Any person who manufactures or imports counterfeit drugs or prohibited drugs shall be subject to punishment with imprisonment for a period of not more than ten (10) years and may in addition thereto, be imposed with a fine of not more than NT$100,000,000. The offender set forth in the preceding Paragraph shall be punished with life imprisonment or imprisonment of not less than ten (10) years and may in addition thereto, be imposed with a fine of not more than NT$200,000,000 in case the said offence results in personal death; or with imprisonment of not less than seven (7) years and may in addition thereto, be imposed with a fine of not more than NT$150,000,000 in case the offence results in serious adverse health consequences.
Any person who commits the offence set forth in the first Paragraph hereof by negligence shall be punished with imprisonment of not more than three (3) years, detention, or a fine of not more than NT$10,000,000.
An attempt of the offence set forth in the first Paragraph hereof shall be punished.

Any person who knowingly sells, supplies, dispenses, transports, stores, brokers, transfers or displays with intent to sell counterfeit drugs or prohibited drugs shall be punished with imprisonment of not more than seven (7) years and may, in addition thereto, be imposed with a fine of not more than NT$50,000,000.
The offender set forth in the preceding Paragraph shall be punished with imprisonment of not less than seven (7) years and may in addition thereto, be imposed with a fine of not more than NT$100,000,000 in case the said offence results in personal death; or with imprisonment of not less than three (3) years but not more than twelve (12) years and may in addition thereto, be imposed with a fine of not more than NT$75,000,000 if the said offence results in serious adverse health consequences.
Any person who commits the offence set forth in the first Paragraph hereof by negligence shall be punished with imprisonment of not more than two (2) years, detention, or a fine of not more than NT$5,000,000.
An attempt of the offence set forth in the first Paragraph hereof shall be punished.

Any person who manufactures or imports medical devices without obtaining prior approval shall be punished with imprisonment of not more than three (3) years and may, in addition thereto, be imposed with a fine of not more than NT$10,000,000.
Any person who knowingly sells, supplies, transports, stores, brokers, transfers or displays with intent to sell the medical implements set forth in the preceding Paragraph shall be subject to the punishment set forth in the preceding Paragraph.
Any person who commits the offence set forth in the preceding Paragraph by negligence shall be punished with imprisonment of not more than six (6) months, detention or a fine of not more than NT$5,000,000.

Any person who manufactures or imports the misbranded drugs set forth in Subparagraph 1 of Article 21 hereof or the defective medical devices set forth in Subparagraph 1 or Subparagraph 2 of Article 23 hereof shall be punished with imprisonment of not more than five (5) years, or detention, and may, in addition thereto, be imposed a fine of not more than NT$50,000,000.
Any person who commits the aforementioned offence by negligence or knowingly sells, supplies, dispenses, transports, stores, brokers, transfers or display with intent to sell the misbranded drugs or defective medical devices set forth in the preceding Paragraph shall be punished with imprisonment of not more than three (3) years or detention and may, in addition thereto, be imposed a fine of not more than NT$10,000,000.
Any person who, by negligence, sells, supplies, dispenses, transports, stores, brokers, transfers or displays with intent to sell the misbranded drugs or the defective medical devices set forth in the first Paragraph hereof shall be punished with detention or a fine of not more than NT$1,000,000.

Any person who makes use, without authorization or as an infringement, of the name, use instructions or labels of the medicaments of others shall be punished with imprisonment of not more than five (5) years, detention, in addition thereto, a fine of not more than NT$20,000,000.
Any person who knowingly imports, sells, supplies, dispenser, transports, stores, brokers, transfers or displays with intent to sell the medicaments set forth in the preceding Paragraph shall be punished with imprisonment of not more than two (2) years, detention or, in addition thereto, a fine of not more than NT$10,000,000.

Where the representative of a legal entity, or an agent, employee or any other operation personnel of a legal entity or a natural person commits, while performing his duty, any of the offence set forth respectively in Articles 82 through 86 hereof, in addition to the offender who shall be punished under the provisions of the respective Articles, the said legal entity or natural person shall also be imposed with not more than 10 times of the fine as set forth in the respective Articles as applicable.

Any devices and materials which are used in manufacturing or dispensing misbranded drugs or prohibited drugs and are seized in accordance with this Act shall be confiscated, regardless of the ownership thereof.
The scope and value of the proceeds of crime in violating of this Act may be based on an estimation if the valuation is deemed difficult. The regulation governing such estimation shall be established by the central competent health authority.

Where a public functionary commits or shelters others to commit, by taking advantage of his/her functional power, opportunity or means, any of the offences as set forth in the Articles of this Chapter, the punishments imposable against him/her under such articles shall be increased by up to one half.

Any person who manufactures or imports the misbranded drugs set forth in Subparagraphs 2 through 8 of Article 21 here of shall be imposed with a fine of not less than NT$100,000 but not more than NT$50,000,000; for those who manufacture or import defective medical devices set forth in Subparagraphs 3 and 4 of Article 23 hereof shall be imposed with a fine of not less than NT$60,000 but not more than NT$50,000,000.
Any person who sells, supplies, dispenses, transports, stores, brokers, transfers or displays with intent to sell the misbranded drugs or defective medical devices set forth in the preceding Paragraph shall be imposed with a fine of not less than NT$30,000 but not more than NT$20,000,000.
In any of the criminal cases set forth in the preceding two Paragraphs, either the administrative personnel or the medicaments, or supervisor of such medicaments, shall also be imposed with the fine set forth in the respective Paragraphs.

Any violator of any of the provisions of Article 65, or Article 80, paragraph 1, subparagraphs 1 through 4 shall be issued a fine of not less than NT$200,000 but not more than NT$5 million.
Any violator of the provisions of Article 69 shall be issued a fine of not less than NT$600,000 but not more than NT$25 million, and the violating products shall be confiscated and destroyed.

Any violator of the provisions of Article 6-1, paragraph 1, Article 27, paragraphs 1 and 3, Article 29, Article 31, Article 36, Article 37, paragraphs 2 and 3, Article 39, paragraph 1, Article 40, paragraph 1, Article 44, Article 45-1, Article 46, Article 49, Article 50, paragraph 1, Articles 51 through 53, Article 53-1 paragraph 1, Article 55 paragraph 1, Article 57 paragraphs 1, 2, and 4, Article 57-1, Article 58, Article 59, Article 60, Article 64, Article 71, paragraph 1, Article 72, Article 74, or Article 75, shall be issued a fine of not less than NT$30,000 but not more than NT$2,000,000.
In the case of any violation of the provisions of Article 59 or dispensing or supplying strongly poisonous drugs in violation of the provisions of Article 60, paragraph 1, the person responsible for managing the quality of the drugs or the production supervisor of the drugs shall also be issued the fines set forth in the preceding paragraph.
Any violator of the provisions of Article 53-1 paragraph 1, Article 57, paragraph 2 or 4 shall be penalized pursuant to paragraph 1 of this Article, and the central competent health authority may publicly announce the name of the medicament factory or pharmaceutical firm and order them to make rectification within a prescribed time period, and during the time period for such rectification, may suspend, in whole or in part, their manufacturing, wholesaling, import, export, and business operations. If rectification is not made within the prescribed time period, the competent health authority may deny approval for extension of the validity of the medicament permit license previously granted, and will not process any other new application for other medicaments from the given factory or firm; in the case of severe violation, the competent health authority may revoke all or part of the medicaments manufacture license.
A violator of any provision of Article 66, paragraph 1 or 2, Article 67, or Article 68 shall be issued a fine of not less than NT$ 200,000 but not more than NT$ 5,000,000.

1. A fine of not less than thirty thousand New Taiwan Dollars (NT$30,000) but no more than five hundred thousand New Taiwan Dollars (NT$500,000) shall be imposed by Central Competent Health Authority if the holder of a new drug permit fails to reply within the period of time prescribed in Paragraph 3, Article 48-7, and after being ordered by the Central Competent Health Authority to reply within a prescribed period of time, still fails to reply within such period.
2. A fine of not less than thirty thousand New Taiwan Dollars (NT$30,000) but no more than two million New Taiwan Dollars (NT$2,000,000) shall be imposed by Central Competent Health Authority the for any failure to issue a notification in accordance with the method and content of notification as stipulated in the regulations promulgated pursuant to Paragraph 1 or 2 of Article 48-19.

Any person who violates any of the provisions of Paragraph 2 of Article 16, Article 28, Article 30, the first Paragraph of Article 32, Article 33, the first Paragraph of Article 37, Article 38, or Article 62 or falls under the following conditions, shall be imposed with a fine of not less than NT$30,000 but not more than NT$5,000,000:
1. Where the manufacturing, labeling, or sale of over-the-counter drugs and preparations of traditional formulas violate the provisions under Paragraph 3 of Article 8 established by the central competent health authority.
2. Where the classification and supervision of medical devices violate the provisions under Paragraph 2 of Article 13 established by the central competent health authority.
3. Where the use or packaging of medicament samples or gifts violate the provisions under Paragraph 2 of Article 55 established by the central competent health authority.
In addition to the imposition of a fine pursuant to the provision of the preceding Paragraph, the competent health authority may also suspend the business operations of the violator if he/she violates the provisions of Paragraph 2 of Article 16 or Article 30.

A violator of any provision of Article 34, paragraph 1, Article 73, paragraph 2, or Article 80, paragraph 1, subparagraphs 5 through 7, or Article 80 paragraph 2, shall be issued a fine of not less than NT$20,000 but not more than NT$100,000.

Any mass media enterprise which violates the provisions of the Paragraph 3 of the Article 66 hereof shall be imposed with a fine of not less than NT$200,000 but not more than NT$5,000,000. If, after having been notified by the competent health authority to cease the law-violating act within a given time limit, it continues to publish or broadcast the advertisement in question, it shall be imposed with a fine of not less than NT$600,000 but not more than NT$25,000,000. The consecutive punishment for each violation may be imposed until the publication or broadcast of the advertisement is suspended.
Any mass media enterprise which violates the provisions of the Paragraph 4 of the Article 66 hereof shall be imposed with a fine of not less than NT$60,000 but not more than NT$300,000, and consecutive punishment for each violation may be imposed.

Any pharmaceutical firm which advertises a medicament in violation of the provisions set forth in Chapter VII hereof shall be punished in accordance with the applicable provisions of this Chapter, and the competent health authority shall announce in the newspaper the name of the person(s) responsible, the name of the medicament, and the act of violation. In the case of serious violation, the permit license previously granted to the said medicament may be also revoked, and no application for use of the original name of the said medicament shall be made within a period of two years thereafter.
The original health competent authority in charge of medicament advertising shall set a time limit and order the pharmaceutical firm making the illegal advertisement, after its permit has been invalidated as described in the preceding Paragraph, to publish or broadcast, via the original mass communication media, an apologetic notice in the same time-frame or same size as that of the illegal advertisement. If the said pharmaceutical firm fails to do so as required, all its previously approved medicament advertisements shall be suspended from publishing or broadcasting, and its further advertising application(s) shall be rejected from the day following the date of expiry of the aforesaid time limit.

Any pharmaceutical firm which violates any one of the provisions under Article 48 shall be subject to a fine of no less than NT$100,000 but no more than NT$2,000,000. In the case that improvement is not made within the time limit notified by the competent health authority, said pharmaceutical firm shall be subject to a fine of double the amount, and shall be fined continuously until improvements are made.
Any pharmaceutical firm which violates any one of the provision under Paragraph 1 of Article 27, the central competent health authority may make a public announcement of the name of the firm, address, name of the responsible person, name of the drug and the violation detail; In the case of a serious violation or continued violation, may be imposed with a fine of not less than NT$60,000 but not more than NT$300,000.

In case a pharmaceutical dealer makes use of false information of evidentiary document(s) in applying for registration and market approval, extension of registration or alteration of registration in connection with a medicament permit license it possess, the said medicament permit license shall be revoked, and in addition thereto, the said pharmaceutical dealer shall be suspended from applying for registration and market approval for the said medicament permit license within a period of two years. Furthermore, if criminal responsibility should be involved, the case shall be referred to the competent judicial authority for investigation.

In the case that the examined medicament does not comply with information stated in applications submitted in accordance with the Criteria Governing Registration and Market Approval of Drugs or the Criteria Governing Registration Market Approval of Medical Devices, the central competent health authority shall not accept nor process new applications for other drugs by said manufacturer for six months, which shall commence from the date the incompliance is verified.
In the case that the result of re-examination upon application within the time limit for response still fails to comply, the central competent health authority shall not accept nor process new applications for other drugs by said manufacturer for one year, which shall commence from the date the incompliance is verified.

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In case a person fined under this Act disagrees with the imposition of such fine, he/she may, within fifteen days from the date such imposition is served, file a written objection requesting for reconsideration. However, no more than one objection shall be filed.
The authority imposing the fine shall, within fifteen days after receipt of the written objection filed under the preceding Paragraph, review the case in issue and shall alter or invalidate the original imposition in issue, if there is ground for objection.
If the person fined disagrees again with the decision of administration review made under the preceding Paragraph, he/she may institute an administrative appeal and further an administrative proceeding in accordance with the applicable laws.

In the case that approval is not given to applications for drug registration and market approval, or change, transfer, or extension of permit licenses submitted in accordance with this Act, the applicant may clearly state reasons and submit an application for re-examination within four months of being served with the punishment notice; provided that only one application for re-examination is allowed. The central competent health authority shall change or revoke the original punishment if the application for re-examination referred to in the preceding Paragraph is justifiable.
If the person applying for re-examination does not agree with decision made under the preceding Paragraph, he/she may institute an administrative appeal and further an administrative proceeding in accordance with the applicable laws.

The fines specified in this Act, unless otherwise stipulated herein, shall be imposed by the municipal or county (city) competent health authority.

(Criminal offences) If the holder of a new drug permit submits the patent information in accordance with Articles 48-3 through 48-6 but provides such information under a fraudulent or incorrect way, and if criminal liability is involved therein, such matter shall be transferred to judicial authority for handling.

Criminal liability, if any, involved in the cases subject to imposition of fines under this Act shall be referred to, and dealt with separately by the judicial authority.