Regulations for Health Risk Assessment Review of Designated Tobacco Products｜第 3 條｜國民健康｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2023-03-22
The application in the preceding Article shall be submitted with the application form promulgated by the central competent authority and the following documents, data, and materials about the products: (1) Health risk research data that have been published, known to, or should reasonably be known to the applicants and health risk comparisons with other tobacco products; (2) Data on raw materials, additives, and other relevant ingredients; (3) Data on emissions; (4) Data on the testing methods for the substances in Subparagraph 2 and 3 of this Paragraph; (5) Processing methods; (6) Research data on addictive substances; (7) Relevant data on the products’ ability to induce people younger than 20 years of age and first-time smokers to use the products; (8) Nicotine and tar yields of the minimum usage unit or in the emissions of the products; (9) Samples of the products and essential components and safety statements for use; (10) Safety certification documents and/or data issued by certified laboratories in accordance with relevant national standards; (11) Documents and/or data on the countries and the permission dates that the products are granted for sale; (12) Specific measures, implementation methods and the commitments for the monitoring and control mechanisms for tobacco hazards prevention and control; and (13) Other documents, data, and materials designated by the central competent authority. The documents and/or data in the preceding Paragraph, except for figures, shall be submitted in Traditional Chinese, and annotated in English where necessary. Where the documents, data, and materials required in Paragraph 1 are incomplete, the central competent authority shall order the applicants to supplement the documents and/or data within a specified period of time. If the applicants fail to supplement the documents, data and/or materials within the specified period of time, the application shall be rejected. International standards recognized by the central competent authority may temporarily substitute for the national standards in Subparagraph 10 of Paragraph 1 before the national standards are promulgated.