{"id":5005,"date":"2022-11-28T08:17:33","date_gmt":"2022-11-28T01:17:33","guid":{"rendered":"http:\/\/medlaw.vn\/?p=5005"},"modified":"2022-11-28T08:33:44","modified_gmt":"2022-11-28T01:33:44","slug":"co-bat-buoc-dang-ky-luu-hanh-thuoc-nguyen-lieu-lam-thuoc-khong","status":"publish","type":"post","link":"https:\/\/medlaw.vn\/en\/co-bat-buoc-dang-ky-luu-hanh-thuoc-nguyen-lieu-lam-thuoc-khong\/","title":{"rendered":"IS IT REQUIRED TO REGISTER FOR THE MARKET OF DRUGS, MEDICINE MATERIALS?"},"content":{"rendered":"<p><b>[HEALTH LAW ARTICLE]<\/b><\/p>\n<p><span style=\"font-weight: 400;\">In medical care, examination and treatment activities, drugs and medicinal ingredients are very important pharmaceuticals, helping patients to be treated effectively, and at the same time preventing abnormal problems and replenishing their health. health. On the other hand, medicine is also a \"double-edged sword\" causing exhaustion of people's health, in which the circulation of drugs and medicinal ingredients on the market of unknown origin, name and main use is one of the causes of this effect. Therefore, the current law has strict regulations on the circulation of drugs and medicinal ingredients to ensure the health of each of us. So is the law required to \"register for circulation of drugs and medicinal ingredients\"? Let's find out with MEDLAW to better understand this issue through the article below!<\/span><\/p>\n<p><b>1. What are drugs and medicinal ingredients?<\/b><\/p>\n<p><span style=\"font-weight: 400;\">According to Clause 2, Article 2 of the 2016 Pharmacy Law, drug means a preparation containing active ingredients or medicinal herbs intended for human use, for the purposes of disease prevention, diagnosis, treatment, disease treatment, disease alleviation, and biological function adjustment. management of the human body, including chemical and pharmaceutical drugs, herbal medicines, traditional drugs, vaccines and biological products. Medicinal ingredients are ingredients that participate in the composition of a drug, including active ingredients, herbal ingredients, excipients, and capsule shells used in the drug manufacturing process as prescribed in Clause 3, Article 2 of the Law on Pharmacy 2016.\u00a0<\/span><\/p>\n<p><b>2. Are medicinal drugs required to be registered for circulation?<\/b><\/p>\n<p><span style=\"font-weight: 400;\">According to Clause 1, Article 54 of the Law on Pharmacy 2016, <\/span><span style=\"font-weight: 400;\">drugs must be registered before being circulated in Vietnam, except for the following cases:<\/span><span style=\"font-weight: 400;\">:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2013\u00a0 Medicines prepared according to prescriptions at pharmacies or manufactured and prepared at medical examination and treatment establishments.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u2013\u00a0 Drugs without a certificate of registration of drug circulation in Vietnam are permitted to be imported and can only be imported not in excess of the quantity stated in the import permit in the case specified in Clause 2, Article 60 of the Law on Pharmacy 2016.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">- Traditional medicine<\/span><\/p>\n<p><span style=\"font-weight: 400;\">+ Have traditional medicine medical examination and treatment establishments processed, prepared, weighed and loaded according to prescriptions and prescriptions for use and retailed according to prescriptions at such establishments; or<\/span><\/p>\n<p><span style=\"font-weight: 400;\">+ Because the hospital has the function of medical examination and treatment with traditional medicine at the provincial <\/span><b>level or higher<\/b><span style=\"font-weight: 400;\"> processing and preparing products are sold to medical treatment establishments that carry out other traditional medical care activities in the same province or centrally run city to treat patients at that facility.<\/span><\/p>\n<p><b>3. Are medicinal ingredients required to be registered for circulation?<\/b><\/p>\n<p><span style=\"font-weight: 400;\">According to Clause 3, Article 54 of the Law on Pharmacy 2016<\/span><span style=\"font-weight: 400;\">, <\/span><span style=\"font-weight: 400;\">Medicinal ingredients must be registered before being sold in Vietnam, except for the following cases:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Medicinal ingredients are active ingredients for drug production according to drug registration dossiers <\/span><b>already has a certificate of circulation in Vietnam<\/b><span style=\"font-weight: 400;\">;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Imported medicinal ingredients are pharmaceutical ingredients that do not have a certificate of drug circulation in Vietnam but are licensed for import, provided that they are only allowed to import not more than the quantity stated in the import permit in the following cases: after:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">To make registration forms, samples for testing, drug research, to participate in exhibitions and fairs;<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">To produce drugs for export, drugs serving national defense and security requirements, disease prevention and control, and overcoming consequences of natural disasters.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Thus, the current legal regulations have strict and clear regulations on drugs and medicinal ingredients that must be registered before being circulated on the Vietnamese market. This contributes to the initiative in the management of drugs and medicinal ingredients.\u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>[B\u00c0I VI\u1ebeT PH\u00c1P LU\u1eacT Y T\u1ebe] Trong ho\u1ea1t \u0111\u1ed9ng ch\u0103m s\u00f3c, kh\u00e1m ch\u1eefa b\u1ec7nh, thu\u1ed1c v\u00e0 nguy\u00ean li\u1ec7u l\u00e0m thu\u1ed1c l\u00e0 d\u01b0\u1ee3c ph\u1ea9m c\u00f3 \u00fd ngh\u0129a v\u00f4 c\u00f9ng quan tr\u1ecdng, gi\u00fap ng\u01b0\u1eddi b\u1ec7nh \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb m\u1ed9t c\u00e1ch hi\u1ec7u qu\u1ea3 c\u0169ng \u0111\u1ed3ng th\u1eddi ng\u0103n ch\u1eb7n c\u00e1c v\u1ea5n \u0111\u1ec1 b\u1ea5t th\u01b0\u1eddng v\u00e0 b\u1ed3i b\u1ed5 s\u1ee9c kh\u1ecfe&#8230;.<\/p>","protected":false},"author":1,"featured_media":5006,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[12],"tags":[],"_links":{"self":[{"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/posts\/5005"}],"collection":[{"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/comments?post=5005"}],"version-history":[{"count":2,"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/posts\/5005\/revisions"}],"predecessor-version":[{"id":5008,"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/posts\/5005\/revisions\/5008"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/media\/5006"}],"wp:attachment":[{"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/media?parent=5005"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/categories?post=5005"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medlaw.vn\/en\/wp-json\/wp\/v2\/tags?post=5005"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}