Regulation for the Issuance and Management of Western Pharmaceuticals Distribution Licenses and Certificates Article 2
The pharmaceutical firm announced by the central competent health authority according to the Paragraph 2 of Article 53-1 of the Act, shall submit an application to the central competent health authority for western pharmaceuticals distribution license after filling out an application form, submitting the photocopy of pharmaceutical firm business permit license and the basic information of the pharmaceutical firm, and pay the application fee; after passing the inspection conducted by the central competent health authority, the western pharmaceuticals distribution license can be issued to the pharmaceutical firm.The license validation period mentioned in the preceding paragraph, may be approved for 3 to 5 years according to the type of the western pharmaceuticals, operation items, the preceding paragraph and inspection record indicated in the Paragraph 1 of Article 71 of the Act.
中文原文 西藥運銷許可及證明文件核發管理辦法第2條
經中央衛生主管機關依本法第五十三條之一第二項公告之藥商，應填具申請書，並檢附藥商許可執照影本、廠商基本資料及繳納費用後，向中央衛生主管機關提出申請西藥運銷許可；經中央衛生主管機關檢查通過者，發給西藥運銷許可。
前項許可有效期間，得視藥商之西藥種類、作業項目及依前項與本法第七十一條第一項規定所為檢查之紀錄，核定為三年至五年。
前項許可有效期間，得視藥商之西藥種類、作業項目及依前項與本法第七十一條第一項規定所為檢查之紀錄，核定為三年至五年。