動物用藥品管理法

This law is enacted to improve the quality of animal medicines, protect animal health, and support the development of the livestock industry.

“仿單” means the instruction sheet attached to veterinary drugs.

“合格封緘”是指動物用生物藥品在查驗合格後，由主管機關核貼的封緘。

製造或輸入動物用藥品前，須向中央主管機關申請檢驗登記、繳費並在核准發證後才可以製造或輸入。

動物用藥品許可證必須記載指定事項，包括許可證字號、品名、製造/輸入業者資料、負責人資料、工廠資料、劑型與包裝、有效成分與含量、效能及其他主管機關指定事項。

動物用藥品的標籤和仿單，應依核准分別記載指定事項；經中央主管機關公告、核准免予記載的事項，不在此限。

This provision is deleted.

中央主管機關負責訂定本法所定許可證證書費、檢驗費、查驗費等收費標準。

經核准登記製造或輸入的動物用藥品，變更原登記事項前須先取得中央主管機關核准。

動物用藥品許可證最長五年；期滿要繼續製造或輸入者，須在到期前二至六個月向中央主管機關申請展延，每次展延不得超過五年。

動物用藥品製造業者或輸入業者若以不實資料或證明文件申請相關登記、展延或變更，中央主管機關應不予核准；已核准的，應撤銷許可證。

中央主管機關得命動物用藥品製造業者或販賣業者，對已廢止或撤銷許可證且有影響動物或人體健康之虞的動物用藥品，限期回收或銷毀。

學術研究機構或動物用藥品製造業者經核准試製動物用藥品樣品時，可免申請檢驗登記及許可證，但須貼上專用標籤且不得移作他用；田間試驗也要先經中央主管機關核准。

If a statutory animal infectious disease is spreading or likely to spread, the central competent authority may take emergency measures and order or directly approve the manufacture or import of veterinary biological products.

Veterinary drugs must be manufactured at a veterinary drug manufacturing plant, unless trial manufacture is approved by the central competent authority under Article 14-3(1).

動物用藥品製造業者在委託或接受委託製造動物用藥品前，必須先取得中央主管機關核准。

Animal drug manufacturing plants must hire a veterinarian for biological animal drugs, and a pharmacist for animal antibiotics or ordinary drugs.

Animal biological products may be sold only after batch sampling inspection has been completed, found qualified, and sealed; manufacturers or importers must apply to the local competent authority after manufacture or import customs clearance and duty payment.

If an inspection fails, the local authority must notify the applicant. The applicant may request one reinspection within 14 days after notice is served, after paying the reinspection fee. If no reinspection is requested in time, the authority may supervise destruction or require the original importer to return the goods.

動物用藥品販賣業者必須先向所在地主管機關申請許可證，審查合格並核發後才能登記營業；販賣或陳列的動物用藥品也必須有可證明來源。

Only animal drug manufacturers or sellers may do labeling, promotion, or advertising for animal drugs, and those materials may not claim exaggerated or off-label ingredients or effects.

This article defines which authorities count as the competent authority under this Act.

Animal drugs must attach labels and insert leaflets, unless the central competent authority approves another way to provide them because compliance is difficult.

動物用藥品販賣業者原則上不得分裝動物用藥品；符合特定條件並經中央主管機關核准的輸入大包裝動物用藥品，例外不受此限制。

動物用藥品製造業者或販賣業者僱用的推銷員，雇主要向所在地直轄市或縣（市）主管機關登記；變更時也一樣。推銷員不得推銷非其雇主製造或經銷的動物用藥品，也不得沿街設攤兜售、拆封改裝或作虛偽宣傳。

Approved imported veterinary drug samples or gifts may not be sold, and drugs imported under a permit or controlled-import status may not be imported as samples or gifts.

經核准製造的動物用藥品要輸出國外時，製造業者應在輸出前向中央主管機關申請輸出證明書。

Local and central authorities inspect animal drug manufacturers, and manufacturers may not refuse those inspections without cause.

主管機關可以進入相關場所抽樣、檢查品質，並可到禽畜與水產養殖場及飼料製造廠稽查動物用藥品使用情形；相關業者不得規避、妨礙或拒絕。

動物用藥品檢查人員在執行第25條第1、2項及第26條第1項任務時，應出示身分證明。

主管機關對涉嫌的動物用偽藥、禁藥或劣藥，若需抽樣鑑定，應先封存，並由廠商出具切結保管；抽取的樣品應儘速鑑定及處理，最長不得超過二個月。

查獲的動物用劣藥，若是國內製造且仍可改製使用，主管機關要派員監督製造廠商限期改製；若是核准輸入的，則應立即封存，並由中央主管機關命原進口商限期向國外原廠商請求退貨。

This provision defines “animal drugs” to include certain raw drugs, preparations, and finished medicines used for preventing, treating, or diagnosing animal disease, or for promoting or regulating animal physiological functions.

This provision defines “製劑” as a veterinary medicine made from active ingredients processed into a specific dosage form and dose, classifies preparations into prescription and non-prescription drugs, and gives the central competent authority power to announce dosage-form categories and set rules for prescription veterinary drugs.

This provision defines “new drug” for veterinary medicines as a product that the central competent authority has reviewed and recognized as having a new ingredient, new combination, new efficacy, new route of administration, new dosage form, or new dosage/use regimen.

經稽查或檢驗屬動物用偽藥、禁藥或劣藥者，除了依本法其他規定處理外，主管機關還要公告；原發證機關並可在特定情況下廢止相關許可證。

對於依本法查處的動物用偽藥、禁藥及劣藥，檢舉應予獎勵；獎勵辦法由中央主管機關訂定。

使用動物用藥品時，應遵守中央主管機關訂定的使用準則。

動物用原料藥只能提供或出售給製造含有該原料藥之動物用藥品製造業者；輸入的動物用原料藥，經中央主管機關核准後，例外可先售予動物用藥品販賣業者再轉售，且每批只能轉售一次。

Animal drug manufacturers and importers must report specified six-month data to the local city/county authority twice a year and keep the data for three years. Local city/county authorities must then report that data to the central authority twice a year.

禽畜、水產養殖業者及飼料製造業者不得把列出的禁用藥品或製劑用於動物或飼料；符合特定檢驗情形的動物或產品不得移動、轉讓、供屠宰、加工或食用。

Manufacturing or importing animal fake drugs or prohibited drugs is punishable by imprisonment and a fine, unless a specified Article 5 proviso applies.

This provision is deleted.

禁止分裝、販賣、運送、寄藏、牙保、轉讓，或為販賣而陳列、貯藏動物用偽藥或禁藥；違者可處徒刑，並可併科罰金。

製造或輸入動物用劣藥，或分裝、販賣、運送、寄藏、牙保、轉讓，或為販賣而陳列、貯藏動物用劣藥，都會被處以罰鍰。

Deleted provision.

Deleted provision.

This article sets fines for several violations involving animal drugs, field trials, labeling/advertising, and feed manufacturers’ misuse of certain drugs or preparations, and it requires the authority to publish details in some cases.

This provision defines when an animal drug is treated as a counterfeit drug.

違反本條列舉的動物用藥品相關規定者，原則上處新臺幣9萬元以上45萬元以下罰鍰；若特定違規致危害人體健康，還可能處7年以下有期徒刑，並得併科新臺幣250萬元以上1,000萬元以下罰金。

禽畜或水產養殖業者違反藥品/製劑使用、動物移動轉讓或主管機關處置命令時，會被罰鍰；情節致危害人體健康者，還可能判刑並可併科罰金。

禽畜或水產養殖業者違反列舉規定之一者，可能被處新臺幣3萬元以上15萬元以下罰鍰。

If one of the listed violations occurs, a fine of NT$100,000 to NT$500,000 is imposed.

If certain representatives, agents, employees, or other staff commit offences under Articles 33 to 38 while carrying out business, the individual is punished under those articles and the legal person or natural person is also fined under the same articles.

Animal drugs found under this Act may be confiscated and destroyed if they are not reworked or returned within the period set by Article 29.

不繳納依本法處罰的罰鍰者，會被移送法院強制執行。

This provision is marked as deleted.

本法規定的罰鍰，由直轄市或縣（市）主管機關處罰。

中央主管機關有權訂定本法的施行細則。

This law takes effect on the date it is published.

This provision defines when animal drugs are treated as prohibited animal drugs, including drugs that the central competent authority has announced as banned and drugs imported without approval, with a narrow exception for certain traveler or transport-worker imports for personal pet use.

This article defines what counts as an animal drug that is considered substandard or inferior under the law.

動物用藥品製造業者是指經營動物用藥品製造、加工、批發、輸出及自用原料輸入的業者；其申請輸入自用原料的要件、程序及其他事項，由中央主管機關訂定。

This provision defines “animal drug seller” as a business operator engaged in wholesale, retail, import, or export of animal drugs.

This provision defines “label” as the marking attached to animal drug containers or packaging that records text, pictures, or symbols.