Set up a vaccination clinic business in Vietnam

Along with the development of medical investment and the current vaccination needs of the people, private vaccination facilities and non-public vaccination services have developed in both quality and quantity. This development has contributed to bringing medical services closer to people in need while also meeting the needs of society. In this article below, Viet An Law will provide legal information related to the conditions to set up a vaccination clinic business in Vietnam.

Legal basis

• Law on Infectious Disease Prevention and Control of 2007, as amended and supplemented in 2008, 2018, and 2020;
• Decree 104/2016/ND-CP regulates vaccination activities, as amended and supplemented by Decree 155/2018/ND-CP and Decree 13/2024/ND-CP;
• Decree 117/2020/ND-CP regulating penalties for administrative violations in the health sector, as amended and supplemented by Decree 124/2021/ND-CP and Decree 96/2023/ND-CP ;
• Circular 34/2018/TT-BYT detailing several articles of Decree 104/2016/ND-CP, as amended and supplemented by Decree 96/2023/ND-CP

What is a vaccination clinic?

According to Decree 104/2016/ND-CP, vaccination is the introduction of vaccines into the human body to create an immune response for the body to prevent disease.

A vaccination clinic is understood as a qualified medical facility that has declared its eligibility for vaccination according to the provisions of law.

Conditions for establishing a private vaccination clinic

Market access conditions for foreign investors

According to Vietnam’s WTO Commitments, industries related to vaccination services have not been committed. WTO has not yet committed, then clearly states that it is not committed. When applying for an investment license, you must consult the relevant ministries and branches and must meet the same conditions as Vietnamese investors.

Conditions for establishing a fixed private vaccination clinic

Regarding facilities

The vaccination area must be protected from rain and sun, airtight, well-ventilated, and arranged according to the one-way principle from reception, guidance, consultation, screening, vaccination, monitoring, and treatment. post-vaccination reactions.

Regarding equipment

• Have refrigerators, vaccine thermos or cold boxes, and temperature monitoring devices at the place of storage and during transportation of vaccines;
• Have an anti-shock box and an anti-shock protocol hanging at the place to monitor and handle post-vaccination reactions according to regulations of the Minister of Health;

Regarding personnel

• Quantity: Have at least 03 medical staff, including at least 01 staff with a medical degree or higher; For vaccination facilities in remote, there must be at least 02 employees with intermediate medical degrees or higher, including at least 01 employee with a medical degree or higher;
• Academic level:
  • Health workers participating in vaccination activities must receive specialized training in vaccination.
  • Staff directly screening, consulting, monitoring, and handling post-vaccination reactions must have the professional qualifications of a physician or higher.
  • Staff have an intermediate degree in Medicine or an intermediate degree in Nursing – Midwifery or higher.

Conditions for establishing a mobile vaccination clinic

Vaccination at home in communes in remote areas and communes with extremely difficult socio-economic conditions

• Only applies to vaccination activities under the Expanded Program on Immunization and anti-epidemic vaccination;
• Have a vaccine thermos and shockproof box according to the regulations of the Minister of Health;
• Personnel: Have at least 02 medical staff with appropriate qualifications similar to regulations for fixed private vaccination clinics.

Conditions for other mobile vaccination sites

• Be performed by a vaccination facility that has declared its eligibility for vaccination;
• Infrastructure: Arranged according to one-way principles from reception, guidance, consultation, screening, vaccination, monitoring and handling of post-vaccination reactions;
• Equipment: Have vaccine thermos or cold box and shockproof box according to regulations of the Minister of Health;
• Personnel: Have at least 02 medical staff with appropriate qualifications similar to regulations for fixed private vaccination clinics.

Some private vaccination clinics in Vietnam

Business registration for private vaccination business

Most private vaccination clinics today are implemented based on the capital of a business to meet the conditions for subsequent operating licenses. When registering to establish a business enterprise in this field, investors should note the following industries:

Regulations on notification of eligibility for vaccination

After meeting the conditions for establishing a private vaccination clinic, it is necessary to carry out procedures to declare the facility eligible for vaccination with the Department of Health where the private vaccination clinic is located.

Step 1: Submit publication documents

Before being put into operation, the head of the private vaccination clinic shall send to the Department of Health where the vaccination facility is located an written notification of eligibility for vaccination according to the form issued in the appendix attached to Decree 104/2016/ND-CP by mail or directly to the Department of Health where the vaccination facility is located.

The head of the vaccination facility that self-declares vaccination eligibility is responsible before the law for the accuracy of the notification dossier.

Step 2: Receive and publish notification

Within 03 days from the date of receiving the written notification of vaccination eligibility, the Department of Health must post information related to the name, address, and head of the facility that has declared vaccination clinic on the website of the Department of Health (the date to calculate the information must be announced based on the incoming dispatch from the Department of Health).

Notes on inspection during the operation of private vaccination clinics

• During the process of inspecting and checking vaccination conditions at vaccination facilities, if it is discovered that the vaccination facility does not comply with the prescribed conditions, the inspection and examination team must make a record of the temporary suspension of operations and propose to the competent authority to decide on handling according to the provisions of law and send a record to the Department of Health where the vaccination facility is located.
• Within 05 working days from the date of receiving the record of temporary suspension of operations specified in Clause 3 of this Article (the time of receipt is determined according to the incoming dispatch from the Department of Health), the Department of Health withdraw the facility’s name from the list of notification facilities posted on the Department of Health’s website.

Company establishment services of Viet An Law

• Legal advice related to procedures for establishing vaccination clinics;
• Draft and complete documents to establish vaccination clinics
• Client representative works with competent authorities related to procedures for establishing vaccination clinics
• Regularly advise service companies on procedures to establish vaccination clinics during operations;
• Providing intellectual property representation services, and legal consulting services in the fields of business, trade, investment, and domestic and international trade dispute resolution.

For advice to set up a vaccination clinic business in Vietnam, please contact Viet An Law Firm for the best support.

Disclaimer: This article was last updated in March 2024. Laws may have changed since then. Please contact Viet An Law to confirm the information in this article is current and for any legal assistance.