Regulations for Reporting Serious Adverse Reactions of Medicaments Article 3

Medical care institutions, pharmacies, and pharmaceutical firms that have obtained a drug manufacturing or importing approval (hereinafter referred to as “pharmaceutical firms”) shall report to the central competent health authority's designated online system by filling out a report form upon becoming aware of a serious adverse reaction to a drug as described in the previous article.Reporting under the previous paragraph may be made orally, by telephone, fax, or email as necessary. However, online reporting must be completed within the time limits specified in Articles 6 or 7.If the central competent health authority deems the report content submitted under the preceding 2 paragraphs unclear or incomplete, it may order the reporter to make corrections within a specified time limit.