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Enforcement Rules of Veterinary Drugs Control Act
1.中華民國六十四年十一月二十一日經濟部（64）經農字第 27972 號令
訂定發布全文 56 條
2.中華民國六十八年九月三日經濟部（68）經農字第 2852 號公告修正發
布
3.中華民國六十九年八月二十一日經濟部（69）經農字第 28530 號令修
正發布第 55 條之附表二
4.中華民國七十年五月九日經濟部（70）經農字第 18050 號令修正發布
第 55 條之附表二、三、四
5.中華民國七十二年七月三十日經濟部（72）經農字第 31153 號令修正
發布第 55 條條文及附表
6.中華民國七十五年五月十五日行政院農業委員會（75）農牧字第 11749
號令修正發布第 55 條及附表
7.中華民國七十八年九月四日行政院農業委員會（78）農牧字第 8050379
A 令修正發布第 10 條條文及附件八、九之格式
8.中華民國七十九年八月十日行政院農業委員會（79）農牧字第 9050368
A 號令修正發布第 55 條及附表
9.中華民國八十一年一月二十七日行政院農業委員會（81）農牧字第 005
0603A 號令修正發布第 55 條及其附表
10. 中華民國八十二年九月十五日行政院農業委員會（82）農牧字第 214
5940A 號令修正發布第 23 條條文及第 26 條附件十三之格式
11. 中華民國八十三年四月二十二日行政院農業委員會令修正發布第 55
條條文
12. 中華民國八十四年八月三十一日行政院農業委員會（84）農牧字第 4
138558A 號令修正發布第 55 條及附表
13. 中華民國八十五年四月二十五日行政院農業委員會（85）農牧字第 5
117771A 號令修正發布第 55 條及附表
14. 中華民國八十七年三月十一日行政院農業委員會（87）農牧字第 871
08744 號令修正發布第 55 條附表
15. 中華民國八十八年八月十一日行政院農業委員會（88）農防字第 885
04677 號令修正發布第 55 條附表
16. 中華民國八十八年十月二十日行政院農業委員會（88）農防字第 885
07511 號令修正發布第 55 條附表
17. 中華民國九十年五月三十一日行政院農業委員會（90）農防字第 901
407041 號令修正發布全文 57 條；並自發布日施行
18. 中華民國九十四年五月四日行政院農業委員會農授防字第 094147228
4 號令修正發布全文 24 條；並自發布日施行
19. 中華民國九十七年九月十七日行政院農業委員會農防字第 097147301
7 號令修正發布第 3、6、14、21、22 條條文；並刪除第 5、12、13
、15～17 條條文
20. 中華民國九十九年一月二十九日行政院農業委員會農防字第 0991472
192 號令修正發布第 6 條條文
21. 中華民國一百零一年六月二十八日行政院農業委員會農防字第 10114
74047 號令修正發布第 7 條條文
22. 中華民國一百零六年一月三日行政院農業委員會農防字第 105147319
5 號令修正發布全文 12 條；並自發布日施行
中華民國一百十二年七月二十七日行政院院臺規字第 1125014346 號
公告第 4 條、第 5 條序文、第 6 條序文、第 7 條所列屬「行
政院農業委員會」之權責事項，自一百十二年八月一日起改由「農業
部」管轄資料來源：全國法規資料庫（ChOrder.json，版本 2026/7/24 上午 12:00:00）・政府資料開放授權
The Enforcement Rules are stipulated in accordance with Article 47 of the Veterinary Drugs Control Act (hereafter referred to as the Act).
1The term “ testing ” in Article 4 and 6 of the Act refers to measures to:
22.1 inspect whether the veterinary drug is approved, is conformed to the original approval, and is secured with the seal of approval or not,
32.2 examine the veterinary drug ’ s characteristics, ingredients, quality, quantity, potency and relevant properties.
The terms “ without government approval ” in Section 4.1 and “ without a permit ” in Section 5.1.2 of the Act refer to the situation that a veterinary drug is not approved in accordance with Section 12.1 of the Act.
The central competent authority may invite experts and scholars to review documents and records of inspection and testing of a veterinary drug in accordance with of the Act.
1The competent authority may delegate its subordinate authorities, or commission administrative authorities with no relationship of administrative subordination, juristic persons or private entities to exercise a part of its powers for the following matters:
25.1 Testing and registration in Article 12 of the Act.
35.2 Changing the entries on registration in Article 13 of the Act
45.3 Renewal of veterinary drug license in Section 14.1 of the Act.
55.4 Sampling and inspection in Article 18 of the Act
65.5 Inspection of veterinary drug manufacturer in Article 25 of the Act.
75.6 Inspection of an entity (a veterinary drug manufacturer or dealer, veterinary care facility, farm of livestock, poultry or aquaculture, feed manufacturer or veterinary drug user, and sampling and testing of its veterinary drug in Article 26 of the Act.
85.7 Sampling and testing of suspicious counterfeit, banned or substandard veterinary drugs in Article 28 of the Act.
1To apply for repacking imported veterinary drugs into smaller sizes in accordance with Section 21.1 of the Act, the veterinary drug dealer shall submit two copies of application and the following documents to the central competent authority:
26.1 A copy of veterinary drug license.
36.2 A copy of customs import declaration.
46.3 A copy of certificate of analysis of the veterinary drug from the original manufacturer.
56.4 A copy of the agreement of the original manufacturer to repack.
66.5 A copy of the agreement of the re-packer and its veterinary drug manufacturer license.
76.6 One sample of each repack container (or container photography), label and package insert.
To apply for an export license in accordance with Article 24 of the Act, the veterinary drug manufacturer shall file the application with the central competent authority for every batch. One must not begin to export the drug until the license is obtained.
The original price, in Section 26.1 of the Act, means the wholesale price.
The veterinary drug manufacturer, who is allowed to modify the substandard veterinary drug before a set deadline in accordance with Article 29 of the Act, shall notify the municipal or country (city) competent authority to send personnel to supervise the process 7 days prior to the modification.
1The recalled veterinary drugs and the inventory, whose veterinary drug licenses are annulled in accordance with Article 30 of the Act, shall be handled according to the following regulations:
210.1 The inventory of qualified veterinary drugs must not be sold until the municipal or county (city) competent authority check thoroughly the amount and affixes the “ veterinary drug checkup stamp ” to the label or the obvious place of the packaging of every bottle.
310.2 The recalled veterinary drugs and the inventory of counterfeit, banned or substandard veterinary drugs shall be sealed their final products, bulks, raw materials, labels and package inserts by the municipal or county (city) competent authority, and dealt with them in accordance with the Act.
The veterinary drug, whose license is revoked, shall be handled in accordance with Section 10.1 of the Enforcement Rules.
The Enforcement Rules take effect on the date of promulgation.