0129nh v\u1ef1c \u0111\u00f2i h\u1ecfi chuy\u00ean m\u00f4n cao. V\u0103n ph\u00f2ng lu\u1eadt s\u01b0 Monolith \u0111\u00e3 th\u00e0nh l\u1eadp \u0111\u1ed9i ng\u0169 ph\u00e1p l\u00fd chuy\u00ean v\u1ec1 Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Nh\u1eadt B\u1ea3n, \u0111\u00e1p \u1ee9ng vi\u1ec7c ki\u1ec3m tra b\u00e0i vi\u1ebft cho c\u00e1c s\u1ea3n ph\u1ea9m th\u01b0\u01a1ng m\u1ea1i t\u1eeb th\u1ef1c ph\u1ea9m b\u1ed5 sung \u0111\u1ebfn d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Gioi_thieu_ve_cac_bien_phap_cua_van_phong_luat_su_cua_chung_toi\"><\/span>Gi\u1edbi thi\u1ec7u v\u1ec1 c\u00e1c bi\u1ec7n ph\u00e1p c\u1ee7a v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u1ee7a ch\u00fang t\u00f4i<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>V\u0103n ph\u00f2ng lu\u1eadt s\u01b0 Monolith, l\u00e0 m\u1ed9t v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u00f3 kinh nghi\u1ec7m phong ph\u00fa v\u1ec1 c\u1ea3 hai m\u1eb7t c\u1ee7a IT, \u0111\u1eb7c bi\u1ec7t l\u00e0 Internet v\u00e0 lu\u1eadt ph\u00e1p. T\u1ea1i v\u0103n ph\u00f2ng c\u1ee7a ch\u00fang t\u00f4i, ch\u00fang t\u00f4i cung c\u1ea5p c\u00e1c d\u1ecbch v\u1ee5 nh\u01b0 ki\u1ec3m tra ph\u00e1p l\u00fd cho b\u00e0i vi\u1ebft v\u00e0 trang \u0111\u00edch, t\u1ea1o h\u01b0\u1edbng d\u1eabn v\u00e0 ki\u1ec3m tra m\u1eabu cho c\u00e1c nh\u00e0 \u0111i\u1ec1u h\u00e0nh truy\u1ec1n th\u00f4ng, nh\u00e0 \u0111i\u1ec1u h\u00e0nh trang web \u0111\u00e1nh gi\u00e1, \u0111\u1ea1i l\u00fd qu\u1ea3ng c\u00e1o, nh\u00e0 s\u1ea3n xu\u1ea5t D2C v\u00e0 m\u1ef9 ph\u1ea9m nh\u01b0 th\u1ef1c ph\u1ea9m b\u1ed5 sung, ph\u00f2ng kh\u00e1m, v\u00e0 c\u00e1c nh\u00e0 \u0111i\u1ec1u h\u00e0nh d\u1ecbch v\u1ee5 \u1ee9ng d\u1ee5ng. Chi ti\u1ebft \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 trong b\u00e0i vi\u1ebft d\u01b0\u1edbi \u0111\u00e2y.<\/p>\n\n\n\n<p>L\u0129nh v\u1ef1c ho\u1ea1t \u0111\u1ed9ng c\u1ee7a V\u0103n ph\u00f2ng lu\u1eadt s\u01b0 Monolith: <a href=\"https:\/\/Monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noreferrer noopener\">Ki\u1ec3m tra b\u00e0i vi\u1ebft &amp; trang \u0111\u00edch theo lu\u1eadt d\u01b0\u1ee3c ph\u1ea9m, v.v.[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, t\u1eeb tr\u01b0\u1edbc \u0111\u1ebfn nay \u0111\u00e3 quy \u0111\u1ecbnh c\u00e1c bi\u1ec7n ph\u00e1p h\u00e0nh ch\u00ednh nh\u01b0 l\u1ec7nh c\u1ea3i thi\u1ec7n c\u00f4ng vi\u1ec7c \u0111\u1ed1i v\u1edbi nh\u1eefng ng\u01b0\u1eddi kinh doanh s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9 [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":61010,"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\/vi\/wp-json\/wp\/v2\/posts\/59551"}],"collection":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/comments?post=59551"}],"version-history":[{"count":1,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/59551\/revisions"}],"predecessor-version":[{"id":61011,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/59551\/revisions\/61011"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media\/61010"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media?parent=59551"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/categories?post=59551"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/tags?post=59551"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}