Circular No. 5/2020/TT-BYT of the Ministry of Health on amending and supplementing certain articles of Circular No. 24/2018/TT-BYT dated September 18, 2018 of the Ministry of Health regarding the establishment, organization, and operation of the Expert Advisory Council for assessing the causes of severe adverse events following immunization.

CIRCULAR

Amending and supplementing certain 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 of the Ministry of Health regarding the establishment, organization, and operation

of the Expert Advisory Council for assessing the causes of severe adverse events

during the use of vaccines

Pursuant to the Law on Prevention and Control of Infectious Diseases 2007;

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 activities related to vaccination;

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

The Minister of Health promulgates this Circular amending and supplementing certain 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 the use of vaccines.

Article 1. Amending and supplementing certain 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 the use of vaccines (hereinafter referred to as Circular No. 24/2018/TT-BYT)

1. Points a, b, and c Clause 4 Article 2 of Circular No. 24/2018/TT-BYT shall be 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 the fields of pharmaceuticals, vaccines, epidemiology;

- Clinical experts in obstetrics, immunology, pediatrics, emergency care 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 summarizing relevant materials concerning severe adverse events following immunization, preparing the agenda for Council meetings, and finalizing the minutes of each meeting."

2. Points a, b, and c Clause 4 Article 3 of Circular No. 24/2018/TT-BYT shall be 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 Department of Health Services - Provincial Health Department, Department of Pharmaceutical Services - Provincial Health Department;

- Clinical experts in obstetrics, pediatrics, emergency care at provincial general hospitals, provincial maternity and children's hospitals, or pediatric hospitals, or obstetrics and pediatrics departments of provincial general hospitals, or 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 Health Center (hereinafter referred to as Disease Control Center), provincial general hospital. The Secretariat's duties include collecting and summarizing relevant materials concerning severe adverse events following immunization, preparing the agenda for Council meetings, and finalizing the minutes of each meeting."

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

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

2. The Standing Office of the Council at the provincial level assisting the Council at the provincial level 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 operation of the Councils at all levels;

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

d) The Standing Office at the Ministry level reports to the Minister of Health, the Standing Office at the provincial level reports to the Director of the Provincial Health Department on 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 Heads of the Ministry's Office, the Preventive Medicine Department, Departments, Bureaus, General Departments under the Ministry of Health, Heads of agencies and units directly under the Ministry, Directors of Health Departments of provinces and centrally governed cities, and Heads of medical units under Ministries, sectors, and related units are responsible for implementing this Circular.

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