Article 2
Terms used in Article 7 of the Act are defined as follows:
1. New composition: a newly invented composition that can be used for pharmaceutical purposes.
2. New therapeutic compound: an already approved drug with new medical efficacy in terms of new indications, reduced side effects, improved therapeutic strength, improved therapeutic period, or altered dosage, or a compound prepared from two or more already approved compositions whose medical efficacy is superior to either of the individual drug compositions.
3. New method of administration: An altered method of administration for an already approved drug.

Article 10
Those applying for registration as a pharmaceutical firm in accordance with Article 27, paragraph 1 shall fill out an application form, submitting it together with a licensing fee and the documents listed below, for approval by the competent health authority of their special municipality or county (or county-level city):
1. The professional licenses or certification documents of the drug administration, manufacturing supervision, or technical personnel that the firm is required to hire under the provisions of the Act.
2. For a pharmaceutical firm organized as a company, photocopies of the firm’s corporate registration and articles of incorporation.
3. For a seller of drugs and medical devices, the firm’s business address and a basic floor plan showing the premises (the drug storage warehouse) and principal equipment.
4. For a manufacturer of drugs or medical devices, the firm’s factory registration certificate and a photocopy of the same, except when the firm is exempt from factory registration under the Factory Management Act.
5. Other documents required by the special municipality or county (or county-level city).
For a newly established pharmaceutical firm organized as a company, the competent health authority may first issue establishment permit documents to the firm, then issue a pharmaceutical firm permit license to the firm after it obtains its corporate registration or factory registration documents.

Article 22-1
To apply for the importation of active pharmaceutical ingredients for the trial production of a drug in accordance with Article 39, paragraph 2 of the Act, an application fee shall be paid and an application form, along with the following materials, submitted to the central competent health authority for approval:
1. The pharmaceutical firm’s permit license.
2. A written trial production plan.
3. The factory registration documents issued by the Ministry of Economic Affairs. Research and development organizations are exempt from this requirement.
4. When another pharmaceutical firm is contracted to handle the importation of active pharmaceutical ingredients for trial production of a drug, the letter of instruction and the pharmaceutical firm permit licenses of the contracting party and the contractor are required.

Article 37
When any circumstance under Article 80, paragraph 1, subparagraphs 1 through 4 of the Act applies to a drug, the pharmaceutical firms, pharmacies, and medical care institutions concerned shall immediately cease their importation, manufacture, wholesaling, display, preparation, and retailing of the drug from the date of public announcement or from a date determined in accordance with the law. Any firm that manufactures or imports the drug shall recall the drugs from the market within the period specified for that purpose, and shall dispose of them, along with the drugs in their stock, in accordance with Article 79 of the Act. The recall period, which at most may not exceed 2 months, shall be determined by the central competent health authority based on the nature of the individual case.
When any circumstance under Article 80, paragraph 1, subparagraphs 5 or 6 of the Act applies to a drug, the drug may not be sold until the firm that manufactures or imports the drug, within 6 months from the date of expiration of the drug permit license or from the date on which the change in packaging, labeling, or usage instructions is approved, has recalled the product from the market and delivered it, along with any product in their stock, to be examined by and receive the seal of the competent health authority of the special municipality or county (or county-level city).
Prior to carrying out recall of a drug, a manufacturer or importer shall formulate a written recall plan, setting out the recall procedure, time period, the deadline for filing a report on the recall results for recordation, and other related matters. The recall plan shall be submitted to the central competent health authority for recordation, and the recall shall then be carried out in accordance with the plan; after the recall has been completed, the report on results of the recall shall be prepared and submitted to health authorities at all levels for recordation.