Regulations for Reporting Serious Adverse Reactions of Medicaments Article 6

Medical institutions and pharmacies shall submit reports under Article 3, Paragraph 1 within the following time limits:1. Subparagraphs 1 and 2 of Article 2: Within 7 days since the day following awareness.2. Subparagraphs 3 to 6 of Article 2: Within 30 days since the day following awareness.Medical care institutions and pharmacies may request pharmaceutical firms to provide product-related information for reporting under the preceding paragraph. The pharmaceutical firms shall not evade, obstruct, or refuse to provide such information.