Regulations for Health Risk Assessment Review of Designated Tobacco Products｜第 6 條｜國民健康｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2023-03-22
The central competent authority may require the applicant to implement and submit information of the following post-market monitoring and control mechanisms for the products that have been granted under the health risk assessment review: (1) Ongoing or completed researches on the use of the products by consumers and the findings; (2) Information on sales of the products and consumer complaints; (3) Information on the use of the products of current and first-time smokers; (4) Any change in the manufacture process or composition of the products; (5) Adverse event reporting, analysis, and response mechanisms; (6) Newly discovered data on addiction; (7) Information on adverse events of health occurring abroad; and (8) Other necessary monitoring and control mechanisms. The data and information referred to in Subparagraphs 1 to 3 of the preceding paragraph involving personal information shall be de-identified. If the applicants fail to comply with the provisions in Paragraph 1, the central competent authority shall order the applicants to make corrections within a specified period of time. If the applicants fail to make corrections within the specified period of time, the authorization for the products under the health risk assessment review shall be repealed.