{"id":58702,"date":"2023-10-06T11:22:18","date_gmt":"2023-10-06T02:22:18","guid":{"rendered":"https:\/\/monolith.law\/vi\/?p=58702"},"modified":"2023-10-19T10:00:45","modified_gmt":"2023-10-19T01:00:45","slug":"pharmaceutical-law-penalties","status":"publish","type":"post","link":"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties","title":{"rendered":"B\u1ecb b\u1eaft khi 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 h\u00ecnh ph\u1ea1t cho vi\u1ec7c 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;"},"content":{"rendered":"\n<p>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Act) quy \u0111\u1ecbnh nhi\u1ec1u quy t\u1eafc li\u00ean quan \u0111\u1ebfn d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf, n\u1ebfu vi ph\u1ea1m nh\u1eefng quy \u0111\u1ecbnh n\u00e0y, c\u00f3 th\u1ec3 b\u1ecb b\u1eaft gi\u1eef, ph\u1ea1t ti\u1ec1n ho\u1eb7c ph\u1ea1t n\u1ed9p, v\u00e0 doanh nghi\u1ec7p c\u00f3 th\u1ec3 ch\u1ecbu thi\u1ec7t h\u1ea1i l\u1edbn.<\/p>\n\n\n\n<p>V\u00ed d\u1ee5, kh\u00f4ng ch\u1ec9 ng\u01b0\u1eddi qu\u1ea3ng c\u00e1o m\u00e0 c\u1ea3 nh\u00e2n vi\u00ean c\u1ee7a c\u00e1c c\u00f4ng ty qu\u1ea3ng c\u00e1o v\u00e0 s\u1ea3n xu\u1ea5t qu\u1ea3ng c\u00e1o c\u0169ng c\u00f3 th\u1ec3 b\u1ecb b\u1eaft gi\u1eef do vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf trong qu\u1ea3ng c\u00e1o cho c\u00e1c s\u1ea3n ph\u1ea9m kh\u00f4ng ph\u1ea3i l\u00e0 d\u01b0\u1ee3c ph\u1ea9m. Ngay c\u1ea3 khi l\u00e0 th\u1ef1c ph\u1ea9m b\u1ed5 sung ho\u1eb7c th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng kh\u00f4ng ph\u1ea3i l\u00e0 d\u01b0\u1ee3c ph\u1ea9m, c\u0169ng c\u00f3 th\u1ec3 tr\u1edf th\u00e0nh \u0111\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf trong bi\u1ec3u hi\u1ec7n qu\u1ea3ng c\u00e1o c\u1ee7a ch\u00fang.<\/p>\n\n\n\n<p>B\u00e0i vi\u1ebft n\u00e0y s\u1ebd gi\u1ea3i th\u00edch v\u1ec1 nh\u1eefng h\u00e0nh vi n\u00e0o vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, h\u00ecnh ph\u1ea1t n\u00e0o \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh, v\u00e0 c\u00e1ch tr\u00e1nh vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf.<\/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\/pharmaceutical-law-penalties\/#Luat_Duoc_pham_va_Thiet_bi_y_te_la_gi\" title=\"Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 g\u00ec?\">Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf 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-2\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Truong_hop_nao_se_bi_bat_giu\" title=\"Tr\u01b0\u1eddng h\u1ee3p n\u00e0o s\u1ebd b\u1ecb b\u1eaft gi\u1eef?\">Tr\u01b0\u1eddng h\u1ee3p n\u00e0o s\u1ebd b\u1ecb b\u1eaft gi\u1eef?<\/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\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Ly_do_bat_giu\" title=\"L\u00fd do b\u1eaft gi\u1eef\">L\u00fd do b\u1eaft gi\u1eef<\/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\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Su_can_thiet_cua_viec_bat_giu\" title=\"S\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a vi\u1ec7c b\u1eaft gi\u1eef\">S\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a vi\u1ec7c b\u1eaft gi\u1eef<\/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\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Vi_du_ve_hanh_vi_vi_pham_va_hinh_phat_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"V\u00ed d\u1ee5 v\u1ec1 h\u00e0nh vi vi ph\u1ea1m v\u00e0 h\u00ecnh ph\u1ea1t theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\">V\u00ed d\u1ee5 v\u1ec1 h\u00e0nh vi vi ph\u1ea1m v\u00e0 h\u00ecnh ph\u1ea1t theo 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\/pharmaceutical-law-penalties\/#Hoi_lo_trong_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"H\u1ed1i l\u1ed9 trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\">H\u1ed1i l\u1ed9 trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf 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\/pharmaceutical-law-penalties\/#San_xuat_va_ban_hang_khong_co_giay_phep\" title=\"S\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p\">S\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Vi_pham_quy_dinh_ve_duoc_pham_chi_dinh\" title=\"Vi ph\u1ea1m quy \u0111\u1ecbnh v\u1ec1 d\u01b0\u1ee3c ph\u1ea9m ch\u1ec9 \u0111\u1ecbnh\">Vi ph\u1ea1m quy \u0111\u1ecbnh v\u1ec1 d\u01b0\u1ee3c ph\u1ea9m ch\u1ec9 \u0111\u1ecbnh<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Trinh_bay_sai_su_that_hoac_phong_dai_trong_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"Tr\u00ecnh b\u00e0y sai s\u1ef1 th\u1eadt ho\u1eb7c ph\u00f3ng \u0111\u1ea1i trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\">Tr\u00ecnh b\u00e0y sai s\u1ef1 th\u1eadt ho\u1eb7c ph\u00f3ng \u0111\u1ea1i trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Vi_du_ve_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"V\u00ed d\u1ee5 v\u1ec1 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\">V\u00ed d\u1ee5 v\u1ec1 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-11\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Vi_du_ve_viec_ban_khong_co_giay_phep_bo_kit_kiem_tra_khang_nguyen_virus_Corona_moi\" title=\"V\u00ed d\u1ee5 v\u1ec1 vi\u1ec7c b\u00e1n kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p b\u1ed9 kit ki\u1ec3m tra kh\u00e1ng nguy\u00ean virus Corona m\u1edbi\">V\u00ed d\u1ee5 v\u1ec1 vi\u1ec7c b\u00e1n kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p b\u1ed9 kit ki\u1ec3m tra kh\u00e1ng nguy\u00ean virus Corona m\u1edbi<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Vi_du_ve_viec_quang_cao_thuc_pham_bo_sung_vi_pham_lenh_cam_quang_cao_duoc_pham_chua_duoc_chap_thuan\" title=\"V\u00ed d\u1ee5 v\u1ec1 vi\u1ec7c qu\u1ea3ng c\u00e1o th\u1ef1c ph\u1ea9m b\u1ed5 sung vi ph\u1ea1m l\u1ec7nh c\u1ea5m qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn\">V\u00ed d\u1ee5 v\u1ec1 vi\u1ec7c qu\u1ea3ng c\u00e1o th\u1ef1c ph\u1ea9m b\u1ed5 sung vi ph\u1ea1m l\u1ec7nh c\u1ea5m qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#De_phong_tranh_bi_bat_giu_vi_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"\u0110\u1ec3 ph\u00f2ng tr\u00e1nh b\u1ecb b\u1eaft gi\u1eef v\u00ec vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\">\u0110\u1ec3 ph\u00f2ng tr\u00e1nh b\u1ecb b\u1eaft gi\u1eef v\u00ec 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-14\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Kiem_tra_noi_dung_cap_phep_va_chap_thuan_huong_dan\" title=\"Ki\u1ec3m tra n\u1ed9i dung c\u1ea5p ph\u00e9p v\u00e0 ch\u1ea5p thu\u1eadn, h\u01b0\u1edbng d\u1eabn\">Ki\u1ec3m tra n\u1ed9i dung c\u1ea5p ph\u00e9p v\u00e0 ch\u1ea5p thu\u1eadn, h\u01b0\u1edbng d\u1eabn<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Tao_huong_dan_su_dung\" title=\"T\u1ea1o h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng\">T\u1ea1o h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Tu_van_voi_luat_su\" title=\"T\u01b0 v\u1ea5n v\u1edbi lu\u1eadt s\u01b0\">T\u01b0 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-17\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Tom_tat_Neu_gap_rac_roi_voi_Luat_Duoc_pham_va_Thiet_bi_y_te_hay_tham_van_voi_luat_su\" title=\"T\u00f3m t\u1eaft: N\u1ebfu g\u1eb7p r\u1eafc r\u1ed1i v\u1edbi Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, h\u00e3y tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0\">T\u00f3m t\u1eaft: N\u1ebfu g\u1eb7p r\u1eafc r\u1ed1i v\u1edbi Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, h\u00e3y tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-law-penalties\/#Huong_dan_cac_bien_phap_cua_van_phong_luat_su_cua_chung_toi\" title=\"H\u01b0\u1edbng d\u1eabn c\u00e1c bi\u1ec7n ph\u00e1p c\u1ee7a v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u1ee7a ch\u00fang t\u00f4i\">H\u01b0\u1edbng d\u1eabn 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=\"Luat_Duoc_pham_va_Thiet_bi_y_te_la_gi\"><\/span>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 g\u00ec?<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, hay c\u00f2n g\u1ecdi l\u00e0 &#8220;Lu\u1eadt v\u1ec1 vi\u1ec7c \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, v.v.&#8221;, l\u00e0 m\u1ed9t lu\u1eadt \u0111\u01b0\u1ee3c ban h\u00e0nh nh\u1eb1m \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng, hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf, c\u0169ng nh\u01b0 c\u1ea3i thi\u1ec7n s\u1ee9c kh\u1ecfe c\u00f4ng c\u1ed9ng. Tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i v\u00e0o n\u0103m 2013 (n\u0103m 25 c\u1ee7a th\u1eddi k\u1ef3 Heisei), lu\u1eadt n\u00e0y \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m&#8221;, do \u0111\u00f3 c\u00f3 th\u1ec3 c\u00f3 ng\u01b0\u1eddi quen thu\u1ed9c h\u01a1n v\u1edbi t\u00ean g\u1ecdi c\u0169.<\/p>\n\n\n\n<p>D\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 nhi\u1ec1u l\u1ee3i \u00edch cho s\u1ee9c kh\u1ecfe con ng\u01b0\u1eddi. Tuy nhi\u00ean, do ch\u00fang c\u00f3 th\u1ec3 t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn c\u01a1 th\u1ec3 con ng\u01b0\u1eddi, n\u1ebfu ch\u00fang \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng m\u00e0 kh\u00f4ng \u0111\u1ea3m b\u1ea3o hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n, ch\u00fang c\u00f3 th\u1ec3 g\u00e2y h\u1ea1i cho s\u1ee9c kh\u1ecfe v\u00e0 \u0111e d\u1ecda \u0111\u1ebfn t\u00ednh m\u1ea1ng.<\/p>\n\n\n\n<p>Do \u0111\u00f3, Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1eb7t ra c\u00e1c quy \u0111\u1ecbnh nghi\u00eam ng\u1eb7t nh\u01b0 c\u1ea5m qu\u1ea3ng c\u00e1o sai l\u1ec7ch ho\u1eb7c ph\u00f3ng \u0111\u1ea1i, c\u1ea5m s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p, nh\u1eb1m ng\u0103n ch\u1eb7n t\u00e1c \u0111\u1ed9ng ti\u00eau c\u1ef1c \u0111\u1ebfn c\u01a1 th\u1ec3 con ng\u01b0\u1eddi v\u00e0 b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe v\u00e0 an to\u00e0n c\u1ee7a ng\u01b0\u1eddi d\u00e2n.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Truong_hop_nao_se_bi_bat_giu\"><\/span>Tr\u01b0\u1eddng h\u1ee3p n\u00e0o s\u1ebd b\u1ecb b\u1eaft gi\u1eef?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh6.googleusercontent.com\/P9beKdAuMx_wBm9mzqy_1G0QUjQBKb7S14zcRQGeD6pepJW1en27LUyEfA7EZ6WgLDGu9YFSPCJ_P3vwoBkkm6l604B0sWE1bc8boh7aeu40yi5Ixt5zXQTgrdCACidsGePoeI346bLj3sI5-sGsj6bnVHVWGgnNx1Czaa_n9EMxCzZEIL-zK0OqBQ0onQ\" alt=\"Tr\u01b0\u1eddng h\u1ee3p n\u00e0o s\u1ebd b\u1ecb b\u1eaft gi\u1eef?\" \/><\/figure>\n\n\n\n<p>C\u1ee5m t\u1eeb &#8220;Vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (Japanese Pharmaceutical and Medical Device Act) s\u1ebd b\u1ecb b\u1eaft gi\u1eef&#8221; kh\u00f4ng ch\u00ednh x\u00e1c. \u0110\u1ea7u ti\u00ean, &#8220;b\u1eaft gi\u1eef&#8221; kh\u00f4ng ph\u1ea3i l\u00e0 h\u00ecnh ph\u1ea1t quy \u0111\u1ecbnh trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, m\u00e0 l\u00e0 m\u1ed9t bi\u1ec7n ph\u00e1p giam gi\u1eef theo Lu\u1eadt T\u1ed1 t\u1ee5ng h\u00ecnh s\u1ef1 (Japanese Code of Criminal Procedure), c\u00f3 th\u1ec3 \u00e1p d\u1ee5ng cho b\u1ea5t k\u1ef3 ai ph\u1ea1m t\u1ed9i, kh\u00f4ng ch\u1ec9 ri\u00eang vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<p>C\u00f3 ba lo\u1ea1i b\u1eaft gi\u1eef: b\u1eaft gi\u1eef t\u1ea1i ch\u1ed7, b\u1eaft gi\u1eef th\u00f4ng th\u01b0\u1eddng v\u00e0 b\u1eaft gi\u1eef kh\u1ea9n c\u1ea5p. Trong tr\u01b0\u1eddng h\u1ee3p vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 b\u1ecb b\u1eaft gi\u1eef, ng\u01b0\u1eddi ta th\u01b0\u1eddng ngh\u0129 \u0111\u1ebfn vi\u1ec7c b\u1eaft gi\u1eef th\u00f4ng th\u01b0\u1eddng ho\u1eb7c b\u1eaft gi\u1eef kh\u1ea9n c\u1ea5p.<\/p>\n\n\n\n<p>\u0110\u1ed1i v\u1edbi vi\u1ec7c b\u1eaft gi\u1eef th\u00f4ng th\u01b0\u1eddng (theo \u0110i\u1ec1u 199, Kho\u1ea3n 1 c\u1ee7a Lu\u1eadt T\u1ed1 t\u1ee5ng h\u00ecnh s\u1ef1) v\u00e0 b\u1eaft gi\u1eef kh\u1ea9n c\u1ea5p (theo \u0110i\u1ec1u 210, Kho\u1ea3n 1 c\u1ee7a Lu\u1eadt T\u1ed1 t\u1ee5ng h\u00ecnh s\u1ef1), c\u1ea7n c\u00f3 l\u1ec7nh b\u1eaft gi\u1eef. \u0110\u1ec3 c\u00f3 l\u1ec7nh b\u1eaft gi\u1eef, c\u1ea7n ph\u1ea3i c\u00f4ng nh\u1eadn l\u00fd do v\u00e0 s\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a vi\u1ec7c b\u1eaft gi\u1eef (theo \u0110i\u1ec1u 199, Kho\u1ea3n 2 c\u1ee7a Lu\u1eadt T\u1ed1 t\u1ee5ng h\u00ecnh s\u1ef1 v\u00e0 \u0110i\u1ec1u 143, Kho\u1ea3n 3 c\u1ee7a Quy t\u1eafc T\u1ed1 t\u1ee5ng h\u00ecnh s\u1ef1).<\/p>\n\n\n\n<p>V\u00ec v\u1eady, c\u1ee5m t\u1eeb ch\u00ednh x\u00e1c l\u00e0 &#8220;N\u1ebfu vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 c\u00f3 l\u00fd do ho\u1eb7c c\u1ea7n thi\u1ebft \u0111\u1ec3 b\u1eaft gi\u1eef, b\u1ea1n s\u1ebd b\u1ecb b\u1eaft gi\u1eef&#8221;.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ly_do_bat_giu\"><\/span>L\u00fd do b\u1eaft gi\u1eef<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>L\u00fd do b\u1eaft gi\u1eef l\u00e0 &#8220;c\u00f3 \u0111\u1ee7 l\u00fd do \u0111\u1ec3 nghi ng\u1edd \u0111\u00e3 ph\u1ea1m t\u1ed9i&#8221; (theo \u0110i\u1ec1u 199, Kho\u1ea3n 2 c\u1ee7a Lu\u1eadt T\u1ed1 t\u1ee5ng h\u00ecnh s\u1ef1). Ch\u1ec9 c\u00f3 kh\u1ea3 n\u0103ng ph\u1ea1m m\u1ed9t t\u1ed9i c\u1ee5 th\u1ec3 kh\u00f4ng \u0111\u1ee7, nh\u01b0ng n\u1ebfu c\u00f3 nghi ng\u1edd \u0111\u00e1ng k\u1ec3, ngay c\u1ea3 khi ch\u01b0a \u0111\u1ea1t \u0111\u1ebfn m\u1ee9c ch\u1eafc ch\u1eafn, l\u00fd do b\u1eaft gi\u1eef s\u1ebd \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn.<\/p>\n\n\n\n<p>N\u1ebfu b\u1ea1n \u0111\u00e3 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, r\u00f5 r\u00e0ng l\u00e0 b\u1ea1n \u0111\u00e3 ph\u1ea1m t\u1ed9i, v\u00ec v\u1eady l\u00fd do b\u1eaft gi\u1eef s\u1ebd \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn m\u1ed9t c\u00e1ch t\u1ef1 nhi\u00ean.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Su_can_thiet_cua_viec_bat_giu\"><\/span>S\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a vi\u1ec7c b\u1eaft gi\u1eef<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>N\u1ebfu l\u00fd do b\u1eaft gi\u1eef \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn, v\u1edbi vi\u1ec7c c\u00f3 \u0111\u1ee7 l\u00fd do \u0111\u1ec3 nghi ng\u1edd r\u1eb1ng ng\u01b0\u1eddi \u0111\u00f3 \u0111\u00e3 ph\u1ea1m t\u1ed9i, b\u1ea1n c\u00f3 th\u1ec3 ngh\u0129 r\u1eb1ng vi\u1ec7c b\u1eaft gi\u1eef ngay l\u1eadp t\u1ee9c l\u00e0 h\u1ee3p l\u00fd. Tuy nhi\u00ean, vi\u1ec7c b\u1eaft gi\u1eef, v\u1edbi vi\u1ec7c giam gi\u1eef ng\u01b0\u1eddi \u0111\u00f3, c\u00f3 nguy c\u01a1 vi ph\u1ea1m quy\u1ec1n con ng\u01b0\u1eddi m\u1ed9t c\u00e1ch kh\u00f4ng c\u00f4ng b\u1eb1ng, v\u00ec v\u1eady s\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a vi\u1ec7c b\u1eaft gi\u1eef c\u0169ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u.<\/p>\n\n\n\n<p>Theo \u0110i\u1ec1u 143, Kho\u1ea3n 3 c\u1ee7a Quy t\u1eafc T\u1ed1 t\u1ee5ng h\u00ecnh s\u1ef1, n\u1ebfu kh\u00f4ng c\u00f3 nguy c\u01a1 ng\u01b0\u1eddi b\u1ecb nghi ng\u1edd s\u1ebd tr\u1ed1n tr\u00e1nh v\u00e0 kh\u00f4ng c\u00f3 nguy c\u01a1 &#8220;ti\u00eau di\u1ec7t ch\u1ee9ng c\u1ee9 t\u1ed9i ph\u1ea1m&#8221;, d\u1ef1a tr\u00ean tu\u1ed5i t\u00e1c v\u00e0 ho\u00e0n c\u1ea3nh c\u1ee7a ng\u01b0\u1eddi b\u1ecb nghi ng\u1edd c\u0169ng nh\u01b0 m\u1ee9c \u0111\u1ed9 nghi\u00eam tr\u1ecdng v\u00e0 t\u00ecnh hu\u1ed1ng c\u1ee7a t\u1ed9i ph\u1ea1m v\u00e0 c\u00e1c t\u00ecnh hu\u1ed1ng kh\u00e1c, th\u00ec kh\u00f4ng c\u1ea7n thi\u1ebft ph\u1ea3i b\u1eaft gi\u1eef.<\/p>\n\n\n\n<p>&#8220;Ch\u1ee9ng c\u1ee9 t\u1ed9i ph\u1ea1m&#8221; n\u00f3i m\u1ed9t c\u00e1ch \u0111\u01a1n gi\u1ea3n, c\u00f3 ngh\u0129a l\u00e0 ch\u1ee9ng c\u1ee9 li\u00ean quan \u0111\u1ebfn t\u1ed9i ph\u1ea1m. V\u00ed d\u1ee5, n\u1ebfu vi ph\u1ea1m quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, d\u1eef li\u1ec7u qu\u1ea3ng c\u00e1o \u0111\u00e3 s\u1eed d\u1ee5ng, trang web \u0111\u00e3 \u0111\u0103ng, v.v., ho\u1eb7c n\u1ebfu s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n thu\u1ed1c kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p, thu\u1ed1c \u0111\u00e3 s\u1ea3n xu\u1ea5t, bi\u00ean lai b\u00e1n h\u00e0ng, v.v. s\u1ebd l\u00e0 ch\u1ee9ng c\u1ee9 t\u1ed9i ph\u1ea1m.<\/p>\n\n\n\n<p>Nguy c\u01a1 tr\u1ed1n tr\u00e1nh v\u00e0 ti\u00eau di\u1ec7t ch\u1ee9ng c\u1ee9 t\u1ed9i ph\u1ea1m ch\u1ec9 l\u00e0 v\u00ed d\u1ee5, v\u00e0 c\u00f3 nh\u1eefng y\u1ebfu t\u1ed1 kh\u00e1c c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c xem l\u00e0 kh\u00f4ng c\u1ea7n thi\u1ebft \u0111\u1ec3 b\u1eaft gi\u1eef, nh\u01b0ng \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 ng\u01b0\u1eddi ra l\u1ec7nh b\u1eaft gi\u1eef l\u00e0 th\u1ea9m ph\u00e1n. D\u00f9 b\u1ea1n kh\u00f4ng c\u00f3 \u00fd \u0111\u1ecbnh tr\u1ed1n tr\u00e1nh hay ti\u00eau di\u1ec7t ch\u1ee9ng c\u1ee9 t\u1ed9i ph\u1ea1m, n\u1ebfu x\u00e9t \u0111\u1ebfn m\u1ee9c \u0111\u1ed9 nghi\u00eam tr\u1ecdng c\u1ee7a t\u1ed9i ph\u1ea1m v\u00e0 ch\u1ee9ng c\u1ee9 c\u00f2n l\u1ea1i, v\u00e0 quy\u1ebft \u0111\u1ecbnh r\u1eb1ng vi\u1ec7c b\u1eaft gi\u1eef l\u00e0 c\u1ea7n thi\u1ebft, l\u1ec7nh b\u1eaft gi\u1eef s\u1ebd \u0111\u01b0\u1ee3c ph\u00e1t h\u00e0nh v\u00e0 b\u1ea1n s\u1ebd b\u1ecb b\u1eaft gi\u1eef.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vi_du_ve_hanh_vi_vi_pham_va_hinh_phat_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>V\u00ed d\u1ee5 v\u1ec1 h\u00e0nh vi vi ph\u1ea1m v\u00e0 h\u00ecnh ph\u1ea1t theo 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\"><img decoding=\"async\" src=\"https:\/\/lh4.googleusercontent.com\/l6A2sj-9ZzoTyhGb0NEaMBV7cFqb-6mrf907WO176CyLNUxxp7j7sI736Sl8jJqf9HBTDztRNG_Z3DRa7kGF7NJeyhwAfNemUE-dMhjClgUnkPvz2xFCkWofKvjBPU_kQqc2UtF_Vxp_fYQ5hTeNifR5sdhmaJGqTOU2f_EEQDLf78sw6Ow1zvt9-1kS0g\" alt=\"V\u00ed d\u1ee5 v\u1ec1 h\u00e0nh vi vi ph\u1ea1m v\u00e0 h\u00ecnh ph\u1ea1t theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\" \/><\/figure>\n\n\n\n<p>V\u1eady th\u00ec, h\u00e0nh vi n\u00e0o \u0111\u01b0\u1ee3c coi l\u00e0 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n? D\u01b0\u1edbi \u0111\u00e2y, ch\u00fang t\u00f4i s\u1ebd gi\u1edbi thi\u1ec7u v\u1ec1 c\u00e1c v\u00ed d\u1ee5 v\u1ec1 h\u00e0nh vi vi ph\u1ea1m v\u00e0 h\u00ecnh ph\u1ea1t t\u01b0\u01a1ng \u1ee9ng.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Hoi_lo_trong_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>H\u1ed1i l\u1ed9 trong 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><\/h3>\n\n\n\n<p>\u0110\u1ed1i v\u1edbi vi\u1ec7c h\u1ed1i l\u1ed9 c\u00e1c c\u00e1n b\u1ed9 v\u00e0 nh\u00e2n vi\u00ean c\u1ee7a c\u01a1 quan ch\u1ee9ng nh\u1eadn tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n, h\u00ecnh ph\u1ea1t n\u1eb7ng nh\u1ea5t l\u00e0 t\u00f9 giam l\u00ean \u0111\u1ebfn 7 n\u0103m (\u0110i\u1ec1u 83-6 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>\u0110\u1ed1i v\u1edbi nh\u1eefng ng\u01b0\u1eddi \u0111\u00f3ng vai tr\u00f2 quan tr\u1ecdng trong vi\u1ec7c ch\u1ee9ng nh\u1eadn s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m, vi\u1ec7c h\u1ed1i l\u1ed9 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn vi\u1ec7c l\u01b0u th\u00f4ng c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m nguy hi\u1ec3m, g\u00e2y ra h\u1eadu qu\u1ea3 nghi\u00eam tr\u1ecdng, do \u0111\u00f3, h\u00ecnh ph\u1ea1t nghi\u00eam kh\u1eafc nh\u01b0 v\u1eady \u0111\u00e3 \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"San_xuat_va_ban_hang_khong_co_giay_phep\"><\/span>S\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0110\u1ec3 ho\u1ea1t \u0111\u1ed9ng kinh doanh s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng d\u01b0\u1ee3c ph\u1ea9m, b\u1ea1n c\u1ea7n ph\u1ea3i nh\u1eadn \u0111\u01b0\u1ee3c s\u1ef1 cho ph\u00e9p c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Lao \u0111\u1ed9ng, S\u1ee9c kh\u1ecfe v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n (\u0110i\u1ec1u 12 v\u00e0 \u0110i\u1ec1u 13 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n). N\u1ebfu vi ph\u1ea1m, b\u1ea1n c\u00f3 th\u1ec3 b\u1ecb ph\u1ea1t t\u00f9 d\u01b0\u1edbi 3 n\u0103m ho\u1eb7c ph\u1ea1t ti\u1ec1n d\u01b0\u1edbi 3 tri\u1ec7u y\u00ean, ho\u1eb7c c\u1ea3 hai (\u0110i\u1ec1u 84-2 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n), n\u1ebfu ho\u1ea1t \u0111\u1ed9ng s\u1ea3n xu\u1ea5t, b\u1ea1n c\u00f3 th\u1ec3 b\u1ecb ph\u1ea1t t\u00f9 d\u01b0\u1edbi 1 n\u0103m ho\u1eb7c ph\u1ea1t ti\u1ec1n d\u01b0\u1edbi 1 tri\u1ec7u y\u00ean, ho\u1eb7c c\u1ea3 hai (\u0110i\u1ec1u 86-1-2 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<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vi_pham_quy_dinh_ve_duoc_pham_chi_dinh\"><\/span>Vi ph\u1ea1m quy \u0111\u1ecbnh v\u1ec1 d\u01b0\u1ee3c ph\u1ea9m ch\u1ec9 \u0111\u1ecbnh<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>D\u01b0\u1ee3c ph\u1ea9m ch\u1ec9 \u0111\u1ecbnh l\u00e0 nh\u1eefng ch\u1ea5t c\u00f3 kh\u1ea3 n\u0103ng g\u00e2y nghi\u1ec7n tinh th\u1ea7n cao v\u00e0 c\u00f3 th\u1ec3 g\u00e2y h\u1ea1i cho s\u1ee9c kh\u1ecfe c\u00f4ng c\u1ed9ng khi \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u01a1 th\u1ec3 con ng\u01b0\u1eddi, \u0111\u01b0\u1ee3c B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Lao \u0111\u1ed9ng, S\u1ee9c kh\u1ecfe v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n ch\u1ec9 \u0111\u1ecbnh (\u0110i\u1ec1u 2-15 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n). C\u00e1c lo\u1ea1i ma t\u00fay nguy hi\u1ec3m v\u00e0 ma t\u00fay l\u1eadu, mi\u1ec5n l\u00e0 ch\u00fang \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch h\u1ee3p ph\u00e1p, v\u1eabn c\u00f3 \u00edch, do \u0111\u00f3, kh\u00f4ng th\u1ec3 c\u1ea5m ho\u00e0n to\u00e0n. Do \u0111\u00f3, vi\u1ec7c ch\u1ec9 \u0111\u1ecbnh nh\u01b0 m\u1ed9t d\u01b0\u1ee3c ph\u1ea9m ch\u1ec9 \u0111\u1ecbnh \u0111\u00e3 c\u1ea5m vi\u1ec7c s\u1ea3n xu\u1ea5t, nh\u1eadp kh\u1ea9u, b\u00e1n h\u00e0ng, s\u1edf h\u1eefu, v.v. cho m\u1ee5c \u0111\u00edch kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ee5c \u0111\u00edch h\u1ee3p ph\u00e1p (\u0110i\u1ec1u 76-4 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>H\u00ecnh ph\u1ea1t cho vi\u1ec7c vi ph\u1ea1m c\u00e1c quy \u0111\u1ecbnh c\u1ea5m n\u00e0y, n\u1ebfu ho\u1ea1t \u0111\u1ed9ng s\u1ea3n xu\u1ea5t, v.v. l\u00e0 m\u1ed9t ng\u00e0nh ngh\u1ec1, b\u1ea1n c\u00f3 th\u1ec3 b\u1ecb ph\u1ea1t t\u00f9 d\u01b0\u1edbi 5 n\u0103m ho\u1eb7c ph\u1ea1t ti\u1ec1n d\u01b0\u1edbi 5 tri\u1ec7u y\u00ean, ho\u1eb7c c\u1ea3 hai (\u0110i\u1ec1u 83-9 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n), n\u1ebfu kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t ng\u00e0nh ngh\u1ec1, b\u1ea1n c\u00f3 th\u1ec3 b\u1ecb ph\u1ea1t t\u00f9 d\u01b0\u1edbi 3 n\u0103m ho\u1eb7c ph\u1ea1t ti\u1ec1n d\u01b0\u1edbi 3 tri\u1ec7u y\u00ean, ho\u1eb7c c\u1ea3 hai (\u0110i\u1ec1u 84-28 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<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Trinh_bay_sai_su_that_hoac_phong_dai_trong_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>Tr\u00ecnh b\u00e0y sai s\u1ef1 th\u1eadt ho\u1eb7c ph\u00f3ng \u0111\u1ea1i trong 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><\/h3>\n\n\n\n<p>V\u00ec d\u01b0\u1ee3c ph\u1ea9m li\u00ean quan \u0111\u1ebfn l\u1ee3i \u00edch quan tr\u1ecdng c\u1ee7a s\u1ee9c kh\u1ecfe c\u00e1 nh\u00e2n, n\u1ebfu c\u00f3 s\u1ef1 sai s\u1ef1 th\u1eadt ho\u1eb7c ph\u00f3ng \u0111\u1ea1i trong n\u1ed9i dung qu\u1ea3ng c\u00e1o, c\u00f3 th\u1ec3 g\u00e2y ra h\u1ea1i nghi\u00eam tr\u1ecdng cho s\u1ee9c kh\u1ecfe c\u00f4ng c\u1ed9ng. Do \u0111\u00f3, Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n c\u1ea5m vi\u1ec7c qu\u1ea3ng c\u00e1o b\u1eb1ng c\u00e1ch tr\u00ecnh b\u00e0y sai s\u1ef1 th\u1eadt ho\u1eb7c ph\u00f3ng \u0111\u1ea1i (\u0110i\u1ec1u 66-1 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>N\u1ebfu vi ph\u1ea1m, b\u1ea1n c\u00f3 th\u1ec3 b\u1ecb ph\u1ea1t t\u00f9 d\u01b0\u1edbi 2 n\u0103m ho\u1eb7c ph\u1ea1t ti\u1ec1n d\u01b0\u1edbi 2 tri\u1ec7u y\u00ean, ho\u1eb7c c\u1ea3 hai (\u0110i\u1ec1u 85-4 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, do s\u1eeda \u0111\u1ed5i Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n v\u00e0o n\u0103m 2019 (n\u0103m 1 c\u1ee7a th\u1eddi k\u1ef3 Reiwa), h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n \u0111\u00e3 \u0111\u01b0\u1ee3c gi\u1edbi thi\u1ec7u, do \u0111\u00f3, ngo\u00e0i h\u00ecnh ph\u1ea1t tr\u00ean, b\u1ea1n c\u0169ng c\u00f3 th\u1ec3 b\u1ecb bu\u1ed9c ph\u1ea3i n\u1ed9p ph\u1ea1t ti\u1ec1n (\u0110i\u1ec1u 75-5-2 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>V\u1ec1 h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n, 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\/corporate\/pharmaceuticals-law-surcharge\" 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 b\u1ecb ph\u1ea1t v\u00e0 tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c gi\u1ea3m ph\u1ea1t[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vi_du_ve_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>V\u00ed d\u1ee5 v\u1ec1 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\"><img decoding=\"async\" src=\"https:\/\/lh6.googleusercontent.com\/egI2EU7rFLc4zGOz3E1suVDwI-4yW0i9dfW4QJa8xMj_SrgkixK1r4onlcZkXpqOg_COSejSkM5K-IiZOJY3MSFxochawZIGlaARvXMT3xwigvYMgX1Pgi-feGqLsBw6epc-GOZjhKHW40LTpzgGLpvyIje2Gfpdp0PURRFEB7k3rnjQ8NBIiWE1kFi8Cg\" alt=\"V\u00ed d\u1ee5 v\u1ec1 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vi_du_ve_viec_ban_khong_co_giay_phep_bo_kit_kiem_tra_khang_nguyen_virus_Corona_moi\"><\/span>V\u00ed d\u1ee5 v\u1ec1 vi\u1ec7c b\u00e1n kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p b\u1ed9 kit ki\u1ec3m tra kh\u00e1ng nguy\u00ean virus Corona m\u1edbi<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>T\u1eeb kho\u1ea3ng n\u0103m 2020 (n\u0103m th\u1ee9 2 c\u1ee7a th\u1eddi k\u1ef3 Reiwa), trong c\u00e1c v\u00ed d\u1ee5 li\u00ean quan \u0111\u1ebfn virus Corona m\u1edbi \u0111ang l\u00e2y lan, v\u00e0o th\u00e1ng 9 n\u0103m 2021 (n\u0103m th\u1ee9 3 c\u1ee7a th\u1eddi k\u1ef3 Reiwa), nh\u1eefng ng\u01b0\u1eddi \u0111\u00e3 qu\u1ea3ng c\u00e1o v\u00e0 b\u00e1n b\u1ed9 kit ki\u1ec3m tra kh\u00e1ng nguy\u00ean virus Corona m\u1edbi m\u00e0 kh\u00f4ng c\u00f3 s\u1ef1 ch\u1ea5p thu\u1eadn c\u1ee7a B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n \u0111\u00e3 b\u1ecb b\u1eaft.<\/p>\n\n\n\n<p>Trong v\u1ee5 vi\u1ec7c n\u00e0y, v\u1ea5n \u0111\u1ec1 kh\u00f4ng ch\u1ec9 l\u00e0 vi\u1ec7c b\u00e1n kh\u00f4ng c\u00f3 gi\u1ea5y ph\u00e9p b\u1ed9 kit ki\u1ec3m tra kh\u00e1ng nguy\u00ean, m\u00e0 c\u00f2n l\u00e0 vi ph\u1ea1m l\u1ec7nh c\u1ea5m qu\u1ea3ng c\u00e1o c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i (\u0110i\u1ec1u 68 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>Hai ng\u01b0\u1eddi b\u1ecb b\u1eaft \u0111\u00e3 nh\u1eadn l\u1ec7nh ph\u1ea1t ti\u1ec1n t\u00f3m t\u1eaft v\u00e0o th\u00e1ng 2 n\u0103m 2022 (n\u0103m th\u1ee9 4 c\u1ee7a th\u1eddi k\u1ef3 Reiwa).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vi_du_ve_viec_quang_cao_thuc_pham_bo_sung_vi_pham_lenh_cam_quang_cao_duoc_pham_chua_duoc_chap_thuan\"><\/span>V\u00ed d\u1ee5 v\u1ec1 vi\u1ec7c qu\u1ea3ng c\u00e1o th\u1ef1c ph\u1ea9m b\u1ed5 sung vi ph\u1ea1m l\u1ec7nh c\u1ea5m qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>V\u00e0o th\u00e1ng 7 n\u0103m 2020 (n\u0103m th\u1ee9 2 c\u1ee7a th\u1eddi k\u1ef3 Reiwa), c\u00f4ng ty b\u00e1n h\u00e0ng, nh\u00e2n vi\u00ean c\u1ee7a h\u1ecd, \u0111\u1ea1i l\u00fd qu\u1ea3ng c\u00e1o \u0111\u1ed1i t\u00e1c v\u00e0 nh\u00e2n vi\u00ean c\u1ee7a h\u1ecd, c\u00f4ng ty s\u1ea3n xu\u1ea5t qu\u1ea3ng c\u00e1o v\u00e0 nh\u00e2n vi\u00ean c\u1ee7a h\u1ecd \u0111\u00e3 b\u1ecb b\u1eaft v\u00ec nghi ng\u1edd \u0111\u00e3 hi\u1ec3n th\u1ecb trong qu\u1ea3ng c\u00e1o v\u00e0 b\u00e1n th\u1ef1c ph\u1ea9m b\u1ed5 sung m\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn l\u00e0m d\u01b0\u1ee3c ph\u1ea9m v\u1edbi c\u00e1c n\u1ed9i dung nh\u01b0 &#8220;c\u00f3 hi\u1ec7u qu\u1ea3 trong vi\u1ec7c ph\u00f2ng ng\u1eeba b\u1ec7nh gan&#8221;.<\/p>\n\n\n\n<p>V\u1ee5 vi\u1ec7c n\u00e0y, gi\u1ed1ng nh\u01b0 v\u00ed d\u1ee5 1, \u0111\u00e3 g\u00e2y ra v\u1ea5n \u0111\u1ec1 v\u00ec vi ph\u1ea1m l\u1ec7nh c\u1ea5m qu\u1ea3ng c\u00e1o v\u00e0 b\u00e1n c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn (\u0110i\u1ec1u 55 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>\u0110\u1eb7c bi\u1ec7t, kh\u00f4ng ch\u1ec9 ch\u1ee7 qu\u1ea3ng c\u00e1o m\u00e0 c\u1ea3 \u0111\u1ea1i l\u00fd qu\u1ea3ng c\u00e1o v\u00e0 c\u00f4ng ty s\u1ea3n xu\u1ea5t qu\u1ea3ng c\u00e1o c\u0169ng b\u1ecb b\u1eaft, cho th\u1ea5y s\u1ef1 \u00e1p d\u1ee5ng nghi\u00eam ng\u1eb7t c\u1ee7a \u0111i\u1ec1u kho\u1ea3n &#8220;kh\u00f4ng ai \u0111\u01b0\u1ee3c qu\u1ea3ng c\u00e1o&#8221; trong \u0110i\u1ec1u 68 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>V\u1ec1 v\u1ee5 vi\u1ec7c n\u00e0y, v\u00e0o th\u00e1ng 3 n\u0103m 2021 (n\u0103m th\u1ee9 3 c\u1ee7a th\u1eddi k\u1ef3 Reiwa), \u0111\u00e3 c\u00f3 l\u1ec7nh ph\u1ea1t ti\u1ec1n t\u00f3m t\u1eaft \u0111\u1ed1i v\u1edbi vi ph\u1ea1m l\u1ec7nh c\u1ea5m qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn, c\u00f2n vi ph\u1ea1m l\u1ec7nh c\u1ea5m b\u00e1n d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn th\u00ec \u0111\u00e3 \u0111\u01b0\u1ee3c x\u1eed l\u00fd kh\u00f4ng kh\u1edfi t\u1ed1.<\/p>\n\n\n\n<p>V\u1ec1 quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o \u0111\u00e3 g\u00e2y ra v\u1ea5n \u0111\u1ec1 trong c\u00e1c v\u00ed d\u1ee5 n\u00e0y, vui l\u00f2ng tham kh\u1ea3o b\u00e0i vi\u1ebft kh\u00e1c.<\/p>\n\n\n\n<p>B\u00e0i vi\u1ebft li\u00ean quan: <a href=\"https:\/\/monolith.law\/corporate\/pharmaceuticals-advertising-regulations\" target=\"_blank\" rel=\"noreferrer noopener\">Quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o 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 c\u00e1c \u0111i\u1ec3m \u0111\u1ec3 t\u1ea1o qu\u1ea3ng c\u00e1o v\u1edbi bi\u1ec3u hi\u1ec7n h\u1ee3p ph\u00e1p[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"De_phong_tranh_bi_bat_giu_vi_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>\u0110\u1ec3 ph\u00f2ng tr\u00e1nh b\u1ecb b\u1eaft gi\u1eef v\u00ec 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\"><img decoding=\"async\" src=\"https:\/\/lh4.googleusercontent.com\/6LBCcWhuGXWL_7GTltWMXAtk8qIuaIBxuer_9l9xY9RzeUnwtzFadr1CUroPMFMVBCWDjB-Ffpcnok7Q1QQ4fHJtlp6d-NSKnnoy5MfWRbTGOcwPly-SjVn1JvJWn-Stvg3_QGPrLbjNktMtneu5Z6ixEcXjYZmvH-MgerUb0g5QqudnAf5JWA1Uu5KymA\" alt=\"\u0110\u1ec3 ph\u00f2ng tr\u00e1nh b\u1ecb b\u1eaft gi\u1eef v\u00ec vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\" \/><\/figure>\n\n\n\n<p>N\u1ebfu b\u1ea1n vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, kh\u00f4ng th\u1ec3 ph\u1ee7 nh\u1eadn kh\u1ea3 n\u0103ng b\u1ecb b\u1eaft gi\u1eef sau \u0111\u00f3. \u0110\u1ec3 tr\u00e1nh b\u1ecb b\u1eaft gi\u1eef, b\u1ea1n ph\u1ea3i tr\u00e1nh vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n t\u1eeb \u0111\u1ea7u.<\/p>\n\n\n\n<p>V\u1eady, l\u00e0m th\u1ebf 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=\"Kiem_tra_noi_dung_cap_phep_va_chap_thuan_huong_dan\"><\/span>Ki\u1ec3m tra n\u1ed9i dung c\u1ea5p ph\u00e9p v\u00e0 ch\u1ea5p thu\u1eadn, h\u01b0\u1edbng d\u1eabn<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0110\u1ea7u ti\u00ean, n\u1ebfu c\u00f4ng ty c\u1ee7a b\u1ea1n \u0111ang ho\u1ea1t \u0111\u1ed9ng trong l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1, b\u1ea1n c\u1ea7n ki\u1ec3m tra xem b\u1ea1n \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c s\u1ef1 cho ph\u00e9p th\u00edch h\u1ee3p hay ch\u01b0a. Sau \u0111\u00f3, h\u00e3y ki\u1ec3m tra xem s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1 c\u1ee7a c\u00f4ng ty c\u00f3 nh\u1eadn \u0111\u01b0\u1ee3c s\u1ef1 ch\u1ea5p thu\u1eadn th\u00edch h\u1ee3p hay kh\u00f4ng.<\/p>\n\n\n\n<p>Ngo\u00e0i ra, n\u1ebfu b\u1ea1n \u0111ang qu\u1ea3ng c\u00e1o cho vi\u1ec7c b\u00e1n h\u00e0ng d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1, b\u1ea1n ph\u1ea3i ki\u1ec3m tra xem b\u1ea1n c\u00f3 vi ph\u1ea1m quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o hay kh\u00f4ng. V\u1ec1 n\u1ed9i dung v\u00e0 ti\u00eau chu\u1ea9n c\u1ee7a quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o, B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n \u0111\u00e3 t\u1ed5ng h\u1ee3p c\u00e1c h\u01b0\u1edbng d\u1eabn, v\u00ec v\u1eady b\u1ea1n n\u00ean n\u1eafm v\u1eefng n\u1ed9i dung \u0111\u00f3.<\/p>\n\n\n\n<p>Tham kh\u1ea3o: <a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/kenkou_iryou\/iyakuhin\/koukokukisei\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">V\u1ec1 quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1 | B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tao_huong_dan_su_dung\"><\/span>T\u1ea1o h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Sau khi n\u1eafm v\u1eefng n\u1ed9i dung c\u1ee7a c\u00e1c h\u01b0\u1edbng d\u1eabn, b\u1ea1n n\u00ean t\u1ea1o h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng n\u1ed9i b\u1ed9 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng to\u00e0n b\u1ed9 c\u00f4ng ty bi\u1ebft nh\u1eefng h\u00e0nh \u0111\u1ed9ng 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 v\u00e0 l\u00e0m th\u1ebf n\u00e0o \u0111\u1ec3 tr\u00e1nh vi ph\u1ea1m lu\u1eadt n\u00e0y.<\/p>\n\n\n\n<p>Nh\u01b0 \u0111\u00e3 gi\u1edbi thi\u1ec7u trong c\u00e1c v\u00ed d\u1ee5 v\u1ec1 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, kh\u00f4ng ch\u1ec9 nh\u1eefng ng\u01b0\u1eddi qu\u1ea3ng c\u00e1o m\u00e0 c\u1ea3 c\u00e1c \u0111\u1ea1i l\u00fd qu\u1ea3ng c\u00e1o v\u00e0 c\u00f4ng ty s\u1ea3n xu\u1ea5t qu\u1ea3ng c\u00e1o c\u0169ng c\u00f3 th\u1ec3 b\u1ecb b\u1eaft gi\u1eef. Do \u0111\u00f3, vi\u1ec7c th\u00f4ng b\u00e1o v\u1ec1 h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng cho c\u00e1c c\u00f4ng ty \u0111\u1ed1i t\u00e1c v\u00e0 ki\u1ec3m tra xem h\u1ecd \u0111\u00e3 th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba ch\u01b0a s\u1ebd gi\u00fap gi\u1ea3m r\u1ee7i ro 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=\"Tu_van_voi_luat_su\"><\/span>T\u01b0 v\u1ea5n v\u1edbi lu\u1eadt s\u01b0<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Tuy nhi\u00ean, ngay c\u1ea3 khi b\u1ea1n \u0111\u00e3 th\u1ef1c hi\u1ec7n nh\u1eefng bi\u1ec7n ph\u00e1p n\u00e0y, vi\u1ec7c t\u1ef1 m\u00ecnh x\u00e1c \u0111\u1ecbnh xem h\u00e0nh \u0111\u1ed9ng c\u1ee5 th\u1ec3 c\u00f3 vi ph\u1ea1m 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\u00e1 kh\u00f3 kh\u0103n. Ngo\u00e0i ra, Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n th\u01b0\u1eddng xuy\u00ean \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i l\u1edbn, v\u00ec v\u1eady vi\u1ec7c hi\u1ec3u \u0111\u00fang n\u1ed9i dung c\u1ee7a lu\u1eadt s\u1eeda \u0111\u1ed5i c\u0169ng l\u00e0 \u0111i\u1ec1u c\u1ea7n thi\u1ebft.<\/p>\n\n\n\n<p>Trong tr\u01b0\u1eddng h\u1ee3p nh\u01b0 v\u1eady, h\u00e3y t\u00ecm \u0111\u1ebfn s\u1ef1 t\u01b0 v\u1ea5n c\u1ee7a m\u1ed9t lu\u1eadt s\u01b0 c\u00f3 kinh nghi\u1ec7m phong ph\u00fa v\u00e0 h\u1ecfi \u00fd ki\u1ebfn v\u1ec1 vi\u1ec7c h\u00e0nh \u0111\u1ed9ng c\u00f3 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n hay kh\u00f4ng.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tom_tat_Neu_gap_rac_roi_voi_Luat_Duoc_pham_va_Thiet_bi_y_te_hay_tham_van_voi_luat_su\"><\/span>T\u00f3m t\u1eaft: N\u1ebfu g\u1eb7p r\u1eafc r\u1ed1i v\u1edbi Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, h\u00e3y tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ngo\u00e0i nh\u1eefng \u0111i\u1ec1u \u0111\u00e3 gi\u1edbi thi\u1ec7u trong b\u00e0i vi\u1ebft n\u00e0y, Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Act) c\u00f2n \u0111\u1eb7t ra r\u1ea5t nhi\u1ec1u quy \u0111\u1ecbnh kh\u00e1c. \u0110\u1ec3 x\u00e1c \u0111\u1ecbnh xem h\u00e0nh vi n\u00e0o vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, b\u1ea1n c\u1ea7n ph\u1ea3i hi\u1ec3u r\u00f5 v\u1ec1 lu\u1eadt n\u00e0y. Vi\u1ec7c n\u1eafm b\u1eaft ch\u00ednh x\u00e1c n\u1ed9i dung v\u00e0 c\u00e1ch th\u1ef1c thi lu\u1eadt l\u1ec7 c\u00f3 th\u1ec3 kh\u00f3 kh\u0103n \u0111\u1ed1i v\u1edbi c\u00e1 nh\u00e2n ho\u1eb7c doanh nghi\u1ec7p, v\u00ec v\u1eady, n\u1ebfu g\u1eb7p r\u1eafc r\u1ed1i li\u00ean quan \u0111\u1ebfn Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, ho\u1eb7c \u0111\u1ec3 ng\u0103n ch\u1eb7n r\u1eafc r\u1ed1i t\u1eeb tr\u01b0\u1edbc, h\u00e3y tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0 c\u00f3 kinh nghi\u1ec7m.<\/p>\n\n\n\n<p>Vi\u1ec7c ki\u1ec3m tra ph\u00e1p l\u00fd v\u00e0 \u0111\u1ec1 xu\u1ea5t bi\u1ec3u hi\u1ec7n b\u1eb1ng v\u0103n b\u1ea3n cho Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf 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 Monolis \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, \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=\"Huong_dan_cac_bien_phap_cua_van_phong_luat_su_cua_chung_toi\"><\/span>H\u01b0\u1edbng d\u1eabn 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, ch\u00fang t\u00f4i 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 lu\u1eadt s\u01b0 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 LP, 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 nh\u01b0 th\u1ef1c ph\u1ea9m b\u1ed5 sung v\u00e0 m\u1ef9 ph\u1ea9m, ph\u00f2ng kh\u00e1m, nh\u00e0 cung c\u1ea5p d\u1ecbch v\u1ee5 \u1ee9ng d\u1ee5ng, v.v. 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; LP theo lu\u1eadt d\u01b0\u1ee3c ph\u1ea9m, v.v.[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n (Japanese Pharmaceutical and Medical Device Act) quy \u0111\u1ecbnh nhi\u1ec1u quy t\u1eafc li\u00ean quan \u0111\u1ebfn d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf, n\u1ebfu vi ph\u1ea1m nh\u1eefng quy \u0111\u1ecbnh n\u00e0y, c\u00f3 th\u1ec3 b\u1ecb b\u1eaft [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":58938,"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\/58702"}],"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=58702"}],"version-history":[{"count":1,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/58702\/revisions"}],"predecessor-version":[{"id":58939,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/58702\/revisions\/58939"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media\/58938"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media?parent=58702"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/categories?post=58702"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/tags?post=58702"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}