Regulations for Drug Recall Article 2
The drugs to be recalled under Subparagraphs 1, 2 and 4 to 6 of Paragraph 1 of Article 80 of the Act shall be classified into the following 3 classes:1. Class I:(1) The counterfeit drugs or prohibited drugs in accordance with Subparagraph 2 of Paragraph 1 of Article 80 of the Act.(2) The drugs damaging the life, body or health of users in accordance with Subparagraph 4 of Paragraph 1 of Article 80 of the Act.(3) The drugs referred to in Subparagraph 1, misbranded drugs referred to in Subparagraph 2 and drugs referred to in Subparagraph 4 of Paragraph 1 of Article 80 of the Act, which are have been deemed by the central competent health authority likely to cause damage to the life, body or health of users.2. Class II: The drugs referred to in Subparagraph 1, misbranded drugs referred to in Subparagraph 2, and drugs referred to in Subparagraph 4 of Paragraph 1 of Article 80 of the Act, other than those referred to in Item 2 and Item 3 in the preceding Subparagraph.3. Class III: The drugs referred to in Subparagraphs 5 and 6 of Paragraph 1 of Article 80 of the Act.The drugs of which the recall has been publicly announced by the central competent health authority in accordance with Subparagraph 7 of Paragraph 1 of Article 80 of the Act may cover the classes referred to in the preceding paragraph.
中文原文 藥物回收處理辦法第2條
本法第八十條第一項第一款、第二款、第四款至第六款應回收之藥品，分為下列三級：
一、第一級：
（一）本法第八十條第一項第二款之偽藥、禁藥。
（二）本法第八十條第一項第四款確有損害使用者生命、身體或健康事實之藥品。
（三）本法第八十條第一項第一款藥品、第二款之劣藥及第四款藥品，經中央衛生主管機關認定對使用者生命、身體或健康有發生重大損害之虞者。
二、第二級：前款第二目及第三目以外之本法第八十條第一項第一款藥品、第二款之劣藥及第四款藥品。
三、第三級：本法第八十條第一項第五款及第六款藥品。
中央衛生主管機關依本法第八十條第一項第七款公告應回收之藥品時，得包括前項回收之分級。
一、第一級：
（一）本法第八十條第一項第二款之偽藥、禁藥。
（二）本法第八十條第一項第四款確有損害使用者生命、身體或健康事實之藥品。
（三）本法第八十條第一項第一款藥品、第二款之劣藥及第四款藥品，經中央衛生主管機關認定對使用者生命、身體或健康有發生重大損害之虞者。
二、第二級：前款第二目及第三目以外之本法第八十條第一項第一款藥品、第二款之劣藥及第四款藥品。
三、第三級：本法第八十條第一項第五款及第六款藥品。
中央衛生主管機關依本法第八十條第一項第七款公告應回收之藥品時，得包括前項回收之分級。