Nowadays, with the growth of medical investment and people’s vaccination needs, in addition to public vaccination facilities, private vaccination services have developed in both quantity and quality. This contributes to providing medical services closer to the majority of people in need, meeting the health care needs of society. So what are the procedures for opening a vaccination center? What documents need to be noted? Let’s read the article below with Viet My Law and Accounting for the answer.

1. Legal basis

• Law on Prevention and Control of Infectious Diseases 2007, amended and supplemented in 2008, 2018, 2020;
• Decree 104/2016/ND-CP regulating vaccination activities;
• Circular 34/2018/TT-BYT details a number of articles of Decree 104/2016/ND-CP, amended and supplemented by Decree 96/2023/ND-CP.

2. What conditions must be met to be licensed to open a vaccination center?

2.1. For fixed vaccination centers

Regarding facilities:

The vaccination area must be clean, protected from rain and sun, windproof, well-ventilated and arranged according to the one-way principle from reception, instructions, consultation, screening, vaccination, monitoring and handling of post-vaccination reactions.

Regarding equipment:

+ There must be a refrigerator, vaccine thermos or cold box, temperature monitoring equipment at the storage area and during the vaccine loading process;

+ There must be an anti-shock box, an anti-shock protocol posted at the monitoring and handling of post-vaccination reactions according to the regulations of the Minister of Health;

Regarding personnel:

+ Number: at least 03 medical staff, of which at least 01 staff must have professional qualifications from a medical doctor or higher; For vaccination facilities in remote, isolated and particularly disadvantaged areas, there must be at least 02 staff with a medical degree or higher, of which at least 01 staff member must have a medical degree or higher;

+ Medical staff participating in vaccination activities must be thoroughly trained in vaccination. Staff directly examining, screening, consulting, monitoring and handling post-vaccination reactions of customers must have a medical degree or higher; staff performing vaccination must have a medical degree or higher.

2.2. For mobile vaccination centers

– Only applicable to vaccination activities under the Expanded Immunization Program, vaccination against epidemics;

– Having full vaccine plugs and anti-shock boxes according to regulations set forth by the Minister of Health;

– Meeting the personnel requirements;

– Must be performed by a vaccination facility that has been declared to meet the Vaccination Conditions;

– Facilities: arranged according to the one-way principle from reception, guidance, consultation, screening, vaccination, monitoring and handling of post-vaccination reactions.

– Equipment: have vaccine plugs or cold boxes and anti-shock boxes according to the legal regulations of the Minister of Health.

– Personnel: have at least 02 medical professionals who meet the conditions: medical staff participating in vaccination activities must be professionally trained in vaccination. Staff directly performing screening, consultation, monitoring and handling of post-vaccination reactions must have professional qualifications from medical doctors or higher; medical staff performing vaccination must have qualifications from intermediate medical school or intermediate nursing – midwifery or higher.

3. Announcement of eligibility for vaccination

According to Decree 104/2016/ND-CP dated July 1, 2016, the regulations are as follows:

– Send a written notice of eligibility for vaccination according to the form to the Department of Health where the vaccination facility is located.

– Within 03 working days from the date of receiving a valid notice of eligibility for vaccination, the Department of Health must post information on the Department of Health’s website about the name, address, and head of the facility that has announced eligibility for vaccination.

– The facility may only carry out vaccination activities after having announced eligibility for vaccination for the people. The head of the vaccination facility that self-announces eligibility for vaccination must be legally responsible before the law for his/her self-announcement.

4. Documents to prepare when opening a vaccination center

To open a vaccination center, you need to prepare all the following documents:

+ Application form for a certificate of eligibility for vaccination according to form No. 1 as prescribed in Appendix No. 1 issued with Circular 12/2014/ND-CP;

+ 1 List of personnel organizations;

+ Legally certified copies of the following documents of each employee performing vaccination work by the competent authority;

+ Recruitment decision or labor contract with a valid stamp of confirmation from the employer;

+ Medical professional degree;

+ Certificate of participation in vaccination training;

+ 1 List of equipment according to the form prescribed in Appendix No. 3 issued with Circular 12/2014/ND-CP;

+ Floor plan of the vaccination area including: waiting area, consultation and triage examination; vaccination, monitoring and handling of post-vaccination reactions of customers;

+ Certified copies of documents proving the establishment and operation of the facility requesting a certificate of eligibility for vaccination, including:

• Operating license for medical examination and treatment facilities according to regulations set forth by law on medical examination and treatment;
• Decision to establish the facility or business registration certificate or investment certificate for other medical facilities.

5. How many steps are involved in the procedure for opening a vaccination center?

Step 1: The facility requesting the issuance of a certificate of eligibility for vaccination submits 01 set of original documents and 01 set of copies to the Department of Health (Medical Affairs Department).

Step 2: Processing the application: upon receiving the application, the Department of Health sends the facility requesting the issuance of a certificate of eligibility for vaccination a receipt of documents.

Step 3: Appraising the application

In case the application must be completely and properly reissued, the Department of Health is responsible for:

• Transferring the application for a new certificate of eligibility for vaccination to the Health Department of the district, town, city at the provincial level (hereinafter referred to as the district) where the medical facility requesting the issuance of a new certificate of eligibility for vaccination is located within only 05 working days, starting from the date of receiving the documents for assessment at the facility.
• Within approximately 15 working days from the date of receipt of the application for a new vaccination eligibility certificate, the District Health Department is responsible for establishing an appraisal team and organizing the assessment.
• The appraisal team consists of: The leader of the District Health Department – Head of the team; representative of the District Health Center; representative of the District Health Center (for districts that have separated from private district hospitals); relevant experts and staff invited at the proposal of the head of the team.
• After the assessment, the Appraisal Team is obliged to draw up an appraisal record and send it to the Department of Health (Medical Affairs Department) within 03 working days, starting from the date of completion of the assessment;

Step 4: Issuing a vaccination eligibility certificate

Within 07 working days from the date of receipt of the appraisal record, the Director of the Department of Health must issue a vaccination eligibility certificate to that facility. In case of not issuing a certificate, there must be a written response stating the reason.

6. How are violations of vaccination regulations handled?

During the operation of a vaccination center, if it is discovered that the center does not comply with the conditions prescribed by law, the inspection and examination team will draw up a record of temporary suspension of operations for that facility and recommend that the competent authority decide on handling according to regulations, and at the same time send a notice and record to the Department of Health where the vaccination facility is located.

Within 05 working days from the date of receipt of the record of violation, the Department of Health will remove the name of that facility from the list of self-declared facilities posted on the Department of Health’s website. Thus, when carrying out the procedures for opening a vaccination center, the subject must meet all the above conditions according to the provisions of law so that after establishment, it can operate normally and in accordance with the regulations.

“Procedures for opening a vaccination center” have been provided by us through the information in the article above. Viet My Law and Accounting always has enthusiastic support from legal service consultants. If you have any problems or need to use our services, please contact us at any time. We will try our best to resolve customer problems, providing services quickly, easily and conveniently.