Circular No. 19/2025/TT-BYT stipulates the division and classification of local government authorities' jurisdiction at two levels in the field of disease prevention, issued by the Minister of Health.

CIRCULAR

REGULATIONS ON THE DETERMINATION AND DELEGATION OF AUTHORITY OF LOCAL ADMINISTRATIONS AT TWO LEVELS IN THE FIELD OF DISEASE PREVENTION

Pursuant to the Law on Government Organization 2025;

Pursuant to Resolution No. 190/2025/QH15 dated February 19, 2025 of the National Assembly on handling certain issues related to the restructuring of state administrative bodies;

Pursuant to Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Preventive Medicine Department;

The Minister of Health issues this Circular to regulate the determination and delegation of authority of local administrations at two levels in the field of disease prevention.

PART I

DETERMINATION OF AUTHORITY IN THE FIELD OF DISEASE PREVENTION

Article 1. Selection of key surveillance sites

The authority to select key surveillance sites is stipulated in Clause 1, Article 15 of Circular No. 07/2023/TT-BYT dated April 4, 2023, guiding the procedures and methods for epidemiological surveillance of HIV/AIDS and sexually transmitted diseases, which shall be carried out by the provincial lead agency for HIV/AIDS prevention and control.

Article 2. Advising on the organization and implementation of activities to respond to infectious diseases

The authority to advise on the organization and implementation of activities to respond to infectious diseases on the administrative area, as stipulated in Clause 2, Article 12 of Circular No. 17/2019/TT-BYT dated July 17, 2019, guiding the surveillance and response to infectious diseases, shall be carried out by the health sector specialized agencies under the People's Committee at the commune level.

Article 3. Management and inspection of occupational hygiene and worker health conditions

The authority to manage and inspect occupational hygiene and worker health conditions at workplaces within the administrative area, as stipulated in Clause 1, Article 16 of Circular No. 19/2016/TT-BYT dated June 30, 2016, guiding the management of occupational hygiene and worker health, shall be carried out by the Provincial Center for Disease Control.

Chapter II

DELEGATION OF AUTHORITY IN THE FIELD OF DISEASE PREVENTION

Article 4. Acceptance of registration files for conformity declarations and issuance of acceptance certificates for conformity declarations based on the results of conformity assessments by designated conformity assessment organizations (third parties) for tobacco products

1. The authority to accept registration files for conformity declarations and issue acceptance certificates for conformity declarations based on the results of conformity assessments by designated conformity assessment organizations (third parties) for tobacco products, as stipulated in Clause 1, Article 7 of Circular No. 49/2015/TT-BYT dated December 11, 2015, amended and supplemented by Circular No. 17/2023/TT-BYT dated September 25, 2023, concerning the declaration of conformity and compliance with regulations for tobacco products, shall be carried out by the health sector specialized agencies under the People's Committee at the provincial level.

2. The file requirements, procedures, and processes for registering and accepting registration files for conformity declarations based on the results of conformity assessments by designated conformity assessment organizations (third parties) for tobacco products shall be implemented according to Part 1 of the Appendix attached to this Circular.

Article 5. Acceptance of registration files for conformity declarations and issuance of acceptance certificates for conformity declarations based on self-assessment results of organizations and individuals producing and trading in tobacco products (first parties)

1. The authority to accept registration files for conformity declarations and issue acceptance certificates for conformity declarations based on self-assessment results of organizations and individuals producing and trading in tobacco products (first parties), as stipulated in Clause 1, Article 7 of Circular No. 49/2015/TT-BYT, amended and supplemented in 2023, shall be carried out by the health sector specialized agencies under the People's Committee at the provincial level.

2. The file requirements, procedures, and processes for accepting registration files for conformity declarations and issuing acceptance certificates for conformity declarations based on self-assessment results of organizations and individuals producing and trading in tobacco products (first parties) shall be implemented according to Part 2 of the Appendix attached to this Circular.

Article 6. Acceptance of resubmission of conformity declaration registration and reissue of conformity declaration acceptance certificate for tobacco products

1. The authority to accept the resubmission of conformity declaration registration and reissue of conformity declaration acceptance certificate for tobacco products as stipulated in Clause 2, Article 8 of Circular No. 49/2015/TT-BYT amended and supplemented in 2023 shall be carried out by the health specialized agencies under the People's Committees of provinces.

2. The dossier, procedures, and formalities for accepting the resubmission of conformity declaration registration and reissue of conformity declaration acceptance certificate based on self-assessment results of organizations and individuals producing and trading in tobacco products (the first party) shall be implemented according to the provisions set forth in Part 2 of the Appendix attached to this Circular.

Chapter III

IMPLEMENTING PROVISIONS

Article 7. Implementation Provisions

Article 32. Responsibilities of Agencies

2. This Circular shall cease to be effective from March 1, 2027.

3. During the period when this Circular takes effect, if the provisions regarding authority and state management responsibilities in this Circular differ from those in other Circulars issued by the Minister of Health before July 1, 2025, they shall be implemented according to the provisions of this Circular.

Article 8. Transitional Provisions

1. For dossiers submitted before the effective date of this Circular: The dossier receiving agency shall continue to process them according to current regulations until the administrative procedure is completed.

2. District, county, town, city-level health centers, commune health stations shall continue to implement reporting systems until the Ministry of Health issues replacement guidelines.

Article 9. Responsibility for implementation

The Directors of the Preventive Medicine Department, the Office of the Ministry, Heads of Departments, Councillors of the Ministry of Health, Provincial Health Directors, Heads of health agencies under Ministries and sectors, and related agencies are responsible for implementing this Circular.

ANNEX

Dossier, Procedures, Formalities for Implementing Certain Administrative Procedures within the Field of Disease Prevention
(Annexed to Circular No. 19/2025/TT-BYT dated June 15, 2025)

Part 1. Registration and Acceptance of Dossier for Conformity Declaration Based on the Results of Conformity Assessment by Designated Conformity Assessment Organizations (Third Party) for Tobacco Products

1. Organizations and individuals declaring conformity shall prepare the declaration dossier in accordance with Clause 1, Article 4 of Circular No. 49/2015/TT-BYT and submit it to the health specialized agency under the People's Committee of the province where their headquarters are located (hereinafter referred to as the dossier receiving agency). In cases where an organization or individual has two or more production facilities producing the same product, the organization or individual shall only handle the product declaration registration at one local government management agency chosen by the organization or individual. Once a government management agency is selected for registration, subsequent registrations must be made at the previously chosen agency.

2. Within seven working days from the date of receipt of a complete and valid dossier, the dossier receiving agency shall issue the acceptance certificate in accordance with Model No. 06 promulgated by Circular No. 49/2015/TT-BYT. If the acceptance certificate is not issued, the dossier receiving agency must provide a written response stating the reasons.

3. Within fifteen working days from the date of receipt of a complete and valid dossier marked with the official stamp, the dossier receiving agency shall issue the confirmation certificate in accordance with Model No. 07 promulgated by Circular No. 49/2015/TT-BYT. If the confirmation certificate is not issued, the dossier receiving agency must provide a written response stating the reasons.

4. Within sixty working days from the date of receipt of the notification letter from the dossier receiving agency explaining the reasons for not issuing the acceptance certificate or confirmation certificate, if the organization or individual declaring conformity does not supplement or complete the dossier as required, the dossier receiving agency will cancel the declaration dossier.

Part 2. Acceptance of registration dossier for conformity declaration, issuance of conformity declaration acceptance receipt based on self-assessment results of organizations and individuals producing and trading tobacco products (the first party) for tobacco products.

1. Organizations and individuals declaring conformity shall establish the declaration dossier in accordance with Clause 1, Article 5 of Circular No. 49/2015/TT-BYT and submit it to the specialized health agency under the People's Committee of the province where the establishment is located (hereinafter referred to as the dossier receiving agency). In cases where an organization or individual has two or more production establishments producing the same product, the organization or individual only needs to register the product declaration at one local state management agency chosen by them. Once a state management agency is selected for registration, subsequent registrations must be made at the previously selected agency.

2. Within seven working days from the date of receipt of a complete and valid dossier, the dossier receiving agency shall issue the acceptance certificate in accordance with Model No. 06 promulgated by Circular No. 49/2015/TT-BYT. If the acceptance certificate is not issued, the dossier receiving agency must provide a written response stating the reasons.

3. Within fifteen working days from the date of receipt of a complete and valid dossier as evidenced by the official stamp, the dossier receiving agency is responsible for issuing the confirmation receipt in accordance with Form No. 07 issued together with Circular No. 49/2015/TT-BYT. In case of non-issuance of the confirmation receipt, the dossier receiving agency must provide a written response stating the reasons.

4. Within sixty working days from the date of receipt of the notification letter from the dossier receiving agency explaining the reasons for not issuing the acceptance certificate or confirmation certificate, if the organization or individual declaring conformity does not supplement or complete the dossier as required, the dossier receiving agency will cancel the declaration dossier.

Part 3. Acceptance of re-registration dossier for conformity declaration, reissuance of conformity declaration acceptance receipt for tobacco products.

1. The re-registration dossier for conformity declaration and reissuance of the conformity declaration acceptance receipt for tobacco products shall be carried out in accordance with Clause 3, Article 8 of Circular No. 49/2015/TT-BYT.

2. The procedure for accepting the re-registration dossier for conformity declaration and reissuance of the conformity declaration acceptance receipt for tobacco products shall be implemented as follows:

a) Within seven working days from the date of receipt of a complete application dossier as evidenced by the official stamp, the specialized health agency under the provincial People's Committee (hereinafter referred to as the dossier receiving agency) is responsible for reissuing the acceptance receipt in accordance with Form No. 09 issued together with Circular No. 49/2015/TT-BYT or issuing the confirmation receipt in accordance with Form No. 10 issued together with Circular No. 49/2015/TT-BYT. In case of non-reissuance, a written response must be provided stating the reasons.

b) In case of any changes during the production or processing process that affect quality criteria and violate safety limits compared to the declaration, organizations and individuals producing and trading tobacco products must re-declare conformity or declare compliance in accordance with Articles 4, 5, and 6 of Circular No. 49/2015/TT-BYT.