Circular No. 05/2020/TT-BYT amends and supplements certain provisions of Circular No. 24/2018/TT-BYT dated September 18, 2018, of the Ministry of Health on the establishment, organization, and operation of the Expert Advisory Board for assessing the causes of severe adverse events following immunization.

CIRCULAR

Amending and supplementing some articles of Circular No. 24/2018/TT-BYT dated September 18, 2018 of the Ministry of Health on the establishment, organization, and operation of the Expert Advisory Council for assessing the causes of severe adverse events during vaccine use

dated September 18, 2018

To assess the causes of severe adverse events

during the vaccine usage process

Pursuant to the Law on Prevention and Control of Infectious Diseases2007;

Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government stipulating vaccination activities;

At the proposal of the Director of the Preventive Medicine Department, Ministry of Health;

The Minister of Health promulgates this Circular amending and supplementing some articles of Circular No. 24/2018/TT-BYT dated September 18, 2018 of the Ministry of Health on the establishment, organization, and operation of the Expert Advisory Council for assessing the causes of severe adverse events during vaccine use (hereinafter referred to as Circular No. 24/2018/TT-BYT).

Article 1. Amending and supplementing some articles of Circular No. 24/2018/TT-BYT dated September 18, 2018 of the Ministry of Health on the establishment, organization, and operation of the Expert Advisory Council for assessing the causes of severe adverse events during vaccine use (hereinafter referred to as Circular No. 24/2018/TT-BYT)

1. Points a, b, c Clause 4 Article 2 of Circular No. 24/2018/TT-BYT are amended and supplemented as follows:

"a) Chairman of the Council: An independent expert with reputation in the field of vaccination and not belonging to the National Regulatory Authority (NRA) of Vietnam;
b) Vice-Chairman of the Council: Leader of a central-level hospital specializing in pediatrics or infectious diseases;
c) Members of the Council:

- Representatives from the Department of Medical Examination and Treatment, Legal Affairs Department, Planning and Finance Department;

- Experts from the Institute of Hygiene and Epidemiology, Pasteur Institute, representatives from the University of Medicine, experts in pharmaceuticals, vaccines, epidemiology;

- Clinical specialists in obstetrics, immunology, pediatrics, critical care medicine from hospitals, one to two persons per unit;

The Chairman of the Council establishes a Secretariat consisting of representatives from the Preventive Medicine Department, Central Institute of Hygiene and Epidemiology. The Secretariat's duties include collecting and compiling relevant materials related to severe adverse events following immunization, preparing the agenda for Council meetings, and finalizing meeting minutes after each session."

2. Points a, b, c Clause 4 Article 3 of Circular No. 24/2018/TT-BYT are amended and supplemented as follows:

"a) Chairman of the Council: Leader of the Provincial Health Department;
b) Vice-Chairman of the Council: Leader of a provincial general hospital or regional general hospital;
c) Members of the Council:

- Leaders of the Medical Services Department - Provincial Health Department, Pharmaceutical Services Department - Provincial Health Department;

- Clinical specialists in obstetrics, pediatrics, critical care medicine at provincial general hospitals, provincial maternity and children's hospitals, or pediatric hospitals, or obstetrics and pediatrics departments at provincial general hospitals, or provincial reproductive health centers, Institute of Hygiene and Epidemiology, Pasteur Institute according to the management area;

The Chairman of the Council establishes a Secretariat consisting of representatives from the Provincial Health Department, Disease Control Center or Provincial Preventive Medicine Center (hereinafter referred to as Disease Control Center), Provincial General Hospital. The Secretariat's duties include collecting and compiling relevant materials related to severe adverse events following immunization, preparing the agenda for Council meetings, and finalizing meeting minutes after each session."

3. Article 5 of Circular No. 24/2018/TT-BYT is amended and supplemented as follows:

"1. The Standing Office of the Ministry-level Council assisting the Ministry-level Council is located at the Preventive Medicine Department and uses the seal of the Preventive Medicine Department."

2. The Standing Office of the provincial-level Council assisting the provincial-level Council is located at the Disease Control Center and uses the seal of the Disease Control Center.

3. Tasks of the Standing Offices at all levels:

a) Directing and guiding units and individuals to provide relevant files as requested by the Councils at all levels;

b) Allocating legitimate financial resources for the operations of the Councils at all levels;

c) Preparing logistical and administrative activities for the Councils at all levels;

d) The Standing Office of the Ministry-level Council reports to the Minister of Health, the Standing Office of the provincial-level Council reports to the Director of the Provincial Health Department about the results of the meetings;

e) Storing files in accordance with regulations."

Article 2. Effective Date

This Circular takes effect from June 1, 2020.

Article 3. Responsibility for Implementation

The Head of the Ministry’s Office, Directors of Departments, Councillors, Heads of Units under the Ministry of Health, Heads of Units directly under the Ministry, Directors of Health Departments of provinces and centrally governed cities, and Heads of Healthcare Units of Ministries, sectors, and related units are responsible for implementing this Circular. In the course of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to report to the Ministry of Health for consideration and resolution.

In the course of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to report to the Ministry of Health for consideration and resolution./.