Circular No. 44/2024/TT-BYT stipulates on Economic and Technical Characteristics and Economic and Technical Norms for pharmaceutical sample testing services and raw materials for drug production issued by the Minister of Health.

 

CIRCULAR

REGULATIONS ON ECONOMIC AND TECHNICAL CHARACTERISTICS AND ECONOMIC AND TECHNICAL STANDARDS FOR DRUG SAMPLE TESTING SERVICES AND RAW MATERIALS FOR DRUG PRODUCTION

Pursuant to the Price Law dated June 19, 2023;

Pursuant to Decree No. 85/2024/NĐ-CP dated July 10, 2024 of the Government detailing certain provisions of the Law on Prices;

Pursuant to Decree No. 32/2019/NĐ-CP dated April 10, 2019 of the Government on assigning tasks, placing orders, or tendering for the provision of products and services using state budget funds from regular expenditure;

Pursuant to Decree No. 60/2021/NĐ-CP dated June 21, 2021 of the Government on the mechanism of self-management of public service units;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Medicine Management, the Director of the Department of Traditional Medicine and Pharmaceutical Management;

The Ministry of Health issues this Circular regulating Economic and Technical Characteristics and Economic and Technical Standards for drug sample testing services and raw materials for drug production.

Article 1. Scope of Regulation

This Circular regulates Economic and Technical Characteristics for drug sample testing services and raw materials for drug production; guides the construction and issuance of Economic and Technical Standards for drug sample testing services and raw materials for drug production (including vaccines and biological products).

Article 2. Applicability

Public service units that self-fund their regular expenses, public service units that partially self-fund their regular expenses, and public service units funded by the State for regular expenses shall implement drug sample testing services and raw materials for drug production and related agencies, organizations, and individuals.

Article 3. Regulations on Economic and Technical Characteristics

1. Economic and technical characteristics of drug sample testing services and raw materials for drug production include:

a) Service code;

b) Service name and technique;

c) Type.

2. The list of Economic and Technical Characteristics for drug sample testing services and raw materials for drug production is specified in Appendix I attached to this Circular.

Article 4. Principles and Criteria for Constructing Economic and Technical Standards

1. Construction principles

a) Economic and technical standards apply to drug sample testing services and raw materials for drug production with standards (Vietnamese Pharmacopoeia or pharmacopoeia of other countries, or basic standards of drugs approved by the Ministry of Health for circulation), or technical regulations or technical procedures prescribed by competent state authorities;

b) Ensuring necessary costs to complete one (1) service according to the standards, technical regulations, or technical procedures prescribed by competent state authorities.

2. Construction criteria

a) Economic and technical standards serve as the basis for preparing budgets for implementing drug sample testing services and raw materials for drug production. Costs not directly and specifically stipulated in economic and technical standards are included in prices in accordance with laws on pricing;

b) Economic and technical standards prescribed in this Circular are not used to control payments at public institutions. Expenditures at public health facilities are implemented in accordance with current laws on financial management at public service units and other relevant laws.

Article 5. Methods for Constructing Economic and Technical Standards

Economic and technical standards for drug sample testing services and raw materials for drug production are determined based on one method or a combination of the following methods:

1. Statistical and comprehensive method is a method of constructing standards based on analyzing cost data collected over previous periods to establish economic and technical standards for a drug sample testing service or raw material for drug production.

2. Analytical method is a method of constructing standards based on analyzing the complexity of work stages, time taken, staff qualifications involved in each stage of work, technical level, and working conditions to calculate labor norms for specific stages of a business process (including survey analysis and calculation analysis).

3. Standard method is a method applying advanced average calculation based on labor time standards, rest regulations, and equipment consumption levels to establish labor norms and equipment norms for individual or group tasks.

4. Expert method is a method using experts' experience in the field to evaluate technical requirements and work content when establishing economic and technical standards for a drug sample testing service or raw material for drug production.

Article 6. Content of Economic and Technical Standards

The economic and technical standards for pharmaceutical sample testing services and raw materials for drug production include the following basic standards:

1. Labor standard: This is the amount of labor consumption calculated in hours required to complete one pharmaceutical sample testing service and raw material for drug production, including direct and indirect labor standards.

2. Machinery, equipment, factory building standards, including:

a) Depreciation standards for machinery and equipment directly used for the service, depreciation costs for infrastructure directly implementing the service, and other auxiliary equipment;

b) Maintenance, repair, calibration expenses for equipment and tools, and inspection and testing costs for equipment directly serving pharmaceutical sample testing and raw material for drug production.

3. Material and chemical standards: This is the quantity of consumable tools, chemicals, and standards used directly in the pharmaceutical sample testing process and raw material for drug production.

4. Management expense standards, including:

a) Electricity, water, fuel costs; telecommunications and postal service fees; information technology rental or management service and software rental fees; security assurance; sanitation, environmental protection, waste disposal costs; other rental and purchase costs;

b) Repair costs for fixed assets, procurement of equipment, tools, materials, means of transportation, office supplies for management work;

c) Translation and transcription fees; costs for purchasing, printing, photocopying documents and publications for professional purposes;

d) Uniforms, protective clothing, labor safety and health protection costs for civil servants, officials, and workers;

đ) Other expenses (costs for ISO/IEC 17025 maintenance and assessment, GLP, and proficient testing registration costs, skill assessment costs...).

Article 7. Method of Determining Economic and Technical Standards

1. Labor Standard

The labor standard includes direct labor consumption and indirect labor consumption to perform one pharmaceutical sample testing service:

a) Direct labor consumption is calculated based on job position, professional level, and time required for one worker to perform one pharmaceutical sample testing service;

b) Indirect labor consumption is calculated as a percentage of direct labor consumption based on the principle established in point b, Clause 1, Article 4 of this Circular, and the method established in Article 5 of this Circular.

2. Equipment Depreciation Standard

The depreciation standard for each piece of equipment for one pharmaceutical sample testing service is calculated according to the following formula:

For equipment used for multiple types of services, the denominator in the above formula is the total number of all completed services during the period of equipment usage.

3. Fixed Asset Depreciation Standard

In cases where the unit meets the conditions for deducting depreciation of fixed assets, the provisions of Circular No. 23/2023/TT-BTC dated April 25, 2023, issued by the Minister of Finance, guiding the management system, wear and tear, and depreciation of fixed assets at agencies, organizations, units, and fixed assets entrusted by the State to enterprises for management without being part of the State capital component in enterprises shall be applied.

4. Material and Chemical Standards

The standard for each type of material and chemical for one pharmaceutical sample testing service is calculated according to the following formula:

For materials and chemicals where one unit quantity can be used for multiple testing services, the numerator in the above formula is one.

Losses of materials and chemicals (if any) are included in the quantity of materials and chemicals used.

Article 8. Economic and Technical Standards for Pharmaceutical Sample Testing Services

The economic and technical standards for pharmaceutical sample testing services include:

1. The economic and technical standards for pharmaceutical sample testing services for chemical drugs, herbal medicines, traditional medicines, and raw materials for drug production as specified in Appendix II attached to this Circular.

2. The economic and technical standards for pharmaceutical sample testing services for vaccines and biological products as specified in Appendix III attached to this Circular.

Article 9. Implementation Organization

1. The Drug Administration Department:

a) Guide units within the testing system to establish economic and technical characteristics and economic and technical standards for pharmaceutical sample testing services;

b) In accordance with its functions and tasks, compile the needs for updating, amending, and supplementing the economic and technical characteristics and standards for pharmaceutical sample testing services from units as stipulated in Clause 3 of this Article to advise the Minister of Health and issue a Circular to amend and supplement the Circular on economic and technical characteristics and standards in accordance with the provisions;

c) Within a maximum period of two years, update the economic and technical characteristics and standards for pharmaceutical sample testing services based on the principles and criteria specified in Article 4 of this Circular.

2. The Traditional Medicine Management Department:

In accordance with its functions and tasks, cooperate with the Drug Administration Department in compiling the needs for updating, amending, and supplementing the economic and technical characteristics and standards for pharmaceutical sample testing services for the field of traditional medicine.

3. The Central Institute of Pharmaceutical Inspection, the National Institute of Vaccine and Biological Product Quality Control, and the lead unit, in collaboration with the Ho Chi Minh City Institute of Pharmaceutical Inspection:

a) Review and propose updates and supplements to the economic and technical characteristics and standards for pharmaceutical sample testing services according to the principles and criteria specified in Article 4 of this Circular;

b) Maintain records and documents for establishing economic and technical standards for pharmaceutical sample testing services as prescribed.

Article 10. Effective Date

This Circular takes effect from February 6, 2025.

Article 11. Cross-Reference Provisions

In cases where referenced documents in this Circular are replaced or amended, they shall be implemented in accordance with the replaced or amended documents.

Article 12. Responsibility for Implementation

The Director of the Drug Administration Department, the Director of the Traditional Medicine Management Department, the Heads of units under and affiliated with the Ministry of Health, the Directors of specialized health agencies under provincial and centrally-administered city People's Committees, pharmaceutical business establishments, and relevant agencies, organizations, and individuals are responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to report them to the Ministry of Health (through the Drug Administration Department and the Traditional Medicine Management Department) for consideration and resolution./.