Regulations for Drug Recall Article 5
The medical care institutions, pharmacies and pharmaceutical firms concerned shall immediately cease the importation, manufacturing, wholesaling, display, preparation and retailing of the drugs referred to in Subparagraphs 1, 2 and 4 of Paragraph 1 of Article 80 of the Act from the date of public announcement by the central competent health authority or from a date determined in accordance with the law.The drugs recalled according to the Regulations along with the stock thereof shall be disposed of in the following manners:1. Counterfeit drugs and prohibited drugs defined under Subparagraph 2 of Paragraph 1 of Article 80 of the Act shall be confiscated and destroyed.2. For the drugs referred to in Subparagraphs 1 and 4 and misbranded drugs referred to Subparagraph 2 of Paragraph 1 of Article 80 of the Act:(1) Where they are drugs made domestically and considered, after testing, to be still usable through re-modification, the municipal or city (county) competent health authority shall direct and assign an official to supervise the original manufacturers to re-modify the drugs within specific time limit. Those that cannot be re-modified or have not been re-modified after expiry of the given time limit shall be confiscated and destroyed.(2) Where they are imported from any foreign country, they shall be placed in confinement immediately and the municipal or county (city) competent health authority shall direct the original importer to return such drugs to the foreign supplier(s) within specific time limit. Those have not been returned beyond the given time limit shall be confiscated and destroyed.3. The drugs referred to in Subparagraphs 5 and 6 of Paragraph 1 of Article 80 of the Act: The drugs still can be sold before their expiry dates or within their shelf life, after to be examined by and receive the seal of the municipal or city (county) competent health authority. Notwithstanding, in the case of changes in the use instructions referred to in Subparagraph 6, the manufacturers or importers may be exempted from the application for examination and seal after notifying the direct sales targets.4. The drugs to be recalled under Subparagraph 7 of Paragraph 1 of Article 80 of the Act: To be recalled in the manner designated through public notice.
中文原文 藥物回收處理辦法第5條
醫療機構、藥局及藥商，應自中央衛生主管機關公告或依法認定之日起，停止本法第八十條第一項第一款、第二款與第四款藥品之輸入、製造、批發、陳列、調劑及零售。
本辦法回收之藥品市售品及庫存品，應依下列規定處理：
一、本法第八十條第一項第二款之偽藥或禁藥，沒入銷燬之。
二、本法第八十條第一項第一款及第四款藥品、第二款劣藥：
（一）屬本國製造，經檢驗後仍可改製使用者，由直轄市、縣（市）衛生主管機關派員監督原製造廠商限期改製；其不能改製或屆期未改製者，沒入銷燬之。
（二）屬國外輸入者，應即封存，並由直轄市、縣（市）衛生主管機關責令原進口商限期退運出口；屆期未能退貨者，沒入銷燬之。
三、本法第八十條第一項第五款及第六款藥品：經直轄市、縣（市）衛生主管機關核准驗章後，於藥品有效期間或保存期限內，仍得販賣。
但屬第六款之仿單變更者，藥品製造或輸入業者，於完成通知直接銷售對象變更內容後，得免辦理驗章。
四、本法第八十條第一項第七款應回收之藥品：依公告指定方式辦理。
本辦法回收之藥品市售品及庫存品，應依下列規定處理：
一、本法第八十條第一項第二款之偽藥或禁藥，沒入銷燬之。
二、本法第八十條第一項第一款及第四款藥品、第二款劣藥：
（一）屬本國製造，經檢驗後仍可改製使用者，由直轄市、縣（市）衛生主管機關派員監督原製造廠商限期改製；其不能改製或屆期未改製者，沒入銷燬之。
（二）屬國外輸入者，應即封存，並由直轄市、縣（市）衛生主管機關責令原進口商限期退運出口；屆期未能退貨者，沒入銷燬之。
三、本法第八十條第一項第五款及第六款藥品：經直轄市、縣（市）衛生主管機關核准驗章後，於藥品有效期間或保存期限內，仍得販賣。
但屬第六款之仿單變更者，藥品製造或輸入業者，於完成通知直接銷售對象變更內容後，得免辦理驗章。
四、本法第八十條第一項第七款應回收之藥品：依公告指定方式辦理。