Article 6-1
Distributors and manufacturers of drugs catagorized and announced by the central competent health authority, shall establish their own tracibility system for tracing the source and tracking the flow of the drugs according to their industry modes.
The central competent health authority shall establish the tracibility report system in the preceding Paragraph; the business in the preceding Paragraph shall use electronic methods to declare the information of the traceability system. The electronic declaration method shall be prescribed by the central competent health authority.
The regulations governing the establishment, matters to be recorded, examination and other matters to be complied with for the traceability system mentioned in the preceding Paragraph shall be prescirbed by the central competent health authority.

Article 27-2
Pharmaceutical firms holding licenses which were announced as essential drugs by the central competent health authority, shall report to the central competent health authority 6 months ahead of time in the case of incability to continue to manufacture, import, or insufficient supply of the drug; if unable to report within the preceding period due to natural disaster or other incidents not attributable to the pharmaceutical firms, shall report to the central competent health authority within 30 days since the occurrence of the incident.
When the central competent health authority receives such report as mentioned in the preceding Paragraph or is notified of the insufficiency supply of the essential drug, the authority may post on a public website, and may grant special permission to manufacture or import the drug, not subject to Article 39.
The application eligibility, reviewing procedure, approvement criteria, and other required regulations of the report in the first Paragrah and the registration procedure and approvement as a special case in the preceding Paragraph, shall be established by the central competent health authority.

Article 48-2
If any of the following circumstances applies, the central competent health authority may approve to manufacture and import the specific drug as a special case and is not subjected to Article 39 and Article 40:
1. For the purpose of prevention, diagnosed as life-threatening, severely disablility diseases, and there is no domestic appropriate drug or alternative treatment.
2. In responding to the necessity of emergency public health circumstances.
If any of the following circumstances applies, the central competent health authority may annul the approvement in the preceding Paragraph, shall order the applicants to handle the unused drug in a limit of time, and may make an announcement for recall.
1. When a drug is completed with registration and market approval, or there is a appropriate treatment to support the necessity of  circumstance prescribed in Subparagraph 1 of the preceding Paragraph.
2. The emergency public health circumstance has been terminated.
3. Drug reviewed by the central competent health authority but has been designated with a doubt of safety or medical efficacy.
The application eligibility, reviewing procedure, approvement criteria, and other requirement regulations of the approvement as a special case in the first paragrah shall be established by the central competent health authority.

Article 2
For purposes of this Act, the term "competent authority" shall mean the Ministry of Health and Welfare at the central government level, the municipal governments at the municipal level, and the county/city governments at the county/city level.

Article 39
For the manufacturing and import of drugs, information concerning the ingredients, source of active pharmaceutical ingredients, specifications, functions, summary of manufacturing process, and the specification and method of testing, as well as other related information and certificates, accompanied by labels and use instructions in the original and Chinese languages, and samples, together with the fee paid, shall be filed with the central competent health authority for registration and market approval. No manufacturing or importation of such drugs shall be allowed until a drug permit license is approved and issued.
Provisions of the preceding Paragraph shall not apply to application to the central competent health authority for importation of raw materials for the manufacturing. Said application criteria and application fee shall be determined by the central competent health authority.
Only the owners of a drug permit license or their authorized persons may apply for import of drugs pursuant to the provisions of the first Paragraph. Application for change or transfer of registration of drug permit license obtained as per for registration and market approval the first Paragraph shall be conducted in accordance with the provisions under Article 46; the issuance of extension of registration, replacement, or new permit license shall be conducted in accordance with the provisions under Article 47. The application criteria, review procedure, approval criteria, and other matters to be complied with shall be established in the Criteria Governing the Review for Registration and Market Approval of Drugs by the central competent health authority.

Article 75
The labels, use instructions and packages of medicaments shall indicate the following particulars as approved:
1. Name and address of the manufacturer;
2. Name of the medicament and permit license number;
3. Lot number;
4. Date of manufacture and period of validity or shelf-life;
5. Major ingredients, dosage and method of administration;
6. Major medical efficacy, functions, and indications;
7. Reactions, counter-indications and other warnings; and
8. Other particulars as required by relevant regulations.
The particulars in Subparagraph 4 or the preceding Paragraph may be omitted, if such omission has been publicly announced by the central competent health authority.
For the medicaments announced by the central competent health authority, the labels, use instructions, and packages shall provide supplementary measures such as Braille characters or other sufficient information for reading along with the regulations prescribed in Paragraph 1; The indicated items, indicate methods and other requirements shall be established by the central competent health authority.

Article 82
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.

Article 83
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.

Article 84
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.

Article 85
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.

Article 86
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.

Article 87
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.

Article 88
Any devices and materials which are used in manufacturing and/or dispensing misbranded drugs or prohibited drugs and are seized in accordance with this Act shall be confiscated, regardless of the ownership thereof.
Any criminally obtained assets or property interests in the possession of those who have intentionally violated this Act shall be confiscated regardless of whether it belongs to the offender or not, with the exception of those which should be returned to the victims; If the above assets or property interests cannot be confiscated in whole or in part, the equivalent value thereof shall be indemnified either by demanding a payment from the offender or be offset by the property of the offender. However, this does not include assets or property interests obtained by the bona fide third party at the equivalent payment.
To ensure the confiscation of the assets or property interests and a levy on payments or property compensation mentioned in the preceding Paragraph, an appropriate amount of properties may be detained where necessary.
The assets or property interests of a natural person, a legal entity or unincorporated body except the offender confiscated pursuant to Paragraph 2 shall be ruled by the court under the request of the prosecutor. Before deciding on the ruling, the court shall notify the parties to appear to state their opinions.
The applicant and the person being ruled may file an interlocutory appeal against the ruling in the preceding Paragraph.
The regulations governing the valuation of criminally obtained assets, property interests, a levy on payments or property compensation which confiscated under the request of the prosecutor pursuant to this Article shall be established by the Executive Yuan.

Article 92
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 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 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, import, 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; 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 6, 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 NT45 million.

Article 93
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.

Article 96-1
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.