Pharmaceutical Affairs Act Enforcement Rules Article 34
After the repackaging of imported active pharmaceutical ingredients in accordance with Article 53, paragraph 2 of the Act has been conducted by an importing pharmaceutical firm that meets the good manufacturing practice standards for drugs, the firm shall fill out an application form, accompanied by a photocopy of the drug permit license, a copy of the import declaration approved and issued by customs, the original manufacturer's certificate of analysis, the method of testing, and other designated documentation, and apply for recordation with the central competent health authority.Repackaged active pharmaceutical ingredients may only be sold to drug manufacturers; the labeling used shall indicate the following matters:1. The manufacturer's name and address.2. The product name and registration number.3. The efficacy of the drug and its indications.4. The lot number.5. The name and address of the repackaging pharmaceutical firm.6. The date of repackaging.7. The date of manufacture and the period of validity or shelf life.8. Other matters that shall be indicated in accordance with relevant provisions.Subparagraph 7 of the preceding paragraph does not apply when the central competent health authority, by public announcement, has ordered exemption from the requirement to indicate the matters set out in that article.
中文原文 藥事法施行細則第34條
依本法第五十三條第二項為輸入原料藥之分裝，應由輸入之藥商於符合優良藥品製造規範之藥廠分裝後，填具申請書，連同藥品許可證影本、海關核發之進口報單副本、原廠檢驗成績書、檢驗方法及其他指定文件，申請中央衛生主管機關備查。
經分裝之原料藥，以銷售藥品製造業者為限；所使用之標籤應分別刊載左列事項：
一、廠商名稱及地址。
二、品名及許可證字號。
三、效能或適應症。
四、批號。
五、分裝藥商名稱及地址。
六、分裝日期。
七、製造日期及有效期間或保存期限。
八、其他依規定應刊載事項。
前項第七款經中央衛生主管機關明令公告免刊載者，不在此限。
經分裝之原料藥，以銷售藥品製造業者為限；所使用之標籤應分別刊載左列事項：
一、廠商名稱及地址。
二、品名及許可證字號。
三、效能或適應症。
四、批號。
五、分裝藥商名稱及地址。
六、分裝日期。
七、製造日期及有效期間或保存期限。
八、其他依規定應刊載事項。
前項第七款經中央衛生主管機關明令公告免刊載者，不在此限。