經濟部國際貿易局 貨品輸入規定變更明細表
貨品號列 貨 名
2937.12.00.00-0 808 835*
2937.21.20.00-5 808 835*
2937.90.00.20-1 808 835*
2937.90.00.90-6 808 835*
2942.00.10.00-5 818 804
3001.90.90.00-5
3002.10.00.19-9
報表代號： FHBE010R01 列印日期： 105/07/27
程式代號： FHBE010 列印時間： 09:13:40
異動編號： R10556
原 列 輸入規定
改 列 輸入規定 胰島素及其鹽類
Insulin and its salts 氫化可體松 Hydrocortisone 胺基酸衍生物
Amino-acid derivatives
其他天然或以合成方法再製之荷爾蒙；及其主要用作荷爾蒙之衍 生物及結構式類似物
Other hormones, natural or reproduced by synthesis; derivatives and structural analogues thereof
供合成原料藥、動物用藥及輔助飼料藥之化學產品
Chemicals, used for manufacturing of pharmaceutical, veterinary medicines
其他未列名之已調製人類或動物物質，供醫療或預防疾病之用者 Other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included
808 B01
835*
B01 其他血清
Other sera
808 B01
835*
B01
3003.90.99.90-5
3004.90.91.00-1 818 804
3004.90.99.10-1 818 804
3004.90.99.90-4
輸入規定代號說明
准許（免除簽發許可證）。
Import permitted (free from licensing)
其他醫藥製劑（不包括第３００２、３００５或３００６節所列 者），包含兩種或以上之成分業經混合供治療或預防疾病之用，
不具有劑量或零售包裝式樣者
Other medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale
818 MP1
804 MP1
抗排斥醫藥製劑
Immunosuppressive preparations 抗過敏抗組織胺用藥
Drugs for antihypersensitivity and antihistamine
其他醫藥製劑〈不包括第３００２、３００５或３００６節所列 者〉包含經混合或未混合產品供治療或預防疾病用，具有劑量（
包括經皮給藥形態者）或零售包裝式樣者
Other medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale
818 MP1
804 MP1
號列項數: 12 (空白)
406 進口動物用藥品（包括原料藥、製劑及生物藥品）：（一）應檢 附(1)動物用藥品販賣業許可證影本及行政院農業委員會核發之輸 入動物用藥品許可證影本（非輸入動物用藥品許可證之持有者，
應加附原證持有者之授權文件或於該許可證影本上加蓋授權使用 之章戳原本），或(2)含該成分製劑之製造動物用藥品許可證影本 及行政院農業委員會動植物防疫檢疫局核發之「動物用藥品自用 原料藥輸入審核通知書」。（二）如屬樣品、贈品，應檢附行政 院農業委員會動植物防疫檢疫局核發之「動物用藥品樣品、贈品 輸入審核通知書」。
For importation of veterinary medicines (including raw material
pharmaceutical products, pharmaceutical products and biological products):
(1) a) A photocopy of veterinary medicine import license issued by the Council of Agriculture, Executive Yuan (Non-licensed importers shall submit an application together with an authorization documentation issued by the owner of such a license or a photocopy of the medicine license with a stamp indicating that authorization to use the license has been granted) and a photocopy of a veterinary drug dealers license are required, or b) a
"Notice For Importing Raw (Bulk) Material Limited to The Veterinary Drug Manufacturer Self Use" issued by the Bureau of Animal and Plant Health Inspection and Quarantine, Council of Agriculture, Executive Yuan, and a photocopy of a license for manufacturing veterinary drug containing the pharmaceutical products are required. (2) If the imported goods are samples or gifts, a "Notice for Importing Veterinary Medicines Samples"
issued by the Bureau of Animal and Plant Health Inspection and Quarantine, Council of Agriculture, Executive Yuan is required.
503
504
進口人用藥品（包括製劑、原料藥、助診藥類及人用生物製劑）
：應檢附（一）藥商許可執照影本及衛生福利部核發之（輸入）
藥品許可證影本，或（二）衛生福利部核發之同意文件。
Importation of drugs (including pharmaceutical products, active
pharmaceutical ingredients, diagnostics and biological products) for human use requires either of the following: (1) a photocopy of the drug (import) license issued by the Ministry of Health and Welfare together with a photocopy of the license of the pharmaceutical firm; or (2) an approval issued by the Ministry of Health and Welfare.
一、進口人用醫療器材應依下列規定辦理：（一）應檢附衛生福 利部核發之醫療器材許可證影本或同意文件，並應申報填列醫療 器材許可證號碼（十四碼）。（二）如屬危險性醫療儀器，除應 檢附衛生福利部核發之醫療器材許可證影本，及申報填列醫療器 材許可證號碼（十四碼）外，並須檢附衛生福利部核准醫療機構 購置之同意文件。二、非供人用者免依上述規定辦理。
1. Importation of medical devices for human use must be handled according to the following regulations: (1) A photocopy of the medical devices pre- marketing license or an approval document issued by the Ministry of Health and Welfare should be submitted. In addition, the number of the pre-
marketing license (consisting of 14 letters and digits) must be declared and listed in the import declaration . (2) If the medical devices being imported are dangerous, then besides the photocopy of the medical device pre- marketing license and the license number declared and listed in the import declaration, an approval of the medical institutions/facilities procurement from the Ministry of Health and Welfare is also required. 2. Importation of
506
508
進口人用藥品（包括製劑、原料藥、助診藥類及人用生物製劑）
：應檢附（一）藥商許可執照影本及衛生福利部核發之（輸入）
藥品許可證影本，或（二）衛生福利部核發之同意文件。（三）
進口人用之藥品（包括製劑、原料藥、助診藥類及生物製劑），
如屬專供研究及實驗使用者，應憑衛生福利部核發之同意文件（
帶有１４碼之簽審文件號碼）通關放行。
Importation of drugs (including pharmaceutical products, active
pharmaceutical ingredients, diagnostics and biological products) for human use requires either of the following: (1) a photocopy of the drug (import) license issued by the Ministry of Health and Welfare together with a photocopy of the license of the pharmaceutical firm; or (2) an approval issued by the Ministry of Health and Welfare.(3)Importation of drugs (including pharmaceutical products, active pharmaceutical ingredients, diagnostics and biological products) for research or experimental study use, an approval ( having the special 14 codes on the import application ) issued by the Ministry of Health and Welfare is required for customs clearance.
一、進口食品添加物應依下列規定辦理：（一）輸入衛生福利部 發布「食品添加物使用範圍及限量暨規格標準」收載之單方食品 添加物（香料除外），應檢附衛生福利部核發之食品添加物許可 證影本，並依Ｆ０１規定辦理。（二）如屬香料或複方食品添加 物，應依Ｆ０１規定辦理。二、進口非食品添加物之食品原料，
應依Ｆ０１規定辦理。三、如屬食品添加物之樣品、贈品，應檢 附衛生福利部核發之「貨品進口同意書申請書（食品、添加物樣 品）」。四、進口非供食品或食品添加物用途者，於進口報單填
804
1. For importation of food additives must be handled according to the following regulations: (1) If the petitioned food additive (excluding flavorings) is a single chemical enlist in the current "Standards for Specification, Scope, Application and Limitation of Food Additives", a photocopy of the food additives license issued by the Ministry of Health and Welfare is required, and shall be governed by the regulation of "F01". (2) For importation of flavorings or food additive mixtures, shall be governed by the regulation of "F01".2. For importation of foods but not food additives, shall be governed by the regulation of "F01". 3. If the imported food additives and it is samples or gifts, a" application import certificate"
issued by the Ministry of Health and Welfare is required. 4. Importation of commodity not to be used as foods or food additives, should list the special code DH999999999508 on the import application and is exempted from the above regulations.
（一）進口人用藥品，應依５０３規定辦理（二）進口人用醫療 器材，應依５０４規定辦理。（三）進口動物用藥品，應依４０ ６規定辦理。（四）進口非屬上述項目者，應註明「本貨品非屬 人用藥品、人用醫療器材、動物用藥品」字樣，免依上述規定辦 理。
(1) Importation of medicines for human use is governed by the regulation of"503".(2) Importation of medical devices for human use is governed by the regulation of"504" (3)Importation of veterinary medicines is governed by the regulation of "406".(4)Importation of commodity not belong the aforesaid items shall be exempted from the aforesaid regulations, but a clear
808
818
（一）進口人用藥品，應依５０６規定辦理（二）進口動物用藥 品，應依４０６規定辦理。（三）進口食品及食品添加物，應依 ５０８規定辦理。（四）進口非屬上述項目者，應註明「本貨品 非屬人用藥品、動物用藥品、食品及食品添加物」字樣，免依上 述規定辦理。
(1) Importation of medicines for human use is governed by the regulation of"506".(2) Importation of veterinary medicines is governed by the regulation of "406".(3) importation of food and food additives is governed by the regulation of "508".(4)Importation of commodity not belong the aforesaid items shall be exempted from the aforesaid regulations, but a clear indication that the commodity is "not to be used as human use, veterinary medicines, food and food additives" is required.
（一）進口人用藥品，應依５０３規定辦理。（二）進口動物用 藥品，應依４０６規定辦理。（三）進口食品添加物，應依５０ ８規定辦理。（四）進口醫療器材，應依５０４規定辦理。（五
）進口非屬上述項目者，應註明「本貨品非屬人用藥品、動物用 藥品、食品添加物、醫療器材」字樣，免依上述規定辦理。
(1) Importation of medicines for human use is governed by the regulation of"503".(2)Importation of veterinary medicinesis governed by the regulation of "406". (3) Importation of food additives is governed by the regulation of
"508".(4) Importation of medical equipmentis governed by the regulation of
"504".(5)Importation of commodity not belong the aforesaid items shall be exempted from the aforesaid regulations, but a clear indication that the commodity is "not to be used as human use, veterinary medicines, food additivesand medical equipment" is required.
835*
B01
MP1
（一）進口人用藥品，應依５０６規定辦理（二）進口動物用藥 品，應依４０６規定辦理。（三）進口非屬上述項目者，應註明
「本貨品非屬人用藥品、動物用藥品」字樣，免依上述規定辦理
。
(1) Importation of medicines for human use is governed by the regulation of"506".(2) Importation of veterinary medicines is governed by the regulation of "406".(3)Importation of commodity not belong the aforesaid items shall be exempted from the aforesaid regulations, but a clear
indication that the commodity is "not to be used as human use, veterinary medicines" is required.
進口時，應依行政院農業委員會動植物防疫檢疫局編訂之「應施 檢疫動植物品目表」及有關檢疫規定辦理。
Importation shall be subject to the prescription set forth in the Table of Commodities Subject to Legal Animal & Plant Quarantine compiled by the Bureau of Animal and Plant Health Inspection and Quarantine Council of Agriculture, Executive Yuan.
（一）大陸物品有條件准許輸入，應符合「大陸物品有條件准許 輸入項目、輸入管理法規彙總表」之規定。（二）「大陸物品有 條件准許輸入項目、輸入管理法規彙總表」內列有特別規定「Ｍ ＸＸ」代號者，應向國際貿易局辦理輸入許可證；未列有特別規 定「ＭＸＸ」代號者，依一般簽證規定辦理。
MW0 大陸物品不准輸入。
Importation of Mainland China products is prohibited.
F01
(1) Importation of Mainland China products in this category is conditionally permitted. The importation should conform to the regulations of
"Consolidated List of Conditional Import Items of Mainland China Origin and Regulations Governing Import of Mainland China Origin
Commodities".(2) Importation of items on the "Consolidated List of Conditional Import Items of Mainland China Origin and Regulations Governing Import of Mainland China Origin Commodities" with "MXX"
code requires Import Permit issued by the BOFT; Importation of items without "MXX" code shall be subject to the general code of import permit issuance.
輸入商品應依照「食品及相關產品輸入查驗辦法」規定，向衛生 福利部食品藥物管理署申請辦理輸入查驗。【註：相關規定應洽 衛生福利部食品藥物管理署】。
Importation of foods shall follow the"Regulations for Inspection of imported Foods and Related Products".The importer shall apply for inspection to the Food and Drug Administration,Ministry of Health and Welfare(FDA).(Note:Please contact FDA for relevant inspection requirements of food imports.)
