Tobacco Hazards Prevention Act Article 7
Before manufacturing or importing designated tobacco products announced by the central competent authority, manufacturers and importers shall apply to the central competent authority for the health risk assessment review, and only those that pass the review may be manufactured or imported.If tobacco products legally declared to the central competent authority are discovered to pose new health risks, the central competent authority may, by announcement, designate the tobacco products to undergo the health risk assessment review within a specified period of time, which shall be accompanied by the recall and ban on manufacturing or importing within a specified period of time. If the tobacco products are unable to pass the health risk assessment review, the central competent authority shall order the recall or destruction within a specified period of time, and issue the ban on manufacturing and importing of that tobacco products.For the tobacco products designated as requiring the health risk assessment review (hereinafter referred to as the designated tobacco products) according to the preceding two paragraphs, matters regarding the health risk assessment review, including the application procedures, the required documents, materials and the essential components, and the scope and procedure of the health risk assessment review, the post-market monitoring and control mechanisms, the repeal of authorization , and other related matters, shall be stipulated by the central competent authority.For the designated tobacco products that are seized or detained at the customs, if the products are not applied for the health risk assessment review within three months of the designation announcement by the central competent authority, or the products are unable to pass the health risk assessment review, the seizing or detaining customs may destruct the products without further notification.For the designated tobacco products seized or detained by the customs under the preceding paragraph, their owners or importers may claim the products within three months after the products pass the health risk assessment review. If the products are not claimed within that time, the seizing or detaining customs may destruct the products without further notification.
中文原文 菸害防制法第7條
中央主管機關公告指定之菸品，業者應於製造或輸入前，向中央主管機關申請健康風險評估審查，經核定通過後，始得為之。
經向中央主管機關依法完成申報之菸品有新發現健康風險時，中央主管機關得公告指定其應於一定期限內申請健康風險評估審查，並應限期命業者回收及停止製造、輸入；申請健康風險評估審查，未經核定通過者，限期命其回收或銷毀並禁止製造、輸入。
前二項所定應申請健康風險評估審查之菸品（以下稱指定菸品），其健康風險評估審查之申請程序、應備文件與資料及必要之組合元件、健康風險評估審查範圍與審查程序、上市後監視與管控機制、核定之廢止及其他相關事項之辦法，由中央主管機關定之。
指定菸品經扣押或扣留於海關者，於中央主管機關公告指定後三個月內未申請健康風險評估審查，或已申請健康風險評估審查而未經核定通過者，得由原扣押或扣留海關逕予銷毀。
前項扣押或扣留於海關之指定菸品，其攜帶或輸入者得於該指定菸品經核定通過健康風險評估審查後三個月內領回；屆期未領回者，原扣押或扣留海關得逕予銷毀。
經向中央主管機關依法完成申報之菸品有新發現健康風險時，中央主管機關得公告指定其應於一定期限內申請健康風險評估審查，並應限期命業者回收及停止製造、輸入；申請健康風險評估審查，未經核定通過者，限期命其回收或銷毀並禁止製造、輸入。
前二項所定應申請健康風險評估審查之菸品（以下稱指定菸品），其健康風險評估審查之申請程序、應備文件與資料及必要之組合元件、健康風險評估審查範圍與審查程序、上市後監視與管控機制、核定之廢止及其他相關事項之辦法，由中央主管機關定之。
指定菸品經扣押或扣留於海關者，於中央主管機關公告指定後三個月內未申請健康風險評估審查，或已申請健康風險評估審查而未經核定通過者，得由原扣押或扣留海關逕予銷毀。
前項扣押或扣留於海關之指定菸品，其攜帶或輸入者得於該指定菸品經核定通過健康風險評估審查後三個月內領回；屆期未領回者，原扣押或扣留海關得逕予銷毀。