{"id":58303,"date":"2023-09-22T15:56:23","date_gmt":"2023-09-22T06:56:23","guid":{"rendered":"https:\/\/monolith.law\/vi\/?p=58303"},"modified":"2025-11-11T14:03:23","modified_gmt":"2025-11-11T05:03:23","slug":"pharmaceutical-affairs-law","status":"publish","type":"post","link":"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-affairs-law","title":{"rendered":"\u300cD\u01b0\u1ee3c ph\u1ea9m\u300d\u300cS\u1ea3n ph\u1ea9m y t\u1ebf kh\u00f4ng thu\u1ed9c d\u01b0\u1ee3c ph\u1ea9m\u300d\u300cM\u1ef9 ph\u1ea9m\u300d\u0111\u01b0\u1ee3c ph\u00e2n bi\u1ec7t nh\u01b0 th\u1ebf n\u00e0o?"},"content":{"rendered":"\n<p>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, t\u00ean ch\u00ednh th\u1ee9c 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\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c&#8221; (Japanese Pharmaceutical and Medical Device Act), ph\u00e2n lo\u1ea1i c\u00e1c lo\u1ea1i s\u1ea3n ph\u1ea9m nh\u01b0 m\u1ef9 ph\u1ea9m v\u00e0 thu\u1ed1c th\u00e0nh &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;, &#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y t\u1ebf&#8221; v\u00e0 &#8220;M\u1ef9 ph\u1ea9m&#8221;. Vi\u1ec7c ph\u00e2n lo\u1ea1i n\u00e0y r\u1ea5t quan tr\u1ecdng trong m\u1ed1i li\u00ean h\u1ec7 v\u1edbi quy \u0111\u1ecbnh 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\/pharmaceutical-affairs-law\/#Phan_biet_giua_%E2%80%9CDuoc_pham%E2%80%9D_%E2%80%9CDuoc_pham_khong_thuoc_phan_y_hoc%E2%80%9D_va_%E2%80%9CMy_pham%E2%80%9D\" title=\" Ph\u00e2n bi\u1ec7t gi\u1eefa &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;, &#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc&#8221; v\u00e0 &#8220;M\u1ef9 ph\u1ea9m&#8221; \"> Ph\u00e2n bi\u1ec7t gi\u1eefa &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;, &#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc&#8221; v\u00e0 &#8220;M\u1ef9 ph\u1ea9m&#8221; <\/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-affairs-law\/#Dinh_nghia_%E2%80%9CDuoc_pham%E2%80%9D_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\" title=\" \u0110\u1ecbnh ngh\u0129a &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n \"> \u0110\u1ecbnh ngh\u0129a &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; theo 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-3\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-affairs-law\/#Dinh_nghia_%E2%80%9CSan_pham_ngoai_y_duoc%E2%80%9D_theo_%E2%80%9CLuat_Duoc_pham_va_Thiet_bi_y_te%E2%80%9D_Nhat_Ban\" title=\" \u0110\u1ecbnh ngh\u0129a &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221; theo &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf&#8221; Nh\u1eadt B\u1ea3n \"> \u0110\u1ecbnh ngh\u0129a &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221; theo &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf&#8221; 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-4\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-affairs-law\/#Dinh_nghia_%E2%80%9CMy_pham%E2%80%9D_theo_%E2%80%9CLuat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban%E2%80%9D\" title=\" \u0110\u1ecbnh ngh\u0129a &#8220;M\u1ef9 ph\u1ea9m&#8221; theo &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8221; \"> \u0110\u1ecbnh ngh\u0129a &#8220;M\u1ef9 ph\u1ea9m&#8221; theo &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8221; <\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/vi\/general-corporate\/pharmaceutical-affairs-law\/#Moi_quan_he_voi_quy_dinh_quang_cao\" title=\"M\u1ed1i quan h\u1ec7 v\u1edbi quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o\">M\u1ed1i quan h\u1ec7 v\u1edbi quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Phan_biet_giua_%E2%80%9CDuoc_pham%E2%80%9D_%E2%80%9CDuoc_pham_khong_thuoc_phan_y_hoc%E2%80%9D_va_%E2%80%9CMy_pham%E2%80%9D\"><\/span> Ph\u00e2n bi\u1ec7t gi\u1eefa &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;, &#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc&#8221; v\u00e0 &#8220;M\u1ef9 ph\u1ea9m&#8221; <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li>&#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; l\u00e0 nh\u1eefng lo\u1ea1i thu\u1ed1c c\u00f3 ch\u1ee9a th\u00e0nh ph\u1ea7n c\u00f3 hi\u1ec7u qu\u1ea3 y h\u1ecdc, d\u00f9ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb ho\u1eb7c ph\u00f2ng ng\u1eeba b\u1ec7nh t\u1eadt.<\/li>\n\n\n\n<li>&#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc&#8221; kh\u00f4ng thu\u1ed9c &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; nh\u01b0ng t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;. N\u00f3 n\u1eb1m gi\u1eefa &#8220;M\u1ef9 ph\u1ea9m&#8221; v\u00e0 &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;.<\/li>\n\n\n\n<li>&#8220;M\u1ef9 ph\u1ea9m&#8221; l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n v\u1edbi m\u1ee5c \u0111\u00edch l\u00e0m \u0111\u1eb9p.<\/li>\n<\/ul>\n\n\n\n<p>\u0110i\u1ec3m quan tr\u1ecdng trong vi\u1ec7c ph\u00e2n bi\u1ec7t 3 lo\u1ea1i tr\u00ean v\u00e0 qu\u1ea3ng c\u00e1o l\u00e0, &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; v\u00e0 &#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc&#8221; c\u00f3 th\u1ec3 ghi r\u00f5 th\u00e0nh ph\u1ea7n c\u00f3 hi\u1ec7u qu\u1ea3, trong khi &#8220;M\u1ef9 ph\u1ea9m&#8221; kh\u00f4ng th\u1ec3 tuy\u00ean b\u1ed1 v\u1ec1 th\u00e0nh ph\u1ea7n c\u00f3 hi\u1ec7u qu\u1ea3. <\/p>\n\n\n\n<p>Ngo\u00e0i ra, &#8220;M\u1ef9 ph\u1ea9m&#8221; theo \u0111\u00fang ngh\u0129a, theo 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\u01b0\u1ee3c ph\u00e2n lo\u1ea1i th\u00e0nh &#8220;M\u1ef9 ph\u1ea9m&#8221; v\u00e0 &#8220;M\u1ef9 ph\u1ea9m y h\u1ecdc&#8221;. &#8220;M\u1ef9 ph\u1ea9m&#8221; \u0111\u01b0\u1ee3c k\u1ef3 v\u1ecdng c\u00f3 hi\u1ec7u qu\u1ea3 to\u00e0n di\u1ec7n nh\u01b0 d\u01b0\u1ee1ng \u1ea9m da, l\u00e0m s\u1ea1ch, v.v. Trong khi \u0111\u00f3, &#8220;M\u1ef9 ph\u1ea9m y h\u1ecdc&#8221; ch\u1ee9a &#8220;th\u00e0nh ph\u1ea7n c\u00f3 hi\u1ec7u qu\u1ea3&#8221; c\u00f3 t\u00e1c d\u1ee5ng nh\u01b0 ng\u0103n ng\u1eeba m\u1ee5n, l\u00e0m tr\u1eafng da, kh\u1eed m\u00f9i, v.v., ngo\u00e0i hi\u1ec7u qu\u1ea3 k\u1ef3 v\u1ecdng c\u1ee7a m\u1ed9t s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m, v\u00e0 \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i v\u00e0o &#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc&#8221;, n\u1eb1m gi\u1eefa m\u1ef9 ph\u1ea9m v\u00e0 d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Dinh_nghia_%E2%80%9CDuoc_pham%E2%80%9D_theo_Luat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban\"><\/span> \u0110\u1ecbnh ngh\u0129a &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; 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 is-resized\"><img decoding=\"async\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2025\/11\/pharmaceutical-affairs-law-2.jpg\" alt=\"\" class=\"wp-image-71848\" style=\"aspect-ratio:1.5;width:841px;height:auto\" srcset=\"https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2025\/11\/pharmaceutical-affairs-law-2.jpg 735w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2025\/11\/pharmaceutical-affairs-law-2-300x200.jpg 300w, https:\/\/monolith.law\/vi\/wp-content\/uploads\/sites\/17\/2025\/11\/pharmaceutical-affairs-law-2-250x167.jpg 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><figcaption class=\"wp-element-caption\">&#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; v\u00e0 &#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc&#8221; \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a nh\u01b0 th\u1ebf n\u00e0o?<\/figcaption><\/figure>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>&#8220;Trong lu\u1eadt n\u00e0y, &#8216;D\u01b0\u1ee3c ph\u1ea9m&#8217; \u0111\u01b0\u1ee3c hi\u1ec3u l\u00e0 c\u00e1c m\u1ee5c sau \u0111\u00e2y:<br> M\u1ed9t &#8211; C\u00e1c m\u1eb7t h\u00e0ng \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea trong D\u01b0\u1ee3c \u0111i\u1ec3n Nh\u1eadt B\u1ea3n<br> Hai &#8211; C\u00e1c m\u1eb7t h\u00e0ng \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 \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 k\u1ebft h\u1ee3p \u0111\u1ec3 c\u00f3 th\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c k\u1ebft qu\u1ea3 nh\u1ea5t \u0111\u1ecbnh. C\u00f9ng hi\u1ec3u nh\u01b0 v\u1eady d\u01b0\u1edbi \u0111\u00e2y.) v\u00e0 ph\u01b0\u01a1ng ti\u1ec7n ghi ch\u00fa n\u00e0y (tr\u1eeb D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o.)<br> Ba &#8211; C\u00e1c m\u1eb7t h\u00e0ng \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 D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c ph\u1ea7n y h\u1ecdc, m\u1ef9 ph\u1ea9m v\u00e0 s\u1ea3n ph\u1ea9m y t\u1ebf t\u00e1i t\u1ea1o.)&#8221;<br><\/p>\n<cite> \u0110i\u1ec1u 2, Kho\u1ea3n 1 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n <\/cite><\/blockquote>\n\n\n\n<p>Theo quy \u0111\u1ecbnh \u0111\u1ecbnh ngh\u0129a tr\u00ean, theo Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n, &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; l\u00e0 nh\u1eefng m\u1eb7t h\u00e0ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u1edbi m\u1ee5c \u0111\u00edch &#8220;ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb ho\u1eb7c ph\u00f2ng ng\u1eeba b\u1ec7nh \u1edf ng\u01b0\u1eddi ho\u1eb7c \u0111\u1ed9ng v\u1eadt&#8221;, &#8220;\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&#8221;. \u0110i\u1ec3m n\u00e0y r\u1ea5t quan tr\u1ecdng, &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a l\u00e0 &#8220;nh\u1eefng m\u1eb7t h\u00e0ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u1edbi m\u1ee5c \u0111\u00edch nh\u01b0 v\u1eady&#8221;.<\/p>\n\n\n\n<p>\u0110\u00e1ng ch\u00fa \u00fd, c\u00e1c lo\u1ea1i b\u1ed5 sung dinh d\u01b0\u1ee1ng l\u00e0 th\u1ef1c ph\u1ea9m b\u1ed5 sung d\u00f9ng \u0111\u1ec3 b\u1ed5 sung c\u00e1c ch\u1ea5t dinh d\u01b0\u1ee1ng kh\u00f4ng th\u1ec3 \u0111\u1ee7 qua b\u1eefa \u0103n, kh\u00f4ng thu\u1ed9c c\u00e1c m\u1ee5c tr\u00ean, do \u0111\u00f3, ch\u00fang \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i l\u00e0 &#8220;Th\u1ef1c ph\u1ea9m&#8221; ch\u1ee9 kh\u00f4ng ph\u1ea3i &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;. N\u00f3i c\u00e1ch kh\u00e1c, vi\u1ec7c \u0103n c\u00e1c lo\u1ea1i b\u1ed5 sung dinh d\u01b0\u1ee1ng kh\u00f4ng ph\u1ea3i l\u00e0 h\u00e0nh \u0111\u1ed9ng v\u1edbi m\u1ee5c \u0111\u00edch ph\u00f2ng ng\u1eeba ho\u1eb7c c\u1ea3i thi\u1ec7n b\u1ec7nh t\u1eadt, m\u00e0 l\u00e0 h\u00e0nh \u0111\u1ed9ng v\u1edbi m\u1ee5c \u0111\u00edch b\u1ed5 sung c\u00e1c ch\u1ea5t dinh d\u01b0\u1ee1ng thi\u1ebfu h\u1ee5t, do \u0111\u00f3, c\u00e1c lo\u1ea1i b\u1ed5 sung dinh d\u01b0\u1ee1ng kh\u00f4ng thu\u1ed9c &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; v\u00e0 do \u0111\u00f3 kh\u00f4ng ph\u1ea3i tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh ph\u00e1p l\u00fd v\u1ec1 &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Dinh_nghia_%E2%80%9CSan_pham_ngoai_y_duoc%E2%80%9D_theo_%E2%80%9CLuat_Duoc_pham_va_Thiet_bi_y_te%E2%80%9D_Nhat_Ban\"><\/span> \u0110\u1ecbnh ngh\u0129a &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221; theo &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf&#8221; Nh\u1eadt B\u1ea3n <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>&#8220;Trong lu\u1eadt n\u00e0y, &#8216;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8217; l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea d\u01b0\u1edbi \u0111\u00e2y c\u00f3 t\u00e1c d\u1ee5ng nh\u1eb9 \u0111\u1ed1i v\u1edbi c\u01a1 th\u1ec3 con ng\u01b0\u1eddi.<br> M\u1ed9t &#8211; Nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch li\u1ec7t k\u00ea t\u1eeb I \u0111\u1ebfn Ha d\u01b0\u1edbi \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 kho\u1ea3n 2 ho\u1eb7c 3 c\u1ee7a \u0111i\u1ec1u tr\u01b0\u1edbc \u0111\u00f3) kh\u00f4ng ph\u1ea3i l\u00e0 m\u00e1y m\u00f3c ho\u1eb7c thi\u1ebft b\u1ecb.<br> I &#8211; Ng\u0103n ch\u1eb7n n\u00f4n m\u1ec7t v\u00e0 c\u00e1c c\u1ea3m gi\u00e1c kh\u00f3 ch\u1ecbu kh\u00e1c ho\u1eb7c h\u00f4i mi\u1ec7ng ho\u1eb7c m\u00f9i c\u01a1 th\u1ec3.<br> Ro &#8211; Ng\u0103n ch\u1eb7n m\u1ed3 h\u00f4i, vi\u00eam da v\u00e0 c\u00e1c t\u00ecnh tr\u1ea1ng t\u01b0\u01a1ng t\u1ef1.<br> Ha &#8211; Ng\u0103n ch\u1eb7n r\u1ee5ng t\u00f3c, k\u00edch th\u00edch m\u1ecdc t\u00f3c ho\u1eb7c t\u1ea9y l\u00f4ng.<br> Hai &#8211; Nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ph\u00f2ng ch\u1ed1ng chu\u1ed9t, ru\u1ed3i, mu\u1ed7i, b\u1ecd ch\u00e9t v\u00e0 c\u00e1c lo\u00e0i sinh v\u1eadt t\u01b0\u01a1ng t\u1ef1 v\u00ec 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 kho\u1ea3n 2 ho\u1eb7c 3 c\u1ee7a \u0111i\u1ec1u tr\u01b0\u1edbc \u0111\u00f3) kh\u00f4ng ph\u1ea3i l\u00e0 m\u00e1y m\u00f3c ho\u1eb7c thi\u1ebft b\u1ecb.<br> Ba &#8211; Nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch quy \u0111\u1ecbnh trong kho\u1ea3n 2 ho\u1eb7c 3 c\u1ee7a \u0111i\u1ec1u tr\u01b0\u1edbc \u0111\u00f3 (tr\u1eeb nh\u1eefng s\u1ea3n ph\u1ea9m li\u1ec7t k\u00ea trong kho\u1ea3n 2 tr\u01b0\u1edbc \u0111\u00f3) m\u00e0 B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Lao \u0111\u1ed9ng, Y t\u1ebf v\u00e0 Ph\u00fac l\u1ee3i ch\u1ec9 \u0111\u1ecbnh.&#8221;<\/p>\n<cite> \u0110i\u1ec1u 2, Kho\u1ea3n 2 c\u1ee7a Lu\u1eadt 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 v\u1ec1 nh\u1eefng s\u1ea3n ph\u1ea9m ph\u00f9 h\u1ee3p v\u1edbi \u0111i\u1ec1u n\u00e0y bao g\u1ed3m vi\u00ean vitamin, kem t\u1ea9y l\u00f4ng, thu\u1ed1c nhu\u1ed9m t\u00f3c, l\u0103n kh\u1eed m\u00f9i, v.v. Ngo\u00e0i ra, t\u1eeb &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221; l\u00e0 m\u1ed9t bi\u1ec3u th\u1ecb \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn trong &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221;, v\u00ec v\u1eady \u0111\u1ed1i v\u1edbi nh\u1eefng s\u1ea3n ph\u1ea9m kh\u00f4ng ph\u1ea3i m\u1ef9 ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m, &#8220;D\u01b0\u1ee3c ph\u1ea9m = S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221;. N\u00f3i c\u00e1ch kh\u00e1c, x\u00e0 ph\u00f2ng d\u01b0\u1ee3c ph\u1ea9m v\u00e0 kem \u0111\u00e1nh r\u0103ng d\u01b0\u1ee3c ph\u1ea9m \u0111\u1ec1u thu\u1ed9c &#8220;S\u1ea3n ph\u1ea9m ngo\u1ea1i y d\u01b0\u1ee3c&#8221;. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Dinh_nghia_%E2%80%9CMy_pham%E2%80%9D_theo_%E2%80%9CLuat_Duoc_pham_va_Thiet_bi_y_te_Nhat_Ban%E2%80%9D\"><\/span> \u0110\u1ecbnh ngh\u0129a &#8220;M\u1ef9 ph\u1ea9m&#8221; theo &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8221; <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>&#8220;Trong lu\u1eadt n\u00e0y, &#8216;M\u1ef9 ph\u1ea9m&#8217; \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng tr\u00ean c\u01a1 th\u1ec3 ng\u01b0\u1eddi \u0111\u1ec3 l\u00e0m s\u1ea1ch, l\u00e0m \u0111\u1eb9p, t\u0103ng s\u1ee9c h\u1ea5p d\u1eabn, thay \u0111\u1ed5i ngo\u1ea1i h\u00ecnh, ho\u1eb7c gi\u1eef cho da ho\u1eb7c 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. Ch\u00fang ch\u1ec9 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. 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 s\u1eed d\u1ee5ng \u0111\u00e3 n\u00eau tr\u00ean, ho\u1eb7c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u00e1c m\u1ee5c \u0111\u00edch quy \u0111\u1ecbnh trong kho\u1ea3n 2 ho\u1eb7c 3 c\u1ee7a \u0111i\u1ec1u 1, c\u0169ng nh\u01b0 c\u00e1c s\u1ea3n ph\u1ea9m kh\u00f4ng thu\u1ed9c danh m\u1ee5c d\u01b0\u1ee3c ph\u1ea9m.&#8221;<\/p>\n<cite>\u0110i\u1ec1u 3, Kho\u1ea3n 2 c\u1ee7a Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n <br><\/cite><\/blockquote>\n\n\n\n<p>Theo \u0111\u1ecbnh ngh\u0129a tr\u00ean, &#8220;M\u1ef9 ph\u1ea9m&#8221; theo &#8220;Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf Nh\u1eadt B\u1ea3n&#8221; l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng tr\u00ean c\u01a1 th\u1ec3 b\u1eb1ng c\u00e1ch thoa, x\u1ecbt, nh\u01b0 d\u1ea7u g\u1ed9i ho\u1eb7c x\u00e0 ph\u00f2ng t\u1eafm d\u00f9ng \u0111\u1ec3 r\u1eeda c\u01a1 th\u1ec3, n\u01b0\u1edbc hoa h\u1ed3ng ho\u1eb7c s\u1eefa d\u01b0\u1ee1ng da d\u00f9ng \u0111\u1ec3 l\u00e0m \u0111\u1eb9p, ho\u1eb7c ph\u1ea5n n\u1ec1n d\u00f9ng \u0111\u1ec3 trang \u0111i\u1ec3m, v.v.<br>V\u00ed d\u1ee5 v\u1ec1 nh\u1eefng s\u1ea3n ph\u1ea9m thu\u1ed9c lo\u1ea1i n\u00e0y bao g\u1ed3m n\u01b0\u1edbc hoa h\u1ed3ng, ph\u1ea5n n\u1ec1n, d\u1ea7u g\u1ed9i, d\u1ea7u x\u1ea3, son d\u01b0\u1ee1ng m\u00f4i, n\u01b0\u1edbc hoa, v.v.<\/p>\n\n\n\n<p>Trong tr\u01b0\u1eddng h\u1ee3p c\u1ee7a m\u1ef9 ph\u1ea9m, do \u0111\u1eb7c t\u00ednh c\u1ee7a s\u1ea3n ph\u1ea9m d\u00e0nh cho \u0111\u1ea1i ch\u00fang kh\u00f4ng c\u1ea7n ki\u1ebfn th\u1ee9c chuy\u00ean m\u00f4n, c\u00f3 nh\u1eefng quy t\u1eafc c\u1ee5 th\u1ec3 d\u1ef1a tr\u00ean lu\u1eadt ph\u00e1p \u0111\u01b0\u1ee3c \u0111\u1eb7t ra cho qu\u1ea3ng c\u00e1o s\u1ea3n ph\u1ea9m th\u00f4ng qua Internet, t\u1edd r\u01a1i, v.v. <br>Vui l\u00f2ng tham kh\u1ea3o b\u00e0i vi\u1ebft d\u01b0\u1edbi \u0111\u00e2y \u0111\u1ec3 bi\u1ebft th\u00eam chi ti\u1ebft.<\/p>\n\n\n\n<p><a href=\"https:\/\/Monolith.law\/corporate\/regulations-on-hyperbole\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/Monolith.law\/corporate\/regulations-on-hyperbole[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Moi_quan_he_voi_quy_dinh_quang_cao\"><\/span>M\u1ed1i quan h\u1ec7 v\u1edbi quy \u0111\u1ecbnh qu\u1ea3ng c\u00e1o<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>V\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m nh\u01b0 &#8220;D\u01b0\u1ee3c ph\u1ea9m&#8221;, &#8220;D\u01b0\u1ee3c ph\u1ea9m kh\u00f4ng thu\u1ed9c b\u1ed9 ph\u1eadn y t\u1ebf&#8221; v\u00e0 &#8220;M\u1ef9 ph\u1ea9m&#8221;, c\u00e1c quy \u0111\u1ecbnh ph\u00e1p l\u00fd v\u1ec1 qu\u1ea3ng c\u00e1o, bao g\u1ed3m vi\u1ec7c ghi r\u00f5 th\u00e0nh ph\u1ea7n c\u00f3 hi\u1ec7u l\u1ef1c, \u0111\u1ec1u kh\u00e1c nhau. C\u00e1c doanh nghi\u1ec7p c\u1ea7n ph\u1ea3i ph\u00e2n bi\u1ec7t r\u00f5 r\u00e0ng gi\u1eefa nh\u1eefng lo\u1ea1i s\u1ea3n ph\u1ea9m n\u00e0y v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n qu\u1ea3ng c\u00e1o \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u1eb7t ra cho t\u1eebng lo\u1ea1i.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lu\u1eadt D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf, t\u00ean ch\u00ednh th\u1ee9c 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\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c&#8221; (Japanese Pharmaceutical and Medical  [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":71847,"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\/58303"}],"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=58303"}],"version-history":[{"count":2,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/58303\/revisions"}],"predecessor-version":[{"id":71849,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/posts\/58303\/revisions\/71849"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media\/71847"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/media?parent=58303"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/categories?post=58303"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/vi\/wp-json\/wp\/v2\/tags?post=58303"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}