Regulations for Drug Recall Article 3

The drug manufacturers or importers shall finish their recall procedure within the time period as following:1. Class I: Within one month since the day following publicly announcement or the date of recall has been deemed duly.2. Class II: within two months since the day following publicly announcement or the date of recall has been deemed duly.3. Class III: within six months since the day following the expiration date of the drug permit license or approval to change the package, label, or use instruction.For 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, the central competent health authority shall define the time periods for recall of those not classified through the public notice under Paragraph 2 of the preceding article.After the counterfeit drugs, prohibited drugs and misbranded drugs are recalled, the municipal or city (county) competent health authority shall treat the same in accordance with Article 78 and Article 79 of the Act.