Circular No. 01/1999/TT-BYT guides the management, use, and pricing of vaccines and immunological products for humans.

CIRCULAR

Guidelines for managing, using, and pricing vaccines and immunological products for human use

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In order to effectively manage the circulation and use of vaccines and immunological products to ensure public health, taking into account the comments submitted by the Government Price Control Board in Circular No. 1168/BVGCP-CNTDDV dated December 14, 1998, and the Ministry of Finance in Circular No. 63 TC/HCSN dated January 6, 1999, the Ministry of Health hereby provides guidelines for managing, using, and pricing vaccines and immunological products for human use as follows:

1. Healthcare facilities permitted to use vaccines and immunological products:

1.1. Preventive Health Centers responsible for administering vaccinations and using all types of vaccines and immunological products approved by the Ministry of Health for disease prevention, diagnosis, and treatment.

1.2. State-run healthcare facilities, private hospitals, and healthcare facilities with foreign investment capital are permitted to administer and use vaccines outside the Expanded Immunization Program and immunological products for disease prevention, diagnosis, and treatment within their authorized scope.

2. Healthcare facilities not permitted to administer vaccines and use immunological products: private healthcare facilities (excluding private hospitals and healthcare facilities with foreign investment capital).

3. Conditions for using vaccines and immunological products:

Healthcare facilities and units implementing vaccination activities must meet the following conditions:

- Having appropriate infrastructure to store vaccines and immunological products under necessary conditions.

- Having sufficient equipment, means, technical devices, etc., to serve injection, testing, emergency care, etc.

- Maintaining purchase records for vaccines and immunological products, monitoring expiration dates, vaccination schedules, and product quality control.

- Having sufficient specialized materials to support vaccination work and relevant legal regulations concerning vaccines and immunological products.

4. Sources of vaccines and immunological products:

4.1. Vaccines and immunological products can only be purchased from Provincial Preventive Health Centers and pharmaceutical companies engaged in medical equipment trading that have been authorized by the Ministry of Health to buy, sell, and produce vaccines and immunological products. Purchasing from individuals or entities without such authorization is strictly prohibited.

4.2. It is strictly forbidden to use vaccines from the Expanded Immunization Program for services.

4.3. Absolutely no expired or origin-unknown vaccines and immunological products without registration numbers from the Ministry of Health should be used for injection or sold to users.

5. Costs associated with using vaccines and immunological products for disease prevention, diagnosis, and treatment (commonly referred to as vaccine prices):

5.1. The management of prices for domestically produced and imported vaccines under the Expanded Immunization Program, which are procured through government orders, shall be carried out according to the provisions of Joint Circular No. 06/TTLB dated July 10, 1993, issued by the Ministry of Finance and the Government Price Control Board, guiding the mechanism for managing prices of goods and services subject to subsidized policies and government orders from state budgets in the fields of Culture, Information, Health, Education and Training, and Sports.

5.2. Imported vaccines and immunological products or those produced in Vietnam outside the Expanded Immunization Program: Provincial Health Departments shall coordinate with Provincial Financial and Price Control Departments to submit to the People's Committees of provinces and centrally-administered cities for setting specific selling prices that are suitable for local conditions.

5.3. Local selling price includes:

- Purchase price at source

- Transportation costs.

- Storage costs.

- Loss costs (if applicable).

6. Recipients of vaccines and immunological products and payment methods:

6.1. Individuals eligible for free vaccination under the Expanded Immunization Program when receiving any of the ten vaccines included in the program (BCG, DPT, Td, OPV, MV, HBV, JE, TT, Ty21a, WC) provided by the program will be exempt from fees.

6.2. Individuals eligible for the Expanded Immunization Program but using vaccines not included in the program must pay.

6.3. Individuals not eligible for the Expanded Immunization Program must pay when receiving any type of vaccine or immunological product for disease prevention, diagnosis, and treatment.

7. Implementation Provisions:

7.1. The Department of Health is responsible for managing the circulation of various types of vaccines and immunological products in the locality in accordance with legal regulations.

The Department of Health Inspectorate is responsible for coordinating with relevant agencies to regularly inspect and check vaccine and immunological product items circulating in the locality according to registered numbers and models, and to strictly handle violations related to the use of vaccines and immunological products.

7.2. Provincial Preventive Health Centers are responsible for implementing the use, storage, and distribution of vaccines and immunological products to ensure quality and meet the vaccination needs of the population.

7.3. Central Institute of Hygiene and Epidemiology, Central Highlands Institute of Hygiene and Epidemiology, Ho Chi Minh City Pasteur Institute, Nha Trang Pasteur Institute, and vaccine and immunological product production units are responsible for providing technical guidance on the use and storage of vaccines and immunological products to localities, planning annual vaccine and immunological product production, and reporting to the Ministry of Health (Preventive Medicine Department).

7.4. Vaccine and immunological product trading enterprises are responsible for purchasing, selling, exporting, and importing vaccines and immunological products in accordance with legal regulations.

7.5. Healthcare facilities using vaccines and immunological products for disease prevention, diagnosis, and treatment for the population must comply with the prescribed prices.

During the implementation process, if there are any issues that are not appropriate or problematic, localities and units must promptly report to the Ministry of Fisheries for research, guidance, supplementation, and amendment./.

Any difficulties encountered during implementation should be reported to the Ministry of Health for research and resolution.