{"id":33660,"date":"2023-10-26T09:03:03","date_gmt":"2023-10-26T02:03:03","guid":{"rendered":"https:\/\/ttud.com.vn\/?p=33660"},"modified":"2023-10-26T09:03:12","modified_gmt":"2023-10-26T02:03:12","slug":"ghi-nhan-dien-tu-va-truy-xuat-nguon-goc-xuat-xu-duoc-pham-tai-viet-nam","status":"publish","type":"post","link":"https:\/\/casta.ttud.com.vn\/index.php\/ghi-nhan-dien-tu-va-truy-xuat-nguon-goc-xuat-xu-duoc-pham-tai-viet-nam\/","title":{"rendered":"Ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c xu\u1ea5t x\u1ee9 d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i Vi\u1ec7t Nam"},"content":{"rendered":"\n

T\u1ea1i H\u1ed9i th\u1ea3o v\u1ec1 Ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 Truy xu\u1ea5t ngu\u1ed3n g\u1ed1c xu\u1ea5t x\u1ee9 d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i Vi\u1ec7t Nam v\u1eeba di\u1ec5n ra, c\u00e1c di\u1ec5n gi\u1ea3 \u0111\u00e3 c\u00f3 nh\u1eefng trao \u0111\u1ed5i v\u1ec1 vi\u1ec7c \u00e1p d\u1ee5ng ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c xu\u1ea5t x\u1ee9 \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m.<\/p>\n\n\n\n

H\u1ed9i th\u1ea3o do Pharma Group thu\u1ed9c Hi\u1ec7p h\u1ed9i Doanh nghi\u1ec7p Ch\u00e2u \u00c2u t\u1ea1i Vi\u1ec7t Nam v\u00e0 Hi\u1ec7p h\u1ed9i Doanh nghi\u1ec7p D\u01b0\u1ee3c Vi\u1ec7t Nam t\u1ed5 ch\u1ee9c, v\u1edbi s\u1ef1 tham gia c\u1ee7a TS. H\u00e0 Minh Hi\u1ec7p, quy\u1ec1n T\u1ed5ng c\u1ee5c tr\u01b0\u1edfng T\u1ed5ng c\u1ee5c TC\u0110LCL (B\u1ed9 KH&CN); c\u00e1c di\u1ec5n gi\u1ea3, chuy\u00ean gia v\u1ec1 ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c \u0111\u1ebfn t\u1eeb H\u1ed9i \u0111\u1ed3ng c\u1ed1 v\u1ea5n IMI Gravitate Health c\u1ee7a Anh Qu\u1ed1c, APAC, Pfizer, c\u01a1 quan qu\u1ea3n l\u00fd D\u01b0\u1ee3c Malaysia (NPRA), C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c – B\u1ed9 Y t\u1ebf.  <\/p>\n\n\n\n

H\u1ed9i th\u1ea3o nh\u1eb1m m\u1ee5c ti\u00eau th\u1ea3o lu\u1eadn chuy\u00ean s\u00e2u v\u1ec1 vi\u1ec7c \u00e1p d\u1ee5ng ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c xu\u1ea5t x\u1ee9 \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m, chia s\u1ebb kinh nghi\u1ec7m tri\u1ec3n khai \u1edf c\u00e1c n\u01b0\u1edbc tr\u00ean th\u1ebf gi\u1edbi, \u0111\u1ed3ng th\u1eddi th\u1ea3o lu\u1eadn l\u1ed9 tr\u00ecnh tri\u1ec3n khai ph\u00f9 h\u1ee3p cho Vi\u1ec7t Nam.<\/p>\n\n\n\n

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Th.s Cao Th\u1ecb B\u00edch H\u00e0 \u2013 Ph\u00f3 C\u1ee5c tr\u01b0\u1edfng Ph\u1ee5 tr\u00e1ch C\u1ee5c Qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m, h\u00e0ng h\u00f3a tr\u00ecnh b\u00e0y \u201cTh\u00f4ng t\u01b0 s\u1ed1 18\/2022\/TT-BKHCN v\u1ec1 ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 111\/2021\/N\u0110-CP\u201d t\u1ea1i H\u1ed9i th\u1ea3o. <\/strong><\/p>\n\n\n\n

T\u1ea1i h\u1ed9i th\u1ea3o, Th.s Cao Th\u1ecb B\u00edch H\u00e0 \u2013 Ph\u00f3 C\u1ee5c tr\u01b0\u1edfng Ph\u1ee5 tr\u00e1ch C\u1ee5c Qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m, h\u00e0ng h\u00f3a (T\u1ed5ng c\u1ee5c TC\u0110LCL) \u0111\u00e3 c\u00f3 ph\u1ea7n tr\u00ecnh b\u00e0y Th\u00f4ng t\u01b0 s\u1ed1 18\/2022\/TT-BKHCN v\u1ec1 ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 111\/2021\/N\u0110-CP; Th.s Nghi\u00eam Thanh H\u1ea3i \u2013 Ph\u00f3 V\u1ee5 tr\u01b0\u1edfng V\u1ee5 \u0110\u00e1nh gi\u00e1 H\u1ee3p chu\u1ea9n H\u1ee3p quy (T\u1ed5ng c\u1ee5c TC\u0110LCL) c\u00f3 b\u00e0i tr\u00ecnh b\u00e0y d\u1ef1 th\u1ea3o Th\u00f4ng t\u01b0 v\u1ec1 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c xu\u1ea5t x\u1ee9.<\/p>\n\n\n\n

Qua c\u00e1c b\u00e0i tr\u00ecnh b\u00e0y, di\u1ec5n gi\u1ea3i \u0111\u00e3 n\u00eau t\u1ed5ng quan v\u1ec1 ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c \u0111\u1ed1i v\u1edbi d\u01b0\u1ee3c ph\u1ea9m, \u0111\u01b0a ra \u0111\u1ecbnh ngh\u0129a, l\u1ed9 tr\u00ecnh, c\u00e1c giai \u0111o\u1ea1n v\u00e0 l\u1ee3i \u00edch ch\u00ednh, y\u00eau c\u1ea7u hi\u1ec7n t\u1ea1i v\u1ec1 ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c tr\u00ean th\u1ebf gi\u1edbi nh\u01b0 Ch\u00e2u \u00c2u, M\u1ef9, APAC: Nh\u1eadt B\u1ea3n, \u00dac, Singapore, \u0110\u00e0i Loan (Trung Qu\u1ed1c), H\u00e0n Qu\u1ed1c, Malaysia, Th\u00e1i Lan, Indonesia\u2026<\/p>\n\n\n\n

C\u1ee5 th\u1ec3, t\u1ea1i Hoa K\u1ef3, h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (HDSD) \u0111\u01b0\u1ee3c cung c\u1ea5p d\u01b0\u1edbi d\u1ea1ng k\u1ebft h\u1ee3p gi\u1eefa HDSD b\u1ea3n gi\u1ea5y v\u00e0 b\u1ea3n \u0111i\u1ec7n t\u1eed. M\u1ecdi b\u1ec7nh nh\u00e2n s\u1ebd nh\u1eadn \u0111\u01b0\u1ee3c th\u00f4ng tin thu\u1ed1c (PMI) d\u01b0\u1edbi d\u1ea1ng b\u1ea3n \u0111i\u1ec7n t\u1eed nh\u01b0ng c\u0169ng s\u1ebd \u0111\u01b0\u1ee3c cung c\u1ea5p b\u1ea3n gi\u1ea5y n\u1ebfu c\u00f3 nhu c\u1ea7u. M\u1ecdi c\u00e1n b\u1ed9 y t\u1ebf s\u1ebd ti\u1ebfp t\u1ee5c nh\u1eadn \u0111\u01b0\u1ee3c t\u1edd HDSD thu\u1ed1c (USPI) d\u01b0\u1edbi d\u1ea1ng b\u1ea3n gi\u1ea5y trong bao b\u00ec s\u1ea3n ph\u1ea9m v\u00e0 d\u01b0\u1edbi d\u1ea1ng HDSD \u0111i\u1ec7n t\u1eed tr\u00ean DailyMed v\u00e0 c\u00e1c n\u1ec1n t\u1ea3ng kh\u00e1c.<\/p>\n\n\n\n

Phi\u00ean b\u1ea3n HDSD d\u00e0nh cho c\u00e1n b\u1ed9 y t\u1ebf lu\u00f4n \u0111\u01b0\u1ee3c cung c\u1ea5p d\u01b0\u1edbi d\u1ea1ng b\u1ea3n in tr\u00ean bao b\u00ec thu\u1ed1c. HDSD b\u1ea3n \u0111i\u1ec7n t\u1eed (e-labelling) \u0111\u01b0\u1ee3c \u0111\u0103ng d\u01b0\u1edbi d\u1ea1ng \u0111i\u1ec7n t\u1eed tr\u00ean c\u00e1c web, v\u00ed d\u1ee5: DailyMed. T\u1edd HDSD thu\u1ed1c c\u1ee7a Hoa K\u1ef3 (USPI) tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n \u0111i\u1ec7n t\u1eed \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 t\u1edd HDSD s\u1ea3n ph\u1ea9m c\u00f3 c\u1ea5u tr\u00fac (SPL) – \u0111\u1ecbnh d\u1ea1ng XML d\u00e0nh ri\u00eang cho Hoa K\u1ef3.<\/p>\n\n\n\n

C\u00e1c \u0111\u1ec1 xu\u1ea5t c\u1ee7a FDA: (1) \u0110\u1ecbnh d\u1ea1ng \u0111i\u1ec7n t\u1eed c\u1ee7a t\u1edd USPI c\u00f3 kh\u1ea3 n\u0103ng s\u1ebd thay \u0111\u1ed5i t\u1eeb SPL sang phi\u00ean b\u1ea3n m\u1edbi nh\u1ea5t c\u1ee7a ti\u00eau chu\u1ea9n HL7 FHIR (v5.0) cho ph\u00e9p kh\u1ea3 n\u0103ng t\u01b0\u01a1ng th\u00edch d\u1eef li\u1ec7u ch\u0103m s\u00f3c s\u1ee9c kh\u1ecfe. (2) Th\u00f4ng tin thu\u1ed1c d\u00e0nh cho b\u1ec7nh nh\u00e2n (PMI) s\u1eed d\u1ee5ng ng\u00f4n ng\u1eef th\u00e2n thi\u1ec7n v\u1edbi b\u1ec7nh nh\u00e2n v\u00e0 tr\u00ecnh b\u00e0y tr\u00ean m\u1ed9t trang \u0111\u01b0\u1ee3c FDA \u0111\u1ec1 xu\u1ea5t thay th\u1ebf cho T\u1edd HDSD thu\u1ed1c (Medication Guide), t\u1edd HDSD thu\u1ed1c d\u00e0nh cho b\u1ec7nh nh\u00e2n (Patient Package Insert) v\u00e0 t\u1edd th\u00f4ng tin thu\u1ed1c d\u00e0nh cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng (Consumer Medicine Information) c\u1ee7a b\u00ean th\u1ee9 ba.<\/p>\n\n\n\n

\u1ede Ch\u00e2u \u00c2u, quy \u0111\u1ecbnh v\u1ec1 t\u1edd HDSD ho\u00e0n to\u00e0n kh\u00e1c v\u1edbi Hoa K\u1ef3. Th\u00f4ng tin s\u1ea3n ph\u1ea9m d\u1ea1ng \u0111i\u1ec7n t\u1eed (ePI) l\u00e0 th\u00f4ng tin s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt d\u00e0nh cho thu\u1ed1c (t\u1ee9c l\u00e0 b\u1ea3n t\u00f3m t\u1eaft \u0111\u1eb7c t\u00ednh s\u1ea3n ph\u1ea9m, t\u1edd HDSD thu\u1ed1c trong bao b\u00ec v\u00e0 nh\u00e3n thu\u1ed1c) \u1edf \u0111\u1ecbnh d\u1ea1ng b\u00e1n c\u1ea5u tr\u00fac \u0111\u01b0\u1ee3c t\u1ea1o l\u1eadp b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng ti\u00eau chu\u1ea9n \u0111i\u1ec7n t\u1eed chung c\u1ee7a EU. ePI \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh \u0111\u1ec3 x\u1eed l\u00fd \u0111i\u1ec7n t\u1eed v\u00e0 cho ph\u00e9p ph\u1ed5 bi\u1ebfn th\u00f4ng qua trang th\u00f4ng tin \u0111i\u1ec7n t\u1eed to\u00e0n c\u1ea7u, c\u00e1c n\u1ec1n t\u1ea3ng \u0111i\u1ec7n t\u1eed v\u00e0 b\u1ea3n in.<\/p>\n\n\n\n

Ti\u00eau chu\u1ea9n \u0111i\u1ec7n t\u1eed chung c\u1ee7a EU d\u00e0nh cho ePI \u0111\u1ec1 c\u1eadp \u0111\u1ebfn \u0111\u1eb7c t\u00ednh k\u1ef9 thu\u1eadt (bao g\u1ed3m ng\u00f4n ng\u1eef \u0111\u00e1nh d\u1ea5u, t\u1eeb v\u1ef1ng \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t v\u00e0 c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt v\u1ec1 kh\u1ea3 n\u0103ng t\u01b0\u01a1ng th\u00edch d\u1eef li\u1ec7u) \u0111\u01b0\u1ee3c c\u01a1 quan qu\u1ea3n l\u00fd v\u00e0 c\u00e1c b\u00ean li\u00ean quan th\u1ed1ng nh\u1ea5t. Ti\u00eau chu\u1ea9n chung s\u1ebd \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 t\u1ea1o ePI.<\/p>\n\n\n\n

M\u1ecdi b\u1ec7nh nh\u00e2n s\u1ebd nh\u1eadn \u0111\u01b0\u1ee3c th\u00f4ng tin thu\u1ed1c (PIL) d\u01b0\u1edbi d\u1ea1ng b\u1ea3n gi\u1ea5y, \u0111\u1ed3ng th\u1eddi c\u00f9ng tu\u00e2n theo ti\u00eau chu\u1ea9n d\u1eef li\u1ec7u ePI nh\u01b0 t\u00f3m t\u1eaft \u0111\u1eb7c t\u00ednh s\u1ea3n ph\u1ea9m (SmPC). M\u1ecdi c\u00e1n b\u1ed9 y t\u1ebf s\u1ebd \u0111\u01b0\u1ee3c cung c\u1ea5p SmPC d\u01b0\u1edbi d\u1ea1ng HDSD \u0111i\u1ec7n t\u1eed, kh\u00f4ng cung c\u1ea5p b\u1ea3n gi\u1ea5y, SmPC s\u1ebd tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n m\u1edbi v\u1ec1 t\u1edd HDSD \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 \u201cePI\u201d.<\/p>\n\n\n\n

T\u1ea1i Nh\u1eadt B\u1ea3n, h\u1ec7 th\u1ed1ng ghi nh\u00e3n \u0111i\u1ec7n t\u1eed \u0111\u00e3 \u0111\u01b0\u1ee3c tri\u1ec3n khai: ch\u1ee7 s\u1edf h\u1eefu gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh (ph\u1ed1i h\u1ee3p v\u1edbi \u0111\u01a1n v\u1ecb b\u00e1n bu\u00f4n) cung c\u1ea5p t\u1edd HDSD b\u1ea3n gi\u1ea5y cho c\u01a1 s\u1edf y t\u1ebf\/nh\u00e0 thu\u1ed1c khi giao s\u1ea3n ph\u1ea9m l\u1ea7n \u0111\u1ea7u. Sau \u0111\u00f3, t\u1ea3i HDSD l\u00ean trang web c\u1ee7a PMDA; ho\u00e0n thi\u1ec7n li\u00ean k\u1ebft gi\u1eefa m\u00e3 GS1 v\u00e0 th\u00f4ng tin HDSD; Ho\u00e0n th\u00e0nh \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn bao b\u00ec; Thi\u1ebft l\u1eadp quy tr\u00ecnh bao g\u1ed3m c\u1eadp nh\u1eadt quy tr\u00ecnh v\u1eadn h\u00e0nh ti\u00eau chu\u1ea9n \u0111\u1ec3 tri\u1ec3n khai ghi nh\u00e3n \u0111i\u1ec7n t\u1eed; H\u01b0\u1edbng d\u1eabn c\u00e1c c\u00e1n b\u1ed9 y t\u1ebf c\u00e1ch s\u1eed d\u1ee5ng HDSD \u0111i\u1ec7n t\u1eed g\u1ed3m c\u1ea3 \u1ee9ng d\u1ee5ng. Qua kh\u1ea3o s\u00e1t t\u1eeb 17\/6 \u0111\u1ebfn 29\/7\/2022 t\u1ea1i Nh\u1eadt B\u1ea3n, ch\u1ec9 c\u00f2n 1,7 % b\u1ec7nh vi\u1ec7n v\u00e0 2,7 % nh\u00e0 thu\u1ed1c ch\u1ec9 s\u1eed d\u1ee5ng t\u1edd HDSD b\u1ea3n gi\u1ea5y, t\u1ec9 l\u1ec7 c\u00f3 s\u1eed d\u1ee5ng truy c\u1eadp th\u00f4ng tin HDSD thu\u1ed1c \u0111i\u1ec7n t\u1eed r\u1ea5t cao.<\/p>\n\n\n\n

Trong t\u01b0\u01a1ng lai t\u1ea1i Nh\u1eadt B\u1ea3n, nghi\u00ean c\u1ee9u th\u00ed \u0111i\u1ec3m v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng th\u00f4ng tin s\u1ea3n ph\u1ea9m (J-PI) \u1edf \u0111\u1ecbnh d\u1ea1ng tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n HL7FHIR-m\u1ed9t ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c li\u00ean minh l\u00ean k\u1ebf ho\u1ea1ch. \u0110\u00e2y l\u00e0 m\u1ed9t trong nh\u1eefng b\u01b0\u1edbc ti\u1ebfn c\u1ee7a H\u1ed9i ngh\u1ecb \u0110\u1ed1i t\u00e1c Ch\u00e2u \u00c1 c\u1ee7a Hi\u1ec7p h\u1ed9i D\u01b0\u1ee3c ph\u1ea9m (APAC).<\/p>\n\n\n\n

\u1ede Malaysia, t\u1edd HDSD cho ng\u01b0\u1eddi d\u00f9ng \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y d\u01b0\u1edbi d\u1ea1ng m\u00e3 QR li\u00ean k\u1ebft v\u1edbi h\u1ec7 th\u1ed1ng NPRA QUATET3+ tr\u00ean \u0111\u00f3 th\u1ec3 hi\u1ec7n th\u00f4ng tin t\u01b0\u01a1ng t\u1ef1 c\u1ee7a s\u1ea3n ph\u1ea9m d\u01b0\u1edbi \u0111\u1ecbnh d\u1ea1ng pdf. Th\u00f4ng tin s\u1ea3n ph\u1ea9m t\u1eeb h\u1ec7 th\u1ed1ng c\u1ee7a NPRA QUATET3+ g\u1ed3m: T\u00ean s\u1ea3n ph\u1ea9m, s\u1ed1 \u0111\u0103ng k\u00fd, ch\u1ee7 s\u1edf h\u1eefu v\u00e0 \u0111\u1ecba ch\u1ec9, nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 \u0111\u1ecba ch\u1ec9, nh\u00e0 nh\u1eadp kh\u1ea9u v\u00e0 \u0111\u1ecba ch\u1ec9, th\u00f4ng tin th\u00e0nh ph\u1ea7n, quy c\u00e1ch \u0111\u00f3ng g\u00f3i, t\u1edd th\u00f4ng tin v\u1ec1 thu\u1ed1c d\u00e0nh cho ng\u01b0\u1eddi d\u00f9ng (RiMUP), nh\u00e3n s\u1ea3n ph\u1ea9m, h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng thu\u1ed1c (PI). Khi m\u00e3 QR \u0111\u01b0\u1ee3c qu\u00e9t b\u1eb1ng \u0111i\u1ec7n tho\u1ea1i th\u00f4ng minh\/m\u00e1y t\u00ednh x\u00e1ch tay\/m\u00e1y t\u00ednh b\u1ea3ng th\u00ec PI v\u00e0 RiMUP m\u1edbi nh\u1ea5t trong NPRA QUATET3+ s\u1ebd hi\u1ec3n th\u1ecb. Ch\u1ee7 s\u1edf h\u1eefu gi\u1ea5y ph\u00e9p \u0111\u0103ng k\u00fd thu\u1ed1c c\u00f3 th\u1ec3 \u0111\u1ec3 m\u00e3 QR tr\u00ean bao b\u00ec b\u00ean ngo\u00e0i ho\u1eb7c nh\u00e3n b\u00ean trong s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n

M\u00e3 QR li\u00ean k\u1ebft \u0111\u1ebfn trang d\u00e0nh ri\u00eang cho s\u1ea3n ph\u1ea9m tr\u00ean trang web c\u1ee7a NPRA. H\u1ec7 th\u1ed1ng n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u01b0 l\u00e0 trang \u0111i\u1ec7n t\u1eed l\u01b0u gi\u1eef d\u1eef li\u1ec7u trong su\u1ed1t giai \u0111o\u1ea1n ti\u1ebfn h\u00e0nh t\u1ef1 nguy\u1ec7n. Ph\u1ea1m vi s\u1ea3n ph\u1ea9m: sinh ph\u1ea9m, thu\u1ed1c m\u1edbi, thu\u1ed1c generic ch\u1ee9a \u0111\u1ed9c ch\u1ea5t theo danh m\u1ee5c. H\u01b0\u1edbng d\u1eabn th\u1ef1c hi\u1ec7n ng\u00e0y 11\/4\/2023, b\u1eaft \u0111\u1ea7u tri\u1ec3n khai t\u1ef1 nguy\u1ec7n t\u1eeb 01\/5\/2023 \u0111\u1ebfn 31\/12\/2026.<\/p>\n\n\n\n

\u0110\u1eb7c bi\u1ec7t, c\u00e1c di\u1ec5n gi\u1ea3 \u0111\u01b0a ra lu\u1eadn \u0111i\u1ec3m v\u1ec1 m\u1ed1i li\u00ean h\u1ec7 gi\u1eefa truy xu\u1ea5t ngu\u1ed3n g\u1ed1c v\u00e0 ghi nh\u00e3n \u0111i\u1ec7n t\u1eed: \u201cM\u1ed9t m\u00e3 v\u1ea1ch cho hai m\u1ee5c \u0111\u00edch\u201d. M\u1ed9t m\u00e3 v\u1ea1ch duy nh\u1ea5t c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u1ea3 m\u1ee5c \u0111\u00edch nh\u1eadn d\u1ea1ng v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c c\u0169ng nh\u01b0 \u0111\u1ec3 truy c\u1eadp n\u1ed9i dung s\u1ed1 (nh\u01b0 nh\u00e3n \u0111i\u1ec7n t\u1eed) b\u1eb1ng c\u00f4ng ngh\u1ec7 li\u00ean k\u1ebft k\u1ef9 thu\u1eadt s\u1ed1. L\u1ee3i \u00edch t\u1eeb ph\u01b0\u01a1ng ph\u00e1p n\u00e0y bao g\u1ed3m \u0111\u01a1n gi\u1ea3n h\u00f3a nh\u00e3n v\u00e0 gi\u1ea3m r\u1ee7i ro nh\u1ea7m l\u1eabn.<\/p>\n\n\n\n

T\u1ea1i h\u1ed9i th\u1ea3o, b\u00e0 Cao Th\u1ecb B\u00edch H\u00e0 \u0111\u00e3 n\u00eau quy \u0111\u1ecbnh c\u1ee7a Vi\u1ec7t Nam hi\u1ec7n nay v\u1ec1 ghi nh\u00e3n \u0111i\u1ec7n t\u1eed, \u00e1p d\u1ee5ng Th\u00f4ng t\u01b0 s\u1ed1 18\/2022\/TT-BKHCN ng\u00e0y 31\/12\/2022 c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Khoa h\u1ecdc v\u00e0 C\u00f4ng ngh\u1ec7. Th\u00f4ng t\u01b0 ra \u0111\u1eddi l\u00e0 b\u01b0\u1edbc ti\u1ebfn l\u1edbn, \u0111i tr\u01b0\u1edbc \u0111\u00f3n \u0111\u1ea7u trong vi\u1ec7c th\u1ef1c hi\u1ec7n ghi nh\u00e3n h\u00e0ng h\u00f3a \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u c\u1ee7a s\u1ef1 ph\u00e1t tri\u1ec3n c\u00f4ng ngh\u1ec7 4.0. Th\u00f4ng t\u01b0 \u0111\u01b0\u1ee3c ban h\u00e0nh \u0111\u00e3 t\u1ea1o thu\u1eadn l\u1ee3i cho doanh nghi\u1ec7p, gi\u1ea3m chi ph\u00ed in \u1ea5n nh\u00e3n h\u00e0ng h\u00f3a b\u1eb1ng gi\u1ea5y v\u00e0 thu\u1eadn l\u1ee3i cho c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd trong c\u00f4ng t\u00e1c qu\u1ea3n l\u00fd nh\u00e0 n\u01b0\u1edbc. Tuy nhi\u00ean, Th\u00f4ng t\u01b0 s\u1ed1 18\/2022\/TT-BKHCN ch\u01b0a \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi nh\u00f3m d\u01b0\u1ee3c ph\u1ea9m do c\u1ea7n ph\u1ea3i c\u00f3 nh\u1eefng nghi\u00ean c\u1ee9u chuy\u00ean s\u00e2u h\u01a1n v\u1ec1 chuy\u00ean ng\u00e0nh d\u01b0\u1ee3c, \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng c\u1ee7a vi\u1ec7c ghi nh\u00e3n \u0111i\u1ec7n t\u1eed \u0111\u1ed1i v\u1edbi d\u01b0\u1ee3c ph\u1ea9m \u0111\u1ec3 \u0111\u01b0a ra quy \u0111\u1ecbnh v\u00e0 l\u1ed9 tr\u00ecnh th\u1ef1c hi\u1ec7n ph\u00f9 h\u1ee3p.<\/p>\n\n\n\n

\u0110\u1ea1i di\u1ec7n C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c – Th.s Nguy\u1ec5n Th\u00e0nh L\u00e2m – Ph\u00f3 C\u1ee5c tr\u01b0\u1edfng c\u0169ng \u0111\u01b0a ra nh\u1eefng d\u1ef1 ki\u1ebfn b\u1ed5 sung quy \u0111\u1ecbnh v\u1ec1 ghi nh\u00e3n h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng thu\u1ed1c b\u1eb1ng ph\u01b0\u01a1ng th\u1ee9c \u0111i\u1ec7n t\u1eed trong th\u1eddi gian t\u1edbi theo h\u01b0\u1edbng s\u1eeda \u0111\u1ed5i Th\u00f4ng t\u01b0 s\u1ed1 01\/2018\/TT-BYT c\u1ee7a B\u1ed9 Y t\u1ebf v\u1ec1 ghi nh\u00e3n thu\u1ed1c, nguy\u00ean li\u1ec7u l\u00e0m thu\u1ed1c tr\u00ean c\u01a1 s\u1edf th\u1ed1ng nh\u1ea5t \u00fd ki\u1ebfn v\u1edbi B\u1ed9 Khoa h\u1ecdc v\u00e0 C\u00f4ng ngh\u1ec7.<\/p>\n\n\n\n

B\u00f9i Th\u1ecb Th\u00f9y D\u01b0\u01a1ng<\/strong><\/p>\n\n\n\n

https:\/\/vietq.vn\/hoi-thao-ve-ghi-nhan-dien-tu-va-truy-xuat-nguon-goc-xuat-xu-duoc-pham-tai-viet-nam-d215373.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

T\u1ea1i H\u1ed9i th\u1ea3o v\u1ec1 Ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 Truy xu\u1ea5t ngu\u1ed3n g\u1ed1c xu\u1ea5t x\u1ee9 d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i Vi\u1ec7t Nam v\u1eeba di\u1ec5n ra, c\u00e1c di\u1ec5n gi\u1ea3 \u0111\u00e3 c\u00f3 nh\u1eefng trao \u0111\u1ed5i v\u1ec1 vi\u1ec7c \u00e1p d\u1ee5ng ghi nh\u00e3n \u0111i\u1ec7n t\u1eed v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c xu\u1ea5t x\u1ee9 \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m d\u01b0\u1ee3c ph\u1ea9m. H\u1ed9i th\u1ea3o do Pharma […]<\/p>\n","protected":false},"author":26,"featured_media":33661,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[47],"tags":[],"class_list":["post-33660","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"_links":{"self":[{"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/posts\/33660","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/users\/26"}],"replies":[{"embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/comments?post=33660"}],"version-history":[{"count":1,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/posts\/33660\/revisions"}],"predecessor-version":[{"id":33662,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/posts\/33660\/revisions\/33662"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/media\/33661"}],"wp:attachment":[{"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/media?parent=33660"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/categories?post=33660"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/tags?post=33660"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}