{"id":59557,"date":"2023-10-27T15:44:01","date_gmt":"2023-10-27T06:44:01","guid":{"rendered":"https:\/\/monolith.law\/vi\/?p=59557"},"modified":"2023-11-09T21:18:33","modified_gmt":"2023-11-09T12:18:33","slug":"pharmaceuticals-law","status":"publish","type":"post","link":"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceuticals-law","title":{"rendered":"Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (c\u00f2n g\u1ecdi l\u00e0 Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m c\u0169) l\u00e0 g\u00ec? M\u1ee5c \u0111\u00edch, \u0111\u1ed1i t\u01b0\u1ee3ng qu\u1ea3n l\u00fd, v\u00e0 quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o \u0111\u01b0\u1ee3c gi\u1ea3i th\u00edch"},"content":{"rendered":"\n<p>Khi nghe \u0111\u1ebfn &#8216;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8217; (\u85ac\u6a5f\u6cd5), c\u00f3 l\u1ebd nhi\u1ec1u ng\u01b0\u1eddi s\u1ebd ngh\u0129 r\u1eb1ng \u0111\u00f3 l\u00e0 &#8216;lu\u1eadt li\u00ean quan \u0111\u1ebfn thu\u1ed1c&#8217; ho\u1eb7c &#8216;lu\u1eadt li\u00ean quan \u0111\u1ebfn hi\u1ec7u thu\u1ed1c v\u00e0 c\u01a1 s\u1edf y t\u1ebf&#8217;. Tuy nhi\u00ean, th\u1ef1c t\u1ebf, \u0111\u00e2y l\u00e0 m\u1ed9t lu\u1eadt c\u00f3 ph\u1ea1m vi quy \u0111\u1ecbnh r\u1ea5t r\u1ed9ng, trong &#8216;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8217; c\u00f3 r\u1ea5t nhi\u1ec1u quy t\u1eafc m\u00e0 c\u00e1c doanh nghi\u1ec7p thu\u1ed9c nhi\u1ec1u ng\u00e0nh ngh\u1ec1 kh\u00e1c nhau ph\u1ea3i tu\u00e2n th\u1ee7.<\/p>\n\n\n\n<p>\u0110\u1ec3 kh\u00f4ng 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; m\u00e0 kh\u00f4ng h\u1ec1 hay bi\u1ebft, b\u1ea1n c\u1ea7n ph\u1ea3i hi\u1ec3u r\u00f5 v\u1ec1 lu\u1eadt n\u00e0y.<\/p>\n\n\n\n<p>B\u00e0i vi\u1ebft n\u00e0y s\u1ebd gi\u1ea3i th\u00edch m\u1ee5c \u0111\u00edch v\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh c\u1ee7a &#8216;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8217;, c\u0169ng nh\u01b0 quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o.<\/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\/pharmaceuticals-law\/#Phap_luat_ve_Duoc_pham_va_Thiet_bi_y_te_Phap_luat_Duoc_pham_cu\" title=\"Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (Ph\u00e1p lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m c\u0169)\">Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (Ph\u00e1p lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m c\u0169)<\/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\/pharmaceuticals-law\/#Tu_Phap_luat_Duoc_pham_den_Phap_luat_ve_Duoc_pham_va_Thiet_bi_y_te\" title=\"T\u1eeb Ph\u00e1p lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m \u0111\u1ebfn Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf\">T\u1eeb Ph\u00e1p lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m \u0111\u1ebfn Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf<\/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\/pharmaceuticals-law\/#Muc_dich_cua_Phap_luat_ve_Duoc_pham_va_Thiet_bi_y_te\" title=\"M\u1ee5c \u0111\u00edch c\u1ee7a Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf\">M\u1ee5c \u0111\u00edch c\u1ee7a Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf<\/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\/pharmaceuticals-law\/#Doi_tuong_quy_dinh_chinh_cua_%E2%80%98Japanese_Pharmaceutical_and_Medical_Device_Act%E2%80%99_va_dinh_nghia\" title=\"\u0110\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh ch\u00ednh c\u1ee7a &#8216;Japanese Pharmaceutical and Medical Device Act&#8217; v\u00e0 \u0111\u1ecbnh ngh\u0129a\">\u0110\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh ch\u00ednh c\u1ee7a &#8216;Japanese Pharmaceutical and Medical Device Act&#8217; v\u00e0 \u0111\u1ecbnh ngh\u0129a<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceuticals-law\/#Duoc_pham\" title=\"D\u01b0\u1ee3c ph\u1ea9m\">D\u01b0\u1ee3c ph\u1ea9m<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceuticals-law\/#San_pham_ngoai_y_duoc\" title=\"S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c\">S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c<\/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\/pharmaceuticals-law\/#My_pham\" title=\"M\u1ef9 ph\u1ea9m\">M\u1ef9 ph\u1ea9m<\/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\/pharmaceuticals-law\/#Thiet_bi_y_te\" title=\"Thi\u1ebft b\u1ecb y t\u1ebf\">Thi\u1ebft b\u1ecb y t\u1ebf<\/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\/pharmaceuticals-law\/#San_pham_y_te_tai_tao\" title=\"S\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o\">S\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o<\/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\/pharmaceuticals-law\/#Quy_dinh_ve_quang_cao_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"Quy \u0111\u1ecbnh v\u1ec1 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\">Quy \u0111\u1ecbnh v\u1ec1 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<\/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\/pharmaceuticals-law\/#%E2%80%9CQuang_cao_phong_dai%E2%80%9D_duoc_danh_gia_dua_tren_tieu_chuan_quang_cao_dung_dan_cho_duoc_pham_va_cac_san_pham_tuong_tu\" title=\"&#8220;Qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i&#8221; \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 d\u1ef1a tr\u00ean ti\u00eau chu\u1ea9n qu\u1ea3ng c\u00e1o \u0111\u00fang \u0111\u1eafn cho d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1\">&#8220;Qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i&#8221; \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 d\u1ef1a tr\u00ean ti\u00eau chu\u1ea9n qu\u1ea3ng c\u00e1o \u0111\u00fang \u0111\u1eafn cho d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1<\/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\/pharmaceuticals-law\/#San_pham_khong_nam_trong_pham_vi_quy_dinh_cua_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"S\u1ea3n ph\u1ea9m kh\u00f4ng n\u1eb1m trong ph\u1ea1m vi quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n\">S\u1ea3n ph\u1ea9m kh\u00f4ng n\u1eb1m trong ph\u1ea1m vi quy \u0111\u1ecbnh c\u1ee7a 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-13\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceuticals-law\/#Hinh_phat_khi_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"H\u00ecnh ph\u1ea1t khi 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 khi vi ph\u1ea1m 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-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceuticals-law\/#Diem_quan_trong_de_tranh_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"\u0110i\u1ec3m quan tr\u1ecdng \u0111\u1ec3 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\">\u0110i\u1ec3m quan tr\u1ecdng \u0111\u1ec3 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<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceuticals-law\/#Hieu_dung_ve_huong_dan\" title=\"Hi\u1ec3u \u0111\u00fang v\u1ec1 h\u01b0\u1edbng d\u1eabn\">Hi\u1ec3u \u0111\u00fang v\u1ec1 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-16\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceuticals-law\/#Chia_se_trong_cong_ty\" title=\"Chia s\u1ebb trong c\u00f4ng ty\">Chia s\u1ebb trong c\u00f4ng ty<\/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\/pharmaceuticals-law\/#Su_khac_biet_giua_Luat_Duoc_pham_va_Thiet_bi_y_te_Japanese_Pharmaceutical_and_Medical_Device_Act_va_Luat_Quang_cao_va_Bieu_hien_Japanese_Act_against_Unjustifiable_Premiums_and_Misleading_Representations\" title=\"S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (Japanese Pharmaceutical and Medical Device Act) v\u00e0 Lu\u1eadt Qu\u1ea3ng c\u00e1o v\u00e0 Bi\u1ec3u hi\u1ec7n (Japanese Act against Unjustifiable Premiums and Misleading Representations)\">S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (Japanese Pharmaceutical and Medical Device Act) v\u00e0 Lu\u1eadt Qu\u1ea3ng c\u00e1o v\u00e0 Bi\u1ec3u hi\u1ec7n (Japanese Act against Unjustifiable Premiums and Misleading Representations)<\/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\/pharmaceuticals-law\/#Tom_tat_Hay_thao_luan_voi_luat_su_neu_gap_rac_roi_voi_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\"T\u00f3m t\u1eaft: H\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0 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 Nh\u1eadt B\u1ea3n\">T\u00f3m t\u1eaft: H\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0 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 Nh\u1eadt B\u1ea3n<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceuticals-law\/#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=\"Phap_luat_ve_Duoc_pham_va_Thiet_bi_y_te_Phap_luat_Duoc_pham_cu\"><\/span>Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (Ph\u00e1p lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m c\u0169)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tu_Phap_luat_Duoc_pham_den_Phap_luat_ve_Duoc_pham_va_Thiet_bi_y_te\"><\/span>T\u1eeb Ph\u00e1p lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m \u0111\u1ebfn Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-1-1.png\" alt=\"\" class=\"wp-image-61025\" srcset=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-1-1.png 735w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-1-1-300x200.png 300w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-1-1-250x167.png 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><\/figure>\n\n\n\n<p>Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 lu\u1eadt \u0111\u1ecbnh r\u00f5 c\u00e1c quy \u0111\u1ecbnh c\u1ea7n thi\u1ebft t\u1ea1i m\u1ed7i giai \u0111o\u1ea1n nh\u01b0 s\u1ea3n xu\u1ea5t, hi\u1ec3n th\u1ecb, b\u00e1n h\u00e0ng, ph\u00e2n ph\u1ed1i, qu\u1ea3ng c\u00e1o, v.v., \u0111\u1ed1i v\u1edbi d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1. T\u00ean ch\u00ednh th\u1ee9c c\u1ee7a n\u00f3 l\u00e0 &#8220;Lu\u1eadt v\u1ec1 \u0110\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;<\/p>\n\n\n\n<p>Tr\u01b0\u1edbc \u0111\u00e2y, n\u00f3 \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 &#8220;Ph\u00e1p lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m&#8221;, nh\u01b0ng \u0111\u1ec3 \u0111\u00e1p \u1ee9ng s\u1ef1 ti\u1ebfn b\u1ed9 c\u1ee7a y h\u1ecdc, d\u01b0\u1ee3c h\u1ecdc, \u0111i\u1ec7n t\u1eed, v.v., n\u00f3 \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i v\u00e0o n\u0103m 2013 (Heisei 25) (\u0111\u01b0\u1ee3c th\u1ef1c thi v\u00e0o n\u0103m 2014 (Heisei 26)) v\u00e0 t\u00ean g\u1ecdi c\u0169ng \u0111\u00e3 \u0111\u01b0\u1ee3c thay \u0111\u1ed5i th\u00e0nh &#8220;Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf&#8221;.<\/p>\n\n\n\n<p>Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf quy \u0111\u1ecbnh d\u01b0\u1ee3c ph\u1ea9m, nh\u01b0ng kh\u00f4ng ch\u1ec9 ri\u00eang c\u00e1c nh\u00e0 b\u00e1n l\u1ebb d\u01b0\u1ee3c ph\u1ea9m nh\u01b0 c\u00e1c hi\u1ec7u thu\u1ed1c v\u00e0 c\u1eeda h\u00e0ng d\u01b0\u1ee3c ph\u1ea9m m\u00e0 c\u00f2n c\u00f3 th\u1ec3 b\u1ecb \u00e1p d\u1ee5ng quy \u0111\u1ecbnh c\u1ee7a Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf. V\u00ed d\u1ee5, nhi\u1ec7t k\u1ebf \u0111\u01b0\u1ee3c coi l\u00e0 &#8220;thi\u1ebft b\u1ecb y t\u1ebf&#8221;, do \u0111\u00f3 quy \u0111\u1ecbnh s\u1ebd \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng khi s\u1ea3n xu\u1ea5t v\u00e0 qu\u1ea3ng c\u00e1o. Ngo\u00e0i ra, khi qu\u1ea3ng c\u00e1o m\u1ef9 ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m, n\u1ebfu b\u1ea1n s\u1eed d\u1ee5ng bi\u1ec3u hi\u1ec7n nh\u01b0 n\u00f3 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn vi\u1ec7c ph\u00f2ng ng\u1eeba b\u1ec7nh, b\u1ea5t k\u1ef3 ai c\u0169ng c\u00f3 th\u1ec3 vi ph\u1ea1m Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<p>Do \u0111\u00f3, v\u00ec quy \u0111\u1ecbnh c\u1ee7a Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf r\u1ed9ng r\u00e3i, n\u1ebfu b\u1ea1n kh\u00f4ng hi\u1ec3u \u0111\u00fang \u0111\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh v\u00e0 n\u1ed9i dung quy \u0111\u1ecbnh, b\u1ea1n c\u00f3 th\u1ec3 vi ph\u1ea1m Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 kh\u00f4ng h\u1ec1 hay bi\u1ebft.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Muc_dich_cua_Phap_luat_ve_Duoc_pham_va_Thiet_bi_y_te\"><\/span>M\u1ee5c \u0111\u00edch c\u1ee7a Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>M\u1ee5c \u0111\u00edch c\u1ee7a Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong \u0110i\u1ec1u 1.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Lu\u1eadt n\u00e0y nh\u1eb1m m\u1ee5c \u0111\u00edch th\u1ef1c hi\u1ec7n c\u00e1c quy \u0111\u1ecbnh 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 d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m ngo\u00e0i ph\u1ea1m vi d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o (d\u01b0\u1edbi \u0111\u00e2y g\u1ecdi chung l\u00e0 &#8220;d\u01b0\u1ee3c ph\u1ea9m, v.v.&#8221;), ng\u0103n ch\u1eb7n s\u1ef1 ph\u00e1t sinh v\u00e0 m\u1edf r\u1ed9ng c\u1ee7a nh\u1eefng t\u1ed5n h\u1ea1i v\u1ec1 s\u1ee9c kh\u1ecfe do vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c s\u1ea3n ph\u1ea9m n\u00e0y, th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p li\u00ean quan \u0111\u1ebfn quy \u0111\u1ecbnh v\u1ec1 &#8220;ch\u1ea5t d\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh&#8221; (ma t\u00fay nguy hi\u1ec3m), v\u00e0 th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p c\u1ea7n thi\u1ebft \u0111\u1ec3 th\u00fac \u0111\u1ea9y nghi\u00ean c\u1ee9u v\u00e0 ph\u00e1t tri\u1ec3n d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o c\u00f3 nhu c\u1ea7u cao trong y t\u1ebf, nh\u1eb1m m\u1ee5c \u0111\u00edch c\u1ea3i thi\u1ec7n s\u1ee9c kh\u1ecfe c\u00f4ng c\u1ed9ng.<\/p>\n<cite>\u0110i\u1ec1u 1 c\u1ee7a Lu\u1eadt v\u1ec1 \u0110\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.<\/cite><\/blockquote>\n\n\n\n<p>Khi s\u1eafp x\u1ebfp c\u00e1c quy \u0111\u1ecbnh c\u1ee7a \u0110i\u1ec1u 1, ch\u00fang ta c\u00f3:<\/p>\n\n\n\n<ol>\n<li>Th\u1ef1c hi\u1ec7n quy \u0111\u1ecbnh v\u00ec an to\u00e0n c\u1ee7a 5 lo\u1ea1i s\u1ea3n ph\u1ea9m: d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m ngo\u00e0i ph\u1ea1m vi d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o (d\u01b0\u1ee3c ph\u1ea9m, v.v.)<\/li>\n\n\n\n<li>Th\u1ef1c hi\u1ec7n quy \u0111\u1ecbnh li\u00ean quan \u0111\u1ebfn &#8220;ch\u1ea5t d\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh&#8221; (ma t\u00fay nguy hi\u1ec3m)<\/li>\n\n\n\n<li>Th\u00fac \u0111\u1ea9y nghi\u00ean c\u1ee9u v\u00e0 ph\u00e1t tri\u1ec3n d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o<\/li>\n<\/ol>\n\n\n\n<p>Ph\u00e1p lu\u1eadt v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf quy \u0111\u1ecbnh c\u00e1c quy \u0111\u1ecbnh theo ba m\u1ee5c ti\u00eau n\u00e0y.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Doi_tuong_quy_dinh_chinh_cua_%E2%80%98Japanese_Pharmaceutical_and_Medical_Device_Act%E2%80%99_va_dinh_nghia\"><\/span>\u0110\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh ch\u00ednh c\u1ee7a &#8216;Japanese Pharmaceutical and Medical Device Act&#8217; v\u00e0 \u0111\u1ecbnh ngh\u0129a<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-2.png\" alt=\"\" class=\"wp-image-61026\" srcset=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-2.png 735w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-2-300x200.png 300w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-2-250x167.png 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><\/figure>\n\n\n\n<p>\u0110\u1ec3 kh\u00f4ng vi ph\u1ea1m &#8216;Japanese Pharmaceutical and Medical Device Act&#8217;, b\u1ea1n c\u1ea7n hi\u1ec3u r\u00f5 v\u1ec1 \u0111\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh c\u1ee7a lu\u1eadt n\u00e0y.<\/p>\n\n\n\n<p>\u0110\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh ch\u00ednh c\u1ee7a &#8216;Japanese Pharmaceutical and Medical Device Act&#8217; g\u1ed3m 5 lo\u1ea1i, nh\u01b0 quy \u0111\u1ecbnh trong \u0110i\u1ec1u 1, \u0111\u00f3 l\u00e0: d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o. H\u00e3y xem x\u00e9t \u0111\u1ecbnh ngh\u0129a c\u1ee7a t\u1eebng lo\u1ea1i.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Duoc_pham\"><\/span>D\u01b0\u1ee3c ph\u1ea9m<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Khi nghe \u0111\u1ebfn t\u1eeb &#8220;d\u01b0\u1ee3c ph\u1ea9m&#8221;, nhi\u1ec1u ng\u01b0\u1eddi th\u01b0\u1eddng ngh\u0129 \u0111\u1ebfn nh\u1eefng lo\u1ea1i thu\u1ed1c \u0111\u01b0\u1ee3c k\u00ea \u0111\u01a1n t\u1ea1i hi\u1ec7u thu\u1ed1c ho\u1eb7c thu\u1ed1c h\u1ea1 s\u1ed1t. Tuy nhi\u00ean, th\u1ef1c t\u1ebf c\u00f3 nhi\u1ec1u v\u1eadt kh\u00e1c c\u0169ng \u0111\u01b0\u1ee3c coi l\u00e0 &#8220;d\u01b0\u1ee3c ph\u1ea9m&#8221;.<\/p>\n\n\n\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) \u0111\u1ecbnh ngh\u0129a v\u1ec1 d\u01b0\u1ee3c ph\u1ea9m trong \u0110i\u1ec1u 2, Kho\u1ea3n 1 nh\u01b0 sau:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Trong lu\u1eadt n\u00e0y, &#8220;d\u01b0\u1ee3c ph\u1ea9m&#8221; bao g\u1ed3m:<\/p>\n\n\n\n<p>1. C\u00e1c v\u1eadt \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea trong D\u01b0\u1ee3c \u0111i\u1ec3n Nh\u1eadt B\u1ea3n<\/p>\n\n\n\n<p>2. C\u00e1c v\u1eadt \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u1edbi m\u1ee5c \u0111\u00edch ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb ho\u1eb7c ph\u00f2ng ng\u1eeba b\u1ec7nh t\u1eadt \u1edf ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt, kh\u00f4ng ph\u1ea3i l\u00e0 m\u00e1y m\u00f3c, thi\u1ebft b\u1ecb, v\u1eadt li\u1ec7u nha khoa, v\u1eadt d\u1ee5ng y t\u1ebf, v\u1eadt d\u1ee5ng v\u1ec7 sinh v\u00e0 ch\u01b0\u01a1ng tr\u00ecnh (l\u1ec7nh cho m\u00e1y t\u00ednh, \u0111\u01b0\u1ee3c t\u1ed5 ch\u1ee9c \u0111\u1ec3 c\u00f3 th\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c k\u1ebft qu\u1ea3 nh\u1ea5t \u0111\u1ecbnh. C\u00f9ng \u00e1p d\u1ee5ng cho c\u00e1c \u0111i\u1ec1u sau.) v\u00e0 ph\u01b0\u01a1ng ti\u1ec7n ghi ch\u00fa n\u00e0y (tr\u1eeb s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u1ea1ng d\u01b0\u1ee3c ph\u1ea9m v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o).<\/p>\n\n\n\n<p>3. C\u00e1c v\u1eadt \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u1edbi m\u1ee5c \u0111\u00edch \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3 ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt, kh\u00f4ng ph\u1ea3i l\u00e0 m\u00e1y m\u00f3c, thi\u1ebft b\u1ecb (tr\u1eeb s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u1ea1ng d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o).<\/p>\n<cite>Lu\u1eadt v\u1ec1 \u0110\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, \u0110i\u1ec1u 2, Kho\u1ea3n 1<\/cite><\/blockquote>\n\n\n\n<p>\u0110i\u1ec1u 1 n\u00f3i v\u1ec1 &#8220;D\u01b0\u1ee3c \u0111i\u1ec3n Nh\u1eadt B\u1ea3n&#8221;, m\u1ed9t cu\u1ed1n s\u00e1ch ti\u00eau chu\u1ea9n do ch\u00ednh ph\u1ee7 Nh\u1eadt B\u1ea3n \u0111\u1ecbnh r\u00f5 v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng d\u01b0\u1ee3c ph\u1ea9m. Trong \u0111\u00f3 kh\u00f4ng ch\u1ec9 c\u00f3 c\u00e1c h\u00f3a ch\u1ea5t d\u01b0\u1ee3c ph\u1ea9m, m\u00e0 c\u00f2n c\u00f3 d\u1ea7u \u00f4 liu, m\u1eadt ong, v.v. Nh\u1eefng v\u1eadt n\u00e0y, n\u1ebfu kh\u00f4ng ch\u1ec9 d\u00f9ng cho m\u1ee5c \u0111\u00edch th\u1ef1c ph\u1ea9m, s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 &#8220;d\u01b0\u1ee3c ph\u1ea9m&#8221;.<\/p>\n\n\n\n<p>\u0110i\u1ec1u 2 quy \u0111\u1ecbnh v\u1ec1 nh\u1eefng v\u1eadt \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u1edbi m\u1ee5c \u0111\u00edch ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb, ph\u00f2ng ng\u1eeba b\u1ec7nh t\u1eadt. V\u00ed d\u1ee5 c\u1ee5 th\u1ec3 c\u00f3 th\u1ec3 k\u1ec3 \u0111\u1ebfn vaccine hay b\u1ed9 kit ki\u1ec3m tra \u0111\u1eb7c t\u00ednh kh\u00e1ng nguy\u00ean.<\/p>\n\n\n\n<p>\u0110i\u1ec1u 3 quy \u0111\u1ecbnh v\u1ec1 nh\u1eefng v\u1eadt \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u1edbi m\u1ee5c \u0111\u00edch \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3 ng\u01b0\u1eddi. V\u00ed d\u1ee5 c\u1ee5 th\u1ec3 c\u00f3 th\u1ec3 k\u1ec3 \u0111\u1ebfn thu\u1ed1c tr\u00e1nh thai nh\u01b0 vi\u00ean thu\u1ed1c &#8220;Pill&#8221;.<\/p>\n\n\n\n<p>\u0110i\u1ec1u c\u1ea7n l\u01b0u \u00fd l\u00e0 Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n quy \u0111\u1ecbnh theo m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng. Th\u1eadm ch\u00ed n\u1ebfu kh\u00f4ng c\u00f3 hi\u1ec7u qu\u1ea3 trong vi\u1ec7c ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb, ph\u00f2ng ng\u1eeba b\u1ec7nh t\u1eadt, nh\u01b0ng n\u1ebfu \u0111\u01b0\u1ee3c b\u00e1n v\u1edbi m\u1ee5c \u0111\u00edch ch\u1ea9n \u0111o\u00e1n, n\u00f3 s\u1ebd b\u1ecb quy \u0111\u1ecbnh nh\u01b0 &#8220;d\u01b0\u1ee3c ph\u1ea9m&#8221;. V\u00ed d\u1ee5, ngay c\u1ea3 khi m\u1ed9t s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c b\u00e1n nh\u01b0 m\u1ed9t lo\u1ea1i th\u1ef1c ph\u1ea9m, n\u1ebfu n\u00f3 c\u00f3 d\u1ea5u hi\u1ec7u nh\u01b0 &#8220;l\u00e0m s\u1ea1ch m\u00e1u&#8221;, n\u00f3 s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 c\u00f3 hi\u1ec7u qu\u1ea3 nh\u01b0 m\u1ed9t &#8220;d\u01b0\u1ee3c ph\u1ea9m&#8221; v\u00e0 s\u1ebd \u0111\u01b0\u1ee3c xem l\u00e0 &#8220;d\u01b0\u1ee3c ph\u1ea9m&#8221;.<\/p>\n\n\n\n<p>Quy \u0111\u1ecbnh ch\u00ednh \u0111\u1ed1i v\u1edbi d\u01b0\u1ee3c ph\u1ea9m, n\u00f3i m\u1ed9t c\u00e1ch \u0111\u01a1n gi\u1ea3n, l\u00e0 c\u1ea5p ph\u00e9p li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n h\u00e0ng. Ngh\u0129a l\u00e0, tr\u1eeb khi c\u00f3 s\u1ef1 cho ph\u00e9p t\u1eeb c\u01a1 quan h\u00e0nh ch\u00ednh, vi\u1ec7c s\u1ea3n xu\u1ea5t v\u00e0 b\u00e1n d\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng \u0111\u01b0\u1ee3c ph\u00e9p.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"San_pham_ngoai_y_duoc\"><\/span>S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>T\u00f4i ngh\u0129 r\u1eb1ng c\u00f3 r\u1ea5t \u00edt ng\u01b0\u1eddi hi\u1ec3u \u0111\u00fang v\u1ec1 &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221;. N\u00f3i m\u1ed9t c\u00e1ch \u0111\u01a1n gi\u1ea3n, s\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m c\u00f3 t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn c\u01a1 th\u1ec3 ng\u01b0\u1eddi nh\u01b0ng m\u1ee9c \u0111\u1ed9 t\u00e1c \u0111\u1ed9ng nh\u1eb9 h\u01a1n so v\u1edbi d\u01b0\u1ee3c ph\u1ea9m, v\u00e0 do \u0111\u00f3 b\u1ecb quy \u0111\u1ecbnh m\u1ed9t c\u00e1ch nh\u1eb9 nh\u00e0ng h\u01a1n so v\u1edbi d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n\n\n\n<p>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (Japanese Pharmaceutical and Medical Device Act) \u0111\u1ecbnh r\u00f5 v\u1ec1 s\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c trong \u0110i\u1ec1u 2, Kho\u1ea3n 2.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Theo lu\u1eadt n\u00e0y, &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221; l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m c\u00f3 t\u00e1c \u0111\u1ed9ng nh\u1eb9 \u0111\u1ed1i v\u1edbi c\u01a1 th\u1ec3 ng\u01b0\u1eddi, bao g\u1ed3m:<\/p>\n\n\n\n<p>1. Nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u00e1c m\u1ee5c \u0111\u00edch sau \u0111\u00e2y (tr\u1eeb nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng c\u00f9ng v\u1edbi m\u1ee5c \u0111\u00edch quy \u0111\u1ecbnh trong s\u1ed1 2 ho\u1eb7c s\u1ed1 3 c\u1ee7a kho\u1ea3n tr\u01b0\u1edbc), kh\u00f4ng ph\u1ea3i l\u00e0 m\u00e1y m\u00f3c ho\u1eb7c thi\u1ebft b\u1ecb:<\/p>\n\n\n\n<p>a. Ng\u0103n ch\u1eb7n c\u1ea3m gi\u00e1c bu\u1ed3n n\u00f4n v\u00e0 c\u00e1c c\u1ea3m gi\u00e1c kh\u00f3 ch\u1ecbu kh\u00e1c ho\u1eb7c m\u00f9i h\u00f4i mi\u1ec7ng ho\u1eb7c m\u00f9i c\u01a1 th\u1ec3<\/p>\n\n\n\n<p>b. Ng\u0103n ch\u1eb7n m\u1ee5n n\u01b0\u1edbc, vi\u00eam da v\u00e0 c\u00e1c t\u00ecnh tr\u1ea1ng t\u01b0\u01a1ng t\u1ef1<\/p>\n\n\n\n<p>c. Ng\u0103n r\u1ee5ng t\u00f3c, k\u00edch th\u00edch m\u1ecdc t\u00f3c ho\u1eb7c t\u1ea9y l\u00f4ng<\/p>\n\n\n\n<p>2. Nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ph\u00f2ng tr\u1eeb chu\u1ed9t, ru\u1ed3i, mu\u1ed7i, b\u1ecd ch\u00e9t v\u00e0 c\u00e1c lo\u00e0i sinh v\u1eadt t\u01b0\u01a1ng t\u1ef1 \u0111\u1ec3 b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt (tr\u1eeb nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng c\u00f9ng v\u1edbi m\u1ee5c \u0111\u00edch quy \u0111\u1ecbnh trong s\u1ed1 2 ho\u1eb7c s\u1ed1 3 c\u1ee7a kho\u1ea3n tr\u01b0\u1edbc), kh\u00f4ng ph\u1ea3i l\u00e0 m\u00e1y m\u00f3c ho\u1eb7c thi\u1ebft b\u1ecb<\/p>\n\n\n\n<p>3. Nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch quy \u0111\u1ecbnh trong s\u1ed1 2 ho\u1eb7c s\u1ed1 3 c\u1ee7a kho\u1ea3n tr\u01b0\u1edbc (tr\u1eeb nh\u1eefng s\u1ea3n ph\u1ea9m quy \u0111\u1ecbnh trong s\u1ed1 1 v\u00e0 s\u1ed1 2), \u0111\u01b0\u1ee3c B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Lao \u0111\u1ed9ng, Y t\u1ebf v\u00e0 Ph\u00fac l\u1ee3i ch\u1ec9 \u0111\u1ecbnh<\/p>\n<cite>Lu\u1eadt v\u1ec1 \u0110\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, \u0110i\u1ec1u 2, Kho\u1ea3n 2<\/cite><\/blockquote>\n\n\n\n<p>Khi xem x\u00e9t c\u00e1c quy \u0111\u1ecbnh tr\u00ean, ch\u00fang ta c\u00f3 th\u1ec3 th\u1ea5y r\u1eb1ng s\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c bao g\u1ed3m nh\u1eefng s\u1ea3n ph\u1ea9m c\u00f3 t\u00e1c \u0111\u1ed9ng nh\u1eb9 \u0111\u1ed1i v\u1edbi c\u01a1 th\u1ec3 ng\u01b0\u1eddi, bao g\u1ed3m \u2460 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho vi\u1ec7c ng\u0103n ch\u1eb7n c\u1ea3m gi\u00e1c bu\u1ed3n n\u00f4n, \u2461 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 ph\u00f2ng tr\u1eeb chu\u1ed9t v\u00e0 c\u00e1c lo\u00e0i sinh v\u1eadt t\u01b0\u01a1ng t\u1ef1, v\u00e0 \u2462 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Lao \u0111\u1ed9ng, Y t\u1ebf v\u00e0 Ph\u00fac l\u1ee3i ch\u1ec9 \u0111\u1ecbnh.<\/p>\n\n\n\n<p>V\u00ed d\u1ee5 v\u1ec1 \u2460 bao g\u1ed3m x\u1ecbt kh\u1eed m\u00f9i mi\u1ec7ng, thu\u1ed1c s\u00fac mi\u1ec7ng, kem ng\u0103n ng\u1eeba vi\u00eam da do c\u1ea1o r\u00e2u, thu\u1ed1c k\u00edch th\u00edch m\u1ecdc t\u00f3c, v\u00e0 kem t\u1ea9y l\u00f4ng.<\/p>\n\n\n\n<p>V\u00ed d\u1ee5 v\u1ec1 \u2461 bao g\u1ed3m n\u1ebfn ch\u1ed1ng mu\u1ed7i, b\u1eaby chu\u1ed9t, v\u00e0 thu\u1ed1c di\u1ec7t c\u00f4n tr\u00f9ng.<\/p>\n\n\n\n<p>\u2462 l\u00e0 quy \u0111\u1ecbnh v\u1ec1 nh\u1eefng s\u1ea3n ph\u1ea9m m\u00e0 theo nguy\u00ean t\u1eafc s\u1ebd thu\u1ed9c lo\u1ea1i &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;, nh\u01b0ng n\u1ebfu \u0111\u01b0\u1ee3c B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Lao \u0111\u1ed9ng, Y t\u1ebf v\u00e0 Ph\u00fac l\u1ee3i ch\u1ec9 \u0111\u1ecbnh, ch\u00fang s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221;. \u0110\u00e2y l\u00e0 quy \u0111\u1ecbnh v\u1edbi m\u1ee5c \u0111\u00edch khuy\u1ebfn kh\u00edch vi\u1ec7c ph\u00e2n ph\u1ed1i nh\u1eefng s\u1ea3n ph\u1ea9m c\u00f3 t\u00e1c \u0111\u1ed9ng nh\u1eb9 v\u00e0 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n t\u1ea1i c\u00e1c c\u1eeda h\u00e0ng b\u00e1n l\u1ebb th\u00f4ng th\u01b0\u1eddng m\u00e0 kh\u00f4ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi d\u00e2n.<\/p>\n\n\n\n<p>V\u00ed d\u1ee5 v\u1ec1 \u2462 bao g\u1ed3m dung d\u1ecbch ti\u1ec7t tr\u00f9ng cho k\u00ednh \u00e1p tr\u00f2ng, dung d\u1ecbch di\u1ec7t khu\u1ea9n, thu\u1ed1c \u0111i\u1ec1u ch\u1ec9nh \u0111\u01b0\u1eddng ru\u1ed9t, v\u00e0 thu\u1ed1c nhu\u1ed9m t\u00f3c.<\/p>\n\n\n\n<p>S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c, gi\u1ed1ng nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m, c\u00f3 t\u00e1c \u0111\u1ed9ng nh\u1ea5t \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi c\u01a1 th\u1ec3 ng\u01b0\u1eddi, nh\u01b0ng \u0111\u1eb7c \u0111i\u1ec3m c\u1ee7a ch\u00fang so v\u1edbi d\u01b0\u1ee3c ph\u1ea9m l\u00e0 t\u00e1c \u0111\u1ed9ng c\u1ee7a ch\u00fang l\u00e0 &#8220;nh\u1eb9&#8221;. V\u00ed d\u1ee5, ch\u00fang t\u00f4i \u0111\u00e3 \u0111\u1ec1 c\u1eadp \u0111\u1ebfn thu\u1ed1c di\u1ec7t c\u00f4n tr\u00f9ng nh\u01b0 m\u1ed9t v\u00ed d\u1ee5 v\u1ec1 \u2461, nh\u01b0ng n\u1ebfu ch\u00fang ch\u1ee9a th\u00e0nh ph\u1ea7n c\u00f3 t\u00e1c \u0111\u1ed9ng m\u1ea1nh \u0111\u1ed1i v\u1edbi c\u01a1 th\u1ec3 ng\u01b0\u1eddi, ch\u00fang s\u1ebd kh\u00f4ng \u0111\u01b0\u1ee3c coi l\u00e0 &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221; m\u00e0 l\u00e0 &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;.<\/p>\n\n\n\n<p>Quy \u0111\u1ecbnh ch\u00ednh \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c, n\u00f3i m\u1ed9t c\u00e1ch \u0111\u01a1n gi\u1ea3n, l\u00e0 c\u1ea5p ph\u00e9p li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1ea3n xu\u1ea5t. M\u1eb7t kh\u00e1c, kh\u00f4ng c\u1ea7n c\u1ea5p ph\u00e9p \u0111\u1ec3 b\u00e1n ch\u00fang. N\u00f3i c\u00e1ch kh\u00e1c, s\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n t\u1ef1 do t\u1ea1i c\u00e1c c\u1eeda h\u00e0ng b\u00e1n l\u1ebb th\u00f4ng th\u01b0\u1eddng. Tuy nhi\u00ean, nh\u01b0 s\u1ebd \u0111\u01b0\u1ee3c \u0111\u1ec1 c\u1eadp sau \u0111\u00e2y, quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o v\u1eabn \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"My_pham\"><\/span>M\u1ef9 ph\u1ea9m<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Khi nghe \u0111\u1ebfn m\u1ef9 ph\u1ea9m, nhi\u1ec1u ng\u01b0\u1eddi th\u01b0\u1eddng ngh\u0129 \u0111\u1ebfn nh\u1eefng s\u1ea3n ph\u1ea9m m\u00e0 ph\u1ee5 n\u1eef s\u1eed d\u1ee5ng \u0111\u1ec3 trang \u0111i\u1ec3m. Tuy nhi\u00ean, &#8220;m\u1ef9 ph\u1ea9m&#8221; theo \u0111\u1ecbnh ngh\u0129a c\u1ee7a 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) l\u1ea1i bao g\u1ed3m m\u1ed9t ph\u1ea1m vi r\u1ed9ng h\u01a1n.<\/p>\n\n\n\n<p>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n \u0111\u1ecbnh ngh\u0129a v\u1ec1 m\u1ef9 ph\u1ea9m trong \u0110i\u1ec1u 2, Kho\u1ea3n 3 nh\u01b0 sau:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>&#8220;M\u1ef9 ph\u1ea9m&#8221; theo lu\u1eadt n\u00e0y, l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 l\u00e0m s\u1ea1ch c\u01a1 th\u1ec3, l\u00e0m \u0111\u1eb9p, t\u0103ng s\u1ee9c h\u1ea5p d\u1eabn, thay \u0111\u1ed5i h\u00ecnh d\u00e1ng, ho\u1eb7c gi\u1eef cho da v\u00e0 t\u00f3c kh\u1ecfe m\u1ea1nh b\u1eb1ng c\u00e1ch thoa, x\u1ecbt ho\u1eb7c c\u00e1c ph\u01b0\u01a1ng ph\u00e1p t\u01b0\u01a1ng t\u1ef1, v\u1edbi t\u00e1c d\u1ee5ng nh\u1eb9 nh\u00e0ng l\u00ean c\u01a1 th\u1ec3 ng\u01b0\u1eddi. Tuy nhi\u00ean, kh\u00f4ng bao g\u1ed3m nh\u1eefng s\u1ea3n ph\u1ea9m c\u00f3 m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng kh\u00e1c ngo\u00e0i nh\u1eefng m\u1ee5c \u0111\u00edch tr\u00ean, ho\u1eb7c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u00e1c m\u1ee5c \u0111\u00edch quy \u0111\u1ecbnh trong Kho\u1ea3n 1, M\u1ee5c 2 ho\u1eb7c M\u1ee5c 3, c\u0169ng nh\u01b0 c\u00e1c s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u1ea1ng thu\u1ed1c.<\/p>\n<cite>\u0110i\u1ec1u 2, Kho\u1ea3n 3 c\u1ee7a Lu\u1eadt v\u1ec1 \u0110\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.<\/cite><\/blockquote>\n\n\n\n<p>Khi \u0111\u1ecdc quy \u0111\u1ecbnh tr\u00ean, ta c\u00f3 th\u1ec3 th\u1ea5y r\u1eb1ng &#8220;m\u1ef9 ph\u1ea9m&#8221; kh\u00f4ng ch\u1ec9 bao g\u1ed3m nh\u1eefng s\u1ea3n ph\u1ea9m trang \u0111i\u1ec3m th\u00f4ng th\u01b0\u1eddng m\u00e0 ph\u1ee5 n\u1eef s\u1eed d\u1ee5ng \u0111\u1ec3 &#8220;l\u00e0m \u0111\u1eb9p, t\u0103ng s\u1ee9c h\u1ea5p d\u1eabn, thay \u0111\u1ed5i h\u00ecnh d\u00e1ng&#8221;, m\u00e0 c\u00f2n bao g\u1ed3m c\u1ea3 nh\u1eefng s\u1ea3n ph\u1ea9m nh\u01b0 d\u1ea7u g\u1ed9i ho\u1eb7c kem \u0111\u00e1nh r\u0103ng gi\u00fap &#8220;l\u00e0m s\u1ea1ch c\u01a1 th\u1ec3&#8221;, c\u0169ng nh\u01b0 c\u00e1c s\u1ea3n ph\u1ea9m ch\u0103m s\u00f3c da ho\u1eb7c d\u01b0\u1ee1ng th\u1ec3 gi\u00fap &#8220;gi\u1eef cho da v\u00e0 t\u00f3c kh\u1ecfe m\u1ea1nh&#8221;.<\/p>\n\n\n\n<p>\u0110\u1ed3ng th\u1eddi, m\u1eb7c d\u00f9 m\u1ef9 ph\u1ea9m c\u00f3 t\u00e1c d\u1ee5ng nh\u1ea5t \u0111\u1ecbnh l\u00ean c\u01a1 th\u1ec3 ng\u01b0\u1eddi, nh\u01b0ng kh\u00f4ng bao g\u1ed3m nh\u1eefng s\u1ea3n ph\u1ea9m c\u00f3 t\u00e1c d\u1ee5ng d\u01b0\u1ee3c l\u00fd ho\u1eb7c kh\u00e1ng khu\u1ea9n. V\u00ed d\u1ee5, kem \u0111\u00e1nh r\u0103ng th\u00f4ng th\u01b0\u1eddng ch\u1ec9 d\u00f9ng \u0111\u1ec3 l\u00e0m s\u1ea1ch r\u0103ng mi\u1ec7ng s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 m\u1ef9 ph\u1ea9m, nh\u01b0ng kem \u0111\u00e1nh r\u0103ng qu\u1ea3ng c\u00e1o v\u1edbi ch\u1ee9c n\u0103ng ph\u00f2ng ng\u1eeba b\u1ec7nh l\u1ee3i s\u1ebd \u0111\u01b0\u1ee3c xem x\u00e9t nh\u01b0 m\u1ed9t s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u1ea1ng thu\u1ed1c ho\u1eb7c thu\u1ed1c, v\u00ec n\u00f3 c\u00f3 ch\u1ee9a th\u00e0nh ph\u1ea7n c\u00f3 t\u00e1c d\u1ee5ng d\u01b0\u1ee3c l\u00fd.<\/p>\n\n\n\n<p>H\u01a1n n\u1eefa, m\u1ef9 ph\u1ea9m ch\u1ec9 bao g\u1ed3m nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c thoa l\u00ean c\u01a1 th\u1ec3, do \u0111\u00f3, nh\u1eefng s\u1ea3n ph\u1ea9m d\u00f9ng \u0111\u1ec3 u\u1ed1ng ho\u1eb7c ti\u00eam v\u00e0o c\u01a1 th\u1ec3 kh\u00f4ng \u0111\u01b0\u1ee3c coi l\u00e0 m\u1ef9 ph\u1ea9m.<\/p>\n\n\n\n<p>C\u00e1c quy \u0111\u1ecbnh ch\u00ednh \u0111\u1ed1i v\u1edbi m\u1ef9 ph\u1ea9m li\u00ean quan \u0111\u1ebfn vi\u1ec7c c\u1ea5p ph\u00e9p v\u00e0 th\u00f4ng b\u00e1o v\u1ec1 s\u1ea3n xu\u1ea5t, v\u1edbi c\u00e1c quy \u0111\u1ecbnh l\u1ecfng l\u1ebbo h\u01a1n so v\u1edbi s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u1ea1ng thu\u1ed1c. M\u1ef9 ph\u1ea9m c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n t\u1ef1 do t\u1ea1i c\u00e1c c\u1eeda h\u00e0ng b\u00e1n l\u1ebb th\u00f4ng th\u01b0\u1eddng. Tuy nhi\u00ean, nh\u01b0 s\u1ebd \u0111\u01b0\u1ee3c \u0111\u1ec1 c\u1eadp sau \u0111\u00e2y, c\u00f3 c\u00e1c quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o. Ngo\u00e0i ra, ph\u1ea1m vi bi\u1ec3u hi\u1ec7n v\u1ec1 hi\u1ec7u qu\u1ea3 v\u00e0 c\u00f4ng d\u1ee5ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 nh\u01b0 m\u1ed9t m\u1ef9 ph\u1ea9m c\u0169ng b\u1ecb h\u1ea1n ch\u1ebf.<\/p>\n\n\n\n<p>Tham kh\u1ea3o: Th\u00f4ng b\u00e1o c\u1ee7a Gi\u00e1m \u0111\u1ed1c C\u1ee5c D\u01b0\u1ee3c ph\u1ea9m ng\u00e0y 21 th\u00e1ng 7 n\u0103m 2011 (n\u0103m 2011 theo l\u1ecbch Gregorian) s\u1ed1 0721-1 v\u1ec1 &#8220;<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/kesyouhin_hanni_20111.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">S\u1eeda \u0111\u1ed5i ph\u1ea1m vi c\u00f4ng d\u1ee5ng c\u1ee7a m\u1ef9 ph\u1ea9m[ja]<\/a>&#8220;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Thiet_bi_y_te\"><\/span>Thi\u1ebft b\u1ecb y t\u1ebf<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Thi\u1ebft b\u1ecb y t\u1ebf th\u01b0\u1eddng bao g\u1ed3m c\u00e1c v\u1eadt d\u1ee5ng y t\u1ebf nh\u01b0 dao m\u1ed5 hay kim ti\u00eam, nh\u01b0ng kh\u00f4ng ch\u1ec9 gi\u1edbi h\u1ea1n \u1edf \u0111\u00f3.<\/p>\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) \u0111\u1ecbnh ngh\u0129a v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf trong \u0110i\u1ec1u 2, Kho\u1ea3n 4 nh\u01b0 sau:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>&#8220;Thi\u1ebft b\u1ecb y t\u1ebf&#8221; trong lu\u1eadt n\u00e0y l\u00e0 c\u00e1c m\u00e1y m\u00f3c, d\u1ee5ng c\u1ee5, v.v. (tr\u1eeb s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o, v.v.) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb ho\u1eb7c ph\u00f2ng ng\u1eeba b\u1ec7nh t\u1eadt c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt, ho\u1eb7c c\u00f3 m\u1ee5c \u0111\u00edch \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3 con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt, v\u00e0 \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh b\u1edfi ph\u00e1p l\u1ec7nh.<\/p>\n<cite>\u0110i\u1ec1u 2, Kho\u1ea3n 4 c\u1ee7a Lu\u1eadt v\u1ec1 \u0110\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<\/cite><\/blockquote>\n\n\n\n<p>Khi \u0111\u1ecdc quy \u0111\u1ecbnh tr\u00ean, ch\u00fang ta c\u00f3 th\u1ec3 hi\u1ec3u r\u1eb1ng, c\u00e1c &#8220;m\u00e1y m\u00f3c, d\u1ee5ng c\u1ee5, v.v.&#8221; c\u00f3 m\u1ee5c \u0111\u00edch \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3 (1), ho\u1eb7c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb, ph\u00f2ng ng\u1eeba (2), v\u00e0 \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh b\u1edfi ph\u00e1p l\u1ec7nh, s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<p>\u0110\u1ecbnh ngh\u0129a c\u1ee7a &#8220;m\u00e1y m\u00f3c, d\u1ee5ng c\u1ee5, v.v.&#8221; \u0111\u01b0\u1ee3c ch\u1ec9 ra trong \u0110i\u1ec1u 2, Kho\u1ea3n 1, M\u1ee5c 2 nh\u01b0 sau:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u0110\u00e2y bao g\u1ed3m m\u00e1y m\u00f3c, d\u1ee5ng c\u1ee5, v\u1eadt li\u1ec7u nha khoa, v\u1eadt d\u1ee5ng y t\u1ebf, v\u1eadt d\u1ee5ng v\u1ec7 sinh c\u0169ng nh\u01b0 ch\u01b0\u01a1ng tr\u00ecnh (l\u00e0 l\u1ec7nh cho m\u00e1y t\u00ednh, \u0111\u01b0\u1ee3c t\u1ed5 ch\u1ee9c \u0111\u1ec3 c\u00f3 th\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c k\u1ebft qu\u1ea3. D\u01b0\u1edbi \u0111\u00e2y c\u00f9ng \u00e1p d\u1ee5ng.) v\u00e0 ph\u01b0\u01a1ng ti\u1ec7n ghi ch\u00fa n\u00e0y.<\/p>\n<cite>\u0110i\u1ec1u 2, Kho\u1ea3n 1, M\u1ee5c 2 c\u1ee7a Lu\u1eadt v\u1ec1 \u0110\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<\/cite><\/blockquote>\n\n\n\n<p>V\u00ed d\u1ee5, d\u1ee5ng c\u1ee5 t\u1eadp th\u1ec3 d\u1ee5c c\u00f3 m\u1ee5c \u0111\u00edch l\u00e0m t\u0103ng c\u01a1 b\u1eafp, do \u0111\u00f3, n\u00f3 c\u00f3 &#8220;m\u1ee5c \u0111\u00edch \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3&#8221;, nh\u01b0ng kh\u00f4ng ph\u1ea3i l\u00e0 &#8220;m\u00e1y m\u00f3c, d\u1ee5ng c\u1ee5, v.v. \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh b\u1edfi ph\u00e1p l\u1ec7nh&#8221;, do \u0111\u00f3, n\u00f3 kh\u00f4ng ph\u1ea3i l\u00e0 thi\u1ebft b\u1ecb y t\u1ebf. Ng\u01b0\u1ee3c l\u1ea1i, m\u00e1y m\u00e1t-xa l\u00e0 &#8220;m\u00e1y m\u00f3c, d\u1ee5ng c\u1ee5, v.v. c\u00f3 m\u1ee5c \u0111\u00edch \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3 v\u00e0 \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh b\u1edfi ph\u00e1p l\u1ec7nh&#8221;, do \u0111\u00f3, n\u00f3 \u0111\u01b0\u1ee3c coi l\u00e0 thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<p>V\u00ed d\u1ee5 kh\u00e1c v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m nhi\u1ec7t k\u1ebf, ch\u1ec9 kh\u00e2u, d\u1ee5ng c\u1ee5 tr\u00e1nh thai, ch\u01b0\u01a1ng tr\u00ecnh ch\u1ea9n \u0111o\u00e1n d\u1ecbch b\u1ec7nh, v.v.<\/p>\n\n\n\n<p>Thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i th\u00e0nh &#8220;Thi\u1ebft b\u1ecb y t\u1ebf th\u00f4ng th\u01b0\u1eddng&#8221;, &#8220;Thi\u1ebft b\u1ecb y t\u1ebf qu\u1ea3n l\u00fd&#8221; v\u00e0 &#8220;Thi\u1ebft b\u1ecb y t\u1ebf qu\u1ea3n l\u00fd cao c\u1ea5p&#8221; d\u1ef1a tr\u00ean m\u1ee9c \u0111\u1ed9 nguy hi\u1ec3m v\u00e0 m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng.<\/p>\n\n\n\n<p>N\u1ed9i dung ch\u00ednh c\u1ee7a quy \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb y t\u1ebf, n\u00f3i m\u1ed9t c\u00e1ch \u0111\u01a1n gi\u1ea3n, l\u00e0 c\u1ea5p ph\u00e9p v\u00e0 th\u00f4ng b\u00e1o li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1ea3n xu\u1ea5t, b\u00e1n h\u00e0ng, cho thu\u00ea v\u00e0 s\u1eeda ch\u1eefa. M\u1ee9c \u0111\u1ed9 quy \u0111\u1ecbnh kh\u00e1c nhau t\u00f9y thu\u1ed9c v\u00e0o lo\u1ea1i thi\u1ebft b\u1ecb y t\u1ebf. V\u00ed d\u1ee5, &#8220;Thi\u1ebft b\u1ecb y t\u1ebf qu\u1ea3n l\u00fd cao c\u1ea5p&#8221; c\u1ea7n c\u00f3 gi\u1ea5y ph\u00e9p khi b\u00e1n, trong khi &#8220;Thi\u1ebft b\u1ecb y t\u1ebf th\u00f4ng th\u01b0\u1eddng&#8221; kh\u00f4ng c\u1ea7n c\u1ea5p ph\u00e9p ho\u1eb7c th\u00f4ng b\u00e1o khi b\u00e1n, v\u00e0 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n t\u1ef1 do.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"San_pham_y_te_tai_tao\"><\/span>S\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp trong l\u1ea7n s\u1eeda \u0111\u1ed5i n\u0103m 2014 (2014). Nh\u01b0 \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n qua vi\u1ec7c ph\u00e1t tri\u1ec3n t\u1ebf b\u00e0o iPS do Gi\u00e1o s\u01b0 Yamanaka Shinya, ti\u1ebfn b\u1ed9 trong y t\u1ebf t\u00e1i t\u1ea1o \u0111\u00e1ng k\u1ec3. Tuy nhi\u00ean, v\u1eabn c\u00f2n nhi\u1ec1u \u0111i\u1ec1u ch\u01b0a bi\u1ebft v\u1ec1 m\u1eb7t nguy hi\u1ec3m, v\u00ec v\u1eady ch\u00fang t\u00f4i \u0111\u00e3 gi\u1edbi thi\u1ec7u m\u1ed9t h\u1ec7 th\u1ed1ng m\u1edbi \u0111\u1ec3 th\u00fac \u0111\u1ea9y an to\u00e0n.<\/p>\n\n\n\n<p>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n \u0111\u1ecbnh ngh\u0129a s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o trong \u0110i\u1ec1u 2, Kho\u1ea3n 9.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Theo lu\u1eadt n\u00e0y, &#8220;s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o&#8221; l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m sau \u0111\u00e2y (tr\u1eeb s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u1ea1ng thu\u1ed1c v\u00e0 m\u1ef9 ph\u1ea9m) \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh b\u1edfi ph\u00e1p l\u1ec7nh.<\/p>\n\n\n\n<p>1. S\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ebf bi\u1ebfn t\u1eeb vi\u1ec7c nu\u00f4i c\u1ea5y ho\u1eb7c x\u1eed l\u00fd kh\u00e1c c\u00e1c t\u1ebf b\u00e0o c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt, v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng trong y t\u1ebf ho\u1eb7c th\u00fa y nh\u01b0 sau:<\/p>\n\n\n\n<p>(i) T\u00e1i t\u1ea1o, s\u1eeda ch\u1eefa ho\u1eb7c h\u00ecnh th\u00e0nh c\u1ea5u tr\u00fac ho\u1eb7c ch\u1ee9c n\u0103ng c\u1ee7a c\u01a1 th\u1ec3 ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt<\/p>\n\n\n\n<p>(ii) \u0110i\u1ec1u tr\u1ecb ho\u1eb7c ph\u00f2ng ng\u1eeba b\u1ec7nh t\u1eadt c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt<\/p>\n\n\n\n<p>2. S\u1ea3n ph\u1ea9m c\u00f3 ch\u1ee9a gen bi\u1ec3u hi\u1ec7n trong c\u01a1 th\u1ec3 sau khi \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o t\u1ebf b\u00e0o c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt, v\u1edbi m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng trong \u0111i\u1ec1u tr\u1ecb b\u1ec7nh t\u1eadt c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt<\/p>\n<cite>\u0110i\u1ec1u 2, Kho\u1ea3n 9 c\u1ee7a Lu\u1eadt v\u1ec1 \u0110\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<\/cite><\/blockquote>\n\n\n\n<p>Khi xem x\u00e9t c\u00e1c quy \u0111\u1ecbnh tr\u00ean, ch\u00fang ta c\u00f3 th\u1ec3 th\u1ea5y r\u1eb1ng c\u00f3 hai lo\u1ea1i ch\u00ednh c\u1ee7a s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o. Th\u1ee9 nh\u1ea5t l\u00e0 &#8220;s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ebf bi\u1ebfn t\u1eeb vi\u1ec7c nu\u00f4i c\u1ea5y ho\u1eb7c x\u1eed l\u00fd kh\u00e1c c\u00e1c t\u1ebf b\u00e0o c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt&#8221;. Th\u1ee9 hai l\u00e0 &#8220;s\u1ea3n ph\u1ea9m c\u00f3 ch\u1ee9a gen bi\u1ec3u hi\u1ec7n trong c\u01a1 th\u1ec3 sau khi \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o t\u1ebf b\u00e0o c\u1ee7a con ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt&#8221;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Quy_dinh_ve_quang_cao_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>Quy \u0111\u1ecbnh v\u1ec1 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<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-3.png\" alt=\"\" class=\"wp-image-61027\" srcset=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-3.png 735w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-3-300x200.png 300w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-3-250x167.png 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><\/figure>\n\n\n\n<p>\u1ede \u0111\u00e2y, ch\u00fang t\u00f4i s\u1ebd gi\u1ea3i th\u00edch v\u1ec1 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, m\u1ed9t quy \u0111\u1ecbnh m\u00e0 nhi\u1ec1u ng\u01b0\u1eddi c\u1ea7n ph\u1ea3i ch\u00fa \u00fd.<\/p>\n\n\n\n<p>Qu\u1ea3ng c\u00e1o v\u1ec1 d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan c\u00f3 m\u1eb7t tr\u00e1i l\u00e0 cung c\u1ea5p th\u00f4ng tin cho c\u00f4ng ch\u00fang, nh\u01b0ng n\u1ebfu bi\u1ec3u hi\u1ec7n qu\u1ea3ng c\u00e1o qu\u00e1 m\u1ee9c t\u0103ng l\u00ean, t\u00ecnh tr\u1ea1ng nh\u01b0 vi\u1ec7c l\u01b0u th\u00f4ng s\u1ea3n ph\u1ea9m k\u00e9m ch\u1ea5t l\u01b0\u1ee3ng hay hi\u1ec3u l\u1ea7m v\u1ec1 an to\u00e0n c\u00f3 th\u1ec3 g\u00e2y h\u1ea1i cho s\u1ee9c kh\u1ecfe c\u00f4ng ch\u00fang. Do \u0111\u00f3, Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n \u0111\u00e3 quy \u0111\u1ecbnh v\u1ec1 vi\u1ec7c ki\u1ec3m so\u00e1t qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan t\u1eeb \u0110i\u1ec1u 66 \u0111\u1ebfn \u0110i\u1ec1u 68.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Kh\u00f4ng ai \u0111\u01b0\u1ee3c ph\u00e9p qu\u1ea3ng c\u00e1o, m\u00f4 t\u1ea3 ho\u1eb7c lan truy\u1ec1n th\u00f4ng tin gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i v\u1ec1 t\u00ean, ph\u01b0\u01a1ng ph\u00e1p s\u1ea3n xu\u1ea5t, c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c t\u00ednh n\u0103ng c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o, d\u00f9 r\u00f5 r\u00e0ng hay ng\u1ee5 \u00fd.<\/p>\n\n\n\n<p>2. Vi\u1ec7c qu\u1ea3ng c\u00e1o, m\u00f4 t\u1ea3 ho\u1eb7c lan truy\u1ec1n th\u00f4ng tin c\u00f3 th\u1ec3 g\u00e2y hi\u1ec3u l\u1ea7m r\u1eb1ng m\u1ed9t b\u00e1c s\u0129 ho\u1eb7c ng\u01b0\u1eddi kh\u00e1c \u0111\u00e3 b\u1ea3o \u0111\u1ea3m c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c t\u00ednh n\u0103ng c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 th\u00f4ng tin gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i theo \u0110i\u1ec1u tr\u00ean.<\/p>\n\n\n\n<p>3. Kh\u00f4ng ai \u0111\u01b0\u1ee3c ph\u00e9p ng\u1ee5 \u00fd vi\u1ec7c ph\u00e1 thai ho\u1eb7c s\u1eed d\u1ee5ng v\u0103n b\u1ea3n ho\u1eb7c h\u00ecnh \u1ea3nh khi\u00eau d\u00e2m li\u00ean quan \u0111\u1ebfn d\u01b0\u1ee3c ph\u1ea9m, s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u01b0\u1ee3c ph\u1ea9m, m\u1ef9 ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o.<\/p>\n<cite>\u0110i\u1ec1u 66 c\u1ee7a Lu\u1eadt v\u1ec1 \u0110\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\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan Nh\u1eadt B\u1ea3n<\/cite><\/blockquote>\n\n\n\n<p>\u0110i\u1ec1u 66, kho\u1ea3n 1 c\u1ea5m qu\u1ea3ng c\u00e1o gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i v\u1ec1 t\u00ean, ph\u01b0\u01a1ng ph\u00e1p s\u1ea3n xu\u1ea5t, c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c t\u00ednh n\u0103ng c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan. N\u1ebfu qu\u1ea3ng c\u00e1o c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 m\u1ed9t c\u00e1ch qu\u00e1 m\u1ee9c, vi\u1ec7c s\u1eed d\u1ee5ng sai l\u1ec7ch c\u00f3 th\u1ec3 t\u0103ng l\u00ean v\u00e0 t\u00ecnh tr\u1ea1ng b\u1ec7nh c\u00f3 th\u1ec3 tr\u1edf n\u00ean t\u1ed3i t\u1ec7 h\u01a1n. \u0110i\u1ec1u 66, kho\u1ea3n 1 l\u00e0 quy \u0111\u1ecbnh ki\u1ec3m so\u00e1t lo\u1ea1i h\u00ecnh qu\u1ea3ng c\u00e1o n\u00e0y.<\/p>\n\n\n\n<p>&#8220;Qu\u1ea3ng c\u00e1o&#8221; \u0111\u01b0\u1ee3c \u0111\u1ec1 c\u1eadp \u1edf \u0111\u00e2y l\u00e0 nh\u1eefng \u0111i\u1ec1u \u0111\u00e1p \u1ee9ng ba y\u00eau c\u1ea7u sau. (Tham kh\u1ea3o: Th\u00f4ng b\u00e1o ng\u00e0y 29 th\u00e1ng 9 n\u0103m 1999 (n\u0103m 1999 theo l\u1ecbch Gregorian) c\u1ee7a Gi\u00e1m \u0111\u1ed1c Ph\u00f2ng Gi\u00e1m s\u00e1t v\u00e0 H\u01b0\u1edbng d\u1eabn An to\u00e0n D\u01b0\u1ee3c ph\u1ea9m, B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n, s\u1ed1 148, &#8220;<a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">V\u1ec1 vi\u1ec7c x\u00e1c \u0111\u1ecbnh qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m[ja]<\/a>&#8220;)<\/p>\n\n\n\n<ol>\n<li>C\u00f3 \u00fd \u0111\u1ecbnh r\u00f5 r\u00e0ng thu h\u00fat kh\u00e1ch h\u00e0ng (k\u00edch th\u00edch \u00fd mu\u1ed1n mua h\u00e0ng c\u1ee7a kh\u00e1ch h\u00e0ng)<\/li>\n\n\n\n<li>T\u00ean c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m c\u1ee5 th\u1ec3 ho\u1eb7c c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan \u0111\u00e3 \u0111\u01b0\u1ee3c ti\u1ebft l\u1ed9 r\u00f5 r\u00e0ng<\/li>\n\n\n\n<li>Tr\u1ea1ng th\u00e1i m\u00e0 ng\u01b0\u1eddi d\u00e2n c\u00f3 th\u1ec3 nh\u1eadn bi\u1ebft<\/li>\n<\/ol>\n\n\n\n<p>\u0110i\u1ec1u 66, kho\u1ea3n 2 quy \u0111\u1ecbnh r\u1eb1ng vi\u1ec7c qu\u1ea3ng c\u00e1o th\u00f4ng tin c\u00f3 th\u1ec3 g\u00e2y hi\u1ec3u l\u1ea7m r\u1eb1ng m\u1ed9t b\u00e1c s\u0129 ho\u1eb7c ng\u01b0\u1eddi kh\u00e1c \u0111\u00e3 b\u1ea3o \u0111\u1ea3m c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c t\u00ednh n\u0103ng c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 th\u00f4ng tin gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i.<\/p>\n\n\n\n<p>\u0110i\u1ec1u 66, kho\u1ea3n 3 quy \u0111\u1ecbnh r\u1eb1ng kh\u00f4ng \u0111\u01b0\u1ee3c ng\u1ee5 \u00fd vi\u1ec7c ph\u00e1 thai ho\u1eb7c s\u1eed d\u1ee5ng bi\u1ec3u hi\u1ec7n khi\u00eau d\u00e2m li\u00ean quan \u0111\u1ebfn d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u0110\u1ed1i v\u1edbi d\u01b0\u1ee3c ph\u1ea9m ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o m\u00e0 m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng l\u00e0 \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb ung th\u01b0 ho\u1eb7c c\u00e1c b\u1ec7nh \u0111\u1eb7c bi\u1ec7t kh\u00e1c v\u00e0 c\u00f3 nguy c\u01a1 g\u00e2y h\u1ea1i \u0111\u1eb7c bi\u1ec7t l\u1edbn n\u1ebfu kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng d\u01b0\u1edbi s\u1ef1 h\u01b0\u1edbng d\u1eabn c\u1ee7a b\u00e1c s\u0129 ho\u1eb7c nha s\u0129, B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i c\u00f3 th\u1ec3 ch\u1ec9 \u0111\u1ecbnh d\u01b0\u1ee3c ph\u1ea9m ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o v\u00e0 quy \u0111\u1ecbnh c\u00e1c bi\u1ec7n ph\u00e1p c\u1ea7n thi\u1ebft \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o vi\u1ec7c s\u1eed d\u1ee5ng \u0111\u00fang c\u00e1ch c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o, nh\u01b0 h\u1ea1n ch\u1ebf ph\u01b0\u01a1ng ph\u00e1p qu\u1ea3ng c\u00e1o d\u00e0nh cho ng\u01b0\u1eddi d\u00e2n kh\u00f4ng li\u00ean quan \u0111\u1ebfn ng\u00e0nh y t\u1ebf.<\/p>\n\n\n\n<p>2. Tr\u01b0\u1edbc khi y\u00eau c\u1ea7u h\u1ecdp n\u1ed9i c\u00e1c v\u1ec1 vi\u1ec7c ban h\u00e0nh ho\u1eb7c b\u00e3i b\u1ecf s\u1eafc l\u1ec7nh quy \u0111\u1ecbnh b\u1ec7nh \u0111\u1eb7c bi\u1ec7t theo kho\u1ea3n tr\u00ean, B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i ph\u1ea3i nghe \u00fd ki\u1ebfn c\u1ee7a H\u1ed9i \u0111\u1ed3ng T\u01b0 v\u1ea5n v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 An to\u00e0n Th\u1ef1c ph\u1ea9m. Tuy nhi\u00ean, \u0111i\u1ec1u n\u00e0y kh\u00f4ng \u00e1p d\u1ee5ng cho c\u00e1c v\u1ea5n \u0111\u1ec1 nh\u1ecf m\u00e0 H\u1ed9i \u0111\u1ed3ng T\u01b0 v\u1ea5n v\u1ec1 D\u01b0\u1ee3c ph\u1ea9m v\u00e0 An to\u00e0n Th\u1ef1c ph\u1ea9m coi l\u00e0 kh\u00f4ng \u0111\u00e1ng k\u1ec3.<\/p>\n<cite>\u0110i\u1ec1u 67 c\u1ee7a Lu\u1eadt v\u1ec1 \u0110\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\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan Nh\u1eadt B\u1ea3n<\/cite><\/blockquote>\n\n\n\n<p>\u0110i\u1ec1u 67 cho ph\u00e9p ch\u00ednh ph\u1ee7 quy \u0111\u1ecbnh c\u00e1c bi\u1ec7n ph\u00e1p nh\u01b0 h\u1ea1n ch\u1ebf ph\u01b0\u01a1ng ph\u00e1p qu\u1ea3ng c\u00e1o \u0111\u1ed1i v\u1edbi d\u01b0\u1ee3c ph\u1ea9m d\u00f9ng cho b\u1ec7nh \u0111\u1eb7c bi\u1ec7t. Th\u1ef1c t\u1ebf, qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m d\u00f9ng cho m\u1ee5c \u0111\u00edch \u0111i\u1ec1u tr\u1ecb ung th\u01b0, u s\u1eafc t\u1ed1, b\u1ec7nh b\u1ea1ch c\u1ea7u \u0111\u00e3 b\u1ecb c\u1ea5m theo s\u1eafc l\u1ec7nh (\u0110i\u1ec1u 228-10, kho\u1ea3n 1 v\u00e0 Ph\u1ee5 l\u1ee5c s\u1ed1 5 c\u1ee7a Quy t\u1eafc thi h\u00e0nh Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf).<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>Kh\u00f4ng ai \u0111\u01b0\u1ee3c ph\u00e9p qu\u1ea3ng c\u00e1o v\u1ec1 t\u00ean, ph\u01b0\u01a1ng ph\u00e1p s\u1ea3n xu\u1ea5t, c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3 ho\u1eb7c t\u00ednh n\u0103ng c\u1ee7a d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o quy \u0111\u1ecbnh trong \u0110i\u1ec1u 14, kho\u1ea3n 1, \u0110i\u1ec1u 23-2-5, kho\u1ea3n 1 ho\u1eb7c \u0110i\u1ec1u 23-2-23, kho\u1ea3n 1 m\u00e0 ch\u01b0a nh\u1eadn \u0111\u01b0\u1ee3c s\u1ef1 ch\u1ea5p thu\u1eadn theo \u0110i\u1ec1u 14, kho\u1ea3n 1, \u0110i\u1ec1u 19-2, kho\u1ea3n 1, \u0110i\u1ec1u 23-2-5, kho\u1ea3n 1, \u0110i\u1ec1u 23-2-17, kho\u1ea3n 1, \u0110i\u1ec1u 23-2-25, kho\u1ea3n 1 ho\u1eb7c \u0110i\u1ec1u 23-2-37, kho\u1ea3n 1 ho\u1eb7c ch\u1ee9ng nh\u1eadn theo \u0110i\u1ec1u 23-2-23, kho\u1ea3n 1.<\/p>\n<cite>\u0110i\u1ec1u 68 c\u1ee7a Lu\u1eadt v\u1ec1 \u0110\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\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan Nh\u1eadt B\u1ea3n<\/cite><\/blockquote>\n\n\n\n<p>\u0110i\u1ec1u 68 c\u1ea5m qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn. C\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3, v.v. ch\u1ec9 \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn c\u00f4ng khai sau khi \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn, do \u0111\u00f3, vi\u1ec7c qu\u1ea3ng c\u00e1o c\u00f4ng d\u1ee5ng, hi\u1ec7u qu\u1ea3, v.v. tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn s\u1ebd g\u00e2y r\u1ed1i lo\u1ea1n. \u0110i\u1ec1u 68 l\u00e0 quy \u0111\u1ecbnh ki\u1ec3m so\u00e1t lo\u1ea1i h\u00ecnh qu\u1ea3ng c\u00e1o n\u00e0y.<\/p>\n\n\n\n<p>\u0110i\u1ec1u c\u1ea7n ch\u00fa \u00fd \u0111\u1eb7c bi\u1ec7t l\u00e0 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i (\u0110i\u1ec1u 66) v\u00e0 vi\u1ec7c c\u1ea5m qu\u1ea3ng c\u00e1o d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn (\u0110i\u1ec1u 68) \u0111\u1ec1u \u00e1p d\u1ee5ng cho &#8220;b\u1ea5t k\u1ef3 ai&#8221;.<\/p>\n\n\n\n<p>C\u00e1c quy \u0111\u1ecbnh n\u00e0y \u00e1p d\u1ee5ng cho &#8220;b\u1ea5t k\u1ef3 ai&#8221;, t\u1ee9c l\u00e0 &#8220;t\u1ea5t c\u1ea3 m\u1ecdi ng\u01b0\u1eddi&#8221;. N\u00f3 kh\u00f4ng ch\u1ec9 \u00e1p d\u1ee5ng cho nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 ng\u01b0\u1eddi b\u00e1n d\u01b0\u1ee3c ph\u1ea9m, m\u00e0 c\u00f2n \u00e1p d\u1ee5ng cho nh\u1eefng ng\u01b0\u1eddi nh\u1eadn y\u00eau c\u1ea7u t\u1eeb nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u1ec3 th\u1ef1c hi\u1ec7n qu\u1ea3ng c\u00e1o.<\/p>\n\n\n\n<p>Do \u0111\u00f3, c\u00e1c ph\u01b0\u01a1ng ti\u1ec7n truy\u1ec1n th\u00f4ng \u0111\u1ea1i ch\u00fang nh\u01b0 truy\u1ec1n h\u00ecnh, b\u00e1o ch\u00ed, c\u00e1c c\u00f4ng ty qu\u1ea3ng c\u00e1o, ng\u01b0\u1eddi ti\u1ebfp th\u1ecb li\u00ean k\u1ebft, ng\u01b0\u1eddi \u1ea3nh h\u01b0\u1edfng c\u1ea7n ph\u1ea3i ch\u00fa \u00fd kh\u00f4ng vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf khi gi\u1edbi thi\u1ec7u d\u01b0\u1ee3c ph\u1ea9m ho\u1eb7c m\u1ef9 ph\u1ea9m.<\/p>\n\n\n\n<p>Ngo\u00e0i ra, ngay c\u1ea3 \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m kh\u00f4ng ph\u1ea3i l\u00e0 \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, t\u00f9y thu\u1ed9c v\u00e0o n\u1ed9i dung bi\u1ec3u hi\u1ec7n, ch\u00fang 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. \u0110i\u1ec3m n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c gi\u1ea3i th\u00edch trong ph\u1ea7n &#8220;S\u1ea3n ph\u1ea9m kh\u00f4ng ph\u1ea3i l\u00e0 \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&#8221;.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E2%80%9CQuang_cao_phong_dai%E2%80%9D_duoc_danh_gia_dua_tren_tieu_chuan_quang_cao_dung_dan_cho_duoc_pham_va_cac_san_pham_tuong_tu\"><\/span>&#8220;Qu\u1ea3ng c\u00e1o ph\u00f3ng \u0111\u1ea1i&#8221; \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 d\u1ef1a tr\u00ean ti\u00eau chu\u1ea9n qu\u1ea3ng c\u00e1o \u0111\u00fang \u0111\u1eafn cho d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>&#8220;Sai l\u1ec7ch&#8221; ngh\u0129a l\u00e0 vi\u1ec7c tr\u00e1i v\u1edbi s\u1ef1 th\u1eadt, c\u00f2n &#8220;ph\u00f3ng \u0111\u1ea1i&#8221; ngh\u0129a l\u00e0 vi\u1ec7c s\u1eed d\u1ee5ng nh\u1eefng bi\u1ec3u \u0111\u1ea1t m\u1ea1nh m\u1ebd nh\u1ea5t. Ti\u00eau chu\u1ea9n \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 xem c\u00f3 ph\u1ea3i l\u00e0 &#8220;sai l\u1ec7ch ho\u1eb7c ph\u00f3ng \u0111\u1ea1i&#8221; hay kh\u00f4ng \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong &#8220;<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179264.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Ti\u00eau chu\u1ea9n qu\u1ea3ng c\u00e1o \u0111\u00fang \u0111\u1eafn cho d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1[ja]<\/a>&#8221; v\u00e0 &#8220;<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179263.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Gi\u1ea3i th\u00edch v\u00e0 c\u00e1c \u0111i\u1ec3m c\u1ea7n l\u01b0u \u00fd v\u1ec1 Ti\u00eau chu\u1ea9n qu\u1ea3ng c\u00e1o \u0111\u00fang \u0111\u1eafn cho d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1[ja]<\/a>&#8221; do B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n ban h\u00e0nh.<\/p>\n\n\n\n<p>V\u00ed d\u1ee5, v\u1ec1 t\u00ean g\u1ecdi, ti\u00eau chu\u1ea9n quy \u0111\u1ecbnh r\u1eb1ng kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng t\u00ean kh\u00e1c ngo\u00e0i t\u00ean \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh trong D\u01b0\u1ee3c \u0111i\u1ec3n Nh\u1eadt B\u1ea3n ho\u1eb7c t\u00ean \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o.<\/p>\n\n\n\n<p>C\u1ee5 th\u1ec3 h\u01a1n, v\u1ec1 t\u00ean c\u1ee7a c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m c\u1ea7n ph\u00ea duy\u1ec7t, kh\u00f4ng \u0111\u01b0\u1ee3c thay th\u1ebf ch\u1eef H\u00e1n b\u1eb1ng ch\u1eef Hiragana ho\u1eb7c ch\u1eef Latin, v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c ph\u00f3ng \u0111\u1ea1i hi\u1ec7u qu\u1ea3 ho\u1ea1t \u0111\u1ed9ng v\u01b0\u1ee3t qu\u00e1 ph\u1ea1m vi \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.<\/p>\n\n\n\n<p>Ngo\u00e0i ra, c\u00f2n c\u00f3 c\u00e1c ti\u00eau chu\u1ea9n c\u1ee5 th\u1ec3 t\u00f9y theo lo\u1ea1i s\u1ea3n ph\u1ea9m, ch\u1eb3ng h\u1ea1n nh\u01b0 kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng c\u00f9ng l\u00fac c\u00e1c bi\u1ec3u \u0111\u1ea1t &#8220;gi\u1eef cho t\u00f3c v\u00e0 da \u0111\u1ea7u kh\u1ecfe m\u1ea1nh&#8221; v\u00e0 &#8220;l\u00e0m cho t\u00f3c m\u1ec1m m\u1ea1i&#8221; trong qu\u1ea3ng c\u00e1o d\u1ea7u g\u1ed9i d\u01b0\u1ee3c li\u1ec7u.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"San_pham_khong_nam_trong_pham_vi_quy_dinh_cua_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>S\u1ea3n ph\u1ea9m kh\u00f4ng n\u1eb1m trong ph\u1ea1m vi quy \u0111\u1ecbnh c\u1ee7a 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 t\u01b0\u1ee3ng quy \u0111\u1ecbnh theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n l\u00e0 &#8220;D\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan&#8221;. Do \u0111\u00f3, \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m kh\u00f4ng thu\u1ed9c &#8220;D\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan&#8221;, c\u00f3 th\u1ec3 cho r\u1eb1ng b\u1ea1n c\u00f3 th\u1ec3 b\u00e1n v\u00e0 qu\u1ea3ng c\u00e1o m\u00e0 kh\u00f4ng c\u1ea7n quan t\u00e2m \u0111\u1ebfn Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n<p>Tuy nhi\u00ean, ngay c\u1ea3 khi l\u00e0 s\u1ea3n ph\u1ea9m kh\u00f4ng thu\u1ed9c &#8220;D\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan&#8221;, n\u1ebfu n\u1ed9i dung hi\u1ec3n th\u1ecb ho\u1eb7c qu\u1ea3ng c\u00e1o c\u00f3 hi\u1ec7u qu\u1ea3 nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m, c\u00f3 kh\u1ea3 n\u0103ng s\u1ebd \u0111\u01b0\u1ee3c coi l\u00e0 d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n\n\n\n<p>V\u00e0 n\u1ebfu \u0111\u01b0\u1ee3c coi l\u00e0 d\u01b0\u1ee3c ph\u1ea9m, n\u1ebfu kh\u00f4ng c\u00f3 s\u1ef1 ch\u1ea5p thu\u1eadn nh\u01b0 m\u1ed9t d\u01b0\u1ee3c ph\u1ea9m, qu\u1ea3ng c\u00e1o s\u1ebd b\u1ecb c\u1ea5m theo \u0110i\u1ec1u 68.<\/p>\n\n\n\n<p>N\u00f3i c\u00e1ch kh\u00e1c, ngay c\u1ea3 khi l\u00e0 s\u1ea3n ph\u1ea9m kh\u00f4ng n\u1eb1m trong ph\u1ea1m vi quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, vi\u1ec7c qu\u1ea3ng c\u00e1o v\u1edbi hi\u1ec7u qu\u1ea3 nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m s\u1ebd 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>Do \u0111\u00f3, \u0111\u1ed1i v\u1edbi th\u1ef1c ph\u1ea9m b\u1ed5 d\u01b0\u1ee1ng v\u00e0 th\u1ef1c ph\u1ea9m b\u1ed5 sung gi\u00fap t\u0103ng c\u01b0\u1eddng s\u1ee9c kh\u1ecfe, v\u00ec ch\u00fang ch\u1ec9 l\u00e0 th\u1ef1c ph\u1ea9m ch\u1ee9 kh\u00f4ng ph\u1ea3i &#8220;D\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan&#8221;, vi\u1ec7c qu\u1ea3ng c\u00e1o v\u1edbi hi\u1ec7u qu\u1ea3 nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng \u0111\u01b0\u1ee3c ph\u00e9p. Qu\u1ea3ng c\u00e1o th\u1ef1c ph\u1ea9m b\u1ed5 d\u01b0\u1ee1ng v\u00e0 th\u1ef1c ph\u1ea9m b\u1ed5 sung nh\u01b0 &#8220;Ph\u00f2ng ng\u1eeba ung th\u01b0&#8221;, &#8220;Ng\u0103n ng\u1eeba l\u00e3o h\u00f3a&#8221; s\u1ebd 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>Tuy nhi\u00ean, n\u1ebfu m\u1ed9t lo\u1ea1i th\u1ef1c ph\u1ea9m b\u1ed5 d\u01b0\u1ee1ng th\u1ef1c s\u1ef1 t\u1ed1t cho s\u1ee9c kh\u1ecfe nh\u01b0ng kh\u00f4ng \u0111\u01b0\u1ee3c ph\u00e9p di\u1ec5n \u0111\u1ea1t nh\u01b0 v\u1eady, \u0111i\u1ec1u n\u00e0y s\u1ebd c\u1ea3n tr\u1edf vi\u1ec7c l\u01b0u th\u00f4ng s\u1ea3n ph\u1ea9m v\u00e0 th\u00f4ng tin m\u1ed9t c\u00e1ch kh\u00f4ng c\u1ea7n thi\u1ebft.<\/p>\n\n\n\n<p>Do \u0111\u00f3, \u0111\u1ed1i v\u1edbi m\u1ed9t s\u1ed1 lo\u1ea1i th\u1ef1c ph\u1ea9m m\u00e0 ch\u00ednh ph\u1ee7 \u0111\u00e3 ki\u1ec3m tra v\u00e0 ph\u00ea duy\u1ec7t v\u1ec1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3, vi\u1ec7c hi\u1ec3n th\u1ecb hi\u1ec7u qu\u1ea3 trong ph\u1ea1m vi m\u00e0 ch\u00ednh ph\u1ee7 \u0111\u00e3 ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c ph\u00e9p nh\u01b0 &#8220;Th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe&#8221;.<\/p>\n\n\n\n<p>&#8220;Th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe&#8221; bao g\u1ed3m:<\/p>\n\n\n\n<ol>\n<li>Th\u1ef1c ph\u1ea9m hi\u1ec3n th\u1ecb ch\u1ee9c n\u0103ng<\/li>\n\n\n\n<li>Th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng dinh d\u01b0\u1ee1ng<\/li>\n\n\n\n<li>Th\u1ef1c ph\u1ea9m d\u00f9ng cho s\u1ee9c kh\u1ecfe c\u1ee5 th\u1ec3<\/li>\n<\/ol>\n\n\n\n<p>\u0111\u1ec1u c\u00f3.<\/p>\n\n\n\n<p>B\u00e0i vi\u1ebft li\u00ean quan: <a href=\"https:\/\/Monolith.law\/?p=49842\" 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 l\u00e0 g\u00ec? Gi\u1ea3i th\u00edch \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=\"Hinh_phat_khi_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>H\u00ecnh ph\u1ea1t khi 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\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1.png\" alt=\"\" class=\"wp-image-61028\" srcset=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1.png 735w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-300x200.png 300w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-250x167.png 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><\/figure>\n\n\n\n<p>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 s\u1ebd b\u1ecb \u00e1p d\u1ee5ng h\u00ecnh ph\u1ea1t h\u00ecnh s\u1ef1. Ngo\u00e0i ra, trong Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n s\u1eeda \u0111\u1ed5i n\u0103m 2021 (n\u0103m 2019 theo l\u1ecbch Gregorian), h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n ph\u1ea1t \u0111\u00e3 \u0111\u01b0\u1ee3c gi\u1edbi thi\u1ec7u.<\/p>\n\n\n\n<p>H\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n ph\u1ea1t l\u00e0 h\u1ec7 th\u1ed1ng m\u00e0 ng\u01b0\u1eddi \u0111\u00e3 th\u1ef1c hi\u1ec7n qu\u1ea3ng c\u00e1o gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i v\u1ec1 d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1 s\u1ebd b\u1ecb bu\u1ed9c ph\u1ea3i n\u1ed9p ti\u1ec1n. S\u1ed1 ti\u1ec1n ph\u1ea1t \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh l\u00e0 4.5% doanh thu trong m\u1ed9t kho\u1ea3ng th\u1eddi gian nh\u1ea5t \u0111\u1ecbnh (\u0110i\u1ec1u 75-5-2, Kho\u1ea3n 1).<\/p>\n\n\n\n<p>V\u1ec1 h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n ph\u1ea1t, 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=49848\" target=\"_blank\" rel=\"noreferrer noopener\">H\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n ph\u1ea1t trong 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 \u00e1p d\u1ee5ng v\u00e0 tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c gi\u1ea3m b\u1edbt[ja]<\/a><\/p>\n\n\n\n<p>T\u00f3m l\u1ea1i, n\u1ebfu b\u1ea1n th\u1ef1c hi\u1ec7n qu\u1ea3ng c\u00e1o gi\u1ea3 m\u1ea1o ho\u1eb7c ph\u00f3ng \u0111\u1ea1i, ngo\u00e0i vi\u1ec7c b\u1ecb \u00e1p d\u1ee5ng h\u00ecnh ph\u1ea1t h\u00ecnh s\u1ef1, b\u1ea1n c\u0169ng c\u00f3 th\u1ec3 ph\u1ea3i ch\u1ecbu thi\u1ec7t h\u1ea1i v\u1ec1 m\u1eb7t t\u00e0i ch\u00ednh do ph\u1ea1t ti\u1ec1n ph\u1ea1t.<\/p>\n\n\n\n<p>H\u01a1n n\u1eefa, vi\u1ec7c 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 g\u00e2y ra v\u1ea5n \u0111\u1ec1 ph\u00e1p l\u00fd m\u00e0 c\u00f2n c\u00f3 nguy c\u01a1 l\u1edbn l\u00e0m m\u1ea5t uy t\u00edn c\u1ee7a ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n h\u00e0nh vi.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Diem_quan_trong_de_tranh_vi_pham_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>\u0110i\u1ec3m quan tr\u1ecdng \u0111\u1ec3 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<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 Nh\u1eadt B\u1ea3n kh\u00f4ng ch\u1ec9 \u00e1p d\u1ee5ng cho c\u00e1c ng\u00e0nh y t\u1ebf nh\u01b0 hi\u1ec7u thu\u1ed1c, m\u00e0 c\u00f2n \u00e1p d\u1ee5ng cho c\u00e1c doanh nghi\u1ec7p trong nhi\u1ec1u ng\u00e0nh c\u00f4ng nghi\u1ec7p kh\u00e1c. \u0110\u1ec3 tr\u00e1nh vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, h\u00e3y x\u00e1c nh\u1eadn hai \u0111i\u1ec3m sau \u0111\u00e2y.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Hieu_dung_ve_huong_dan\"><\/span>Hi\u1ec3u \u0111\u00fang v\u1ec1 h\u01b0\u1edbng d\u1eabn<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0110\u1ec3 tr\u00e1nh vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, b\u1ea1n c\u1ea7n hi\u1ec3u r\u00f5 li\u1ec7u s\u1ea3n ph\u1ea9m c\u1ee7a c\u00f4ng ty c\u00f3 thu\u1ed9c ph\u1ea1m vi c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf hay kh\u00f4ng, v\u00e0 quy \u0111\u1ecbnh n\u00e0o s\u1ebd \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t, b\u00e1n h\u00e0ng, qu\u1ea3ng c\u00e1o, v.v.<\/p>\n\n\n\n<p>\u0110\u1ec3 l\u00e0m \u0111i\u1ec1u n\u00e0y, b\u1ea1n c\u1ea7n x\u00e1c nh\u1eadn n\u1ed9i dung c\u1ee7a h\u01b0\u1edbng d\u1eabn do B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n \u0111\u01b0a ra, kh\u00f4ng ch\u1ec9 l\u00e0 c\u00e1c lu\u1eadt li\u00ean quan.<\/p>\n\n\n\n<p>Tuy nhi\u00ean, vi\u1ec7c n\u1eafm b\u1eaft to\u00e0n di\u1ec7n c\u00e1c lu\u1eadt, h\u01b0\u1edbng d\u1eabn, ti\u1ec1n l\u1ec7 t\u1ed1 t\u1ee5ng, v\u00ed d\u1ee5 h\u01b0\u1edbng d\u1eabn h\u00e0nh ch\u00ednh, v.v. l\u00e0 r\u1ea5t kh\u00f3 kh\u0103n, n\u00ean n\u1ebfu b\u1ea1n kh\u00f4ng th\u1ec3 x\u00e1c \u0111\u1ecbnh li\u1ec7u c\u00f3 vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf hay kh\u00f4ng, ch\u00fang t\u00f4i khuy\u00ean b\u1ea1n n\u00ean tham v\u1ea5n v\u1edbi lu\u1eadt s\u01b0.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Chia_se_trong_cong_ty\"><\/span>Chia s\u1ebb trong c\u00f4ng ty<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0110\u1ec3 tr\u00e1nh vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, quan tr\u1ecdng l\u00e0 ph\u1ea3i chia s\u1ebb trong c\u00f4ng ty b\u1eb1ng c\u00e1ch l\u1ef1a ch\u1ecdn c\u00e1c quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 th\u1ec3 xung \u0111\u1ed9t v\u1edbi s\u1ea3n ph\u1ea9m c\u1ee7a c\u00f4ng ty, t\u1ea1o ra b\u1ea3ng ki\u1ec3m tra, v.v.<\/p>\n\n\n\n<p>\u0110\u1eb7c bi\u1ec7t, quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o \u00e1p d\u1ee5ng cho &#8220;m\u1ecdi ng\u01b0\u1eddi&#8221;, v\u00ec v\u1eady b\u1ea1n c\u1ea7n thi\u1ebft l\u1eadp m\u1ed9t h\u1ec7 th\u1ed1ng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng kh\u00f4ng c\u00f3 qu\u1ea3ng c\u00e1o vi ph\u1ea1m Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n t\u1ea1i n\u01a1i \u0111\u01b0\u1ee3c \u1ee7y th\u00e1c.<\/p>\n\n\n\n<p>B\u1eb1ng c\u00e1ch thi\u1ebft l\u1eadp m\u1ed9t h\u1ec7 th\u1ed1ng \u0111\u1ec3 cho ph\u00e9p t\u1ea5t c\u1ea3 nh\u00e2n vi\u00ean x\u00e1c nh\u1eadn c\u00e1c \u0111i\u1ec3m li\u00ean quan \u0111\u1ebfn quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, b\u1ea1n c\u00f3 th\u1ec3 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<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Su_khac_biet_giua_Luat_Duoc_pham_va_Thiet_bi_y_te_Japanese_Pharmaceutical_and_Medical_Device_Act_va_Luat_Quang_cao_va_Bieu_hien_Japanese_Act_against_Unjustifiable_Premiums_and_Misleading_Representations\"><\/span>S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (Japanese Pharmaceutical and Medical Device Act) v\u00e0 Lu\u1eadt Qu\u1ea3ng c\u00e1o v\u00e0 Bi\u1ec3u hi\u1ec7n (Japanese Act against Unjustifiable Premiums and Misleading Representations)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-4.png\" alt=\"\" class=\"wp-image-61029\" srcset=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-4.png 735w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-4-300x200.png 300w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2023\/11\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-4-250x167.png 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><\/figure>\n\n\n\n<p>\u0110\u1ebfn \u0111\u00e2y, ch\u00fang t\u00f4i \u0111\u00e3 gi\u1ea3i th\u00edch v\u1ec1 quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, \u0111\u1eb7c bi\u1ec7t c\u1ea7n l\u01b0u \u00fd l\u00e0 quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o \u00e1p d\u1ee5ng cho t\u1ea5t c\u1ea3 m\u1ecdi ng\u01b0\u1eddi. Cu\u1ed1i c\u00f9ng, ch\u00fang t\u00f4i s\u1ebd n\u00eau l\u00ean Lu\u1eadt Qu\u1ea3ng c\u00e1o v\u00e0 Bi\u1ec3u hi\u1ec7n, c\u0169ng c\u00f3 quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o gi\u1ed1ng nh\u01b0 Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, v\u00e0 gi\u1ea3i th\u00edch s\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o c\u1ee7a hai lu\u1eadt n\u00e0y.<\/p>\n\n\n\n<p>M\u1ee5c \u0111\u00edch c\u1ee7a Lu\u1eadt Qu\u1ea3ng c\u00e1o v\u00e0 Bi\u1ec3u hi\u1ec7n l\u00e0 ng\u0103n ch\u1eb7n vi\u1ec7c c\u1ea3n tr\u1edf s\u1ef1 l\u1ef1a ch\u1ecdn t\u1ef1 nguy\u1ec7n v\u00e0 h\u1ee3p l\u00fd c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng th\u00f4ng th\u01b0\u1eddng. Do \u0111\u00f3, m\u1ee5c ti\u00eau c\u1ee7a quy \u0111\u1ecbnh n\u00e0y l\u00e0 t\u1ea5t c\u1ea3 c\u00e1c s\u1ea3n ph\u1ea9m. M\u1eb7t kh\u00e1c, m\u1ee5c ti\u00eau c\u1ee7a quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 &#8220;d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1&#8221;.<\/p>\n\n\n\n<p>Quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt Qu\u1ea3ng c\u00e1o v\u00e0 Bi\u1ec3u hi\u1ec7n ch\u1ec9 \u00e1p d\u1ee5ng cho c\u00e1c doanh nghi\u1ec7p cung c\u1ea5p s\u1ea3n ph\u1ea9m ho\u1eb7c d\u1ecbch v\u1ee5. M\u1eb7t kh\u00e1c, quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf \u00e1p d\u1ee5ng cho &#8220;t\u1ea5t c\u1ea3 m\u1ecdi ng\u01b0\u1eddi&#8221;.<\/p>\n\n\n\n<p>Ngo\u00e0i ra, Lu\u1eadt Qu\u1ea3ng c\u00e1o v\u00e0 Bi\u1ec3u hi\u1ec7n c\u0169ng quy \u0111\u1ecbnh v\u1ec1 h\u1ec7 th\u1ed1ng ph\u1ea1t ti\u1ec1n. Tuy nhi\u00ean, so v\u1edbi s\u1ed1 ti\u1ec1n ph\u1ea1t theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 4.5% doanh thu, s\u1ed1 ti\u1ec1n ph\u1ea1t theo Lu\u1eadt Qu\u1ea3ng c\u00e1o v\u00e0 Bi\u1ec3u hi\u1ec7n ch\u1ec9 l\u00e0 3% doanh thu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tom_tat_Hay_thao_luan_voi_luat_su_neu_gap_rac_roi_voi_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span>T\u00f3m t\u1eaft: H\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0 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 Nh\u1eadt B\u1ea3n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ch\u00fang t\u00f4i \u0111\u00e3 gi\u1ea3i th\u00edch v\u1ec1 c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng v\u00e0 n\u1ed9i dung quy \u0111\u1ecbnh 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\u1ec3 nh\u1eafc l\u1ea1i, c\u00e1c m\u1eb7t h\u00e0ng 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 Nh\u1eadt B\u1ea3n c\u00f3 ph\u1ea1m vi r\u1ed9ng l\u1edbn, ngay c\u1ea3 nh\u1eefng v\u1eadt d\u1ee5ng g\u1ea7n g\u0169i v\u1edbi ch\u00fang ta c\u0169ng c\u00f3 th\u1ec3 b\u1ecb quy \u0111\u1ecbnh theo lu\u1eadt n\u00e0y.<\/p>\n\n\n\n<p>\u0110\u1ed3ng th\u1eddi, ngay c\u1ea3 nh\u1eefng s\u1ea3n ph\u1ea9m kh\u00f4ng ph\u1ea3i l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng quy \u0111\u1ecbnh c\u0169ng ph\u1ea3i tu\u00e2n theo c\u00e1c quy \u0111\u1ecbnh m\u00e0 &#8220;m\u1ecdi ng\u01b0\u1eddi&#8221; ph\u1ea3i tu\u00e2n th\u1ee7, nh\u01b0 quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3ng c\u00e1o. N\u1ebfu b\u1ea1n tham gia v\u00e0o qu\u1ea3ng c\u00e1o, h\u00e3y l\u01b0u \u00fd r\u1eb1ng quy \u0111\u1ecbnh kh\u00f4ng ch\u1ec9 \u00e1p d\u1ee5ng cho ngu\u1ed3n b\u00e1n h\u00e0ng, m\u00e0 c\u00f2n \u0111\u1ed1i v\u1edbi c\u00e1c \u0111\u1ea1i l\u00fd qu\u1ea3ng c\u00e1o, ng\u01b0\u1eddi ti\u1ebfp th\u1ecb li\u00ean k\u1ebft, v\u00e0 ng\u01b0\u1eddi \u1ea3nh h\u01b0\u1edfng.<\/p>\n\n\n\n<p>Khi b\u1ea1n lo l\u1eafng v\u1ec1 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, h\u00e3y th\u1ea3o lu\u1eadn v\u1edbi lu\u1eadt s\u01b0 chuy\u00ean m\u00f4n.<\/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 Monolis, chuy\u00ean v\u1ec1 IT, \u0111\u1eb7c bi\u1ec7t l\u00e0 Internet v\u00e0 lu\u1eadt, l\u00e0 m\u1ed9t v\u0103n ph\u00f2ng lu\u1eadt s\u01b0 c\u00f3 chuy\u00ean m\u00f4n cao v\u1ec1 c\u1ea3 hai m\u1eb7t. 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 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 v\u00e0 m\u1ef9 ph\u1ea9m nh\u01b0 th\u1ef1c ph\u1ea9m b\u1ed5 sung, ph\u00f2ng kh\u00e1m, nh\u00e0 \u0111i\u1ec1u h\u00e0nh d\u1ef1 \u00e1n ASP, 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><a href=\"https:\/\/monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/operationofmedia[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Khi nghe \u0111\u1ebfn &#8216;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8217; (\u85ac\u6a5f\u6cd5), c\u00f3 l\u1ebd nhi\u1ec1u ng\u01b0\u1eddi s\u1ebd ngh\u0129 r\u1eb1ng \u0111\u00f3 l\u00e0 &#8216;lu\u1eadt li\u00ean quan \u0111\u1ebfn thu\u1ed1c&#8217; ho\u1eb7c &#8216;lu\u1eadt li\u00ean quan \u0111\u1ebfn hi\u1ec7u thu\u1ed1c v\u00e0 c\u01a1 s [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":61024,"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\/59557"}],"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=59557"}],"version-history":[{"count":1,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/59557\/revisions"}],"predecessor-version":[{"id":61030,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/59557\/revisions\/61030"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media\/61024"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media?parent=59557"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/categories?post=59557"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/tags?post=59557"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}