Decision No. 1170/1999/QĐ-BYT on Issuing the "Regulations on Managing National Medical Reserve Goods"

Pursuant to …;

Regarding the issuance of "Regulations on Managing National Medical Reserve Goods"

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THE MINISTER OF HEALTH

Pursuant to Decree No. 10/CP dated February 24, 1996 of the Government on the Regulations on Managing National Reserve Goods;

Pursuant to Circular No. 170/CSDT dated April 4, 1997 of the National Reserve Administration guiding the implementation of the Regulations on Managing National Reserve Goods;

Pursuant to Circular No. 29/1998/TT-BTC dated March 11, 1998 of the Ministry of Finance on guiding financial management systems for implementing the Regulations on Managing National Reserve Goods issued together with Decree No. 10/CP dated February 24, 1996 of the Government;

At the proposal of the Heads of the Planning Department, the Financial Accounting Department, the Medical Equipment and Construction Department, and the Director of the Vietnam Drug Administration.

DECISION:

Article 1. Issued together with this Decision is the "Regulations on Managing National Medical Reserve Goods".

Article 2. This Decision takes effect from the date of signature and issuance.

Article 3. The Heads of the Office, the Planning Department, the Financial Accounting Department, the Medical Equipment and Construction Department, the Director of the Vietnam Drug Administration, the General Directors of the Vietnam Medical Equipment Corporation and the Vietnam Pharmaceutical Corporation, and the Heads of units entrusted by the Ministry with the task of storing and preserving national reserve goods, as well as the Heads of related units shall be responsible for implementing this Decision.

REGULATIONS

Management of National Medical Reserve Goods

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(Issued together with Decision No. 1170/1999/QĐ-BYT dated April 16, 1999 of the Minister of Health)

In accordance with Decree No. 10/CP dated February 24, 1996 of the Government on the Regulations on Managing National Reserve Goods, Circular No. 170/CSDT dated April 4, 1997 of the National Reserve Administration guiding the implementation of the Regulations on Managing National Reserve Goods, and Circular No. 29/1998/TT-BTC dated March 11, 1998 of the Ministry of Finance guiding financial management systems for implementing the Regulations on Managing National Reserve Goods issued together with Decree No. 10/CP dated February 24, 1996 of the Government, the Minister of Health stipulates specific points regarding the management of national medical reserve goods as follows:

1. Importing goods:

- Goods and materials put into national reserves (referred to as reserve goods) are essential items for use in purposes such as preventing and mitigating the consequences of natural disasters, epidemics, serving national defense, and performing other tasks assigned by the Government. The list, types, and quantities of medical reserve goods purchased and stored must comply with the list of goods proposed by the Minister of Health and approved by the Government after purchasing according to current regulations.

- National medical reserve goods can be imported under the following circumstances: increasing the reserve fund according to plan, rotating new goods according to plan, internal transfers within managing units, imports pursuant to the Decision of the Government or the Minister of Health when authorized by the Government, and other sources of importation.

2. Exporting goods:

- National medical reserve goods can be exported under the following circumstances: selling according to plan, exporting pursuant to the Decision of the Government, exporting pursuant to the Decision of the Minister of Health when authorized by the Government, internal transfers within managing units, rotating new goods according to plan, and other sources of exportation.

Importing and exporting national medical reserve goods must strictly adhere to the type, quantity, specifications, and quality as prescribed by the competent authority. All cases of importing and exporting reserve goods must have complete legal documents and procedures as prescribed, organize accounting books and warehouse cards separately to track the import and export of reserve goods as prescribed.

The purchase price and sale price of reserve goods are the amounts paid to customers for buying and selling goods, including tax (if applicable). The purchase and sale prices are determined according to the price management mechanism for each item decided by the competent state authority. The import price is the purchase price delivered at the warehouse of reserve units without including taxes payable to the State.

Implement purchases and sales of batches of goods through bidding. The reserve agency (Ministry of Health) organizes bidding to increase reserve goods according to the annual plan approved by the Government and bidding to sell and rotate reserve goods.

3. Storing national medical reserve goods:

- National medical reserve goods must be managed strictly and centrally under the unified direction of the Government, ensuring absolute confidentiality and always being ready to meet the highest requirements in all situations.

- National medical reserve goods must be stored and preserved in accordance with the requirements for storing goods correctly according to procedures, standards, and warehouse management systems.

Warehouses storing national medical reserve goods must meet the requirements suitable for the physical and chemical properties of each type of goods; preserve and maintain the quantity and quality of goods safely in the warehouse. The warehouse must have sufficient equipment and facilities necessary for preservation work; ensure temperature, light, and air humidity conditions, prevent pests, natural disasters, fires, theft, and any other harm... Warehouses storing national reserve goods must have strict security measures and confidentiality protection.

- National medical reserve goods must be stored in the correct warehouse and location as specified, preserved according to the procedures and standards, and must have complete records clearly stating the quantity, quality, value, and changes during the process of import, export, and storage. The Head of the unit entrusted with the task of storing and preserving national medical reserve goods must organize the implementation of good preservation procedures and standards for national medical reserve goods assigned by the Ministry of Health.

Preservation procedures and standards for each item are developed by the two Corporations (Vietnam Pharmaceutical Corporation and Vietnam Medical Equipment Corporation) and approved by the Ministry of Health after receiving opinions from relevant agencies.

4. Rotating and updating national medical reserve goods.

Items that have reached the rotation period (at least 12 months before expiration), deteriorated quality goods, and goods that are not compatible with technological progress must be rotated and updated.

Units entrusted by the Ministry of Health with the task of storing and preserving goods (Central Pharmaceutical Companies 1, 2 and Central Medical Equipment Companies 1, 2) must have the responsibility to rotate and update reserve goods according to the approved plan. The plan for rotating and updating reserve goods must be reported to the Ministry of Health so that the Ministry can prepare a rotation plan (12 months in advance) and report to the Government and relevant agencies for approval.

All cases of force majeure (inventory goods stored in warehouses reaching their expiration date but having exceeded the import period, unable to continue production, expired visas... at the time of exchange) must be reported in detail to the Ministry of Health so that the Ministry can report to the Government and relevant agencies for advice on resolution.

5. Handling of National Medical Reserve inventory damaged or reduced in quality:

Any medical reserve inventory damaged or reduced in quality due to any cause must be immediately reported to all relevant agencies for handling. The agency responsible for storing medical reserve inventory must promptly establish a record in accordance with national regulations to allow relevant agencies to take measures to minimize losses. Subsequently, the cause and responsibility must be clarified, and a report made to the Government and relevant agencies regarding the total loss and results of remediation.

6. Handling of National Medical Reserve inventory, if excesses or shortages within the quota are discovered, the unit responsible for storage must immediately report to the Ministry of Health, which will then report to relevant agencies to process the increase or decrease in the reserve inventory fund.

National Medical Reserve inventory shortages beyond the quota, damage, or shortages due to various causes, the unit responsible for retaining and storing must report to the Ministry of Health so that the Ministry can report to the Government and relevant agencies. Depending on the nature and degree of violation, actions causing damage or shortages will be administratively handled or criminally prosecuted according to the law.

The quota for losses and surpluses during the storage process for each item shall be established by the two General Corporations (Vietnam Pharmaceutical Corporation and Vietnam Medical Equipment Corporation), and approved by the Ministry of Health after obtaining opinions from relevant agencies.

7. Monitoring and Reporting System

Units tasked with retaining National Medical Reserve inventory must strictly comply with monthly, quarterly, and annual reporting and statistical systems. The accounting system for National Medical Reserve inventory, the warehouse monitoring system, must clearly record quantity, quality, value, and processes of entry and exit of goods. Monthly, units tasked with retaining National Medical Reserve inventory must report to the directly supervising General Corporations, which in turn report to the Ministry of Health on the situation of entry, exit, stock, quality of goods, especially the shelf life of medicines stored in warehouses by item, along with recommendations.

(See attached form).

All proposals and recommendations from units must be studied and considered by higher management authorities and responded to within fifteen days from the date of receipt of related documents.

8. Management of National Reserve Capital:

Capital for purchasing National Reserve inventory includes the state budget portion allocated annually by the Ministry of Finance according to the plan approved by the Government and retained proceeds from selling National Reserve inventory kept in the State Treasury account. The National Reserve agency (Ministry of Health) may proactively use this capital to purchase National Reserve inventory according to the annual plan. The remainder is submitted to the state budget.

9. Units tasked with retaining and storing National Medical Reserve:

National Medical Reserve inventory is assigned by the Ministry of Health to be retained and stored in Hanoi and Ho Chi Minh City as follows:

- Hanoi:

+ Hanoi Central Pharmaceutical Company retains finished pharmaceutical products and raw materials for drugs.

+ Hanoi Central Medical Equipment Company retains medical equipment.

- Ho Chi Minh City:

+ Ho Chi Minh City Central Pharmaceutical Company retains finished pharmaceutical products and raw materials for drugs.

+ Ho Chi Minh City Central Medical Equipment Company retains medical equipment.

10. Funding for the operation of the National Reserve agency:

Funding for the operation of the National Reserve agency is provided by the state budget according to quotas, plans, and current financial regulations, including funding for administrative operations, storage, preservation, and protection of goods...

Fees for entry, exit, storage, preservation, and circulation of National Medical Reserve inventory funded by the state budget are applied based on cost standards established according to economic and technical indicators set by the Ministry of Planning and Investment, Ministry of Finance, Ministry of Health, and the Government Price Control Board. The use of fees must comply strictly with the prescribed standards, purposes, and financial accounting regulations for National Reserve.

11. Protection, inspection, supervision system:

Agencies and units tasked with National Medical Reserve inventory storage must strictly implement the Law on State Secrets Protection and the Regulations on National Reserve Inventory Management. Agencies tasked with directing and organizing regular, periodic, and spot inspections of National Reserve inventory storage to detect and prevent violations of storage procedures, standards, and safety regulations concerning quantity, quality of goods, and warehouse systems for storing and preserving National Reserve inventory.

12. Organizational structure for managing the National Reserve in the health sector:

The organizational structure and management system for the National Reserve in the health sector are assigned tasks and specific persons responsible as follows:

12.1. Overall responsibility: Cadre Committee, Leadership of the Ministry of Health;

12.2. Specific responsibility: Deputy Minister in charge of the Ministry of Health;

12.3. Specific units:

- Department of Planning: serves as the focal point and assists the Minister in performing the function of state management over the National Reserve in the health sector.

Specifically responsible: one leader of the Department and one specialist.

- Department of Medical Equipment and Construction: responsible for the list, standards, quality, and types of machinery and equipment.

Specifically responsible: one leader of the Department and one specialist.

- Vietnam Drug Administration: responsible for the list, standards, quality, and types of drugs and raw materials for drugs.

Specifically responsible: one leader of the Administration and one specialist.

- Department of Finance and Accounting: responsible for processing funds for purchasing National Reserve inventory, funding for National Reserve operations, and guiding relevant units to comply with financial management regulations in the National Reserve.

Specifically responsible: one leader of the Department and one specialist.

- Vietnam Medical Equipment Corporation: responsible for organizing implementation, urging, inspecting, and supervising the Central Medical Equipment Companies 1 and 2 in the retention and preservation of National Medical Reserve equipment.

Specifically responsible: one leader of the Corporation and one specialist.

- Vietnam National Pharmaceutical Corporation: shall be responsible for organizing, urging, inspecting, and supervising the implementation of the storage and preservation of medical supplies (medicines, raw materials for disease prevention and treatment for humans) in national reserves by the Central Pharmaceutical Companies 1 and 2.

Specifically responsible: one leader of the Corporation and one specialist.

- Central Pharmaceutical Company 1, Hanoi: Shall implement the work of storing medicines and raw materials for medicines in national reserves in accordance with regulations.

Specifically responsible: One company leader and the Planning Department.

- Central Medical Equipment Company 2, Ho Chi Minh City: Shall implement the work of storing medicines and raw materials for medicines in national reserves in accordance with regulations.

Specifically responsible: One company leader and the Planning Department.

- Central Medical Equipment Company 1, Hanoi: Shall implement the work of storing machines and equipment in national reserves in accordance with regulations.

Specifically responsible: One company leader and the Planning Department.

- Central Medical Equipment Company 2, Ho Chi Minh City: Shall implement the work of storing machines and equipment in national reserves in accordance with regulations.

Specifically responsible: One company leader and the Planning Department.

In the course of implementation, if there are difficulties or obstacles, they are requested to report to the Ministry of Health (Planning Department) for study, supplementation, and amendment as appropriate.