Article 12
To manufacture or import veterinary drugs, one shall apply to the central competent authority for product registration and shall not proceed to manufacture or import the drugs until the application has been duly approved and a license obtained from the authority.
The application shall specify the ingredients, efficacy, summary of preparation, analytic method and relevant information, and shall be supported by certificates, labels, packing inserts and samples.
Payment of the license fees and inspection fees shall also be attached.
The product registration, review procedure of the veterinary drug and amendment, extension, replacement, renewal or revocation of the license set forth in the preceding paragraph as well as any other requirement shall be enacted by the central competent authority.
The manufacture or import of veterinary drug license, their criteria to issue or the extension of its validity year based on Good Manufacture Practice (GMP) by which shall be prescribed by the central competent authority.
The review criteria and procedure of veterinary drugs which are manufactured for the sole purpose of export may be simplified, and such veterinary drugs shall not be sold in Taiwan or used for any other purpose.
According to the characteristics of the drug, the central competent authority shall undertake safety and efficacy studies on a new drug by itself, or a commissioned institution (agency), or institutions (agencies) approved by the central authority before such drug is approved for registration, and the registration fee shall be borne by the applicant. The regulations governing the studies shall be enacted by the central competent authority.
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Article 14
A veterinary drug license for manufacture or importation purposes shall be valid for five years. Where continuing manufacture or importation is contemplated upon expiration of the validity, an prior application for extension of the validity shall be filed with the central competent authority for approval; provided each such extension period shall not exceed five years. In the event that an application for extension fails to be filed within the deadline or the application is not approved which results in the invalidity of the license, the central competent authority has the right to directly cancel the license and publicize such cancellation in the Government Gazette.
The central competent authority may, for the protection of animal and human health or other major reasons, re-evaluate the veterinary drug and restrict its method and scope of use, and, in addition thereto, revoke the aforementioned license within its valid period as the case may be.
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Article 26
The competent authorities may assign officers to the offices of a veterinary drug manufacturer, dealer, veterinary hospital or clinic or other users of veterinary drugs to conduct random inspections of their drugs and to take samples at the original prices thereof to inspect their quality.
The competent authorities may assign officers to animal, aquatic farms or feed manufacturers to audit the usage of veterinary drugs, and may conduct random physical examinations on animals.
In no event shall a veterinary drug manufacturer, dealer, veterinary hospital or clinic, animal and aquatic farmer, feed manufacturer or other user of veterinary drugs evade, hinder or refuse the above inspection, sampling, audit, and examination.
If the competent authority discovers after inspection or examination that a user uses a veterinary drug which is inconsistent with this Act, the competent authority may order it to provide the information in relation to the source of such drug. No veterinary drug manufacturer, dealer, veterinary hospital or clinic, animal and aquatic farmer, feed manufacturer or any other user of veterinary drugs may evade, hinder or refuse such order, or provide untruthful data.
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Article 33
Whoever is guilty of manufacturing or importing counterfeit or forbidden veterinary drugs shall be imprisoned for no less than one year and no more than seven years; in addition, a fine of not more than NTD4.5 million may also be imposed.
Whoever commits the crime set forth in the preceding paragraph causing death of another shall be imprisoned for life for no less than seven years; in the case of grievous bodily harm, the offender shall be imprisoned for no less than three years and no more than ten years.
Whoever commits the crime set forth in Paragraph 1 by negligence shall be sentenced to no more than three-year imprisonment, detention or a fine of no more than NTD500,000.
Whoever is guilty of making an attempt to commit the crime in Paragraph 1 shall also be punishable.
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Article 35
Whoever is guilty of repacking, selling, transporting, consigning for storage, brokering, assigning displaying or storing with intent to offer for sale counterfeit or forbidden veterinary drugs shall be imprisoned for no less than six months and no more than five years; in addition, a fine of not more than NTD5 million may also be imposed.
Whoever commits the crime set forth in the preceding paragraph causing death of another shall be imprisoned for no less than seven years; in the case of grievous bodily harm, the offender shall be imprisoned for no less than one year and no more than seven years.
Whoever commits the crime set forth in Paragraph 1 by negligence shall be sentenced to no more than a two-year imprisonment, detention or a fine of no more than NTD300,000.
Whoever is guilty of making an attempt to commit the crime in Paragraph 1 shall also be punishable.
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Article 36
Whoever is guilty of manufacturing or importing any inferior veterinary drugs shall be fined no less than NTD60,000 and no more than NTD300,000.
Whoever is guilty of repacking, selling, transporting, consigning for storage, brokering, assigning displaying or storing with intent to offer for sale inferior veterinary drugs shall be fined no less than NTD30,000 and no more than NTD150,000.
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Article 40
A fine ranging from NTD90,000 to NTD450,000 shall be imposed if a person:
1. Violates the fourth paragraph of Article 3-1;
2. Violates the third paragraph of Article 7;
3. Violates the fourth paragraph of Article 12;
4. Violates Article 13 by changing the original registered material facts without the prior approval of the competent authority;
5. Violates the third paragraph of Article 16 by failing to meet the factory establishment criteria on the buildings, environment, equipments, facilities, and measures in factory, operation sites, inspection and storage sites, or health management of workers;
6. Violates Article 16-1 by entrusting or being entrusted to produce veterinary drugs without permission;
7. Violates Article 17 by failing to employ a veterinarian or a pharmacist;
8. Violates the first paragraph of Article 19 by operating business without a license; or the second paragraph of Article 19 on application of changing the original registered material facts of license, the hanging location of license, making or displaying of sales clerk identification cards, application of operation suspension, resumption or close, qualification and training of veterinary drugs management technicians, environment and equipment of operation sites, storage, transport, operation and recording sale information of drugs, duties of notifying information of drugs to buyers, reporting adverse response cases or offering of drug sale information to the competent authorities;
9. Violates Articles 14-2, 20, 21, 24, the third paragraph of Article 25 or the third paragraph of Article 26;
10. Violates the first or third paragraph of Article 23 on labeling of samples or complimentary items of veterinary drugs, setting, recording and keeping the records of related information;
11. Violates Article 32 by failing to meet the criteria on the drugs application of target animals or aquatic species, purpose, usage, amount, withdrawal period and notice matters, user qualification, preparation, setting, recording and keeping the records of related information;
12. Violate Article 32-1, 32-2, or Article 32-3.
In the event that an animal or aquatic farmer violates Paragraph 4 of Article 3-1, Paragraph 3 of Article 26, Article 32 or Paragraph 2 or 3 of Article 32-3, he or she shall be sentenced to a fine of no less than NTD30,000 and no more than NTD150,000. In the case of violation against Paragraph 1 of Article 32-3, the offender shall be sentenced to a fine of no less than NTD60,000 and no more than NTD300,000.
If the offender re-violates Paragraph 1 of Article 32-3 within one year, the offender shall be sentenced to a fine of no less than NTD500,000 and no more than NTD2,500,000.
Whoever commits the violation set forth in the two preceding paragraphs causing harm to human health shall be imprisoned for no more than seven years or, in addition thereto, a fine of no more than NTD10,000,000.
The competent authority shall publicize the name and address of the enterprise, the name of the responsible person and the facts surrounding the violation in the case of the preceding three paragraphs.
Whoever/whichever evades, hinders or refuses, or is unwilling to provide the information in relation to the source of a veterinary drug which is in violation of Paragraph 4 of Article 26 of this Act shall be sentenced to a fine of no less than NTD30,000 and no more than NTD150,000.
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Article 43
The equipment used for the manufacture and processing of veterinary drugs, which are discovered in accordance with this Act to be counterfeit or forbidden veterinary drugs, shall be confiscated regardless of whether it is owned by the wrongdoer. The counterfeit and forbidden drugs discovered shall also be destroyed.
Any and all veterinary drugs which are discovered in accordance with this Act to be inferior but are neither reprocessed nor returned within a prescribed time limit pursuant to Article 29 shall be confiscated and destroyed.
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