{"id":1356,"date":"2022-05-17T16:01:39","date_gmt":"2022-05-17T09:01:39","guid":{"rendered":"https:\/\/thuyanbio.com\/?page_id=1356"},"modified":"2022-06-02T14:42:36","modified_gmt":"2022-06-02T07:42:36","slug":"dang-ky-so-luu-hanh-san-pham","status":"publish","type":"page","link":"https:\/\/thuyanbio.com\/dang-ky-so-luu-hanh-san-pham\/","title":{"rendered":"\u0110\u0103ng k\u00fd s\u1ed1 l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m"},"content":{"rendered":"<h2><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\"><label class=\"text-uppercase\"><strong>C\u1ea4P NHANH S\u1ed0 L\u01afU H\u00c0NH \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/strong><\/label><\/span><\/h2>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">M\u00e3 th\u1ee7 t\u1ee5c<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">1.002155<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">L\u0129nh v\u1ef1c<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Trang thi\u1ebft b\u1ecb v\u00e0 c\u00f4ng tr\u00ecnh y t\u1ebf<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Tr\u00ecnh t\u1ef1 th\u1ef1c hi\u1ec7n<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">B\u01b0\u1edbc 1: C\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh n\u1ed9p h\u1ed3 s\u01a1 t\u1ea1i B\u1ed9 Y t\u1ebf (V\u1ee5 Trang thi\u1ebft b\u1ecb v\u00e0 C\u00f4ng tr\u00ecnh Y t\u1ebf).<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">B\u01b0\u1edbc 2: Khi nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7, B\u1ed9 Y t\u1ebf c\u1ea5p cho c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf theo m\u1eabu s\u1ed1 04 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP.<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u00f3 y\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i, b\u1ed5 sung h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m: T\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 30 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1.Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ch\u01b0a ho\u00e0n ch\u1ec9nh th\u00ec B\u1ed9 Y t\u1ebf ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ec3 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1, trong \u0111\u00f3 ph\u1ea3i n\u00eau c\u1ee5 th\u1ec3 l\u00e0 b\u1ed5 sung nh\u1eefng t\u00e0i li\u1ec7u n\u00e0o, n\u1ed9i dung n\u00e0o c\u1ea7n s\u1eeda \u0111\u1ed5i trong th\u1eddi h\u1ea1n 15 ng\u00e0y l\u00e0m vi\u1ec7c.<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">B\u01b0\u1edbc 3: Khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n y\u00eau c\u1ea7u b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i b\u1ed5 sung, s\u1eeda \u0111\u1ed5i theo \u0111\u00fang nh\u1eefng n\u1ed9i dung \u0111\u00e3 \u0111\u01b0\u1ee3c ghi trong v\u0103n b\u1ea3n v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf. Ng\u00e0y ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i \u0111\u01b0\u1ee3c ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Tr\u01b0\u1eddng h\u1ee3p c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 nh\u01b0ng kh\u00f4ng \u0111\u00fang v\u1edbi y\u00eau c\u1ea7u th\u00ec B\u1ed9 Y t\u1ebf s\u1ebd th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf \u0111\u1ec3 ti\u1ebfp t\u1ee5c ho\u00e0n ch\u1ec9nh h\u1ed3 s\u01a1 theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 4 \u0110i\u1ec1u n\u00e0y;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Sau 90 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 v\u0103n b\u1ea3n y\u00eau c\u1ea7u m\u00e0 c\u01a1 s\u1edf kh\u00f4ng b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 ho\u1eb7c n\u1ebfu sau 05 l\u1ea7n s\u1eeda \u0111\u1ed5i, b\u1ed5 sung h\u1ed3 s\u01a1 k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 y\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i, b\u1ed5 sung l\u1ea7n \u0111\u1ea7u m\u00e0 h\u1ed3 s\u01a1 v\u1eabn kh\u00f4ng \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u th\u00ec ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u th\u1ee7 t\u1ee5c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Trong qu\u00e1 tr\u00ecnh s\u1eeda \u0111\u1ed5i, b\u1ed5 sung h\u1ed3 s\u01a1 n\u1ebfu c\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m c, d, e kho\u1ea3n 1 \u0110i\u1ec1u 26 h\u1ebft hi\u1ec7u l\u1ef1c th\u00ec t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh ph\u1ea3i n\u1ed9p b\u1ed5 sung c\u00e1c gi\u1ea5y t\u1edd thay th\u1ebf c\u00f2n hi\u1ec7u l\u1ef1c. C\u00e1c gi\u1ea5y t\u1edd n\u00e0y ph\u1ea3i \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 28 Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP.<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">B\u01b0\u1edbc 4: Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf c\u00e1c th\u00f4ng tin sau:<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">a) T\u00ean, ph\u00e2n lo\u1ea1i, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, n\u01b0\u1edbc s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">b) S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">c) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">d) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">\u0111) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a c\u01a1 s\u1edf b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf;<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">C\u00e1ch th\u1ef1c hi\u1ec7n<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">N\u1ed9p h\u1ed3 s\u01a1 tr\u1ef1c tuy\u1ebfn<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Th\u00e0nh ph\u1ea7n h\u1ed3 s\u01a1<\/span><\/h3>\n<\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh theo m\u1eabu s\u1ed1 04 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/N\u0110-CP;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; B\u1ea3n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c V ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/N\u0110-CP;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; Gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf cho c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VI ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 1 \u0110i\u1ec1u 21 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; Gi\u1ea5y x\u00e1c nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ea5p theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1 \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; T\u00e0i li\u1ec7u m\u00f4 t\u1ea3 t\u00f3m t\u1eaft k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo m\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP k\u00e8m theo t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt m\u00f4 t\u1ea3 ch\u1ee9c n\u0103ng, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ban h\u00e0nh; Ri\u00eang \u0111\u1ed1i v\u1edbi thu\u1ed1c th\u1eed, ch\u1ea5t hi\u1ec7u chu\u1ea9n, v\u1eadt li\u1ec7u ki\u1ec3m so\u00e1t in vitro: t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo m\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/\/N\u0110-CP k\u00e8m theo t\u00e0i li\u1ec7u v\u1ec1 nguy\u00ean v\u1eadt li\u1ec7u, v\u1ec1 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, c\u00e1c b\u00e1o c\u00e1o nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 ti\u1ec1n l\u00e2m s\u00e0ng bao g\u1ed3m b\u00e1o c\u00e1o \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh.<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; H\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung th\u1ef1c hi\u1ec7n theo h\u01b0\u1edbng d\u1eabn t\u1ea1i Hi\u1ec7p \u0111\u1ecbnh ASEAN v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; T\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C, D c\u00f3 x\u00e2m nh\u1eadp c\u01a1 th\u1ec3 ng\u01b0\u1eddi: B\u1ea3n t\u00f3m t\u1eaft d\u1eef li\u1ec7u th\u1eed l\u00e2m s\u00e0ng theo m\u00e2\u0303u quy \u0111i\u0323nh ta\u0323i Phu\u0323 lu\u0323c IX ban ha\u0300nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP k\u00e8m theo k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u th\u1eed l\u00e2m s\u00e0ng, tr\u1eeb c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau: &#8211; Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh v\u00e0 c\u00e2\u0301p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc sau: c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU, Nh\u1eadt B\u1ea3n, Canada, \u00dac (TGA), M\u1ef9 (FDA); &#8211; Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p l\u01b0u h\u00e0nh tr\u01b0\u1edbc khi Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c; &#8211; C\u00e1c tr\u01b0\u1eddng h\u1ee3p kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf.<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">\u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro thu\u1ed9c lo\u1ea1i C, D ph\u1ea3i c\u00f3 th\u00eam gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m \u0111\u1ecbnh theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf, tr\u01b0\u0300 c\u00e1c tr\u01b0\u01a1\u0300ng h\u01a1\u0323p sau: &#8211; Trang thi\u00ea\u0301t bi\u0323 y t\u00ea\u0301 \u0111a\u0303 \u0111\u01b0\u01a1\u0323c c\u00e2\u0301p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc sau: c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU, Nh\u1eadt B\u1ea3n, Canada, \u00dac (TGA), M\u1ef9 (FDA); &#8211; Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p l\u01b0u h\u00e0nh tr\u01b0\u1edbc khi Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; M\u1eabu nh\u00e3n s\u1ebd s\u1eed d\u1ee5ng khi l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t ph\u00f9 h\u1ee3p v\u1edbi s\u1ea3n ph\u1ea9m xin c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; B\u00e1o c\u00e1o k\u1ebft qu\u1ea3 ho\u1ea1t \u0111\u1ed9ng kinh doanh trong th\u1eddi h\u1ea1n \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh theo m\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/N\u0110-CP \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p l\u01b0u h\u00e0nh tr\u01b0\u1edbc khi Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/N\u0110-CP c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh thu\u1ed9c di\u1ec7n mi\u1ec5n n\u1ed9p b\u1ea3n t\u00f3m t\u1eaft d\u1eef li\u1ec7u th\u1eed l\u00e2m s\u00e0ng ho\u1eb7c mi\u1ec5n gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m \u0111\u1ecbnh.<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">\u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 2 \u0110i\u1ec1u 25 Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/N\u0110-CP: C\u00f3 th\u00eam \u00edt nh\u1ea5t 01 gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u1ee7a c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc sau: c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU, Nh\u1eadt B\u1ea3n, Canada, \u00dac (TGA), M\u1ef9 (FDA) c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">\u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 2 \u0110i\u1ec1u 25 Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/N\u0110-CP: &#8211; C\u00f3 t\u1ed1i thi\u1ec3u 03 h\u1ee3p \u0111\u1ed3ng cung c\u1ea5p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 v\u1edbi c\u00e1c c\u01a1 s\u1edf y t\u1ebf t\u1ea1i Vi\u1ec7t Nam; &#8211; V\u0103n b\u1ea3n x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf y t\u1ebf v\u1ec1 vi\u1ec7c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 kh\u00f4ng co\u0301 th\u00f4ng tin c\u1ea3nh b\u00e1o li\u00ean quan \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 trong qu\u00e1 tr\u00ecnh s\u1eed d\u1ee5ng.&#8221; (Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi m\u1ed9t s\u1ed1 gi\u1ea5y t\u1edd trong b\u1ed9 h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh: a) \u0110\u1ed1i v\u1edbi Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c ho\u1eb7c b\u1ea3n sao c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh. Tr\u01b0\u1eddng h\u1ee3p Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng kh\u00f4ng b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng b\u1eb1ng ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt b) \u0110\u1ed1i v\u1edbi gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 gi\u1ea5y x\u00e1c nh\u1eadn c\u01a1 s\u1edf \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh: &#8211; \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c; &#8211; \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u: N\u1ed9p b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c c\u1ee7a b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1. c) \u0110\u1ed1i v\u1edbi gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do: N\u1ed9p b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c c\u1ee7a b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1. Tr\u01b0\u1eddng h\u1ee3p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do kh\u00f4ng b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng b\u1eb1ng ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt. Tr\u01b0\u1eddng h\u1ee3p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do kh\u00f4ng ghi r\u00f5 th\u1eddi h\u1ea1n h\u1ebft hi\u1ec7u l\u1ef1c th\u00ec th\u1eddi \u0111i\u1ec3m h\u1ebft h\u1ebft hi\u1ec7u l\u1ef1c c\u1ee7a gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do \u0111\u01b0\u1ee3c t\u00ednh l\u00e0 36 th\u00e1ng, k\u1ec3 t\u1eeb ng\u00e0y c\u1ea5p. d) \u0110\u1ed1i v\u1edbi t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf: N\u1ed9p b\u1ea3n c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh. Tr\u01b0\u1eddng h\u1ee3p t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt kh\u00f4ng b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng b\u1eb1ng ti\u1ebfng Vi\u1ec7t, th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt; \u0111) \u0110\u1ed1i v\u1edbi t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf: N\u1ed9p b\u1ea3n b\u1eb1ng ti\u1ebfng Vi\u1ec7t c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh. e) \u0110\u1ed1i v\u1edbi gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m \u0111\u1ecbnh: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c ho\u1eb7c b\u1ea3n sao c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh g) \u0110\u1ed1i v\u1edbi m\u1eabu nh\u00e3n: N\u1ed9p b\u1ea3n m\u1eabu nh\u00e3n c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh. M\u1eabu nh\u00e3n ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 54 Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP)<\/span><\/div>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Ph\u00ed<\/span><\/h3>\n<\/div>\n<p><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Ph\u00ed : 5.000.000 \u0110\u1ed3ng (Ph\u00ed th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf lo\u1ea1i C,D)<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Ph\u00ed : 3.000.000 \u0110\u1ed3ng (Ph\u00ed th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf lo\u1ea1i B)<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Th\u1eddi h\u1ea1n gi\u1ea3i quy\u1ebft<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">60 ng\u00e0y l\u00e0m vi\u1ec7c<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">\u0110\u1ed1i t\u01b0\u1ee3ng th\u1ef1c hi\u1ec7n<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Doanh nghi\u1ec7p, T\u1ed5 ch\u1ee9c<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">C\u01a1 quan th\u1ef1c hi\u1ec7n<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">V\u1ee5 Trang thi\u1ebft b\u1ecb v\u00e0 C\u00f4ng tr\u00ecnh y t\u1ebf<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">K\u1ebft qu\u1ea3 th\u1ef1c hi\u1ec7n<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">S\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf<\/span><\/p>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">C\u0103n c\u1ee9 ph\u00e1p l\u00fd<\/span><\/h3>\n<\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; 67\/2014\/QH13 Lu\u1eadt 67\/2014\/QH13 26-11-2014 Qu\u1ed1c H\u1ed9i<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; 278\/2016\/TT-BTC Th\u00f4ng t\u01b0 278\/2016\/TT-BTC &#8211; Quy \u0111\u1ecbnh m\u1ee9c thu, ch\u1ebf \u0111\u1ed9 thu, n\u1ed9p, qu\u1ea3n l\u00fd v\u00e0 s\u1eed d\u1ee5ng ph\u00ed trong l\u0129nh v\u1ef1c y t\u1ebf 14-11-2016 B\u1ed9 T\u00e0i ch\u00ednh<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; 36\/2016\/N\u0110-CP Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP V\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf 15-05-2016 Ch\u00ednh ph\u1ee7<\/span><\/div>\n<div><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; 169\/2018\/N\u0110-CP Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/N\u0110-CP S\u1eeda \u0111\u1ed5i, b\u1ed5 sung m\u1ed9t s\u1ed1 \u0111i\u1ec1u c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP ng\u00e0y 15 th\u00e1ng 5 n\u0103m 2016 c\u1ee7a Ch\u00ednh ph\u1ee7 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf 31-12-2018 Ch\u00ednh ph\u1ee7<\/span><\/div>\n<div class=\"panel-heading\">\n<h3><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">\u0110i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n<\/span><\/h3>\n<\/div>\n<p class=\"panel-body\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">\u0110i\u1ec1u 21 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP: \u0110i\u1ec1u ki\u1ec7n c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">1. T\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m:<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">a) Doanh nghi\u1ec7p, h\u1ee3p t\u00e1c x\u00e3, h\u1ed9 kinh doanh c\u1ee7a Vi\u1ec7t Nam l\u00e0 ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">b) Doanh nghi\u1ec7p, h\u1ee3p t\u00e1c x\u00e3, h\u1ed9 kinh doanh c\u1ee7a Vi\u1ec7t Nam c\u00f3 ch\u1ee9c n\u0103ng kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf \u1ee7y quy\u1ec1n \u0111\u0103ng k\u00fd;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">c) V\u0103n ph\u00f2ng \u0111\u1ea1i di\u1ec7n th\u01b0\u1eddng tr\u00fa t\u1ea1i Vi\u1ec7t Nam c\u1ee7a th\u01b0\u01a1ng nh\u00e2n n\u01b0\u1edbc ngo\u00e0i m\u00e0 th\u01b0\u01a1ng nh\u00e2n \u0111\u00f3 l\u00e0 ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf.<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">2. T\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 c\u01a1 s\u1edf b\u1ea3o h\u00e0nh t\u1ea1i Vi\u1ec7t Nam ho\u1eb7c ph\u1ea3i c\u00f3 h\u1ee3p \u0111\u1ed3ng v\u1edbi t\u1ed5 ch\u1ee9c \u0111\u1ee7 n\u0103ng l\u1ef1c b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 m\u00ecnh \u0111\u1ee9ng t\u00ean \u0111\u0103ng k\u00fd, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf.<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Tr\u01b0\u1eddng h\u1ee3p t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m c kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y th\u00ec ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 h\u1ee3p \u0111\u1ed3ng v\u1edbi c\u01a1 s\u1edf \u0111\u1ee7 n\u0103ng l\u1ef1c b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 m\u00ecnh \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ho\u1eb7c \u0111\u0103ng k\u00fd, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf.<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">C\u01a1 s\u1edf b\u1ea3o h\u00e0nh ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ee9ng nh\u1eadn \u0111\u1ee7 n\u0103ng l\u1ef1c b\u1ea3o h\u00e0nh s\u1ea3n ph\u1ea9m m\u00e0 t\u1ed5 ch\u1ee9c \u0111\u00f3 \u0111\u1ee9ng t\u00ean \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Kho\u1ea3n 2 \u0110i\u1ec1u 25. C\u00e1c h\u00ecnh th\u1ee9c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">2. C\u1ea5p nhanh s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh m\u1edbi \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau \u0111\u00e2y:<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">a) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh t\u1ea1i \u00edt nh\u1ea5t 02 n\u01b0\u1edbc thu\u1ed9c c\u00e1c n\u01b0\u1edbc sau: Nh\u1eadt B\u1ea3n, Ca-na-\u0111a, \u00dac, M\u1ef9, c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">b) \u0110\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam \u0111\u1ebfn tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2018 v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n sau :<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; \u0110\u00e3 l\u01b0u h\u00e0nh \u00edt nh\u1ea5t 03 n\u0103m trong th\u1eddi h\u1ea1n 05 n\u0103m t\u00ednh \u0111\u1ebfn ng\u00e0y n\u1ed9p h\u1ed3 s\u01a1;<\/span><br \/>\n<span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">&#8211; Kh\u00f4ng co\u0301 th\u00f4ng tin c\u1ea3nh b\u00e1o li\u00ean quan \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3.<\/span><\/p>\n<p><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">NGU\u1ed2N: <\/span><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">H\u1ec6 TH\u1ed0NG TH\u00d4NG TIN GI\u1ea2I QUY\u1ebeT TH\u1ee6 T\u1ee4C H\u00c0NH CH\u00cdNH B\u1ed8 Y T\u1ebe<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>C\u1ea4P NHANH S\u1ed0 L\u01afU H\u00c0NH \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe M\u00e3 th\u1ee7 t\u1ee5c 1.002155 L\u0129nh v\u1ef1c Trang thi\u1ebft b\u1ecb v\u00e0 c\u00f4ng tr\u00ecnh y t\u1ebf Tr\u00ecnh t\u1ef1 th\u1ef1c hi\u1ec7n B\u01b0\u1edbc 1: C\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh n\u1ed9p h\u1ed3 s\u01a1 t\u1ea1i B\u1ed9 Y t\u1ebf (V\u1ee5 Trang thi\u1ebft b\u1ecb v\u00e0 C\u00f4ng tr\u00ecnh Y &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/thuyanbio.com\/dang-ky-so-luu-hanh-san-pham\/\"> <span class=\"screen-reader-text\">\u0110\u0103ng k\u00fd s\u1ed1 l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m<\/span> Read More &raquo;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"class_list":["post-1356","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/thuyanbio.com\/wp-json\/wp\/v2\/pages\/1356","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thuyanbio.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/thuyanbio.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/thuyanbio.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thuyanbio.com\/wp-json\/wp\/v2\/comments?post=1356"}],"version-history":[{"count":3,"href":"https:\/\/thuyanbio.com\/wp-json\/wp\/v2\/pages\/1356\/revisions"}],"predecessor-version":[{"id":1391,"href":"https:\/\/thuyanbio.com\/wp-json\/wp\/v2\/pages\/1356\/revisions\/1391"}],"wp:attachment":[{"href":"https:\/\/thuyanbio.com\/wp-json\/wp\/v2\/media?parent=1356"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}