Regulations for Drug Recall Article 15

The drug manufacturers or importers, with respect to the recall procedure under Class I and Class II, shall produce an outcome report as referred to in Subparagraph 6 of Article 9 and submit it to the municipal or county(city) competent health authority and central competent health authority within 3 days since the date of completion of the recall. The competent authority may request for supplements or correction.The outcome report referred to in the preceding paragraph shall include the following contents:1. Name, address, and phone number of the drug manufacturer or importer.2. Name, specifications, and permit license number of the drug.3. Batch number, serial number or any other identification information or number of the drugs;4. The total quantity, sales quantity, and inventory quantity of the drugs manufactured domestically or imported, and product descriptions and quantity of the drugs which are recalled and yet recalled to be specified separately.5. The recall items and quantity lists from each recall targets.6. Recall completion date, storage location for recalled products, and the follow-up handling method and date.7. Follow-up corrective and preventive actions for the reason to recall.