Pharmaceutical Affairs Act Enforcement Rules 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.
中文原文 藥事法施行細則第10條
依本法第二十七條第一項規定申請藥商登記者，應填具申請書，連同執照費及下列文件，申請直轄市或縣（市）衛生主管機關核准：
一、依本法規定，應聘用藥物管理、監製或技術人員者，其所聘人員之執業執照或證明文件。
二、藥商為公司組織者，其公司登記、公司組織章程影本。
三、藥物販賣業者，其營業地址、場所（貯存藥品倉庫）及主要設備之平面略圖。
四、藥物製造業者，其工廠登記證明文件及其影本。
但依工廠管理輔導法規定免辦理工廠登記者，免附。
五、直轄市或縣（市）衛生主管機關所定之其他文件。
新設立公司組織之藥商，得由衛生主管機關先發給籌設許可文件，俟取得公司登記或工廠登記證明文件後，再核發藥商許可執照。
一、依本法規定，應聘用藥物管理、監製或技術人員者，其所聘人員之執業執照或證明文件。
二、藥商為公司組織者，其公司登記、公司組織章程影本。
三、藥物販賣業者，其營業地址、場所（貯存藥品倉庫）及主要設備之平面略圖。
四、藥物製造業者，其工廠登記證明文件及其影本。
但依工廠管理輔導法規定免辦理工廠登記者，免附。
五、直轄市或縣（市）衛生主管機關所定之其他文件。
新設立公司組織之藥商，得由衛生主管機關先發給籌設許可文件，俟取得公司登記或工廠登記證明文件後，再核發藥商許可執照。