Glossary
Recall by the Business Operator (Korea)
In Korea, a recall in which the marketing authorisation holder or importer withdraws distributed product on its own initiative once it learns of a safety or efficacy problem, without waiting for an order from the authority.
Source · 「약사법」 제39조제1항(위해의약품등의 회수); 「의약품 등의 안전에 관한 규칙」 제50조(위해등급평가 및 회수계획서 제출) Korean original
Details
This is the Korean distinction based on who started the recall: unlike a recall ordered by the authority, the business operator begins it on its own judgement. The parties obliged to recall are the marketing authorisation holder, quasi-drug manufacturers, and importers; they assess the hazard as Class 1 to 3, submit a recall plan to the regional office within 5 days of learning of the problem, and must complete the recall within 15 days for Class 1 and 30 days for Classes 2 and 3. Published Korean cases are often precautionary recalls citing impurity levels above the limit, or related substance and microbial limit failures found in post-marketing stability testing. That a diligently executed recall can reduce an administrative penalty also bears on the decision.
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Source
「약사법」 제39조제1항(위해의약품등의 회수); 「의약품 등의 안전에 관한 규칙」 제50조(위해등급평가 및 회수계획서 제출) Korean originalGRM Regulatory Glossary
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