Regulations for the Management of Drug Safety Surveillance Article 11
In the event that the periodic and summary reports of drug safety indicated in Article 8 or 9 are not submitted or the Risk Assessment and Control Plan in the preceding article is not completely enforced as a result of the pharmaceutical dealer suspends business operations or going out of business, a report shall be submitted on the portion that is already completed within 60 days after the occurrence of facts of suspended or discontinued operation. Implementation shall be continuing upon restored operation in the future.
中文原文 藥物安全監視管理辦法第11條
藥商申請停業或歇業，致第八條或第九條藥品安全性定期及總結報告未能繳交，或前條藥品風險評估及管控計畫未執行完竣者，應自停、歇業事實發生日起六十日內，就已執行部分，繳交報告；其嗣後復業者，應接續予以完成。