{"id":2210,"date":"2026-03-11T22:04:49","date_gmt":"2026-03-11T15:04:49","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&#038;p=2210"},"modified":"2026-06-13T14:44:11","modified_gmt":"2026-06-13T07:44:11","slug":"giai-phap-dang-ky-luu-hanh-thuoc-duoc-pham-tai-viet-nam-hop-phap-ben-vung","status":"publish","type":"dich_vu","link":"https:\/\/mednovum.com.vn\/vi\/dich-vu\/giai-phap-dang-ky-luu-hanh-thuoc-duoc-pham-tai-viet-nam-hop-phap-ben-vung\/","title":{"rendered":"Gi\u1ea3i ph\u00e1p \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh thu\u1ed1c, d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i Vi\u1ec7t Nam"},"content":{"rendered":"<p style=\"text-align: center;\"><span style=\"font-size: 18pt; color: #3366ff;\"><strong>GI\u1ea2I PH\u00c1P \u0110\u0102NG K\u00dd L\u01afU H\u00c0NH THU\u1ed0C, D\u01af\u1ee2C PH\u1ea8M<\/strong> <strong>T\u1ea0I VI\u1ec6T NAM \u2013 H\u1ee2P PH\u00c1P &amp; B\u1ec0N V\u1eeeNG<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\">Vi\u1ec7t Nam \u0111ang tr\u1edf th\u00e0nh th\u1ecb tr\u01b0\u1eddng tr\u1ecdng \u0111i\u1ec3m c\u1ee7a ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m t\u1ea1i ch\u00e2u \u00c1 nh\u1edd quy m\u00f4 d\u00e2n s\u1ed1 h\u01a1n 100 tri\u1ec7u d\u00e2n, nhu c\u1ea7u ch\u0103m s\u00f3c s\u1ee9c kh\u1ecfe ng\u00e0y c\u00e0ng gia t\u0103ng v\u00e0 d\u01b0 \u0111\u1ecba t\u0103ng tr\u01b0\u1edfng \u1ed5n \u0111\u1ecbnh trong nh\u1eefng n\u0103m t\u1edbi. \u0110\u1eb7c bi\u1ec7t l\u00e0 th\u1ecb ph\u1ea7n \u0111\u00e1ng k\u1ec3 cho c\u00e1c s\u1ea3n ph\u1ea9m nh\u1eadp kh\u1ea9u.<\/p>\n<p style=\"text-align: justify;\">Tuy nhi\u00ean, \u0111\u1ec3 s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ph\u00e9p l\u01b0u h\u00e0nh h\u1ee3p ph\u00e1p t\u1ea1i Vi\u1ec7t Nam, doanh nghi\u1ec7p b\u1eaft bu\u1ed9c ph\u1ea3i \u0111\u01b0\u1ee3c c\u1ea5p Gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd D\u01b0\u1ee3c \u2013 B\u1ed9 Y t\u1ebf. \u0110\u00e2y kh\u00f4ng ch\u1ec9 l\u00e0 y\u00eau c\u1ea7u ph\u00e1p l\u00fd c\u1ed1t l\u00f5i v\u00e0 b\u1eaft bu\u1ed9c m\u00e0 c\u00f2n l\u00e0 n\u1ec1n t\u1ea3ng \u0111\u1ea3m b\u1ea3o \u0111\u1ec3 doanh nghi\u1ec7p th\u1ef1c hi\u1ec7n nh\u1eadp kh\u1ea9u, ph\u00e2n ph\u1ed1i t\u1ea1i b\u1ec7nh vi\u1ec7n, nh\u00e0 thu\u1ed1c, tham gia \u0111\u1ea5u th\u1ea7u v\u00e0 tri\u1ec3n khai c\u00e1c ho\u1ea1t \u0111\u1ed9ng kinh doanh \u1ed5n \u0111\u1ecbnh v\u00e0 l\u00e2u d\u00e0i. Qu\u00e1 tr\u00ecnh \u0111\u0103ng k\u00fd \u0111\u00f2i h\u1ecfi b\u1ed9 h\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt \u0111\u1ea7y \u0111\u1ee7 \u0111\u1ec3 c\u01a1 quan qu\u1ea3n l\u00fd th\u1ea9m \u0111\u1ecbnh to\u00e0n di\u1ec7n v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng, an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a s\u1ea3n ph\u1ea9m; do \u0111\u00f3, vi\u1ec7c ch\u1eadm tr\u1ec5 ho\u1eb7c kh\u00f4ng tu\u00e2n th\u1ee7 \u0111\u00fang quy \u0111\u1ecbnh c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn t\u1eeb ch\u1ed1i c\u1ea5p ph\u00e9p, thu h\u1ed3i s\u1ea3n ph\u1ea9m, x\u1eed ph\u1ea1t h\u00e0nh ch\u00ednh ho\u1eb7c gi\u00e1n \u0111o\u1ea1n k\u1ebf ho\u1ea1ch kinh doanh.<\/p>\n<p style=\"text-align: justify;\"><strong>Nh\u1eefng th\u00e1ch th\u1ee9c m\u00e0 doanh nghi\u1ec7p th\u01b0\u1eddng g\u1eb7p ph\u1ea3i?<\/strong><\/p>\n<p style=\"text-align: justify;\"><b><i>Th\u1ee9 nh\u1ea5t, th\u1eddi gian \u0111\u0103ng k\u00fd thu\u1ed1c<\/i><\/b> t\u1ea1i Vi\u1ec7t Nam th\u01b0\u1eddng k\u00e9o d\u00e0i kh\u00e1 l\u00e2u t\u00ednh t\u1eeb l\u00fac b\u1eaft \u0111\u1ea7u n\u1ed9p h\u1ed3 s\u01a1 \u0111\u1ebfn l\u00fac c\u00f3 \u0111\u01b0\u1ee3c s\u1ed1 \u0111\u0103ng k\u00fd thu\u1ed1c. Th\u1eddi gian \u0111\u0103ng k\u00fd trung b\u00ecnh: Thu\u1ed1c Generic: 18\u201324 th\u00e1ng; Thu\u1ed1c m\u1edbi\/bi\u1ec7t d\u01b0\u1ee3c: 24-36 th\u00e1ng; Sinh ph\u1ea9m\/Vaccine: 24-48 th\u00e1ng. Th\u1ef1c t\u1ebf c\u00f3 th\u1ec3 k\u00e9o d\u00e0i l\u00e2u h\u01a1n t\u00f9y thu\u1ed9c v\u00e0o t\u00ednh ch\u1ea5t h\u1ed3 s\u01a1 s\u1ea3n ph\u1ea9m v\u00e0 qu\u00e1 tr\u00ecnh s\u1eeda \u0111\u1ed5i b\u1ed5 sung t\u00e0i li\u1ec7u c\u1ee7a c\u01a1 s\u1edf \u0111\u0103ng k\u00fd theo y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd trong th\u1eddi gian x\u00e9t duy\u1ec7t h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd.<\/p>\n<p style=\"text-align: justify;\"><strong><em>Th\u1ee9 hai, <\/em><\/strong>v\u1edbi c\u00e1c doanh nghi\u1ec7p n\u01b0\u1edbc ngo\u00e0i b\u1eaft bu\u1ed9c ph\u1ea3i c\u00f3 <strong>V\u0103n ph\u00f2ng \u0111\u1ea1i di\u1ec7n<\/strong> v\u00e0 ph\u1ea3i c\u00f3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n kinh doanh thu\u1ed1c t\u1ea1i Vi\u1ec7t Nam th\u00ec m\u1edbi c\u00f3 th\u1ec3 tr\u1ef1c ti\u1ebfp \u0111\u1ee9ng t\u00ean \u0111\u0103ng k\u00fd thu\u1ed1c. Ho\u1eb7c c\u00f3 th\u1ec3 \u1ee7y quy\u1ec1n cho C\u01a1 s\u1edf kinh doanh thu\u1ed1c (Distributor) t\u1ea1i Vi\u1ec7t Nam \u0111\u1ee9ng t\u00ean \u0111\u0103ng k\u00fd thu\u1ed1c. C\u1ea3 hai h\u00ecnh th\u1ee9c \u0111\u1ec1u c\u00f3 nh\u1eefng h\u1ea1n ch\u1ebf nh\u1ea5t \u0111\u1ecbnh. V\u1edbi c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t nh\u1ecf, nh\u00e0 s\u1ea3n xu\u1ea5t m\u1edbi gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam th\u00ec vi\u1ec7c duy tr\u00ec V\u0103n Ph\u00f2ng \u0111\u1ea1i di\u1ec7n t\u1ea1i Vi\u1ec7t Nam s\u1ebd t\u1ed1n m\u1ed9t kho\u1ea3n chi ph\u00ed kh\u00f4ng h\u1ec1 nh\u1ecf. Trong khi l\u1ef1a ch\u1ecdn c\u00e1ch \u1ee7y quy\u1ec1n cho Distributor s\u1ebd b\u1ecb ph\u1ee5 thu\u1ed9c ho\u00e0n to\u00e0n v\u00e0o Distributor, khi mu\u1ed1n thay \u0111\u1ed5i Distributor s\u1ebd ph\u1ea3i th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c \u0111\u0103ng k\u00fd l\u1ea1i.<\/p>\n<p style=\"text-align: justify;\"><b><i>Th\u1ee9 ba, h\u1ed3 s\u01a1 kh\u00f4ng \u0111\u1ea1t chu\u1ea9n k\u1ef9 thu\u1eadt. <\/i><\/b>H\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd d\u01b0\u1ee3c ph\u1ea9m \u0111\u00f2i h\u1ecfi m\u1ee9c \u0111\u1ed9 chi ti\u1ebft v\u00e0 t\u00ednh ph\u00e1p l\u00fd cao; vi\u1ec7c kh\u00f4ng chu\u1ea9n h\u00f3a t\u00e0i li\u1ec7u \u0111\u00fang \u0111\u1ecbnh d\u1ea1ng, ng\u00f4n ng\u1eef, y\u00eau c\u1ea7u h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 ho\u1eb7c quy \u0111\u1ecbnh c\u1eadp nh\u1eadt c\u00f3 th\u1ec3 khi\u1ebfn h\u1ed3 s\u01a1 b\u1ecb y\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i, b\u1ed5 sung nhi\u1ec1u l\u1ea7n.<\/p>\n<p style=\"text-align: justify;\"><b><i>Th\u1ee9 t\u01b0, thi\u1ebfu kinh nghi\u1ec7m x\u1eed l\u00fd y\u00eau c\u1ea7u b\u1ed5 sung trong qu\u00e1 tr\u00ecnh th\u1ea9m \u0111\u1ecbnh.\u00a0<\/i><\/b>Trong qu\u00e1 tr\u00ecnh th\u1ea9m \u0111\u1ecbnh, n\u1ebfu doanh nghi\u1ec7p kh\u00f4ng ph\u1ea3n h\u1ed3i \u0111\u00fang tr\u1ecdng t\u00e2m ho\u1eb7c kh\u00f4ng k\u1ecbp th\u1eddi b\u1ed5 sung t\u00e0i li\u1ec7u theo y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd, h\u1ed3 s\u01a1 c\u00f3 th\u1ec3 b\u1ecb k\u00e9o d\u00e0i th\u1eddi gian x\u1eed l\u00fd ho\u1eb7c b\u1ecb t\u1eeb ch\u1ed1i c\u1ea5p ph\u00e9p.<\/p>\n<p style=\"text-align: justify;\"><strong><em>Cu\u1ed1i c\u00f9ng<\/em><\/strong><strong>, <\/strong>sau khi c\u00f3 s\u1ed1 \u0111\u0103ng k\u00fd thu\u1ed1c vi\u1ec7c kinh doanh nh\u1eadp kh\u1ea9u, mua b\u00e1n c\u1ee7a c\u01a1 s\u1edf \u0111\u0103ng k\u00fd thu\u1ed1c c\u00f2n ch\u1ecbu nhi\u1ec1u quy \u0111\u1ecbnh qu\u1ea3n l\u00fd v\u00e0 tr\u00e1ch nhi\u1ec7m ph\u00e1p l\u00fd li\u00ean quan: Ph\u1ea3i k\u00ea khai gi\u00e1 thu\u1ed1c, ph\u1ea3i c\u00f3 h\u1ec7 th\u1ed1ng c\u1ea3nh gi\u00e1c D\u01b0\u1ee3c (pharmacovigilance). B\u00ean c\u1ea1nh \u0111\u00f3 s\u1ed1 \u0111\u0103ng k\u00fd thu\u1ed1c c\u00f3 th\u1eddi h\u1ea1n 5 n\u0103m, n\u00ean vi\u1ec7c duy tr\u00ec v\u00e0 gia h\u1ea1n s\u1ed1 \u0111\u0103ng k\u00fd c\u0169ng c\u1ea7n ti\u1ebfn h\u00e0nh th\u01b0\u1eddng xuy\u00ean v\u00e0 k\u1ecbp th\u1eddi.<\/p>\n<p style=\"text-align: justify;\"><strong>MedNovum \u2013 <\/strong><strong>\u0110\u1ed1i t\u00e1c ph\u00e1p l\u00fd chi\u1ebfn l\u01b0\u1ee3c trong \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam<\/strong><\/p>\n<p style=\"text-align: justify;\">T\u1ef1 h\u00e0o l\u00e0 \u0111\u01a1n v\u1ecb ti\u00ean phong cung c\u1ea5p d\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh t\u1ea1i th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam, MedNovum c\u00f3 kinh nghi\u1ec7m h\u1ee3p t\u00e1c c\u00f9ng nhi\u1ec1u \u0111\u1ed1i t\u00e1c v\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t qu\u1ed1c t\u1ebf, \u0111\u1ed3ng th\u1eddi am hi\u1ec3u s\u00e2u r\u1ed9ng h\u1ec7 th\u1ed1ng ph\u00e1p lu\u1eadt v\u00e0 quy \u0111\u1ecbnh qu\u1ea3n l\u00fd c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n<p style=\"text-align: justify;\">\u0110\u1ed9i ng\u0169 chuy\u00ean m\u00f4n c\u1ee7a ch\u00fang t\u00f4i g\u1ed3m d\u01b0\u1ee3c s\u0129, lu\u1eadt s\u01b0, k\u1ef9 s\u01b0 v\u00e0 chuy\u00ean vi\u00ean t\u01b0 v\u1ea5n, ph\u1ed1i h\u1ee3p \u0111a l\u0129nh v\u1ef1c gi\u00fap ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 kh\u00e1ch h\u00e0ng chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1 m\u1ed9t c\u00e1ch b\u00e0i b\u1ea3n, gi\u1ea3m thi\u1ec3u r\u1ee7i ro ph\u00e1p l\u00fd, t\u1ed1i \u01b0u th\u1eddi gian x\u1eed l\u00fd h\u1ed3 s\u01a1 v\u00e0 x\u00e2y d\u1ef1ng n\u1ec1n t\u1ea3ng tu\u00e2n th\u1ee7 v\u1eefng ch\u1eafc khi ti\u1ebfp c\u1eadn v\u00e0 ph\u00e1t tri\u1ec3n ho\u1ea1t \u0111\u1ed9ng kinh doanh t\u1ea1i th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam.<\/p>\n<p style=\"text-align: justify;\"><strong>D\u1ecbch v\u1ee5 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh d\u01b0\u1ee3c ph\u1ea9m m\u00e0 MedNovum cung c\u1ea5p<\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li>T\u01b0 v\u1ea5n ph\u00e2n lo\u1ea1i s\u1ea3n ph\u1ea9m v\u00e0 x\u00e1c \u0111\u1ecbnh h\u00ecnh th\u1ee9c \u0111\u0103ng k\u00fd ph\u00f9 h\u1ee3p<\/li>\n<li>Chu\u1ea9n b\u1ecb, r\u00e0 so\u00e1t v\u00e0 ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh<\/li>\n<li>H\u1ed7 tr\u1ee3 doanh nghi\u1ec7p n\u1ed9p h\u1ed3 s\u01a1 v\u00e0 l\u00e0m vi\u1ec7c v\u1edbi c\u01a1 quan qu\u1ea3n l\u00fd<\/li>\n<li>Theo d\u00f5i qu\u00e1 tr\u00ecnh th\u1ea9m \u0111\u1ecbnh, x\u1eed l\u00fd y\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i, b\u1ed5 sung<\/li>\n<li>Th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c gia h\u1ea1n, thay \u0111\u1ed5i, b\u1ed5 sung n\u1ed9i dung Gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh sau c\u1ea5p ph\u00e9p<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Vui l\u00f2ng cung c\u1ea5p th\u00f4ng tin s\u1ea3n ph\u1ea9m \u0111\u1ec3 \u0111\u1ed9i ng\u0169 MedNovum th\u1ef1c hi\u1ec7n \u0111\u00e1nh gi\u00e1 ti\u1ec1n kh\u1ea3 thi v\u00e0 \u0111\u1ec1 xu\u1ea5t l\u1ed9 tr\u00ecnh \u0111\u0103ng k\u00fd ph\u00f9 h\u1ee3p theo quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt Vi\u1ec7t Nam.<\/p>\n<p style=\"text-align: justify;\">Ch\u00fang t\u00f4i cam k\u1ebft ph\u1ea3n h\u1ed3i k\u1ecbp th\u1eddi v\u1edbi ph\u00e2n t\u00edch r\u00f5 r\u00e0ng, minh b\u1ea1ch v\u00e0 \u0111\u1ecbnh h\u01b0\u1edbng th\u1ef1c ti\u1ec5n cho k\u1ebf ho\u1ea1ch gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng c\u1ee7a Kh\u00e1ch h\u00e0ng.<\/p>\n<p style=\"text-align: justify;\"><strong>\u00a0<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>GI\u1ea2I PH\u00c1P \u0110\u0102NG K\u00dd L\u01afU H\u00c0NH THU\u1ed0C, D\u01af\u1ee2C PH\u1ea8M T\u1ea0I VI\u1ec6T NAM \u2013 H\u1ee2P PH\u00c1P &amp; B\u1ec0N V\u1eeeNG Vi\u1ec7t Nam \u0111ang tr\u1edf th\u00e0nh th\u1ecb tr\u01b0\u1eddng tr\u1ecdng \u0111i\u1ec3m c\u1ee7a ng\u00e0nh d\u01b0\u1ee3c<\/p>\n","protected":false},"featured_media":2211,"template":"","danh_muc_dich_vu":[16],"class_list":["post-2210","dich_vu","type-dich_vu","status-publish","has-post-thumbnail","hentry","danh_muc_dich_vu-thi-truong-viet-nam"],"acf":[],"_links":{"self":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/dich_vu\/2210","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/dich_vu"}],"about":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/types\/dich_vu"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/media\/2211"}],"wp:attachment":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/media?parent=2210"}],"wp:term":[{"taxonomy":"danh_muc_dich_vu","embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/danh_muc_dich_vu?post=2210"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}