Decree No. 13/2024/NĐ-CP amends and supplements certain Articles of Decree No. 104/2016/NĐ-CP dated July 1, 2016, of the Government on vaccination activities.

DECREE

Amending and supplementing certain articles of Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on vaccination activities

On the basis of Law on Government Organization dated June 19, 2015;

On the basis of Law on State Budget Management dated June 25, 2015;

On the basis of Law on Prevention and Control of Infectious Diseases dated November 21, 2007;

On the basis of The Law on Local Administration Organization dated November 22, 2019 and the Law amending and supplementing certain articles of the Law on Government Organization;

On the basis of The Public Investment Law dated June 13, 2019 and The Law amending and supplementing certain articles of the Public Investment Law, the Law on Investment under the Public-Private Partnership Model, the Investment Law, the Housing Law, the Bidding Law, the Enterprise Law, the Special Consumption Tax Law, and the Civil Enforcement Law dated January 11, 2022;

Pursuant to Resolution No. Decision No. 99/2023/QH15 dated June 24, 2023 of the National Assembly on specialized supervision regarding the mobilization, management, and utilization of resources for COVID-19 prevention and control work; the implementation of policies and laws on primary healthcare and preventive healthcare;

At the proposal of the Minister of Health;

THE GOVERNMENT ISSUES THE DECREE AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS OF DECREE NO. Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on vaccination activities.

Article 1. Amending and supplementing certain articles of Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on vaccination activities as follows:

1. Adding Clause 7 of Article 3 as follows:

"7. The Expanded Immunization Program is a program organized by the State to provide free vaccinations with mandatory vaccines for preventing infectious diseases for children and pregnant women."

2. Amending Clause 2 and Clause 3 of Article 7 as follows:

"2. Based on the number of people to be vaccinated, the time frame, and the usage quota of each type of vaccine, the vaccination facility shall be responsible for preparing the forecasted demand for vaccines specified in Clause 1 of this Article for the entire year and submit it to the agency in charge of vaccination management at the district level for consolidation and submission to the Department of Health before May 30 of each year to direct the supply of vaccines in the Expanded Immunization Program.

3. Based on the proposal of vaccine demand from the agency in charge of vaccination management at the district level, the Department of Health shall be responsible for consolidating and submitting it to the People's Committee of the province for approval and then sending it to the Ministry of Health before June 30 of each year to develop the annual plan for vaccine supply, use, and vaccination."

3. Adding Clause 3 of Article 14 as follows:

"3. The central budget shall allocate funds within the regular budget of the Ministry of Health to ensure funding for the following activities in the Expanded Immunization Program:

a) Purchasing vaccines for individuals covered by the Expanded Immunization Program.

b) Testing vaccines.

c) Receiving, transporting, and storing vaccines up to the provincial and municipal levels.

d) Information, education, communication, training costs, scientific research expenses to apply new techniques and methods in vaccination, and monitoring the effectiveness of vaccines at the central level.

đ) Compensating when adverse events occur during vaccine use that seriously affect health or cause loss of life for the vaccinated person at vaccination facilities under central ministries and agencies.

In cases where adverse events occur during vaccine use at local vaccination facilities and the cause is determined to be due to vaccine quality, inherent characteristics of the vaccine, or errors in vaccine storage and transportation from the central level to the provincial and municipal levels, the central budget shall allocate funds for compensation."

4. Amending Clause 2 of Article 21 as follows:

"2. Ensuring resources and local budgets for the activities of the Expanded Immunization Program and epidemic control vaccination within the locality, excluding activities already guaranteed by the central budget as stipulated in Clause 3 of this Article."

5. Amending Clause 1 of Article 22 as follows:

"1. Developing and implementing the annual plan for using vaccines under the Expanded Immunization Program."

6. Adding Clause 6 and Clause 7 of Article 22 as follows:

"6. Guiding localities to prepare plans, determine vaccine needs by type, necessary vaccine structure, and plans for receiving each type of vaccine to ensure the approved increase in the number of vaccines in the Expanded Immunization Program.

7. Organizing the purchase of vaccines for the Expanded Immunization Program in accordance with the provisions of the law."

7. Amending Clause 3 of Article 23 as follows:

"3. The Ministry of Finance shall be responsible for presenting proposals to competent authorities to allocate funds for the implementation of the Expanded Immunization Program and epidemic control vaccination in accordance with the State Budget Law and this Decree."

Article 2. Effective Date

This Decree takes effect from the date of issuance./.