Article 1(Purpose) #
The purpose of this Decree is to prescribe the matters mandated by the Tobacco Products Harm Control Act and other matters necessary for the enforcement thereof.
Article 2(Formulation of master plan) #
(1) "Matters prescribed by Presidential Decree" in Article 5(3)5 of the Tobacco Products Harm Control Act (hereinafter referred to as the "Act") means matters regarding the following:
1. International cooperation in the control of the harmful nature of tobacco products;
2. Management of statistics and information on the harmful nature of tobacco products.
(2) When the Minister of Health and Welfare and the Minister of Food and Drug Safety have jointly formulated or modified a master plan for the control of harmful nature of tobacco products under Article 5(1) of the Act (hereinafter referred to as "master plan"), they shall notify the heads of relevant central administrative agencies of the details thereof; provided, upon consultation between the Minister of Health and Welfare and the Minister of Food and Drug Safety, the Minister of Food and Drug Safety may notify the heads of relevant central administrative agencies of such details.
(3) In jointly establishing basic objectives of and directions for policies on the control of harmful nature of tobacco products under Article 5(3)1 of the Act, the Minister of Health and Welfare and the Minister of Food and Drug Safety shall ensure that such objectives and directions are in line with those provided in international treaties, arrangements, agreements, etc. relating to the control of tobacco products.
Article 3(Formulation of implementation plan) #
(1) In accordance with Article 6(2) of the Act, the Minister of Health and Welfare and the Minister of Food and Drug Safety shall jointly formulate an annual implementation plan under Article 6(1) of the Act (hereinafter referred to as "implementation plan") by every December 31st after conducting consultations with the heads of relevant central administrative agencies and undergoing deliberation by the Tobacco Products Harm Control Policy Committee under Article 9 of the Act (hereinafter referred to as the "Policy Committee").
(2) An implementation plan shall include the performance in the promotion of the implementation plan for the pertinent year and an implementation plan for the following year.
(3) When the Minister of Health and Welfare and the Minister of Food and Drug Safety have jointly formulated an implementation plan, they shall notify the heads of relevant central administrative agencies of the details thereof; provided, upon consultation between the Minister of Health and Welfare and the Minister of Food and Drug Safety, the Minister of Food and Drug Safety may notify the heads of relevant central administrative agencies of such details.
Article 4(Scope and method of survey and research) #
(1) In accordance with Article 7(1) of the Act, the Minister of Health and Welfare and the Minister of Food and Drug Safety may jointly conduct surveys and research on the following matters:
1. Types of tobacco products, tobacco emissions, etc. and content thereof;
2. Health impacts of tobacco products, tobacco emissions, etc. on human body and demographic groups (including impacts by gender or other factors);
3. Other matters regarding analyses of the conditions for promoting domestic and overseas policies relating to tobacco products, tobacco emissions, etc. and the effects of such policies.
(2) The Minister of Health and Welfare and the Minister of Food and Drug Safety may entrust a research institution, corporation or organization with expertise in tobacco products, tobacco emissions, etc. with the conduct of surveys and research under Article 7(1) of the Act.
Article 5(Exclusion of, challenge to, or recusal of members) #
(1) A member of the Policy Committee (hereinafter referred to as "member") falling under any of the following cases shall be excluded from deliberation and resolution by the Policy Committee:
1. Where the member or the member's current or former spouse is either a party to the relevant agenda item (where the party is a corporation or organization, including an executive officer thereof; hereinafter the same shall apply) or a person holding any right or duty jointly with the party to such agenda item;
2. Where the member is or was related by blood or marriage to a party to the relevant agenda item;
3. Where the member or the corporation, organization, etc. to which he or she belongs is a current or former agent for a party to the relevant agenda item;
4. Where the member has served for the corporation, organization, etc. that is a party to the relevant agenda item as an executive officer or employee during the latest 5 years;
5. Where the member has provided advice or served as an advisor in response to a request from a party to the relevant agenda item or has been involved in the business of a party to the relevant agenda item in the form of research or service partnership with the party or any other form, during the latest 5 years.
(2) Where a member falls under any ground for exclusion under the subparagraphs of paragraph (1) or where the circumstances indicate that it would be impracticable to expect impartial deliberation and resolution from a member, a party to the agenda item may file a request for challenge with the Policy Committee, which shall decide whether to accept the challenge by resolution. In such cases, the member subject to the request for challenge shall not participate in the resolution.
(3) Where a member falls under any ground for exclusion under the subparagraphs of paragraph (1) or deems that there are circumstances that make it impracticable to expect impartial deliberation, he or she shall recuse himself or herself from the deliberation or resolution on the relevant agenda item.
Article 6(Dismissal of members) #
The Minister of Health and Welfare and the Minister of Food and Drug Safety may dismiss a member commissioned under Article 9(4)2 and 3 of the Act after consultation thereon, in any of the following cases:
1. Where the member becomes unable to perform his or her duties due to physical or mental infirmity for a long period of time;
2. Where the member commits any wrongdoing related to his or her duties;
3. Where the member is deemed unfit as a member due to neglect of duties, injury to dignity, or any other grounds;
4. Where the member does not recuse himself or herself, despite falling under any subparagraph of Article 5(1) or having circumstances in which impartial deliberation cannot reasonably be expected;
5. Where the member voluntarily declares that it is impracticable for him or her to perform his or her duties.
Article 7(Operation of the Policy Committee) #
(1) The chairpersons of the Policy Committee under Article 9(3) of the Act (hereinafter referred to as "chairpersons") shall individually represent the Policy Committee and exercise overall control over its business affairs.
(2) The chairpersons shall jointly convene a Policy Committee meeting and take turns to preside over the meeting; provided, upon mutual consultation, they may jointly preside over a meeting.
(3) Where both of the chairpersons are unable to perform their duties due to unavoidable reasons, a member designated in advance by the chairpersons shall act on their behalf.
(4) A Policy Committee meeting shall be convened when the chairpersons deem it necessary or at the request of at least 1/3 of its members.
(5) The chairpersons shall notify the members of the schedule and agenda item of a meeting and other necessary information no later than 7 days before the meeting; provided, this shall not apply where urgency exists or where the disclosure of the agenda item may harm the public interest.
(6) A majority of the members of the Policy Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present.
(7) Where necessary for deliberation, the chairpersons may request persons relevant to the agenda item or experts in the relevant field to appear and state their opinions.
(8) The Policy Committee shall have 2 executive secretaries to ensure efficient operation and support, each of whom shall be appointed respectively by the Minister of Health and Welfare and the Minister of Food and Drug Safety from among director-level public officials who take charge of relevant business affairs at the Ministries.
Article 8(Allowances and travel expenses) #
Allowances and travel expenses may be paid to members who attend a Policy Committee meeting, within the budget; provided, this shall not apply where a member who is a public official attends such meeting in direct connection with his or her duties.
Article 9(Detailed operational regulations) #
Except as provided in Articles 5 through 8, matters necessary for the operation of the Policy Committee shall be determined jointly by the chairpersons following resolution by the Policy Committee.
Article 10(Scope of disclosure of information on harmful constituents) #
(1) The scope of disclosure of information on harmful constituents by type of tobacco products under Article 14(1) of the Act shall be as follows:
1. Information on harmful constituents publicly notified by the Minister of Food and Drug Safety under Article 11(2) of the Act; and in such cases, details of disclosure shall be subject to deliberation and determination by the Policy Committee;
2. Information on the human health hazards of harmful constituents under subparagraph 1, including toxicity and carcinogenicity.
(2) When the scope of disclosure has been determined following deliberation by the Policy Committee, the Minister of Food and Drug Safety shall disclose information prescribed in the subparagraphs of paragraph (1) on the website, etc. of the Ministry of Food and Drug Safety within 10 days from the date such determination is made.
Article 11(Delegation of authority) #
(1) In accordance with Article 22 of the Act, the Minister of Food and Drug Safety may delegate authority over the following matters to the Director General of the National Institute of Food and Drug Safety Evaluation Service:
1. Receipt of data on the matters listed in the subparagraphs of Article 12(1) of the Act (hereinafter referred to as "inspection results, etc.");
2. Forwarding of inspection results, etc. under Article 13 of the Act;
3. Review of inspection results, etc. under Article 14(1) of the Act.
(2) In accordance with Article 22 of the Act, the Minister of Food and Drug Safety may delegate authority over the following matters to the heads of regional offices of food and drug safety:
1. A corrective order under Article 18(1) of the Act;
2. An order for recall, destruction, or any other necessary measures under Article 18(2) of the Act;
3. Vicarious execution and collection of expenses under Article 18(3) of the Act;
4. An order for reporting, and access, inspection and collection under Article 21(1) of the Act (limited to cases relevant to subparagraphs 1 through 3).
Article 12(Processing of personally identifiable information) #
If it is unavoidable for conducting the following administrative affairs, the Minister of Food and Drug Safety may process data that include resident registration numbers or alien registration numbers referred to in subparagraph 1 or 4 of Article 19 of the Enforcement Decree of the Personal Information Protection Act:
1. Administrative affairs regarding the designation of an institution to conduct inspections under Article 16(1) of the Act; (hereinafter referred to as "inspection institution")
2. Administrative affairs regarding approval for change and report on change granted to or submitted by an institution designated under Article 16(1) of the Act (hereinafter referred to as "inspection institution") in accordance with paragraph (3) of that Article;
3. Administrative affairs regarding revocation of designation of an inspection institution and suspension of its business operations under Article 17(1) of the Act;
4. Administrative affairs regarding hearings under Article 17(4) of the Act.
Article 13(Criteria for imposing administrative fines) #
The criteria for imposing administrative fines under Article 26(1) of the Act shall be as specified in the Appendix.