Pharmaceutical Affairs Act

2018-01-31

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Chapter I General Provisions

Article 1

The administration of pharmaceutical affairs shall be executed in accordance with the regulations of the Pharmaceutical Affairs Act (hereinafter “this Act”). Any matter not provided for in this Act shall be governed by the regulations of other relevant laws. For matters governed by the Controlled Drugs Act, its provisions shall prevail.
The term “pharmaceutical affairs” used in the preceding paragraph shall refer to medicaments, pharmaceutical firms, pharmacies, and other relevant matters.

Article 2

For purposes of this Act, the term “competent health 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 3

The central competent health authority may establish a special organization to be in charge of the administration of medicaments. The municipal and county (city) governments may also establish a similar organization if necessary and with the approval of the higher authorities concerned.

Article 4

The term “medicaments,” as used in this Act, shall refer to drugs and medical devices.

Article 5

The term “investigational medicaments” as used in this Act shall refer to the medicaments whose therapeutic efficacy and safety are not yet verified and which are provided for exclusive use in the pharmacological assessment of toxicity on animals or clinical trials.

Article 6

The term “drugs” as used in this Act shall refer to any of the following active pharmaceutical ingredients and pharmaceutical preparations:
1. Drugs that are listed in the Chinese Pharmacopoeia, the Pharmacopoeia of other countries, the official National Formularies, or any of their supplements recognized by the central competent health authority;
2. Drugs that are not included in the preceding subparagraph but are used in diagnosing, treating, alleviating, or preventing the diseases of human beings;
3. Other drugs which are sufficient to affect the body structure and physiological functions of human beings; or
4. Drugs which are used in preparing such drugs set forth in the preceding three subparagraphs.

Article 6-1

Dealers and manufacturers of drugs categorized and announced by the central competent health authority shall establish their own traceability 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 traceability report system in the preceding paragraph; the business in the preceding paragraph shall use electronic methods to declare the information to the traceability report system. The electronic declaration method shall be prescribed by the central competent health authority.
Regulations governing the establishment of the traceability report system mentioned in the preceding paragraph, items that should be recorded, inspections, and other matters requiring compliance shall be established by the central competent health authority.

Article 7

The term “new drugs” as used in this Act shall refer to drugs that are pharmaceutical preparations that have new molecular entities, new combinations, new indications, and a new route of administration as verified and recognized by the central competent health authority.

Article 8

The term “pharmaceutical preparations,” as used in this Act, shall refer to drugs that are processed and compounded from active pharmaceutical ingredients into a specific pharmaceutical form and dosage.
Pharmaceutical preparations are classified into medicines to be prescribed by physicians; medicines designated by physicians, pharmacists, and/or assistant pharmacists; general sale medicines; and pharmaceutical preparations of inherited formulations.
Regulations governing the clarification and review of general sale medicines and the manufacturing and sale of inherited formulation set forth in the preceding paragraph, and regulations governing the management of the sale of general sale medicines and inherited formulations and other matters requiring compliance shall be formulated by the central competent health authority.

Article 9

The term “general sale medicines” as used in this Act shall refer to drugs that are processed and manufactured from active pharmaceutical ingredients without retaining their original names, with the drugs contained therein being limited to a level not in excess of the limitations of use thereof as specified by the central competent health authority, and characterized by mild action, non-accumulativeness, long storage life, and easy administration, and duly indicated with their efficacy, dosage, and use, and the serial number of permit for general sale medicines indicated, and which can be used for the treatment of illnesses without requiring the instructions of physicians.

Article 10

The term “pharmaceutical preparations of inherited formulation,” as used in this Act, shall refer to medicines that are prepared in accordance with traditional Chinese prescriptions and have medical efficacy, as selected and published by the central competent health authority.

Article 11

The term “controlled drugs,” as used in this Act, shall refer to controlled drugs specified in Article 3 of the Controlled Drugs Act.

Article 12

The term “strongly poisonous drugs,” as used in this Act, shall refer to drugs that are included in the Table of Strongly Poisonous Drugs in the Chinese Pharmacopoeia. Those not included in the Table of Strongly Poisonous Drugs shall be designated by the central competent health authority.

Article 13

The term “medical devices,” as used in this Act, shall refer to any instruments, machines, apparatus, materials, software, reagent for in vitro use, and other similar or related articles that are used in diagnosing, treating, alleviating, or directly preventing human diseases, regulating fertility, or which may affect the body structure or functions of human beings, and do not achieve its primary intended action by pharmacological, immunological or metabolic means in or on the human body.
The central competent health authority shall establish regulations governing the management of medical devices in regard to their scope, classification, management, and other matters in accordance with practical needs.

Article 14

The term “pharmaceutical firms” as used in this Act shall refer to any of the following business undertakings:
1. Dealers of drugs or medical devices.
2. Manufacturers of drugs or medical devices.

Article 15

The term “drug dealers” as used in this Act shall refer to any of the following business undertakings:
1. Business undertakings engaged in wholesaling, retailing, importing and exporting western pharmaceuticals; or
2. Business undertakings engaged in wholesaling, retailing, dispensing, importing, and exporting Chinese medicines.

Article 16

The term “drug manufacturers” as used in this Act shall refer to the business undertakings that are engaged in manufacturing and processing drugs, wholesaling and exporting their own products, and importing raw materials for their own use.
The aforementioned drug manufacturers may only import the raw materials for their own use after each import application has been approved by the central competent health authority. Raw materials for own use which have already been imported shall not be transferred or re-sold unless approved by the central competent health authority.
Drug manufacturers may concurrently engage in the retailing of their own manufactured products.

Article 17

The term “medical device dealers” used in this Act shall refer to the business undertakings that are engaged in wholesaling, retailing, importing, and exporting medical devices.
Provisions governing the medical device dealers set forth in this Act shall also apply to firms engaged in the rentals of medical devices.

Article 18

The term “medical device manufacturers,” as used in this Act, shall refer to the business undertakings that are engaged in manufacturing and assembling medical devices, wholesaling and exporting their own products, and importing raw materials for their own use.
Medical device manufacturers, as specified in the preceding paragraph, may concurrently engage in the retailing of their own manufactured products.

Article 19

The term “pharmacy” used in this Act shall refer to premises managed by a pharmacist or an assistant pharmacist, where drugs are legally dispensed and supplied.
Pharmacies defined in the preceding paragraph may concurrently engage in the retailing of drugs and medical devices at a certain level.
The scope and classifications of the medical devices of certain levels mentioned in the preceding paragraph shall be decided by the central competent health authority.

Article 20

The term “counterfeit drugs” as used in this Act shall refer to the drugs that are found to fall within any of the following circumstances after inspection or testing:
1. The drugs that are manufactured without prior approval;
2. The active ingredients of the drugs are inconsistent with the ingredients thereof previously approved;
3. The drugs that are packed or alternated with the products of others; or
4. The duration of validity label of the drugs has been altered or replaced.

Article 21

The term “substandard drugs” as used in this Act shall refer to the approved drugs that are found to fall within any of the following circumstances after inspection or testing:
1. The drugs that add non-statutory coloring agents, preservatives, aromatics, flavoring agents, and excipients without prior approval;
2. The quality, quantity, or potency of the active ingredients contained in the drugs are inconsistent with those previously approved;
3. The whole or part of the drugs contain filthy or peculiar objects;
4. The drugs apparently demonstrate color change, turbidity, precipitation, hydrolysis, or have decomposed due to corrosion;
5. The main therapeutic efficacy of the drugs is inconsistent with that previously approved;
6. The duration of validity or expiration date of the drugs has expired;
7. The drugs have deteriorated as a result of overtime storage or improper methods of storage;
8. The drugs are kept in containers made of deleterious substances or in recycled containers.

Article 22

The term “prohibited drugs” as used in this Act shall refer to any of the following:
1. The poisonous or harmful drugs that are prohibited by an order publicly announced by the central competent health authority from manufacturing, dispensing, importing, exporting, selling, or displaying; or
2. The drugs that are imported without prior approval, except the drugs that are carried into this country for personal use by passengers or service personnel on board during transportation.
Quotas regarding the personal-use pharmaceuticals referred to in Subparagraph 2 of the preceding paragraph shall be determined by the central competent health authority in conjunction with the Ministry of Finance.

Article 23

The term “defective medical devices” as used in this Act shall refer to the medical devices which fall within any of the following circumstances after inspection or testing:
1. Which, when used, is liable to cause danger or harm to the human body or to mislead diagnosis;
2. Which contains toxic or hazardous substances and so be, when used, detrimental to the health of human beings;
3. Which has expired its duration of validity or expiration date; or
4. of Which the quality, quantity, or potency is inconsistent with those previously approved.

Article 24

The term “advertisement of medicaments” as used in this Act shall refer to the act of advertising the medical efficacy of medicaments by means of communications aiming to solicit and promote the sale thereof.

Article 25

The term “labels” as used in this Act shall refer to the identification articles used to specify, in words, pictures, or signs, on the container or package of drugs or medical devices.

Article 26

The term “use instructions,” as used in this Act, shall refer to the instruction sheets accompanied by drugs or medical devices.

Chapter II Management of Pharmaceutical Firms

Article 27

Any person with the intent to be a pharmaceutical firm shall apply to the municipal or county (city) competent health authority for approval and registration and shall start the permit operation only after having paid the license fee and obtained the business permit. In case of any changes in the particulars registered, an application for such change registration shall be completed.
Matters to be registered under the preceding paragraph shall be specified by the central competent health authority.
To set up a branch office or branch factory, the pharmaceutical firm concerned shall further be required to file a separate application for pharmaceutical firm registration in accordance with the provisions of the first paragraph hereof.

Article 27-1

To apply for suspension of business, pharmaceutical firms shall clearly state the reason and term of suspension and hand in the business permits and medicament licenses to the local competent health authority, which shall be returned after the resumption of business is approved. Each period of suspension shall not exceed one year at the maximum. In the case that the local competent health authority has not approved the continuation of suspension when the period of suspension expires, said pharmaceutical firm shall apply for resumption of business operations within 30 days before the period of suspension expires.
To apply for termination of business, pharmaceutical firms shall hand in the business permits and medicament licenses for cancellation. In the case that the said permits and licenses are not handed in for cancellation, the said permits and licenses shall be canceled by the original issuing competent health authority.
In the case that the pharmaceutical firm does not apply for suspension, termination, or resumption of business within the giver period, the original issuing competent health authority shall nullify related permits and licenses after the municipal or county (city) competent health authority verifies that no business operations exist in the original establishment address.
For any pharmaceutical firm that violates the provisions under this Act and is subject to suspension of business imposed by the competent health authority, its permits and licenses shall be processed in accordance with the provisions under the first paragraph.

Article 27-2

Pharmaceutical firms holding drug licenses that 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 inability 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 a report as mentioned in the preceding paragraph or is notified of the insufficient supply of the essential drug, the authority may post it on a public website. It may also 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 paragraph, as well as the registration procedure and approval as a special case in the preceding paragraph, shall be established by the central competent health authority.

Article 28

Dealers of western pharmaceuticals and their sales shall have a full-time resident pharmacist for management. However, a full-time assistant pharmacist may be applied if no narcotic drugs are sold.
Dealers of Chinese medicines and their sales shall have a full-time resident Chinese medicine doctor or a pharmacist or assistant pharmacist who has received training in Chinese medicines to an appropriate level for management.
The provisions of the preceding two paragraphs shall also apply to the case where a dealer of either western pharmaceuticals or Chinese medicines intends to set up a separate business branch.

Article 29

Manufacturers of western pharmaceuticals shall have a full-time resident pharmacist to supervise the manufacturing. Manufacturers of Chinese medicines shall have a full-time resident Chinese medicine doctor or a pharmacist who has received training in Chinese medicines to an appropriate level to supervise the manufacturing.
In addition to the provisions of the preceding paragraph, if a manufacturer of Chinese medicines plans to manufacture Chinese medicines in the form of western pharmaceuticals or to adulterate western pharmaceuticals in Chinese medicines, there shall be an additional full-time pharmacist to supervise the manufacturing.
The provisions of the preceding two paragraphs shall also apply to the case where a manufacturer of either western pharmaceuticals or Chinese medicines intends to set up a separate branch factory.

Article 30

In case the pharmacist, assistant pharmacist, or Chinese medicine doctor employed by a pharmaceutical firm is discharged or resigns, a replacement shall be employed by the firm immediately.

Article 31

A manufacturer engaged in the manufacturing of biological drugs for human use shall employ qualified technicians who must be a graduate of the department of medical science, pharmacy, or biology from a domestic or foreign university or college, having possessed professional knowledge with more than five-year experience in the manufacturing of microbiological and immunological drugs to conduct the manufacturing.

Article 32

Medical device dealers or manufacturers shall employ qualified technicians according to the relevant categories of medical devices.
The categories of medical devices and the qualification requirements of technicians set forth in the preceding paragraph shall be established by the central competent health authority.

Article 33

Salespersons employed by a pharmaceutical firm shall be permitted to promote the sales only after their employment has been registered with the municipality or county (city) competent health authority.
The salespersons referred to in the preceding paragraph shall be limited to promoting the drugs manufactured or sold by the pharmaceutical firm at which they are employed to pharmacies, pharmaceutical firms, health and medical care institutions, or medical research institutions and those which have been approved and registered to the competent health authority to retail drugs, and shall not commit acts of peddling, street vending, breaking seal of medicament or repackage medicament without authorization, or illegal advertisement.

Chapter III Management of Pharmacies and Dispensation of Drugs

Article 34

A pharmacy shall obtain a pharmacy license and shall have the status and the name of the managing person thereof marked at a conspicuous place in the pharmacy. The provisions of the first paragraph of Article 27 hereof shall apply mutatis mutandis to the registration of its establishment and/or alteration of particulars registered.
Where a pharmacy is concurrently engaged in business in the second paragraph of Article 19, it shall be subject to the relevant provisions governing pharmaceutical firms without obtaining a separate business permit for a pharmaceutical firm.

Article 35

Where a pharmacy is managed in person by a pharmacist who has received training in Chinese medicine to an appropriate level, such pharmacy may engage in, concurrently, dispensation, supplying, or retailing Chinese medicines.

Article 36

Where a pharmacy managed in person by a pharmacist is equipped with assessment facilities, it may perform drug assessment operations.

Article 37

Dispensation of drugs shall not be performed unless it follows established operational procedures; the operational guidelines shall be established by the central competent health authority.
The dispensing mentioned in the preceding paragraph shall be performed by a pharmacist. However, the dispensation of non-narcotic drugs may be performed by an assistant pharmacist.
Dispensation of drugs in hospitals shall be performed by a pharmacist. However, an assistant pharmacist who had performed the dispensation of drugs before the amendment of this Act passed into force on February 5, 1993, shall apply to the provisions of the preceding paragraph and may continue performing the dispensation of drugs in the same hospital or any other hospital.
Unless otherwise provided by the law, the dispensation of Chinese medicines shall be performed under the supervision of a Chinese medicine doctor.

Article 38

The provisions of Article 12 and Articles 16 through 20 of the Pharmacists’ Act shall apply mutatis mutandis to the dispensation of drugs by assistant pharmacists.

Chapter IV Registration and Market Approval of Medicaments

Article 39

For the manufacture or import of drugs, information concerning the ingredients, sources of active pharmaceutical ingredients, specifications, functions, summaries of the manufacturing process, specifications, and analytical methods, 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 manufacture or import shall be allowed until such approval is granted and a drug license is issued.
Provisions of the preceding paragraph do not apply to an application to the central competent health authority for the importation of active pharmaceutical ingredients for trial manufacturing. Said application criteria and application fee shall be determined by the central competent health authority.
Only the drug license holder or their authorized persons may apply for the import of drugs pursuant to the provisions of the first paragraph.
For the application for registration and market approval referred to in the first paragraph, change or transfer of registration of a drug license in accordance with Article 46, issuance of extension, replacement, or re-issuance of a drug license in accordance with Article 47, the application criteria, review procedure, approval criteria, and other matters to be complied with shall be established in the Regulations for Registration of Medicinal Products by the central competent health authority.

Article 40

For the manufacture or import of medical devices, an application, together with fees paid, shall be filed with the central competent health authority for registration and market approval. No manufacture or import shall be allowed until such approval is granted and a medical device license is issued.
Only the medical device license holder or their authorized persons may apply for the import of medical devices pursuant to the provisions of the preceding paragraph.
The application criteria, review procedure, approval criteria, and other matters to be complied with for the application for registration and market approval, change, transfer, extension, replacement, and re-issuance of a medical device license shall be established by the central competent health authority.

Article 40-1

For the public benefit, the central competent health authority may, if necessary, publicize the active pharmaceutical ingredients, package inserts, or relevant information that are submitted by pharmaceutical firms in their applications for the manufacture or import of medicaments and thus held and kept by the central competent health authority. However, for information that is considered trade secrets in the new drug registration applications, the central competent health authority shall keep it confidential.
The central competent health authority shall enact measures governing the extent and method of the publication authorized by the preceding paragraph.

Article 40-2

1. Upon the issuance of a new drug license, the central competent health authority shall publish the patent numbers or file numbers that have already been disclosed to the public as submitted by the applicant.
2. Within 3 years after the issuance of a new drug license for a new molecular entity, no other pharmaceutical firm may apply for registration of the same drug by citing the application data submitted by said drug license holder without such holder’s consent.
3. Starting from the next day to the expiration of the period stipulated in Paragraph 2 hereof, other pharmaceutical firms may apply for registration of drugs in accordance with this Act and relevant regulations; for those in compliance with relevant regulations, the central competent health authority may issue a drug license only after the next day to the expiration of a 5-year period after the issuance of said new drug license for the new molecular entity as stipulated in Paragraph 2 hereof.
4. Paragraph 2 hereof is applicable only when an application for registration of a drug containing a new molecular entity is filed with the central competent health authority within 3 years after marketing approval is obtained for such drug in a foreign country.

Article 40-3

1. For a drug that has been approved by the central competent health authority to supplement or amend the indications thereof, within 2 years after the approval of such supplements or amendments to indications, no other pharmaceutical firm may apply for registration of the same indication by citing the application data submitted by said drug license holder without such holder’s consent.
2. Starting from the next day to the expiration of the period stipulated in Paragraph 1 hereof, other pharmaceutical firms may apply for registration of drugs in accordance with this Act and relevant regulations; for those in compliance with relevant regulations, the central competent health authority may issue a drug license only after the next day to the expiration of a 3-year period after the approval of supplements or amendments to indications as stipulated in Paragraph 1 hereof. However, if the drug license holder obtaining the approval of supplements or amendments to indications conducts a domestic clinical trial regarding such supplements or amendments to indications, the central competent health authority may issue a drug license to other pharmaceutical firms only after the next day to the expiration of a 5-year period after the approval of supplements or amendments to indications.
3. Paragraph 1 hereof is applicable only when an application for registration of such supplements or amendments to drug indications is filed with the central competent health authority within 2 years after such approval of indications is obtained for such drug in a foreign country.

Article 41

To enhance the standards of the pharmaceutical manufacturing industry and the quality of clinical trials, as well as to promote the research and development of pharmaceutical technology, the central competent health authority shall commission professional medical organizations annually to conduct educational training and cultivate talents for clinical trials.
The research and development of emerging pharmaceutical technology may be rewarded by the central competent health authority and the central competent industry authority.
The required qualifications, reviewing procedures, and other matters to be followed for the rewards under the preceding paragraph shall be established by the central competent health authority and the central competent industry authority.

Article 42

The central competent health authority shall establish operational guidelines as standards for issuance, change, and extension of medicament licenses in regard to the manufacture or import of medicaments.
The operational guidelines referred to in the preceding paragraph shall be established by the central competent health authority.

Article 43

Application forms to be used for applying for registration and market approval of manufacture or import of medicaments, quantities of samples and relevant information required and registration fees shall be established by the central competent health authority.

Article 44

Investigational medicaments shall be supplied to approved teaching hospitals for use in clinical trials to confirm the safety and medical efficacy thereof only after obtaining approval from the central competent health authority.

Article 45

The central competent health authority may set a specific period for monitoring the safety of the medicaments approved for manufacture or import.
The central competent health authority shall establish matters that the pharmaceutical firms shall adhere to during the safety monitoring period referred to in the preceding paragraph.

Article 45-1

Medical care institutions, pharmacies, and pharmaceutical firms shall report any serious adverse reactions caused by medicaments. Regulations regarding reporting method, content, and other matters to be complied with shall be established by the central competent health authority.

Article 46

Without approval of the central competent health authority, no alteration may be made to any of the originally registered particulars pertaining to any medicament approved for manufacture or import.
Transfer registration shall be required if an approved medicament manufacture or import license is to be transferred.

Article 47

A medicament manufacture or import license shall be valid for five (5) years. Where it is necessary to continue the manufacture or import of medicament upon expiration, a prior application shall be filed with the central competent authority for approval of license extension. The term of each extension shall not exceed five (5) years. The license shall be revoked upon expiry of the term thereof if the license holder fails to apply for an extension or if the application for an extension is disapproved.
In case a license set forth in the preceding paragraph is stained, damaged, or lost, an application specifying the cause shall be filed with the original issuing authority for replacement or re-issuance; the original license shall be revoked or canceled through public notice by the issuing authority.

Article 48

If there is a safety or medical efficacy concern of medicaments as re-evaluated and confirmed by the central competent health authority within the validity period of the manufacture or import license, pharmaceutical firms may be ordered to rectify any concerns within a time limit. For those who fail to make corrections within the given time limit, their licenses shall be revoked. Where there is a serious safety concern, the central competent health authority may revoke the license directly.

Article 48-1

The manufactured or imported medicaments referred to in Paragraph 1 of Article 39 shall display Chinese labels, use instructions, or packaging before being sold, wholesaled, or retailed. However, this shall not apply to those determined by the central competent health authority due to the difficulty in compliance.

Article 48-2

If any of the following circumstances apply, the central competent health authority may approve the manufacture or import of specific medicaments as a special case and is not subjected to Article 39 and Article 40:
1. For the purpose of prevention, diagnosis, and treatment of life-threatening, severely disabling diseases, there are no appropriate medicaments or alternative treatments available.
2. In responding to the necessity of emergency public health circumstances.
If any of the following circumstances apply, the central competent health authority may annul the approval in the preceding paragraph, shall order the applicants to handle the unused drug within a time limit, and may make an announcement for recall.
1. When a medicament obtains market approval for registration, or an appropriate treatment becomes available to support the necessity of circumstance prescribed in Subparagraph 1 of the preceding paragraph.
2. The emergency public health circumstance has been terminated.
3. The medicament was reviewed and considered with concerns about its safety or medical efficacy by the central competent health authority.
The application eligibility, reviewing procedure, approvement criteria, and other matters to be complied with in regard to the approval as a special case in the first paragraph shall be established by the central competent health authority.

Chapter 4-1 Patent Linkage of Drugs

Article 48-3

If a new drug license holder deems it necessary to submit the patent information regarding the new drug, the holder shall submit relevant documents and information to the central competent health authority within 45 days after the next day of the receipt of the drug license. If the holder fails to file such submission within the stipulated period, the regulations under this Chapter do not apply.
The drug patent stipulated under Paragraph 1 hereof shall be limited to the following:
1. Substance.
2. Composition or Formulation.
3. Medical use.

Article 48-4

The “patent information” stipulated in Article 48-3 shall include the following items:
1. Certification number of the invention patent(s); if the invention patent refers to medical use, the number of claims shall be concurrently provided.
2. The expiration date of the patent(s).
3. The patentee’s name, nationality, place of domicile, or business office; for a patentee having a legal representative, the name of the legal representative shall be listed. If said patent has been exclusively licensed and has been recorded in accordance with the Patent Act, the aforementioned information of the exclusive licensee shall be listed.
4. If the patentee or the exclusive licensee in Subparagraph 3 hereunder does not have a domicile or a business office in the R.O.C., an agent thereof shall be appointed. The appointed agent’s name, place of domicile, or business office shall be submitted.
If the new drug license holder is different from the patentee, the patentee’s consent shall be obtained when submitting the patent information; if the patent has been exclusively licensed and has been recorded in accordance with the Patent Act, it is only required to obtain the exclusive licensee’s consent.

Article 48-5

If the new drug license holder obtains the approval of an application for an invention patent(s) from the competent patent authority after the approval of said new drug license from the central competent health authority, and such patent(s) is subject to the scope of drug patent set forth in Paragraph 2 of Article 48-3, the patent information thereof shall be submitted within 45 days after the next day to the patent issuance in accordance with Article 48-4. If the holder fails to file such submission within the stipulated period, the regulations under this Chapter do not apply.

Article 48-6

The new drug license holder shall amend or delete the listed patent information within 45 days after the next day of the occurrence of any matter set forth below:
1. The patent term extension is approved and issued by the competent patent authority.
2. The post-grant amendment to patent claim(s) is approved and issued by the competent patent authority.
3. The patent has been revoked finally and bindingly.
4. The patent has been extinguished.
5. The patent information set forth in Subparagraphs 3 and 4, Paragraph 1 of Article 48-4, has been amended.
If the new drug license holder is different from the patentee or the exclusive licensee, Paragraph 2 of Article 48-4 shall apply hereto mutatis mutandis when dealing with the matters stipulated in Paragraph 1 of this Article.

Article 48-7

Anyone may notify any of the following items to the central competent health authority with written explanations and evidence attached:
1. The invention listed in the patent information is irrelevant to the approved drug.
2. The invention listed in the patent information does not comply with Paragraph 2 of Article 48-3.
3. The patent information listed is incorrect.
4. No amendment or deletion has been made for any of the occurrences stipulated in Article 48-6.
The central competent health authority shall, within 20 days after the next day of its receipt of the notification under Paragraph 1 hereof, forward said notification to the new drug license holder.
The new drug license holder shall, within 45 days of the next day of its receipt of said notification, respond to the central competent health authority with written explanations and may amend or delete the patent information as the case may be.

Article 48-8

1. The central competent health authority shall establish a Registration System for Patent Linkage of Drugs to list and publish the patent information submitted by the new drug license holder. The aforementioned shall also apply to the amendment and deletion of the patent information.
2. Upon the occurrence of the matters stipulated in Article 48-7 for the listed patent information, the central competent health authority shall publish the third party’s allegations and the written responses made by the new drug license holder.

Article 48-9

The applicant for a generic drug license shall, with respect to the patent(s) of the approved new drug listed by the said new drug license holder, declare one of the following item(s) when applying for a generic drug license:
1. No patent information on said new drug has been listed.
2. The patent(s) corresponding to said new drug has been extinguished.
3. The central competent health authority will issue the generic drug license after the patent(s) corresponding to said new drug are extinguished.
4. The patent(s) corresponding to said new drugs shall be revoked, or the patent(s) corresponding to said new drugs will not be infringed by the generic drug subject to the application for drug license.

Article 48-10

For the application for a generic drug license that only involves a declaration based on Subparagraph 1 or 2 of Article 48-9, if in compliance with the regulations under this Act after examination, the central competent health authority shall issue the drug license thereof.

Article 48-11

For the application for a generic drug license that involves a declaration based on Subparagraph 3 of Article 48-9, if in compliance with the regulations under this Act after examination, the central competent health authority shall issue the drug license thereof after all of the listed patent(s) of said new drug extinguishes.

Article 48-12

For an application for a generic drug license that involves a declaration under Subparagraph 4 of Article 48-9, the applicant shall, within 20 days from the day following the receipt of notification from the central competent health authority confirming the completeness of the drug license application documents, issue a notification in writing to both the new drug license holder and the central competent health authority. If the said new drug license holder is different from the patentee or the exclusive licensee, the patentee and the exclusive licensee shall also be notified.
The applicant of a generic drug license shall provide an explanation and evidence in the aforementioned notification regarding its allegation that the patent shall be revoked or that there is no patent infringement.
The central competent health authority shall dismiss the application for a generic drug license if the applicant fails to issue the notification in accordance with Paragraphs 1 and 2 hereof.

Article 48-13

If the patentee or the exclusive licensee intends to file a patent infringement complaint on the basis of the listed patent(s) after its receipt of the notification stipulated by Paragraph 1 of Article 48-12, it shall file the complaint within 45 days after the next day to its receipt of said notification and notify the central competent health authority.
The central competent health authority shall stay the issuance of the drug license for twelve (12) months as of the next day to the new drug license holder’s receipt of the notification stipulated in Paragraph 1 of Article 48-12. However, if there are any of the following matters, the central competent health authority may issue the drug license if said application is examined to comply with the regulations under this Act:
1. The patentee or the exclusive licensee, after its receipt of the notification stipulated by Paragraphs 1 of Article 48-12, fails to file an infringement complaint within the 45-day period.
2. The patentee or the exclusive license files an infringement complaint based on the patents that are not those listed before the date of the application for the generic drug license.
3. The patent infringement complaint filed by the patentee or the exclusive licensee pursuant to Paragraph 1 hereof is overruled by the court according to Paragraph 1 or 2 of Article 249 of the Code of Civil Procedure.
4. The court has determined that all of the patents pending in the infringement lawsuit shall be revoked, or a non-infringement judgment is obtained by the applicant for the generic drug license.
5. All the patents under the declaration stipulated in Subparagraph 4 of Article 48-9 made by the applicant for the generic drug license are determined as invalid by the competent patent authority in a cancellation action.
6. A settlement or mediation has been reached by the parties.
7. All the patents under the declaration stipulated in Subparagraph 4 of Article 48-9 made by the applicant for the generic drug license have been extinguished.
The period [for notification] stipulated in Subparagraph 1, Paragraph 2 hereof shall be commenced upon the receipt of the notification by the patentee(s) or the exclusive licensee(s), whichever is later.
If the patentee or the exclusive licensee obtains a final and binding judgment confirming infringement of the listed patent(s) within the 12-month period stipulated in Paragraph 2 hereof, the central competent health authority shall issue the generic drug license after said patent(s) extinguishes.
Where the patent infringement complaint filed by the patentee or the exclusive licensee pursuant to Paragraph 1 hereof, if by reason of being an improper exercise of patent right ab initio, the stay of drug license issuance has caused damages to the applicant of a generic drug license, such patentee or the exclusive licensee shall be held liable for compensation.

Article 48-14

For the application for the generic drug license filed by the same applicant for the same drug, the central competent health authority may only stay the issuance of the drug license in accordance with Paragraph 2, Article 48-13 once.

Article 48-15

During the period of stay of drug license issuance stipulated in Paragraph 2 of Article 48-13, if the examination for the application for a generic drug license has been completed, the central competent health authority shall inform the applicant for said generic drug license.
The applicant for a generic drug license may apply for drug listing and reimbursement price with the National Health Insurance Administration after receiving the notification stipulated in Paragraph 1 hereof. However, no manufacture or importation of the generic drug is permitted before the central competent health authority’s issuance of the generic drug license.

Article 48-16

The application for a generic drug license in accordance with Subparagraph 4 of Article 48-9 with application documents duly prepared at the earliest shall be granted a 12-month period of marketing exclusivity; the central competent health authority shall not issue other drug licenses to other applicants for a generic drug license before the expiration of the aforementioned period.
For the aforementioned application for a generic drug license with documents duly prepared under Subparagraph 4 of Article 48-9, upon the occurrence of vacancy due to any of the following matters, the vacancy will be fulfilled by the subsequent applicant with application documents duly prepared:
1. During the period of drug license examination, the declaration under Subparagraph 4 of Article 48-9 is amended.
2. The earliest applicant fails to obtain notification from the central competent health authority that the examination of the application for a generic drug license has been completed within 12 months after the next day to the date that all the application documents are duly prepared.
3. Any matter as stipulated in Paragraph 4 of Article 48-13 occurs.
If more than one application for a generic drug license in compliance with the requirements regarding the earliest duly prepared application documents is filed on the same date, such applications are jointly subject to the 12-month period of marketing exclusivity.

Article 48-17

The generic drug license holder shall market the drug within 6 months after the next day of such holder’s obtaining of said drug license and shall, within 20 days after the next day to the earliest marketing date, provide the evidence of the actual marketing date to the central competent health authority for its determination of the marketing exclusivity period granted and the commencement date and end date thereof.
The marketing exclusivity period stipulated in Paragraph 1 hereof starts from the date of the actual marketing of the drug.
If more than one application for the generic drug license is jointly subject to the marketing exclusivity period, the commencement date thereof shall be the date on which any of such drugs are actually first marketed.

Article 48-18

If any of the following matters occur to the applicant for a generic drug license subject to the marketing exclusivity period, the central competent health authority may issue generic drug licenses to other applicants without being restricted by Paragraph 1 of Article 48-16:
1. Failure to collect the drug license within the period prescribed by the central competent health authority.
2. Failure to abide by Paragraph 1 of Article 48-17.
3. All the patents declared under Subparagraph 4 of Article 48-9 have been extinguished.

Article 48-19

For any settlement agreement or other agreement involving the manufacture, sales, and marketing exclusivity period of drug related to the regulations under this Chapter executed between the applicant for a new drug license, the new drug license holder, the applicant for a generic drug license, the generic drug license holder, and the patentee or exclusive licensee of a drug patent, within 20 days after the next day to the occurrence of such matter, both parties shall notify the central competent health authority, and if reverse payment interest agreement is involved, shall also notify the Fair Trade Commission.
The method and content of the notification stipulated in Paragraph 1 hereof, as well as other matters, shall be abided by in this regard and shall be promulgated by the central competent health authority jointly with the Fair Trade Commission.
If the central competent health authority considers that the agreement notified under Paragraph 1 hereof is likely to violate the Fair Trade Act, it may notify the Fair Trade Commission.

Article 48-20

The provisions under Articles 48-9 through 48-15 hereof related to the application for a generic drug license shall apply mutatis mutandis to the new drugs not having a new ingredient.
The provisions related to the stay of drug license issuance and the marketing exclusivity period under Articles 48-13 to 48-18 are not applicable to the application for a generic drug license set forth in Article 48-12 if the following circumstances are met:
1. The patent(s) registered under an approved new drug is still valid and is a patent for medical use under Subparagraph 3, Paragraph 2 of Article 48-3.
2. The applicant of a generic drug license excludes the indication corresponding to the patent for medical use referred to in Subparagraph 1 hereof and declares that the generic drug does not infringe the said patent.
The exclusion of indication, declaration, and other matters shall be abided by in this regard as stipulated in Paragraph 2 hereof shall be promulgated by the central competent health authority.

Article 48-21

Before the enforcement of the provisions amended on December 29, 2017, the new drug license holders whose drug patent(s) is subject to the drug patent as stipulated in Paragraph 2, Article 48-3 and has not extinguished yet may submit patent information in accordance with Article 48-4 within 3 months after the enforcement of the amended provisions.

Article 48-22

The details of the following should be promulgated by the central competent health authority: the method and content of submission of the patent information, the amendment and deletion thereof, the listing and publication of the patent information as stipulated in Articles 48-4 to 48-8; the declaration made by the applicant for a generic drug license as stipulated in Article 48-9; the method and content of the written notification made by the applicant for the generic drug license as stipulated in Article 48-12; the method and content of the notification relating to completion of the examination procedures of an application for a generic drug license by the central competent health authority as stipulated in Article 48-15; the commencement and termination of the marketing exclusivity period as stipulated in Articles 48-16 to 48-18; other matters that shall be abided by.

Chapter V Sales and Manufacture of Medicaments

Article 49

Pharmaceutical firms shall not purchase or sell drugs or medical devices from unknown sources or from firms not holding pharmaceutical firm business permits.

Article 50

Drugs requiring the prescription of a physician shall not be dispensed or supplied in the absence of such prescription except under any of the following circumstances:
1. In which drugs are wholesaled or sold between pharmaceutical firms in the same business;
2. In which drugs are purchased by hospitals, clinics, medical care institutions of agencies, organizations and schools, or laboratories, and academic research institutions; or
3. In which drugs are dispensed in accordance with the formula set forth in the Chinese Pharmacopoeia and the official National Formularies.
Drugs requiring the prescription of physicians set forth in the preceding paragraph shall be designated separately with reference to Chinese medicines and western pharmaceuticals by the central competent health authority.

Article 51

Dealers of western pharmaceuticals cannot concurrently sell Chinese medicines, and vice versa, except for general sale medicines.

Article 52

Drug dealers shall not concurrently sell pesticides, drugs for annual use, or other toxic substances.

Article 53

Drugs imported by drug dealers may be sold after repackaging conducted according to the following:
1. For pharmaceutical preparations: After approval for repackaging is obtained from the central competent health authority, the repackaging shall be conducted by manufacturers that meet the GMP standards for drugs.
2. For active pharmaceutical ingredients: repackaging shall be conducted by manufacturers that meet the GMP standards for drugs. After repackaging, the repacked products shall be filed with the central competent health authority for record.
The conditions, procedures, timeframe, and procedure for filing the abovementioned repackaging, as well as matters to be complied with for selling the repackaged products, shall be established by the central competent health authority.

Article 53-1

Business undertakings engaged in wholesaling, importing, and exporting western pharmaceuticals, their product procuring, holding, and supplying related to the quality management, organization and personnel, premises and equipment, documentation, operation procedures, customer complaints, returns and recalls, outsourced activities, self-inspections, transportation, and other pharmaceuticals distribution practice, shall meet the standard of Western Pharmaceuticals Good Distribution Practice Regulations and shall obtain the western pharmaceuticals distribution license upon the inspection and approval from the central competent health authority.
The contents from the previous paragraph shall be enforced in several phases. The enforcement of pharmaceuticals, the types of pharmaceutical firms, requirements, methods, and schedules shall be announced by the central competent health authority.
Business undertakings that meet the standard of Paragraph 1 in obtaining the western pharmaceuticals distribution license may pay the corresponding application fees to apply for certificates with the central competent health authority.
Western Pharmaceuticals Good Distribution Practice Regulations and western pharmaceuticals distribution licenses of paragraph 1, the application requirements, review procedures, and criteria, approval and issuance, validity period, revocation, return, and cancellation of the license of the previous paragraph and other matters requiring compliance shall be prescribed by the central competent health authority.

Article 54

For the purpose of protecting national interests, the central competent health authority may enforce control over the import of drugs or medical devices that have been granted a medicament import license. However, this provision does not apply to those medicaments for which a foreign exchange settlement certificate has been approved prior to the enforcement of such import control.

Article 55

Samples or gifts of medicaments that have been approved for manufacture or import shall not be sold.
Regulations governing the management of samples and gifts referred to in the preceding paragraph shall be established by the central competent health authority.

Article 56

Where any medicament manufactured and sold under official approval is intended to be sold abroad through export and if the importing country requires a literal certificate, the manufacturer of such medicament shall apply to the central competent health authority to issue an export certificate prior to the exportation thereof.
The central competent health authority may, in consideration of the insufficiency to meet domestic demands, restrict or limit the export of the medicament(s) referred to in the preceding paragraph.

Article 57

The medicaments shall be manufactured by medicament manufacturing factories. Any medicament manufacturing factory shall be established pursuant to the Standards for Medicament Factory Establishment and shall carry out factory registration pursuant to the Factory Management Act, except when exemption from factory registration is allowed pursuant to the Factory Management Act or if such manufacture, as approved by the central competent health authority, is for research and development purposes.
For purposes of medicament manufacture, the factory facilities, equipment, organization and personnel, production, quality control, storage, logistics, handling of customer complaints, and other matters requiring compliance shall comply with the Pharmaceutical Good Manufacturing Practice Regulations; the manufacture may only begin after the central competent health authority has completed its inspection and granted approval and the medicament manufacture license has been obtained. These restrictions do not apply to manufacturers of medical devices that, per a public announcement by the central competent health authority, do not need to comply with the Pharmaceutical Good Manufacturing Practice Regulations.
A pharmaceutical firm that has met the requirements of the preceding paragraph and obtained the medicament manufacture license may pay the corresponding application fees to apply for certificates with the central competent health authority.
The provisions of the preceding two paragraphs shall apply mutatis mutandis to overseas manufacturing factories importing medicaments, and the central competent health authority shall send personnel overseas to inspect such foreign manufacturing factories on a periodical basis or as necessary.
The Standards for Medicament Factory Establishment of paragraph 1 shall be jointly prescribed by the central competent health authority and the central competent industry authority. The Pharmaceutical Good Manufacturing Practice Regulations of paragraph 2 shall be prescribed by the central competent health authority.
The medicament manufacture license of paragraph 2, the application requirements, review procedures and criteria, approval and issuance, validity period, revocation, return, and cancellation of the certificates of paragraph 3, and other matters requiring compliance shall be prescribed by the central competent health authority.

Article 57-1

Institutions or companies for the research and development of medicaments, their products shall be manufactured by factories or establishments in accordance with central competent health authority regulations.
The factories or establishments referred to in the preceding paragraph shall not, concurrently, manufacture other products without authorization from the central competent health authority. Medicaments manufactured for research and development purposes by said factories or establishments shall not be used on the human body without authorization from the central competent health authority.

Article 58

A medicament manufacturing factory may not commission another factory to manufacture or accept the commission from another factory to manufacture any medicament unless otherwise approved by the central competent health authority.

Chapter VI Management of Controlled Drugs and Strongly Poisonous Drugs

Article 59

Dealers and manufacturers of western pharmaceuticals shall, in purchasing, storing, or selling controlled drugs and strongly poisonous drugs, keep in detail a list of the names and quantity of such drugs for future inspection. Controlled drugs shall be further stored in separate cabinet(s) installed with locks.
The labels of controlled drugs and strongly poisonous drugs shall be marked with warning words and drawings or colors sufficient to indicate the warning effect.

Article 60

No controlled drugs or strongly poisonous drugs shall be dispensed and supplied without the prescription of a physician.
The controlled drugs mentioned in the preceding paragraph shall be supplied against the identification certificate of the receiver, and the name, address, and uniform serial number of the receiver and the quantity of controlled drugs they received shall be listed in detail and kept together with the prescriptions they presented for future inspection.
The central competent health authority may place restrictions on prescriptions and dispensation of controlled drugs.

Article 61

(Deleted)

Article 62

The prescriptions and books, as required under the provisions of Articles 59 through 60, shall be kept for at least a period of five (5) years.

Article 63

(Deleted)

Article 64

Unless otherwise approved by the central competent health authority, dealers or manufacturers of Chinese medicines shall not sell or use controlled drugs.
No dealers or manufacturers of Chinese medicines selling strongly poisonous Chinese medicines shall sell them without the prescription duly affixed to the signature and seal of a Chinese medicine doctor. The provisions of Article 59 hereof shall apply mutatis mutandis to the purchase, storage, or sale of strongly poisonous Chinese medicines.

Chapter VII Management of Advertisements on Medicaments

Article 65

Persons other than pharmaceutical firms are not allowed to make advertisements for medicaments.

Article 66

For publishing or broadcasting medicament advertisements, pharmaceutical firms shall, before publishing or broadcasting, submit all texts, drawings, or pictures constituting an advertisement to the central or municipal competent health authority for approval and shall forward the approval to mass media enterprises for verification. If the competent health authority who issues the approval discovers the content of the medicament advertisement or the way it is displayed may be harmful or possibly endangering to the health of the public, it shall issue an order for an immediate stop of the display and for a remedy to the situation within a given time; failure to comply shall be subject to revoking the approval.
No modifications or alterations to the approved contents are allowed during the term being permitted to be published or broadcast.
No mass media enterprise shall publish or broadcast any medicament advertisement that has not been approved, has been different from the approved particular, has been withdrawn, or has not yet made amendments in time as ordered by the central or municipal competent health authority.
A mass media enterprise being commissioned by a principal to publish or broadcast an advertisement shall maintain the particulars of its principal, including its name (corporate or group name), identification number, business license number, domicile (firm or business office) and telephone number, etc., for six months from the date of such advertisement. It shall not evade, impede, or refuse any request by the competent authority for such particulars.

Article 66-1

The term of validity for medicament advertisements approved by the central or municipal competent health authority shall be one year, which shall commence from the date of issuance of the approval document. A period of extension may be applied for and approved by the issuing competent health authority as necessary. Each period of extension shall not exceed one year.
The term of validity referred to in the preceding paragraph shall be clearly indicated in the approval document of said advertisement.

Article 67

For medicaments that require prescriptions of physicians or that have been specifically designated by the central competent health authority through public notice(s), the advertisements thereof shall be published only in academic medical journals.

Article 68

Medicament advertisements shall not be made in any of the following manners:
1. To publicize the medicament by making use of the name of other person(s);
2. To warrant the efficacy or functions of the medicament by making use of the materials or information contained in a book or publications;
3. To publicize the medicament by means of releasing an interview or news report; or
4. To publicize the medicament by any other improper means.

Article 69

No pictorial or literal description or propaganda regarding the medical efficacy of any product other than the medicaments defined in this Act shall be made.

Article 70

Interviews, news reports, or propaganda containing information implying or suggesting medical efficacy shall be regarded as advertisements for medicaments.

Chapter VIII Investigation and Interdiction

Article 71

Competent health authorities may assign their respective officials to inspect the facilities and relevant business operations of pharmaceutical manufacturers and/or dealers. They may sample-test the medicaments concerned by issuing a receipt for such purpose. Manufacturers and dealers shall not refuse such inspections without valid reasons. However, the quantity of samples to be taken shall be limited to the extent sufficient for the use of testing.
Where it seems necessary, as the case may be, an inspection of manufacturers of medicaments may be conducted in conjunction with the competent industry authority.
Regulations governing the performance of the inspections set forth in this Article shall be established by the central competent health authority in conjunction with the central competent industry authority.

Article 71-1

In order to enhance border control for medicament imports, the central competent health authority may issue a public notice requiring test inspections at the time of importation, and the medicaments may only be imported after passing an inspection.
The methods and methodologies, items and scope to be checked, fees for test checks and inspections, and other matters requiring compliance for the import of medicaments as set out in the preceding paragraph shall be prescribed by the central competent health authority.

Article 72

Competent health authorities may assign their respective officials to inspect the relevant business operations of the medical care institutions or pharmacies. They may sample-test the medicaments concerned by issuing a receipt for such purpose. The institutions being inspected shall not refuse without valid reasons. However, the quantity of samples to be taken shall be limited to the extent sufficient for the use of testing.

Article 73

The municipal or county (city) competent health authority shall conduct a census of pharmaceutical firms and pharmacies each year.
No pharmaceutical firm or pharmacy may refuse, evade, or impede the general inspection set forth in the preceding paragraph.

Article 74

Serums, antitoxins, vaccines, toxoids, and bacterial suspensions produced in accordance with microbiological and immunological principles may not be sold unless the central competent health authority has sampled from each batch after production or importation, conducted tests to verify their compliance, and affixed a seal indicating that the inspection has been completed. The inspection and lot release procedures shall be established by the central competent health authority.
The importation of the drug substances for biological drugs referred to in the preceding paragraph shall be restricted to the biological drug manufacturers.

Article 75

The labels, use instructions, and packaging of medicaments shall indicate the following particulars as approved:
1. Name and address of the manufacturer;
2. Name of the medicament and license number;
3. Lot number;
4. Date of manufacture and period of validity or expiration date;
5. Active ingredients contents, dosage, and method of administration;
6. Main medical efficacy, functions, or indications;
7. Adverse reactions, contraindications, and other warnings and precautions;
8. Other particulars as required by relevant regulations.
The particulars in Subparagraph 4 of 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 packaging 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, methods, and other requirements shall be established by the central competent health authority.

Article 76

In case any medicament approved for manufacture or import is found to cause serious hazards, the central competent health authority shall, at any time, announce prohibiting its manufacture or import and further revoke the medicament license. As for those medicaments that have already been manufactured or imported, they shall be prohibited from export, dispensation, sale, supply, transport, storage, brokerage, transfer, or display with intent to sell within a time limit. Such medicaments may be confiscated and destroyed if necessary.

Article 77

Municipal or county (city) competent health authority shall first place suspicious counterfeit drugs, substandard drugs, prohibited drugs, or defective medical devices in confinement and then take samples therewith for testing before taking further actions. As for those which may cause serious hazards to health, the competent health authority concerned shall confiscate and destroy them after reporting to and obtaining the approval of the central competent health authority.
The provisions in the preceding paragraph shall apply mutatis mutandis to medical devices manufactured or imported without prior approval.

Article 78

In addition to the actions to be taken under other relevant provisions of this Act, the following disciplinary actions shall be taken when any counterfeit drugs, substandard drugs, prohibited drugs, or defective medical devices are found during any inspection or testing:
1. For any firm that manufactures or imports counterfeit drugs or prohibited drugs or that engages in imposture by using another party’s permit licenses, the original issuing authority shall revoke their entire medicament licenses, pharmaceutical firm business permits, and medicament manufacture licenses, and all or part of the items for which the company, business, or factory is registered.
2. For any firm that sells or displays with intent to sell counterfeit drugs or prohibited drugs, the municipality or county (or city) competent health authority shall publicly announce the name, address, and the responsible person of the firm or the business, the name of the drugs involved, and the details of the violation. In the event of any further violation, its business operations may be suspended.
3. For any firm that manufactures, imports, sells, or displays with intent to sell substandard drugs or defective medical devices, the municipality or county (or city) competent health authority shall publicly announce the name, address, and the responsible person of the firm or the business, the name of the drugs involved and the details of the violation. In the case of a serious violation or repeated violation, each respective medicament license or medicament manufacture license may be revoked, and its business operations may be suspended.
The provisions of the preceding paragraph shall apply mutatis mutandis to medical devices that are manufactured or imported without approval.

Article 79

The counterfeit drugs or prohibited drugs seized shall be confiscated and destroyed.
In case the substandard drugs or defective medical devices seized are domestically manufactured and considered, after testing, to be still usable through re-modification, the municipal or county (city) competent health authority shall direct and assign an official to supervise the original manufacturer to re-modify within a time limit. Those that cannot be re-modified or have not been re-modified within the given time limit shall be confiscated and destroyed. If approved for import, they shall be placed in confinement immediately, and the municipal or county (city) competent health authority shall direct the original importer to return such products to the foreign supplier(s) within a time limit. Those which have not been returned beyond the given time limit shall be confiscated and destroyed.
The provisions of the preceding paragraph shall also apply mutatis mutandis to medical devices that are legally determined to be manufactured or imported without approval.

Article 80

If any of the following circumstances apply to any medicament, its manufacturer or importer shall immediately notify medical care institutions, pharmacies, and pharmaceutical firms and, within a prescribed time limit, shall recall the medicament in question from the market and dispose of it together with its stock of the medicament pursuant to the relevant provisions of this Act:
1. Where the medicament has been granted a license but is subsequently prohibited by public announcement from being manufactured or imported.
2. Where the drug has duly been deemed counterfeit, substandard, or prohibited in accordance with the law.
3. Where the medical device has duly been deemed defective or has been manufactured or imported without approval in accordance with the law.
4. Medicaments produced by a medicament manufacturing factory are found, after inspection, to be damaging or likely to damage the life, body, or health of users.
5. Where an application for extension of a medicament manufacture or import license previously granted has not been filed, or its approval has been denied.
6. Where a change registration of the packaging, labels, or use instructions of the medicament has been approved.
7. Other medicaments whose recall has been publicly announced by the central competent health authority.
Medical care institutions, pharmacies, and pharmaceutical firms shall cooperate with manufacturers or importers in recalling the medicaments set forth in the subparagraphs of the preceding paragraph.
Regulations governing recalled medicaments under the provision of the first paragraph, such as classification, method of handling, recalling, and other requirements, are announced by the central competent health authority.

Article 81

Persons who contribute to the exposure or capture of counterfeit drugs, substandard drugs, prohibited drugs, and defective medical devices shall be entitled to incentives.

Chapter IX Penal Provisions

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 offense 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 offense results in serious adverse health consequences.
Any person who commits the offense 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 offense 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 offense 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 offense results in serious adverse health consequences.
Any person who commits the offense 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 offense 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 devices set forth in the preceding paragraph shall be subject to the punishment set forth in the preceding paragraph.
Any person who commits the offense 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 substandard 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 offense by negligence or knowingly sells, supplies, dispenses, transports, stores, brokers, transfers, or displays with intent to sell the substandard 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 substandard 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, dispensers, 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 offenses 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 that are used in manufacturing or dispensing counterfeit 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 this Act may be based on an estimation of whether the valuation is deemed difficult. The regulation governing such estimation shall be established by the central competent health authority.

Article 89

Where a public functionary commits or shelters others to commit, by taking advantage of his/her functional power, opportunity, or means, any of the offenses 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.

Article 90

Any person who manufactures or imports the substandard drugs set forth in Subparagraphs 2 through 8 of Article 21 hereof 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 substandard 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 person responsible for managing the medicaments or the production supervisor of such medicaments shall also be imposed with the fine set forth in the respective paragraphs.

Article 91

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.

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 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$2,000,000.
In the case of any violation of the provisions of Article 59 or dispensing or supplying strongly poisonous drugs in violation of the provisions of Article 60, Paragraph 1, either the person responsible for managing the drugs or the production supervisor of the drugs shall also be issued the fines set forth in the preceding paragraph.
Any violator of the provisions of Article 53-1 Paragraph 1, Article 57, Paragraph 2 or 4 shall be penalized pursuant to Paragraph 1 of this Article. The central competent health authority may publicly announce the name of the medicament factory or pharmaceutical firm and order them to make rectification within a prescribed time period, and during the time period for such rectification, may suspend, in whole or in part, their manufacturing, wholesaling, import, export, and business operations. If rectification is not made within the prescribed time period, the central competent health authority may deny approval for an extension of the validity of the medicament license previously granted and will not process any other new application for other medicaments from the given factory or firm in the case of severe violation, and the central competent health authority may revoke all or part of the medicaments manufacture or distribution license.
A violator of any provision of Article 66, Paragraph 1 or 2, Article 67, or Article 68 shall be issued a fine of not less than NT$ 200,000 but not more than NT$ 5,000,000.

Article 92-1

If the new drug license holder 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, shall be imposed with a fine of not less than NT$30,000 but no more than five NT$500,000 by the central competent health authority.
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 shall be imposed with a fine of not less than NT$30,000 but no more thanNT$2,000,000 by the central competent health authority.

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 general sale medicines and pharmaceutical preparations of inherited formulations 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 violates 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 94

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.

Article 95

Any mass media enterprise which violates the provisions of Paragraph 3 of 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 that violates the provisions of Paragraph 4 of 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.

Article 96

Any pharmaceutical firm that 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 license previously granted to the said medicament may also be 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 competent health authority in charge of medicament advertising shall set a time limit and order the pharmaceutical firm making the illegal advertisement, after its license has been revoked as described in the preceding paragraph, to publish or broadcast via the original mass communication media, an apologetic notice in the same timeframe 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.

Article 96-1

Any pharmaceutical firm that violates any one of the provisions under Article 48-1 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 consecutively until improvements have been made.
Any pharmaceutical firm that violates any one of the provisions 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 repeated violation, it may be imposed with a fine of not less than NT$60,000 but not more than NT$300,000.

Article 97

In case a pharmaceutical firm makes use of false information in evidentiary document(s) in applying for registration and market approval, extension of registration, or change of registration in connection with a medicament license it possesses, the said medicament license shall be revoked. In addition, the said pharmaceutical firm shall be suspended from applying for registration and market approval for the said medicament 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.

Article 97-1

In the case that the examined medicament does not comply with information stated in applications submitted in accordance with the Regulations for Registration of Medicinal Products or the Regulations for Registration of Medical Devices, the central competent health authority shall not accept nor process new applications for other medicaments by the said manufacturers for six months, which shall commence from the date the incompliance is verified.
In the case that the result of re-examination upon the 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 medicaments by the said manufacturers for one year, which shall commence from the date the incompliance is verified.

Article 98

(Deleted)

Article 99

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 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 revoke the original imposition if it deems the objection justifiable.
If the person fined does not agree with the decision made under the preceding paragraph, he/she may institute an administrative appeal and further an administrative proceeding in accordance with the applicable laws.

Article 99-1

In the case where an application for medicament registration and market approval, change, transfer, or extension of medicament licenses submitted in accordance with this Act is not approved, the applicant may clearly state reasons and apply for re-examination within four months from the date of receiving the decision notice; provided that only one application for re-examination is allowed.
The central competent health authority shall alter or revoke the original decision notice 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 the decision made under the preceding paragraph, he/she may institute an administrative appeal and further an administrative proceeding in accordance with the applicable laws.

Article 100

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

Article 100-1

If the new drug license holder submits the patent information in accordance with Articles 48-3 through 48-6 but provides such information fraudulently or incorrectly, and if criminal liability is involved therein, such matter shall be transferred to judicial authority for handling.

Article 101

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

Chapter X Supplementary Provisions

Article 102

Any physician having dispensation facilities as specified in this Act may, for the purpose of medical treatment, dispense drugs by himself/herself based on his/her own prescriptions.
After two years of the implementation of the National Health Insurance, the provision of the preceding paragraph shall be enforceable only in the remote areas where practicing pharmaceutical personnel are not available as announced by the central or municipal competent health authorities or in the case of urgent need of medical treatment services.

Article 103

After the promulgation of this Act, those who have a record of obtaining a business permit as a Chinese medicine dealer by May 31, 1974, as prescribed, may continue to operate the business of selling Chinese medicines outlined in Article 15.
Those who have been duly reviewed and registered by the central competent health authority before February 5, 1993, or have obtained a certificate of Chinese medicine dealer and have received education in Chinese medicines to an appropriate degree may continue to operate the business of selling Chinese medicines.
The scope of business operations for Chinese medicines dealers referred to in the preceding paragraph include the import, export, and wholesale of Chinese medicine materials and Chinese medicine preparations; retail of Chinese medicine materials and non-prescription Chinese medicines; non-poisonous Chinese medicine materials or traditional pellets, powdered medicine, ointment, pills, or decoct medicines dispensed from preparations of traditional formulas.
The scope of business operations for the aforementioned persons, licensed Chinese medicine doctors who have passed their certification exams, or the responsible persons of Chinese medicine firms who have employed Chinese medicine doctors, pharmacists, and assistant pharmacists managing Chinese medicine businesses for more than three years before the establishment of the Chinese medicine pharmacists; who have completed the Chinese medicine course to an appropriate standard and obtained certification from the local competent health authority; and who have passed the national examination shall be as follows:
1. The import, export, and wholesale of Chinese medicine materials and Chinese medicine preparations;
2. The retail of Chinese medicine materials and non-prescription Chinese medicines;
3. Non-poisonous Chinese medicine materials or traditional pellets, powdered medicine, ointment, pills, or decoct medicines dispensed from preparations of traditional formulas; and
4. The dispensing of medicaments prescribed by a Chinese medicine doctor.
The examination referred to in the preceding paragraph shall be determined by the Examination Yuan in conjunction with the Executive Yuan.

Article 104

The full-time pharmacists or assistant pharmacists retained by western pharmaceutical dealers duly approved, registered, and licensed before December 31, 1989, shall not be subject to the resident management requirement set forth in the first paragraph of Article 28 of this Act.

Article 104-1

The western pharmaceutical dealers duly approved, registered, and licensed before December 31, 1989, referred to in the preceding Article, shall refer to responsible persons of pharmaceutical firms who have not changed and are still in business as of January 1, 1990. Pharmaceutical firms registered as retailers that continue to operate under the supervision of the spouse after the death of the original responsible persons shall not apply.

Article 104-2

Persons who apply for a license or formally inquire about the Regulations for Registration of Medicinal Products, Regulations for Registration of Medical Devices, and related regulations shall be subject to a fee.
The classification and amount of the fee referred to in the preceding paragraph shall be determined by the central competent health authority.

Article 104-3

When necessary, a competent health authority at any level may designate a subordinate agency or commission a relevant agency (or organization) to conduct all or part of the test checks and inspections. The regulations governing such designation or commissioning and related matters shall be prescribed by the central competent health authority.

Article 104-4

The central competent health authority may carry out certification for the inspection institutions for medicament inspection operations. The regulations governing their certification and management shall be prescribed by the central competent health authority.
The central competent health authority may designate a subordinate agency or commission another agency (or organization) to carry out the certification of the preceding paragraph. The regulations governing such designation or commissioning and other relevant matters shall be prescribed by the central competent health authority.

Article 105

The Enforcement Rules of this Act shall be established by the central competent health authority.

Article 106

1. This Act becomes effective from the date of promulgation.
2. The enforcement date of Article 53 hereof, which was amended and published on May 7, 1997, shall be set by the Executive Yuan. Articles that have been amended on May 5, 2006, shall be enforced as of July 1, 2006.
3. The enforcement date of Chapter 4-1 and Articles 92-1, 100, and 100-1 and 92-2 hereof, which have been amended on December 29, 2017, shall be set by the Executive Yuan.