Resolution 80/2023/QH15 use certificates of free sale of drugs or drug materials, which expire from January 1, 2023, to December 31, 2024

RESOLUTION

On continuing to implement a number of policies for COVID-19 prevention and control and use of certificates of free sale of drugs or drug materials, which expire from January 1, 2023, to December 31, 2024

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THE NATIONAL ASSEMBLY

Pursuant to the Constitution of the Socialist Republic of Vietnam;

Pursuant to the Law on Organization of the National Assembly No. 57/2014/QH13, amended and supplemented under the Law No. 65/2020/QH14;

In the consideration of Report No. 494/TTr-CP and Report No. 495/BC-CP dated December 21, 2022, of the Government, Verification Reports No. 1356/BC-UBXH15, 1357/BC-UBXH15 dated December 29, 2022, of the Social Committee, Report of explanation, acquisition and correction No. 397/BC-UBTVQH15 dated January 9, 2023, of the National Assembly Standing Committee and opinions of the National Assembly deputies;

RESOLVES:

Article 1. Results of the implementation of policies on COVID-19 prevention and control in Resolution No. 30/2021/QH15 dated July 28, 2021, on the first session of the XV^th National Assembly

1. Policies on COVID-19 prevention and control given in Resolution No. 30/2021/QH15 dated July 28, 2021, on the first session of the XV^th National Assembly (hereinafter referred to as Resolution No. 30/2021/QH15), include unprecedented legislative initiatives in legislative activities; which are correct and timely decisions to meet practical requirements, demonstrating the high sense of responsibility of the National Assembly to the People, affirming that the National Assembly always acts, accompanies the Government and the political system in the prevention and control of COVID-19 pandemic, with the spirit of putting people's lives, health and safety first and foremost; ensuring social-economic recovery and development.

Resolution No. 30/2021/QH15 created a solid legal foundation at an urgent time when the COVID-19 pandemic broke out so that the National Assembly Standing Committee, the Government, the Prime Minister, ministries, sectors and local authorities can proactively implement creative, flexible, fast and effective decisions in leading, directing and organizing the implementation of pandemic prevention and control measures as in a state of emergency. Especially, the Government issued Resolution No. 128/NQ-CP dated October 11, 2021, promulgating the Interim Regulation on “safe and flexible adaptation and effective control over the COVID-19 pandemic”, and proactively, creatively, flexibly applied and redirected the pandemic prevention and control strategy in a timely and proper manner at the decisive moment, contributing to the control of the pandemic, mobilizing the participation of the entire political system and the strength of national unity.

2. The National Assembly recognized and highly appreciated the drastic, timely and effective direction and management of the Government, the Prime Minister, the National Steering Committee for COVID-19 Prevention and Control, ministries, sectors, Party committees and local authorities in organizing the implementation of measures to prevent and control the COVID-19 pandemic specified in Resolution No. 30/2021/QH15. With the solidarity, joint effort, unanimity, determination to overcome all difficulties, and the strong participation of the entire Party, army, people, frontline forces against the pandemic, with the support of the business and international community, the pandemic has been put under control, the country back has been brought into the new normal, with socio-economic stability, recovery and development. This is the result of the wise, proactive and drastic leadership of the Party and State leaders, the active participation of the Vietnam Fatherland Front, its member organizations and the entire People.

3. The National Assembly basically approved the content of the Government's Report No. 495/BC-CP dated December 21, 2022, on evaluating the implementation of Resolution No. 30/2021/QH15 on COVID-19 prevention and control policies with the achieved results, existence, limitations and causes. The policies, measures and solutions promulgated on the basis of Resolution No. 30/2021/QH15 have basically been implemented synchronously, effectively and fully with special, exceptional and specific measures, contributing to timely solving and removing difficulties and obstacles, creating resources for the COVID-19 prevention and control.

4. The National Assembly found that the implementation of Resolution No. 30/2021/QH15 on COVID-19 prevention and control policies still had some shortcomings and limitations. Specifically, the promulgation of documents guiding the implementation of policies, solutions and measures under Resolution No. 30/2021/QH15 and the resolutions of the National Assembly Standing Committee is sometimes slow, inconsistent and not close to reality; the propaganda and dissemination are sometimes not timely; the extension of the certificates of free sale of drugs or drug materials is delayed, leading to the risk of drug shortages; the payment and settlement of expenses related to disease prevention and control and medical examination and treatment expenses for COVID-19 patients have not yet met the requirements.

The aforesaid shortcomings and limitations are due to many reasons, but mainly due to the complicated, unpredictable and unprecedented developments of the COVID-19 pandemic in the world as well as in Vietnam. Therefore, the pandemic prevention and control measures were taken in an urgent context, by learning from experience. In some areas, the social distancing is prolonged, affecting social security; the health system, especially grassroots and preventive medicine, has not yet met the requirements on capacity for pandemic prevention and control; the coordination in leadership and direction among a number of ministries, sectors and local authorities is still confused, not timely and effective; some administrative procedures are inappropriate in the context of the pandemic.

Article 2. Policies in COVID-19 prevention and control shall continue to be implemented from January 1, 2023, to the end of December 31, 2023

1. Expenses for COVID-19 prevention and control of medical facilities, COVID-19 treatment facilities, and regimes and policies for persons mobilized to participate in COVID-19 prevention and control, that have been implemented before December 31, 2022, but have not yet been paid, shall continue to be paid in accordance with Article 2, Clause 1 and Clause 2 Article 3, Clause 1 and Clause 2 Article 4, Article 8 of Resolution No. 12/2021/UBTVQH15 dated December 30, 2021, of the National Assembly Standing Committee, on allowing the application of a number of health-related mechanisms and policies for the prevention and control of COVID-19 pandemic (hereinafter referred to as Resolution No. 12/2021/UBTVQH15) and detailed regulations and implementation guidelines. Expenses for the implementation of these costs, regimes and policies shall be transferred to 2023 for payment and accounting and shall be settled in the 2023 budget year.

2. The payment of expenses for COVID-19 prevention and control to medical facilities and medical examination and treatment expenses for COVID-19 patients shall continue to comply with the provisions of Clause 2 Article 1 of Resolution No. 268/NQ-UBTVQH15 dated August 6, 2021, of the National Assembly Standing Committee, on allowing the Government to issue a resolution with a number of regulations different from the law to meet the requirements of COVID-19 prevention and control (hereinafter referred to as Resolution No. 268/NQ-UBTVQH15), Article 2, Clauses 1 and 2 Article 3, Clauses 1 and 2 Article 4, Article 8 of Resolution No. 12/2021/UBTVQH15 and detailed regulations and implementation guidelines.

3. Goods stored at duty-free shops, warehouses of duty-free enterprises, goods stored in bonded warehouses of which the retention period has been prolonged under Resolution No. 10/2021/UBTVQH15 dated December 8, 2021, of the National Assembly Standing Committee, on prolongation of the period of goods retention at duty-free shops, warehouses of enterprises selling duty-free goods and bonded warehouses to meet requirements of COVID-19 prevention and control, shall continue to be retained from January 1, 2023, to the end of December 31, 2023, at the latest.

Goods stored in bonded warehouses that are entitled to a prolongation of the retention period under this Clause must be exported through international border gates or main border gates.

 Article 3. Use of certificates of free sale of drugs or drug materials that expire from January 1, 2023, to December 31, 2024

1. Certificates of free sale of drugs or drug materials expiring from January 1, 2023, to December 31, 2024, which have been submitted by registration agencies for an extension, and those that are entitled to an extension under Clause 5 Article 6 of Resolution No. 12/2021/UBTVQH15, but have not yet been extended timely in accordance with the Law on Pharmacy, shall continue to be used from their expiry dates to the end of December 31, 2024, except for the following cases:

a) Drugs and drug materials are recalled in accordance with the law on pharmacy;

b) Drugs showing unsafe signs for users are suspended from trading, using and sealed and preserved in accordance with the law on pharmacy;

c) Drugs with a certificate of free sale with a term of 3 years in accordance with the law on pharmacy.

2. The Ministry of Health shall publicize the list of drugs and drug materials with certificates of free sale that are permitted to continue to be used under Clause 1 of this Article.

Article 4. Effect

1. This Resolution takes effect from the date of its adoption.

2. The National Assembly Standing Committee’s Resolutions on implementing Resolution No. 30/2021/QH15 in the Appendix to this Resolution expire from January 1, 2023. The provisions in Clause 2 Article 1 of Resolution No. 268/NQ-UBTVQH15, Article 2, Clauses 1 and 2 Article 3, Clauses 1 and 2 Article 4, Article 8 of Resolution No. 12/2021/UBTVQH15 and detailed regulations and implementation guidelines continue to be implemented from January 1, 2023, to the end of December 31, 2023.

Article 5. Organization of implementation

1. The Government, the Prime Minister, ministries, ministerial-level agencies, government-attached agencies, Supreme People's Court, Supreme People's Procuracy, State Audit Office, and local governments shall urgently amend, supplement and replace documents under the competence to effectively and timely implement this Resolution and annul documents under the competence that have been issued on the basis of Resolution No. 30/2021/QH15, except for detailed provisions and implementation guidelines, that continue to be implemented in accordance with Clause 2 Article 4 of this Resolution.

2. The Government shall take the following solutions:

a) Scrutinizing and handling the procurement of quantities higher than the actual demand for the complicated development of the pandemic. The use of drugs, supplies, chemicals, biological products and equipment purchased from the state budget for COVID-19 medical examination and treatment shall be transferred to the medical examination and treatment of common illnesses;

b) Deciding on handling problems in payment and settlement of medical examination and treatment expenses for COVID-19 patients, regimes and policies for persons participating in COVID-19 prevention and control; in the procurement of drugs, supplies, chemicals, and equipment for COVID-19 prevention and control, which have been made in the form of advances, loans, borrowings, mobilization and receipt of grants and aid;

c) Continuing to scrutinize and develop mechanisms, policies, resources, predictability, promoting biomedical research, developing the pharmaceutical industry, vaccines, biological products, and medical equipment in the country to be proactive in pandemic prevention and control, and respond to new strains of SARS-CoV-2 virus, newly arising dangerous infectious diseases in order to improve the efficiency of care and protection of the people's health.

3. For the tasks of COVID-19 prevention and control, which have been carried out in accordance with regulations, policies and documents promulgated under Resolution No. 30/2021/QH15, when inspecting, examining, supervising, auditing, paying, finalizing and implementing other law enforcement activities, it is necessary to compare and apply them according to the regulations and specificities specified in Resolution No. 30/2021/QH15.

4. The National Assembly Standing Committee, Ethnic Council, and Committees of the National Assembly, delegations of National Assembly deputies and National Assembly deputies shall, within the ambit of their tasks and powers, supervise the implementation of this Resolution.

5. The Vietnam Fatherland Front and its member organizations shall supervise and encourage the people to implement this Resolution.

This Resolution was passed on January 9, 2023, by the XV^th National Assembly of the Socialist Republic of Vietnam at its 2^nd extraordinary session.

* All Appendices are not translated herein.