Competent health authorities may send their respective officials to inspect the facilities and relevant business operations of pharmaceutical manufacturers and/or dealers and may sample-test the medicaments concerned by issuing a receipt for such purpose, to which the manufacturers or dealers shall not reject without good cause, however, that the quantity of samples to be taken shall be limited to the extent sufficient for use of testing.
Where it seems necessary as case may be, inspection of manufacturers of medicaments may be conducted in conjunction with the central competent authority in charge of industries.
Regulations governing the performance of the inspection set forth in this Article shall be established by the central competent health authority in conjunction with the central competent authority in charge of industries.

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

Competent health authorities may send their respective officials to inspect the relevant business operations of the medical care institutions or pharmacies, and may sample-test the medicaments concerned by issuing a receipt for such purpose, to which the agency undertaking such inspection shall not reject without good cause, however, that the quantity of samples to be taken shall be limited to the extent sufficient for use of testing.

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

No serum, antitoxin, vaccine, toxcid and drugs produced biologically, immunologically may be put to sale, unless each lot of such drugs has been sampled-tested after importation or manufacturing evidencing their approval and batch-sealed by the central competent health authority. The inspection and batch-sealing procedures shall be established by the central competent health authority.
The importation of the raw liquid of biological drugs referred to in the preceding Paragraph shall be restricted to biological drug manufacturers.

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

In case any medicament to be manufactured or imported under official approval is found to cause serious hazards, the central competent health authority may, at any time, announce prohibiting its import and manufacture and further revoke the medicament permit license previously granted. As for medicaments of same kind already manufactured or imported, they shall be prohibited within a time limit from export, dispensation, sale, supply, transport, storage, brokerage, transfer, or display with intent to sell, and may be confiscated and incinerated if necessary as case may be.

Municipal or county (city) competent health authority may first place the suspicious counterfeit drugs, misbranded 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 may confiscate and incinerate or destroyed 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.

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 audits or inspections:
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 in their entirety its drug permit license, pharmaceutical firm business permit license, and medicament manufacture license, 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 Executive Yuan-governed 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 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 Executive Yuan-governed 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 violation. In the case of a serious violation or continued violation, each respective drug permit 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.

The counterfeit drugs or prohibited drugs seized shall be confiscated and destroyed.
In case the misbranded drugs or defective medical devices seized are of domestic products 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 which can not be re-modified or have not been re-modified after expiry of the given time limit shall be confiscated and destroyed. If the use seized are of approved imports, 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 the medical devices which are legally held as domestic products or imports without approval.

If any of the following circumstances applies 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 permit 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 to have 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 to be likely to damage, the life, body or health of users.
5. Where an application for extension of a medicament manufacture or import permit license previously granted has not been filed or its approval has been denied.
6. Where an amended registration of the package, label, or use instructions of the medicament in question 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, is announced by the central competent health authority.

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