Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms Article 14

Law:: Regulations Governing Management of Manufacturing Schedule 1 and 2 Controlled Drugs Commissioned to Pharmaceutical Firms
Chinese:: 藥商受託製造第一級及第二級管制藥品管理辦法第14條

The FDA shall order the commissioned pharmaceutical firm to improve within a specified time in the following circumstances, and shall terminate the contract if the improvement is not made at the end of the specified time, or in severe circumstances, where the commissioned pharmaceutical firm:1. Violates Paragraph 2, Article 2;2. Does not meet the qualifications in Paragraph 1, Article 3;3. Violates Paragraphs 1 or 3, Article 4;4. Violates Article 5;5. Violates Article 6;6. Violates Paragraph 1, Article 7, or does not prepare its safety and protection plan according to the requirements in Paragraph 2;7. Violates Article 8;8. Violates Article 9;9. Violates Article 10;10. Violates Article 11;11. Violates Paragraph 3, Article 12; or12. Violates Paragraph 1, Article 13.

中文原文藥商受託製造第一級及第二級管制藥品管理辦法第14條

受託藥商有下列情形之一者，食品藥物署應令其限期改善；屆期未改善或情節重大者，應終止委託：
一、違反第二條第二項規定。
二、未具備第三條第一項資格。
三、違反第四條第一項或第三項規定。
四、違反第五條規定。
五、違反第六條規定。
六、違反第七條第一項規定，或其保全計畫內容與第二項規定不符。
七、違反第八條規定。
八、違反第九條規定。
九、違反第十條規定。
十、違反第十一條規定。
十一、違反第十二條第三項規定。
十二、違反第十三條第一項規定。

English translation for reference only; the Chinese text prevails. Not legal advice.