{"id":3849,"date":"2023-12-01T18:52:33","date_gmt":"2023-12-01T11:52:33","guid":{"rendered":"https:\/\/anlitalog.com\/?p=3849"},"modified":"2024-02-03T22:58:20","modified_gmt":"2024-02-03T15:58:20","slug":"duoc-lieu","status":"publish","type":"post","link":"https:\/\/www.anlitalog.com\/vi\/duoc-lieu\/","title":{"rendered":"D\u01b0\u1ee3c li\u1ec7u"},"content":{"rendered":"\t\t
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Tr\u00ean th\u1ef1c t\u1ebf, d\u01b0\u1ee3c ph\u1ea9m l\u00e0 lo\u1ea1i m\u1eb7t h\u00e0ng \u0111\u01b0\u1ee3c \u01b0u ti\u00eau nh\u1eadp kh\u1ea9u v\u00e0 l\u00e0m m\u1edbi li\u00ean t\u1ee5c nh\u1eb1m \u0111\u00e1p \u1ee9ng nhu c\u1ea7u c\u1ee7a con ng\u01b0\u1eddi. M\u1eb7t kh\u00e1c, c\u00e1c lo\u1ea1i thu\u1ed1c nh\u1eadp ngo\u1ea1i c\u0169ng \u0111ang ng\u00e0y c\u00e0ng gia t\u0103ng g\u1ea5p b\u1ed9i theo c\u1ea5p s\u1ed1 nh\u00e2n.<\/span><\/p>\n

V\u1eady n\u00ean, c\u00f3 kh\u00e1 nhi\u1ec1u kh\u00e1ch h\u00e0ng v\u1eabn c\u00f2n b\u0103n kho\u0103n kh\u00f4ng bi\u1ebft <\/span>th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span> \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh nh\u01b0 th\u1ebf n\u00e0o? V\u1eady Anlita xin gi\u1ea3i \u0111\u00e1p cho Qu\u00fd v\u1ecb th\u00f4ng qua b\u00e0i vi\u1ebft d\u01b0\u1edbi \u0111\u00e2y: <\/span> <\/span><\/p>\n

<\/p>\n

1. Quy \u0111\u1ecbnh nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m v\u1ec1 vi\u1ec7t nam<\/span><\/p>\n

Th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 t\u1ea1i m\u1ee5c 2, ch\u01b0\u01a1ng 2, tu\u00e2n th\u1ee7 <\/span>Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 54\/2017\/N\u0110 \u2013 CP<\/span> (s\u1eeda \u0111\u1ed5i b\u1ed5 sung b\u1edfi Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 155\/2018\/N\u0110 \u2013 CP). Trong \u0111\u00f3, thu\u1ed1c ch\u1ec9 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u khi m\u1ecdi ng\u01b0\u1eddi \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c ti\u00eau ch\u00ed nh\u01b0:<\/span><\/p>\n

    \n
  1. C\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh t\u1ea1i n\u01b0\u1edbc s\u1ea3n xu\u1ea5t, n\u01b0\u1edbc th\u00e0nh vi\u00ean c\u1ee7a h\u1ed9i ngh\u1ecb qu\u1ed1c t\u1ebf v\u00e0 h\u00e0i h\u00f2a h\u00f3a c\u00e1c th\u1ee7 t\u1ee5c \u0111\u0103ng k\u00fd d\u01b0\u1ee3c ph\u1ea9m cho ng\u01b0\u1eddi (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use \u2013 ICH) ho\u1eb7c Australia.<\/span><\/li>\n
  2. C\u00f3 s\u1eb5n h\u01b0\u1edbng d\u1eabn ch\u1ea9n \u0111o\u00e1n, ph\u00f2ng b\u1ec7nh, \u0111i\u1ec1u tr\u1ecb do B\u1ed9 Y T\u1ebf ban h\u00e0nh v\u00e0 ph\u00ea duy\u1ec7t \u0111\u1ea7y \u0111\u1ee7.<\/span><\/li>\n
  3. Thu\u1ed1c ph\u1ee5c v\u1ee5 cho m\u1ee5c \u0111\u00edch c\u1ea5p c\u1ee9u, ch\u1ed1ng \u0111\u1ed9c, ch\u1ed1ng th\u1ea3i gh\u00e9p,\u2026<\/span><\/li>\n
  4. Thu\u1ed1c d\u00f9ng \u0111\u1ec3 ch\u1ea9n \u0111o\u00e1n, d\u1ef1 ph\u00f2ng ho\u1eb7c \u0111i\u1ec1u tr\u1ecb k\u1ecbp th\u1eddi c\u00e1c b\u1ec7nh truy\u1ec1n nhi\u1ec5m nh\u00f3m A, b\u1ec7nh ung th\u01b0, HIV\/AIDS, b\u1ec7nh vi\u00eam gan virus, b\u1ec7nh lao, b\u1ec7nh s\u1ed1t r\u00e9t v\u00e0 c\u00e1c b\u1ec7nh do B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y T\u1ebf quy\u1ebft \u0111\u1ecbnh.<\/span><\/li>\n
  5. Tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m v\u1ec1 Vi\u1ec7t Nam<\/span><\/li>\n<\/ol>\n

    2. \u0110i\u1ec1u ki\u1ec7n nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i Vi\u1ec7t Nam<\/span><\/p>\n

    Ngo\u00e0i vi\u1ec7c th\u00f4ng th\u1ea1o kh\u00e1i ni\u1ec7m thu\u1ed1c th\u00ec c\u00e1 nh\u00e2n, t\u1ed5 ch\u1ee9c hay doanh nghi\u1ec7p \u0111\u1ec1u ph\u1ea3i hi\u1ec3u v\u00e0 tu\u00e2n th\u1ee7 nh\u1eefng \u0111i\u1ec1u ki\u1ec7n khi l\u00e0m <\/span>th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span>:<\/span><\/p>\n

      \n
    1. C\u00e1c doanh nghi\u1ec7p s\u1ea3n xu\u1ea5t, kinh doanh thu\u1ed1c b\u1eaft bu\u1ed9c ph\u1ea3i s\u1edf h\u1eefu ch\u1ee9ng nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t, kinh doanh d\u01b0\u1ee3c ph\u1ea9m theo \u0111\u00fang quy \u0111\u1ecbnh.<\/span><\/li>\n
    2. Ng\u01b0\u1eddi qu\u1ea3n l\u00fd chuy\u00ean m\u00f4n c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, kinh doanh ph\u1ea3i \u0111\u01b0\u1ee3c c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 d\u01b0\u1ee3c. Kh\u00f4ng nh\u1eefng th\u1ebf, h\u1ecd c\u1ea7n ph\u1ea3i c\u00f3 \u0111\u1ea1o \u0111\u1ee9c ngh\u1ec1 nghi\u1ec7p, trang b\u1ecb s\u1ee9c kh\u1ecfe h\u00e0nh ngh\u1ec1 v\u00e0 s\u1edf h\u1eefu gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t, kinh doanh thu\u1ed1c, d\u01b0\u1ee3c ph\u1ea9m.<\/span><\/li>\n
    3. C\u01a1 s\u1edf v\u1eadt ch\u1ea5t c\u1ee7a doanh nghi\u1ec7p \u0111\u1ea1t chu\u1ea9n. \u0110\u1ed3ng th\u1eddi, \u0111\u01a1n v\u1ecb nh\u1eadn s\u1ef1 ho\u1ea1t \u0111\u1ed9ng c\u0169ng ph\u1ea3i n\u00e2ng cao tr\u00ecnh \u0111\u1ed9 chuy\u00ean m\u00f4n v\u00e0 t\u01b0\u01a1ng \u1ee9ng v\u1edbi h\u00ecnh th\u1ee9c kinh doanh m\u1eb7t h\u00e0ng d\u01b0\u1ee3c ph\u1ea9m, thu\u1ed1c nh\u1eadp kh\u1ea9u.<\/span><\/li>\n
    4. \u0110\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m<\/span><\/li>\n<\/ol>\n

      3. Ph\u00e1p l\u00fd v\u1ec1 th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m v\u1ec1 Vi\u1ec7t Nam<\/span><\/p>\n

      Hi\u1ec7n nay, trong h\u1ec7 th\u1ed1ng v\u0103n b\u1ea3n ph\u00e1p lu\u1eadt \u0111\u00e3 hi\u1ec3n th\u1ecb s\u1eb5n quy \u0111\u1ecbnh v\u1ec1 <\/span>th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span>. C\u1ee5 th\u1ec3 nh\u01b0:<\/span><\/p>\n

        \n
      1. Lu\u1eadt D\u01b0\u1ee3c c\u00f4ng b\u1ed1 n\u0103m 2016.<\/span><\/li>\n
      2. Ngh\u1ecb \u0111\u1ecbnh 54\/2017\/N\u0110 \u2013 CP do Ch\u00ednh ph\u1ee7 ban h\u00e0nh Quy \u0111\u1ecbnh chi ti\u1ebft m\u1ed9t s\u1ed1 \u0111i\u1ec1u v\u00e0 bi\u1ec7n ph\u00e1p thi h\u00e0nh lu\u1eadt d\u01b0\u1ee3c v\u00e0o n\u0103m 2016.<\/span><\/li>\n
      3. Theo ngh\u1ecb \u0111\u1ecbnh s\u1ed1 155\/2018\/N\u0110 \u2013 CP s\u1eeda \u0111\u1ed5i v\u00e0 b\u1ed5 sung Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 54\/2017\/N\u0110 \u2013 CP.<\/span><\/li>\n
      4. Th\u00f4ng t\u01b0 03\/2016\/TT \u2013 BYT c\u1ee7a B\u1ed9 Y T\u1ebf quy \u0111\u1ecbnh chung v\u1ec1 ho\u1ea1t \u0111\u1ed9ng kinh doanh d\u01b0\u1ee3c li\u1ec7u.<\/span><\/li>\n
      5. C\u00e1c v\u0103n b\u1ea3n ph\u00e1p lu\u1eadt li\u00ean quan b\u1ea5t k\u1ef3.<\/span><\/li>\n<\/ol>\n

        4. H\u1ed3 s\u01a1 th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span><\/p>\n

        Anlita s\u1ebd b\u1eadt m\u00ed cho m\u1ecdi ng\u01b0\u1eddi h\u1ed3 s\u01a1 <\/span>th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span> chu\u1ea9n x\u00e1c v\u00e0 \u0111\u1ea7y \u0111\u1ee7 nh\u01b0 sau:<\/span><\/p>\n

          \n
        1. Gi\u1ea5y xin nh\u1eadp kh\u1ea9u (b\u1ea3n g\u1ed1c).<\/span><\/li>\n
        2. \u0110\u01a1n h\u00e0ng nh\u1eadp kh\u1ea9u.<\/span><\/li>\n
        3. Gi\u1ea5y ch\u1ee9ng nh\u1eadn s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c (c\u00f3 th\u1ec3 thay th\u1ebf b\u1eb1ng FSC v\u00e0 GMP). Tr\u01b0\u1eddng h\u1ee3p c\u00f3 nhi\u1ec1u c\u01a1 s\u1edf \u0111\u1ed3ng lo\u1ea1t h\u1ee3p t\u00e1c v\u00e0o qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t thu\u1ed1c th\u00ec h\u1ecd bu\u1ed9c ph\u1ea3i n\u1ed9p gi\u1ea5y ch\u1ee9ng nh\u1eadn GMP c\u1ee7a t\u1ea5t c\u1ea3 trung t\u00e2m tham gia trong qu\u00e1 tr\u00ecnh t\u1ea1o ra th\u00e0nh ph\u1ea9m.<\/span><\/li>\n
        4. Ti\u00eau chu\u1ea9n k\u00e8m ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng thu\u1ed1c.<\/span><\/li>\n
        5. Nh\u00e3n thu\u1ed1c v\u00e0 t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng \u0111\u00e3 \u0111\u00f3ng d\u1ea5u s\u1eb5n t\u00ean \u0111\u01a1n v\u1ecb nh\u1eadp kh\u1ea9u. Bao g\u1ed3m 01 b\u1ed9 nh\u00e3n k\u00e8m t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng g\u1ed1c \u0111ang \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh th\u1ef1c t\u1ebf \u1edf n\u01a1i xu\u1ea5t x\u1ee9 (tr\u1eeb v\u1eafc xin, sinh ph\u1ea9m y t\u1ebf), 02 b\u1ed9 nh\u00e3n d\u1ef1 ki\u1ebfn l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam k\u00e8m t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng d\u1ecbch sang ti\u1ebfng Vi\u1ec7t.<\/span><\/li>\n
        6. B\u00e1o c\u00e1o l\u01b0\u1ee3ng thu\u1ed1c t\u1ed3n kho.<\/span><\/li>\n
        7. Chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 l\u00e2m s\u00e0ng v\u00e0 ti\u1ec1n l\u00e2m s\u00e0ng \u0111\u1ed1i v\u1edbi thu\u1ed1c ch\u1ee9a d\u01b0\u1ee3c ch\u1ea5t m\u1edbi hay thu\u1ed1c c\u00f3 s\u1ef1 k\u1ebft h\u1ee3p c\u00f9ng m\u1ed9t s\u1ed1 d\u01b0\u1ee3c ch\u1ea5t \u0111\u00e3 l\u01b0u h\u00e0nh.<\/span><\/li>\n
        8. Chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u ch\u00ednh x\u00e1c v\u00e0 \u0111\u1ea7y \u0111\u1ee7<\/span><\/li>\n<\/ol>\n

          5. Th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m chi ti\u1ebft<\/span><\/p>\n

          Khi nh\u1eadp kh\u1ea9u, doanh nghi\u1ec7p c\u1ea7n x\u00e1c \u0111\u1ecbnh xem d\u01b0\u1ee3c ph\u1ea9m c\u1ee7a m\u00ecnh \u0111\u00e3 c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam hay ch\u01b0a. N\u1ebfu ch\u01b0a c\u00f3, \u0111\u01a1n v\u1ecb ph\u1ea3i ti\u1ebfn h\u00e0nh \u0111i xin gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u v\u00e0 \u0111\u0103ng k\u00fd s\u1ed1 l\u01b0u h\u00e0nh. Th\u1ebf n\u00ean, <\/span>th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c<\/span> ph\u1ea9m th\u01b0\u1eddng \u0111\u01b0\u1ee3c chia th\u00e0nh hai lo\u1ea1i:<\/span><\/p>\n

          1. Th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam<\/span><\/p>\n

          \u0110\u1ed1i v\u1edbi c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m \u0111\u00e3 s\u1edf h\u1eefu s\u1eb5n s\u1ed1 l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam, doanh nghi\u1ec7p c\u00f3 th\u1ec3 tr\u1ef1c ti\u1ebfp l\u00e0m th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u t\u1ea1i c\u01a1 quan H\u1ea3i quan. H\u1ed3 s\u01a1 bao g\u1ed3m:<\/span><\/p>\n

            \n
          1. H\u00f3a \u0111\u01a1n th\u01b0\u01a1ng m\u1ea1i ho\u00e0n ch\u1ec9nh.<\/span><\/li>\n
          2. H\u1ee3p \u0111\u1ed3ng ngo\u1ea1i th\u01b0\u01a1ng r\u00f5 n\u00e9t.<\/span><\/li>\n
          3. V\u1eadn t\u1ea3i \u0111\u01a1n k\u00e8m theo.<\/span><\/li>\n
          4. Gi\u1ea5y ch\u1ee9ng nh\u1eadn xu\u1ea5t x\u1ee9 (b\u1ea3n g\u1ed1c).<\/span><\/li>\n
          5. Cung c\u1ea5p gi\u1ea5y ph\u00e9p ho\u1ea1t \u0111\u1ed9ng v\u1ec1 thu\u1ed1c v\u00e0 nguy\u00ean li\u1ec7u l\u00e0m thu\u1ed1c t\u1ea1i Vi\u1ec7t Nam.<\/span><\/li>\n
          6. Danh m\u1ee5c thu\u1ed1c nh\u1eadp kh\u1ea9u ho\u00e0n ch\u1ec9nh.<\/span><\/li>\n
          7. Gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh s\u1ea3n ph\u1ea9m ho\u1eb7c Quy\u1ebft \u0111\u1ecbnh c\u1ea5p s\u1ed5 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh (b\u1ea3n ch\u00ednh ho\u1eb7c photo c\u00f4ng ch\u1ee9ng).<\/span><\/li>\n<\/ol>\n

            2. Th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam<\/span><\/strong><\/p>\n

            Ng\u01b0\u1ee3c l\u1ea1i, n\u1ebfu m\u1eb7t h\u00e0ng ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh th\u00ec \u0111\u01a1n v\u1ecb ph\u1ea3i di chuy\u1ec3n \u0111i xin gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u v\u00e0 \u0111\u0103ng k\u00fd s\u1ed1 l\u01b0u h\u00e0nh. Tr\u00ecnh t\u1ef1 bao g\u1ed3m 3 b\u01b0\u1edbc:<\/span><\/p>\n

            B\u01b0\u1edbc 1: Xin gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m (b\u1eaft bu\u1ed9c)<\/strong><\/span><\/p>\n

            \u0110\u00e2y \u0111\u01b0\u1ee3c xem l\u00e0 b\u01b0\u1edbc quan tr\u1ecdng nh\u1ea5t \u0111\u1ec3 nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m v\u1ec1 \u0111\u0103ng k\u00fd s\u1ed1 l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam. Do \u0111\u00f3, doanh nghi\u1ec7p c\u1ea7n ph\u1ea3i chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 xin c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u theo m\u1eabu \u0111\u00e3 quy \u0111\u1ecbnh chi ti\u1ebft t\u1ea1i Kho\u1ea3n 2, \u0110i\u1ec1u 65, Ngh\u1ecb \u0111\u1ecbnh 54\/2017\/N\u0110 \u2013 CP. C\u1ee5 th\u1ec3 nh\u01b0 sau:<\/span><\/p>\n

              \n
            1. \u0110\u01a1n h\u00e0ng nh\u1eadp kh\u1ea9u M\u1eabu s\u1ed1 15, 16 ho\u1eb7c 17 t\u1ea1i Ph\u1ee5 l\u1ee5c III k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 54\/2017\/N\u0110 \u2013 CP (03 b\u1ea3n g\u1ed1c).<\/span><\/li>\n
            2. Gi\u1ea5y ch\u1ee9ng nh\u1eadn s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c (b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao ch\u1ee9ng th\u1ef1c).<\/span><\/li>\n
            3. B\u1ea3n ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m nghi\u1ec7m thu\u1ed1c c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t \u0111\u00e3 \u0111\u00f3ng d\u1ea5u (photo).<\/span><\/li>\n
            4. B\u1ed9 m\u1eabu nh\u00e3n v\u00e0 h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng \u0111ang \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh \u1edf n\u01b0\u1edbc c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c (1 b\u1ea3n ch\u00ednh).<\/span><\/li>\n
            5. B\u1ed9 m\u1eabu nh\u00e3n d\u1ef1 ki\u1ebfn l\u01b0u h\u00e0nh \u1edf Vi\u1ec7t Nam k\u00e8m t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng Ti\u1ebfng Vi\u1ec7t \u0111\u00e3 \u0111\u00f3ng d\u1ea5u c\u01a1 s\u1edf nh\u1eadp kh\u1ea9u (2 b\u1ed9).<\/span><\/li>\n
            6. B\u00e1o c\u00e1o k\u1ebft qu\u1ea3 kinh doanh thu\u1ed1c trong tr\u01b0\u1eddng h\u1ee3p thu\u1ed1c nh\u1eadp kh\u1ea9u l\u00e0 thu\u1ed1c nghi\u1ec7n, thu\u1ed1c h\u01b0\u1edbng th\u1ea7n,\u2026 theo M\u1eabu s\u1ed1 18 t\u1ea1i Ph\u1ee5 l\u1ee5c III ban h\u00e0nh.<\/span><\/li>\n
            7. Gi\u1ea5y ch\u1ee9ng nh\u1eadn th\u1ef1c h\u00e0nh t\u1ed1t c\u1ee7a t\u1ea5t c\u1ea3 c\u00e1c c\u01a1 s\u1edf tham gia s\u1ea3n xu\u1ea5t thu\u1ed1c nh\u1eadp kh\u1ea9u trong tr\u01b0\u1eddng h\u1ee3p thu\u1ed1c \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t b\u1edfi nhi\u1ec1u doanh nghi\u1ec7p kh\u00e1c nhau (b\u1ea3n ch\u00ednh ho\u1eb7c photo c\u00f4ng ch\u1ee9ng).<\/span><\/li>\n
            8. Gi\u1ea5y cho ph\u00e9p ti\u1ebfn h\u00e0nh c\u00f4ng vi\u1ec7c b\u1ee9c x\u1ea1 c\u1ee7a c\u01a1 s\u1edf nh\u1eadp kh\u1ea9u \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u thu\u1ed1c ph\u00f3ng x\u1ea1 (b\u1ea3n sao ch\u1ee9ng th\u1ef1c ho\u1eb7c b\u1ea3n sao \u0111\u00f3ng d\u1ea5u c\u01a1 s\u1edf).<\/span><\/li>\n<\/ol>\n

              B\u01b0\u1edbc 2: Th\u1ef1c hi\u1ec7n \u0111\u0103ng k\u00fd s\u1ed1 l\u01b0u h\u00e0nh d\u01b0\u1ee3c ph\u1ea9m<\/span><\/strong><\/p>\n

              Ngay khi ho\u00e0n t\u1ea5t v\u00e0 n\u1ed9p \u0111\u1ea7y \u0111\u1ee7 h\u1ed3 s\u01a1 nh\u1eadp kh\u1ea9u theo \u0111\u00fang quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt, \u0111\u01a1n v\u1ecb h\u00e3y b\u1eaft \u0111\u1ea7u qu\u00e1 tr\u00ecnh \u0111\u0103ng k\u00fd s\u1ed1 l\u01b0u h\u00e0nh cho d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i Vi\u1ec7t Nam. M\u1eb7t kh\u00e1c, th\u1ee7 t\u1ee5c v\u00e0 h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd \u0111\u00e3 \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea t\u1ea1i Kho\u1ea3n 2, \u0110i\u1ec1u 56 Lu\u1eadt D\u01b0\u1ee3c 2106. T\u00f3m g\u1ecdi chi ti\u1ebft nh\u01b0 sau:<\/span><\/p>\n

              H\u1ed3 s\u01a1 h\u00e0nh ch\u00ednh:<\/span><\/strong><\/em><\/p>\n

                \n
              1. \u0110\u01a1n \u0111\u1ec1 ngh\u1ecb \u0111\u0103ng k\u00fd gi\u1ea5y l\u01b0u h\u00e0nh v\u00e0 nguy\u00ean li\u1ec7u ch\u1ebf bi\u1ebfn thu\u1ed1c.<\/span><\/li>\n
              2. B\u1ea3n sao ch\u1ee9ng th\u1ef1c Gi\u1ea5y ph\u00e9p th\u00e0nh l\u1eadp v\u0103n ph\u00f2ng \u0111\u1ea1i di\u1ec7n c\u00f2n hi\u1ec7u l\u1ef1c \u0111\u1ed1i v\u1edbi c\u01a1 s\u1edf kinh doanh thu\u1ed1c ho\u1eb7c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n kinh doanh d\u01b0\u1ee3c c\u00f2n th\u1eddi h\u1ea1n.<\/span><\/li>\n
              3. B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao ch\u1ee9ng th\u1ef1c Gi\u1ea5y ch\u1ee9ng nh\u1eadn s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m \u0111\u1ed1i v\u1edbi thu\u1ed1c nh\u1eadp kh\u1ea9u c\u00f2n hi\u1ec7u l\u1ef1c.<\/span><\/li>\n
              4. M\u1eabu nh\u00e3n, nguy\u00ean li\u1ec7u, th\u00f4ng tin v\u1ec1 thu\u1ed1c v\u00e0 c\u00e1c t\u1eadp t\u00e0i li\u1ec7u kh\u00e1c li\u00ean quan \u0111\u1ebfn kinh doanh, l\u01b0u h\u00e0nh, nguy\u00ean li\u1ec7u.<\/span><\/li>\n
              5. H\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt ch\u1ee9ng minh thu\u1ed1c, nguy\u00ean li\u1ec7u l\u00e0m thu\u1ed1c ph\u1ea3i \u0111\u00e1p \u1ee9ng t\u1ea5t c\u1ea3 c\u00e1c y\u00eau c\u1ea7u t\u1ea1i Kho\u1ea3n 4 \u0110i\u1ec1u 54 Lu\u1eadt D\u01b0\u1ee3c 2016.<\/span><\/li>\n<\/ol>\n

                Thu\u1ed1c m\u1edbi, sinh ph\u1ea9m tham chi\u1ebfu, v\u1eafc xin,\u2026 c\u00f3 ch\u1ec9 \u0111\u1ecbnh trong nh\u1eefng d\u1ea1ng b\u1ec7nh thu\u1ed9c danh M\u1ee5c do B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y T\u1ebf ban h\u00e0nh th\u00ec doanh nghi\u1ec7p ph\u1ea3i s\u1edf h\u1eefu th\u00eam b\u1ed9 h\u1ed3 s\u01a1 l\u00e2m s\u00e0ng ch\u1ee9ng minh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3.<\/span><\/p>\n

                Sinh ph\u1ea9m t\u01b0\u01a1ng t\u1ef1 ph\u1ea3i c\u00f3 th\u00eam h\u1ed3 s\u01a1 ch\u1ee9ng minh ch\u1ea5t l\u01b0\u1ee3ng so v\u1edbi m\u1ed9t sinh ph\u1ea9m tham chi\u1ebfu.<\/span><\/p>\n

                Ngo\u00e0i ra, thu\u1ed1c c\u00f3 y\u00eau c\u1ea7u th\u1eed t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc ph\u1ea3i c\u00f3 th\u00eam b\u00e1o c\u00e1o s\u1ed1 li\u1ec7u nghi\u00ean c\u1ee9u t\u01b0\u01a1ng \u0111\u01b0\u01a1ng sinh h\u1ecdc c\u1ee7a thu\u1ed1c.<\/span><\/p>\n

                <\/p>\n

                B\u01b0\u1edbc 3: L\u00e0m h\u1ed3 s\u01a1 nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span><\/strong><\/p>\n

                Nh\u01b0 Anlita v\u1eeba \u0111\u1ec1 c\u1eadp tr\u00ean m\u1ee5c \u201cH\u1ed3 s\u01a1 l\u00e0 <\/span>th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span>\u201d, ch\u1ec9 c\u1ea7n th\u1ef1c hi\u1ec7n xong c\u00f4ng \u0111o\u1ea1n n\u00e0y l\u00e0 doanh nghi\u1ec7p \u0111\u00e3 g\u1ea7n nh\u01b0 ho\u00e0n t\u1ea5t 100%.<\/span><\/p>\n

                 <\/span><\/p>\n

                3. M\u00e3 HS code v\u00e0 thu\u1ebf nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span><\/strong><\/p>\n

                Tu\u00e2n th\u1ee7 theo \u0111\u00fang quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt m\u00e0 nh\u00e0 n\u01b0\u1edbc Vi\u1ec7t Nam ban h\u00e0nh, m\u00e3 HS Code v\u00e0 thu\u1ebf \u0111\u01b0\u1ee3c ghi nh\u1eadn nh\u01b0 sau:<\/span><\/p>\n

                HS Code<\/span><\/p>\n

                300410: Thu\u1ed1c ch\u1ee9a Penicillin c\u00f3 c\u1ea5u tr\u00fac Axit Penicillanic.<\/span><\/p>\n

                300420: Thu\u1ed1c t\u1ed3n t\u1ea1i kh\u00e1ng sinh.<\/span><\/p>\n

                300432: Thu\u1ed1c ch\u1ee9a Hormon tuy\u1ebfn th\u01b0\u1ee3ng th\u1eadn ho\u1eb7c c\u00e1c d\u1eabn xu\u1ea5t c\u1ee7a ch\u00fang.<\/span><\/p>\n

                300440: Thu\u1ed1c ch\u1ee9a Alkaloid ho\u1eb7c d\u1eabn xu\u1ea5t c\u1ee7a ch\u00fang nh\u01b0ng kh\u00f4ng ch\u1ee9a Hormon v\u00e0 kh\u00e1ng sinh.<\/span><\/p>\n

                300450: Thu\u1ed1c ch\u1ee9a Vitamin ho\u1eb7c s\u1ea3n ph\u1ea9m n\u1eb1m trong nh\u00f3m 29.36.<\/span><\/p>\n

                30049049: C\u00e1c lo\u1ea1i thu\u1ed1c kh\u00e1ng nh\u01b0 ch\u1ed1ng s\u1ed1t r\u00e9t, gi\u1ea3m \u0111au, t\u1ea9y giun,\u2026<\/span><\/p>\n

                C\u00f3 \u0111\u1ea7y \u0111\u1ee7 m\u00e3 HS v\u00e0 \u0111\u00f3ng thu\u1ebf theo \u0111\u00fang quy \u0111\u1ecbnh<\/span><\/p>\n

                <\/p>\n

                4. Thu\u1ebf<\/span><\/p>\n

                \u0110\u00fang nh\u01b0 C\u1ee5c Qu\u1ea3n L\u00fd c\u00f4ng b\u1ed1, nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m ch\u1ecbu thu\u1ebf GTGT v\u1edbi thu\u1ebf su\u1ea5t 5% khi l\u00e0m th\u1ee7 t\u1ee5c khai b\u00e1o h\u1ea3i quan.<\/span><\/p>\n

                 <\/span><\/p>\n

                5. Q&A nh\u1eefng c\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m<\/span><\/p>\n

                Q: C\u01a1 s\u1edf Vi\u1ec7t Nam nh\u1eadp kh\u1ea9u thu\u1ed1c c\u1ea7n \u0111\u00e1p \u1ee9ng nh\u1eefng y\u00eau c\u1ea7u g\u00ec?<\/span><\/p>\n

                A: \u0110\u01a1n v\u1ecb ph\u1ea3i h\u1ed9i t\u1ee5 \u0111\u1ea7y \u0111\u1ee7 c\u00e1c ti\u00eau ch\u00ed nh\u01b0:<\/span><\/p>\n

                C\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n kinh doanh thu\u1ed1c v\u1edbi ph\u1ea1m vi bu\u00f4n b\u00e1n d\u01b0\u1ee3c li\u1ec7u.<\/span><\/p>\n

                \u0110\u1ea1t nguy\u00ean t\u1eafc \u201cTh\u1ef1c h\u00e0nh t\u1ed1t b\u1ea3o qu\u1ea3n thu\u1ed1c\u201d do B\u1ed9 Y T\u1ebf ki\u1ec3m tra ch\u1eb7t ch\u1ebd.<\/span><\/p>\n

                Q: Th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh th\u01b0\u1eddng th\u00f4ng qua m\u1ea5y giai \u0111o\u1ea1n?<\/span><\/p>\n

                A: C\u00e2u tr\u1ea3 l\u1eddi l\u00e0 3 giai \u0111o\u1ea1n:<\/span><\/p>\n

                \u0110\u1ea7u ti\u00ean, xin gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m.<\/span><\/p>\n

                Th\u1ee9 hai, \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i Vi\u1ec7t Nam.<\/span><\/p>\n

                Th\u1ee9 ba, th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c h\u1ea3i quan nh\u1eadp kh\u1ea9u gi\u1ed1ng s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c \u0111\u00e3 trang b\u1ecb s\u1ed1 l\u01b0u h\u00e0nh.<\/span><\/p>\n

                 <\/span><\/p>\n

                T\u1ed5ng\nh\u1ee3p m\u1ecdi th\u00f4ng tin gi\u1ea3i \u0111\u00e1p v\u1ea5n \u0111\u1ec1 th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c\nch\u00fang t\u1ed5ng <\/span>h\u1ee3p l\u1ea1i h<\/span>y\nv\u1ecdng s\u1ebd gi\u00fap \u00edch \u0111\u01b0\u1ee3c cho Qu\u00fd <\/span>v\u1ecb<\/span> <\/span>trong\nqu\u00e1 tr\u00ecnh nh\u1eadp kh\u1ea9u d\u01b0\u1ee3c ph\u1ea9m.<\/span><\/p>

                \n\n<\/p>

                N\u1ebfu\nb\u1ea1n c\u00f2n \u0111i\u1ec1u g\u00ec th\u1eafc m\u1eafc v\u1eabn ch\u01b0a hi\u1ec3u, li\u00ean h\u1ec7 Hotline \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n h\u1ed7\ntr\u1ee3 nh\u00e9!<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

                Tr\u00ean th\u1ef1c t\u1ebf, d\u01b0\u1ee3c ph\u1ea9m l\u00e0 lo\u1ea1i m\u1eb7t h\u00e0ng \u0111\u01b0\u1ee3c<\/p>\n

                Read More<\/a><\/div>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[101],"tags":[],"class_list":["post-3849","post","type-post","status-publish","format-standard","hentry","category-thu-tuc-hai-quan-cu-the-tung-mat-hang"],"_links":{"self":[{"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/posts\/3849","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/comments?post=3849"}],"version-history":[{"count":7,"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/posts\/3849\/revisions"}],"predecessor-version":[{"id":4646,"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/posts\/3849\/revisions\/4646"}],"wp:attachment":[{"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/media?parent=3849"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/categories?post=3849"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anlitalog.com\/vi\/wp-json\/wp\/v2\/tags?post=3849"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}