Any person with the intent to be a pharmaceutical firm shall file application 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 license. 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.
For setting 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.

To apply for suspension of business, pharmaceutical firms shall clearly state the reason and term of suspension, and hand in the business permit license and drug permit license to the local competent health authority, which shall be returned after 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 cancel in the business permit license and drug permit license. In the case that in the said license and permit license and not cancelled, said license and permit license shall be cancelled 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 licenses and permit license after the municipal or county (city) competent health authority verifies that no business operations exists in the original establishment address. Licenses and permit license of any pharmaceutical firm that violates the provisions under this Act, and in ordered suspension of business the competent health authority, shall be processed in accordance with the provisions under the first Paragraph.

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

Dealers of western pharmaceuticals and their sales shall have a full-time resident pharmacist for management. However, a full-time assistant pharmacist, if no narcotics 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 the training of 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.

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 the training of Chinese medicines to an appropriate level to supervise the manufacturing.
In addition to provisions of the preceding Paragraph, in case 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.

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.

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

Dealers or manufacturers of medical devices shall employ qualified technicians by the relevant categories of devices.
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.

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, who are employed at pharmacies, pharmaceutical firms, health and medical care institutions, or medical research institutions, and have been approved and registered by the competent health authority, shall only sell drugs manufactured or sold by the pharmaceutical firm at which he/she is employed, and shall not commit acts of peddling, street vending, breaking seal of medicament or repackage medicament without authorization, or illegal advertisement.