RESOLUTION

REGARDING CONTINUATION IN IMPLEMENTATION OF CERTAIN COVID-19 MANAGEMENT POLICIES AND USE OF MARKETING AUTHORIZATION LICENSES OF MEDICINES OR PHARMACEUTICAL MATERIALS EXPIRED FROM JANUARY 1, 2023 TO DECEMBER 31, 2024

NATIONAL ASSEMBLY

Pursuant to the Constitution of the Socialist Republic of Vietnam;

Pursuant to the Law on National Assembly Organization No. 57/2014/QH13 in which several Articles are amended and supplemented by the Law No. 65/2020/QH14;

In the light of the Transmittal Letter No. 494/TTr-CP and the Report No. 495/BC-CP dated December 21, 2022 of the Government; the Review Reports No. 1356/BC-UBXH15 and No. 1357/BC-UBXH15 dated December 29, 2022 of the Committee on Social Affairs; the Report on answering of questions, handling of opinions and revision No. 397/BC-UBTVQH15 dated January 9, 2023 of the National Assembly’s Standing Committee; and opinions of the National Assembly’s deputies, 

herein RESOLVES as follows:

Article 1. Review of implementation of COVID-19 management policies included in the Resolution No. 30/2021/QH15 dated July 28, 2021 passed in the first meeting session of the 15^th National Assembly

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Resolution No. 30/2021/QH15 has laid a firm legal foundation during the COVID-19 epidemic outbreak crisis in order for the National Assembly’s Standing Committee, the Government, the Prime Minister, ministries, central authorities, and local authorities to actively implement creative, flexible, rapid and effective decisions involving acts of leading, directing and organizing the implementation of epidemic prevention and control measures in a way that applies in a state of emergency; In particular, the Government adopted the Resolution No. 128/NQ-CP dated October 11, 2021, issuing provisional regulations pertaining to "safe and flexible adaptation to and effective control of COVID-19"; proactively and creatively developed, flexibly applied and changed disease prevention and control strategies in a timely and due manner in the decisive moment as a way to contributing to the success in disease control, and promoting the participation of the entire political system and the strength of the great solidarity of the People.

2. The National Assembly recognizes and highly appreciates the drastic, timely and effective direction and management efforts of the Government, the Prime Minister, the National Steering Committee for COVID-19 prevention and control, ministries, central authorities, Party committees and local authorities in implementing COVID-19 management measures specified in the Resolution No. 30/2021/QH15. Owing to solidarity, joint effort, unanimity, determination to overcome all difficulties, the strong participation of the entire Party, army, people, frontline forces of response to the disease, support, grants or aids received from the business and international community, the disease has been successfully controlled, which serves as a prerequisite to the success in leading the country to a new normal, socio-economic stability, recovery and development. This achievement is attributed to the wise, proactive and drastic governance of the Party and State leaders, the active participation of the Vietnam Fatherland Front and its affiliated units and the People.

3. The National Assembly basically approves the content of the Government's Report No. 495/BC-CP dated December 21, 2022 on review of the implementation of the regulatory provisions of Resolution No. 30/2021/QH15 on COVID-19 management policies, including achievements, failures, issues and causes.  The policies, measures and solutions constituting the Resolution No. 30/2021/QH15 have basically been implemented synchronously, effectively and fully in line with special, privileged and specific measures contributing to promptly solving and eliminating issues and problems, and creating resources for the prevention and control of COVID-19.

4. The National Assembly realizes that there exist issues and problems arising during the process of implementation of the regulatory provisions of the Resolution No. 30/2021/QH15 on COVID-19 management policies, especially those involving the following situations: instructional documents on the implementation of COVID-19 management policies, solutions and measures according to the Resolution No. 30/2021/QH15 and resolutions of the National Assembly’s Standing Committee are issued, sometime and somewhere, slowly, inconsistent, and not closely based on the actual situation; propaganda and dissemination thereof are sometimes untimely; extension of the marketing authorization licenses of medicines and pharmaceutical materials is delayed, which causes the risk of shortages in medicines; requirements concerning payment and settlement of expenses related to disease prevention and control and medical costs of COVID-19 patients are not satisfied.

The above issues and problems are due to many reasons, mainly the complicated, unpredictable and unprecedented developments of COVID-19 in the world and Vietnam which led to a situation where disease prevention and control measures were taken in a rush and in a trial-and-error manner; some places implemented prolonged social distancing measures, harming social security; the health system, especially grassroots and preventive medicine, did not meet the requirements concerning competence in performing disease prevention and control activities; coordination in leadership and direction amongst a number of ministries, central authorities and local authorities was still awkward, untimely and ineffective; some administrative procedures were not fitted in the prevalence of the disease.

Article 2. Extension of COVID-19 management policies for the period from January 1, 2023 to end of December 31, 2023

1. If COVID-19 prevention and control expenses of medical facilities, concentrated quarantine and and/or treatment facilities, benefits and allowances paid to engaged or assigned anti-COVID-19 personnel that incurred before December 31, 2022 have not been fully paid yet, the outstanding amounts thereof shall remain to be paid according to the regulatory provisions of Article 2, Clause 1 and Clause 2 of Article 3, Clause 1 and Clause 2 of Article 4 and Article 8 in the Resolution No. 12/2021/UBTVQH15 dated December 30, 2021 of the National Assembly’s Standing Committee, regarding consent to the implementation of a number of mechanisms and policies in the health sector for COVID-19 management purposes (hereinafter referred to as Resolution No. 12/2021/UBTVQH15), and detailed regulations and instructions for implementation thereof. Expenditures on these payments, benefits and allowances shall be allowed and accounted for, and recorded in the final accounts of state budget in the budget year 2023.  

2. All repayment or reimbursement of the outstanding amounts of COVID-19 prevention and control expenses incurred by medical facilities, and medical costs of COVID-19 patients, shall continue in compliance with Clause 2 of Article 1 in the Resolution No. 268/NQ-UBTVQH15 dated August 6, 2021 of the National Assembly’s Standing Committee, authorizing the Government to adopt Resolutions of which content may conflict with the regulatory provisions of Laws to meet COVID-19 prevention and control requirements (hereinafter referred to as Resolution No. 268/NQ-UBTVQH15), Article 2, Clause 1 and Clause 2 of Article 3, Clause 1 and Clause 2 of Article 4 and Article 8 in the Resolution No. 12/2021/UBTVQH15, and detailed regulations or instructions for implementation thereof.

3. If goods stored at duty-free stores, warehouses or storage facilities of duty-free enterprises, and goods stored in bonded warehouses, of which the storage period has been extended as defined in the Resolution No. 10/2021/UBTVQH15 dated December 8, 2021 of the National Assembly’s Standing Committee on extension of the period of storage of goods at duty-free stores, warehouses or storage facilities of duty-free enterprises, and goods stored in bonded warehouses, meet COVID-19 prevention and control requirements, the storage thereof may continue from January 1, 2023 to end of December 31, 2023 at the latest.

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Article 3. Use of marketing authorization licenses of medicines or pharmaceutical materials expired from January 1, 2023 to December 31, 2024  

1. For a marketing authorization license of medicine or pharmaceutical material expired from January 1, 2023 to December 31, 2024 that is eligible for renewal as defined in clause 5 of Article 6 in the Resolution No. 12/2021/UBTVQH15, if renewal by written application is not obtained by the due date, it shall remain valid for use till end of December 31, 2024, except as: 

a) that licensed medicine or pharmaceutical material is recalled under pharmacy laws;

b) there is a sign that the licensed medicine is unsafe for use to the extent that a sanction, such as the temporary suspension of business, usage and custodial sealing thereof, defined in pharmacy laws, is imposed;   

c) the validity period of the marketing authorization license of that medicine is 03 years in accordance with pharmacy laws.

2. The Ministry of Health shall publish the list of medicines and pharmaceutical materials with marketing authorization licenses that are eligible to obtain renewal as stated in clause 1 of this Article above.

Article 4. Entry into force

1. This Resolution is entering into force as from the signing date.

2. Resolutions of the National Assembly’s Standing Committee providing guidance on implementation of the Resolution No. 30/2021/QH15 as listed in the Appendix to this Resolution shall be invalidated from January 1, 2023, except for the regulatory provisions laid down in Clause 2 of Article 1 in the Resolution No. 268/NQ-UBTVQH15, Article 2, Clause 1 and Clause 2 of Article 3, Clause 1 and Clause 2 of Article 4 and Article 8 of the Resolution No. 12/2021/UBTVQH15 and detailed regulations or instructions for implementation thereof that will continue to be in force from January 1, 2023 to the end of December 31, 2023.

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1. The Government, the Prime Minister, Ministries, ministerial-level agencies, governmental bodies, the Supreme People's Court, the Supreme People's Procuracy, the State Audit, and local authorities shall urgently amend, supplement and replace written documents under their authority to implement this Resolution in an effective and timely manner, and annul those under their competence that have been issued under the Resolution No. 30/2021/QH15, except for detailed regulations or instructions for implementation thereof that will continue to be implemented under the regulatory provisions of Clause 2 of Article 4 in this Resolution.

2. The Government shall be mandated to take the following actions:

a) Review and manage the procurement of commodities in a higher quantity than the actual demand in order to provide against the complicated development or unexpected situation of the epidemic; the use of drugs, supplies, chemicals, biological products, and equipment purchased by the state budget for COVID-19 examination and treatment purposes that are converted for use in conventional medical services;

b) Decide to handle issues and problems arising from payment, repayment and settlement of medical examination and treatment costs of COVID-19 patients, benefits and allowances for anti- COVID-19 personnel; from the procurement of drugs, supplies, chemicals and equipment for COVID-19 prevention and control purposes of which costs and expenses incurred under financial advance, lending, borrowing, mobilization, grant or aid arrangements;

c) Continue to review and improve mechanisms, policies, available resources and forecast capabilities; promote biomedical researches, develop the domestic pharmaceutical, vaccine, biological product and medical equipment industries to have the initiative in carrying out disease prevention and control activities, responding to new strains of SARS-CoV-2 virus and emerging dangerous infectious diseases with the aim of enhancing the efficiency of public health care and protection activities.

3. As for COVID-19 prevention and control tasks which have been carried out in accordance with regulations, policies, and forms of written documents promulgated under the Resolution No. 30/2021/QH15, when performing inspection, examination, supervision, audit, payment, settlement, and other law enforcement activities, regulations and specific regulatory provisions laid down in the Resolution No. 30/2021/QH15 should be consulted.

4. The National Assembly’s Standing Committee, the Committee for Ethnic Affairs and other Committees of the National Assembly, Delegations to the National Assembly and deputies of the National Assembly shall, within their remit and jurisdiction, oversee the implementation of this Resolution.  

5. The Vietnam Fatherland Front and its affiliates shall supervise the implementation of this Resolution and encourage people from all social classes to get involved in implementing this Resolution.

This Resolution is passed in the second extraordinary meeting of the 15^th National Assembly of Socialist Republic of Vietnam on January 9, 2023.

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CHAIRMAN




Vuong Dinh Hue

APPENDIX

LIST OF EXPIRED RESOLUTIONS OF THE NATIONAL ASSEMBLY’S STANDING COMMITTEE  
(to the Resolution No. 80/2023/QH15 dated January 9, 2023)

1. List of fully expired Resolutions of the National Assembly’s Standing Committee  

No.

Type of document/Issuing body

Reference number/Symbol and Issuance Date

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1.

Resolution of the National Assembly’s Standing Committee

Ref #. 285/NQ-UBTVQH15 dated Aug. 27, 2021

Regarding establishment of a Working Group of the National Assembly’s Standing Committee for implementation of the Resolution No. 30/2021/QH15 of the National Assembly pertaining to COVID-19 prevention and control activities

2.

Resolution of the National Assembly’s Standing Committee

Ref #. 296/NQ-UBTVQH15 dated Sep. 7, 2021

Regarding budget transfers for purchase of rice compensating for the amount of rice taking out from the national reserve for aid, relief and support granted to COVID-19-stricken people

3.

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Ref #. 393/NQ-UBTVQH15 dated Sep. 30, 2021

Regarding transfers to the central budget reserve from sources of reduced or unused expenditures of the 2021 central budget that are used to spend on COVID-19 prevention and control activities

4.

Resolution of the National Assembly’s Standing Committee

Ref #. 406/NQ-UBTVQH15 dated Oct. 19, 2021

Regarding introduction of several measures to grant support to businesses and people affected by the COVID-19 pandemic

5.

Resolution of the National Assembly’s Standing Committee

Ref #. 10/2021/UBTVQH15 dated Dec. 8, 2021

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6.

Resolution of the National Assembly’s Standing Committee

Ref #. 17/2022/UBTVQH15 dated Mar. 23, 2022

Regarding the number of overtime hours per year or month of employees in the context of COVID-19 prevention and control, socio-economic recovery and development

7.

Resolution of the National Assembly’s Standing Committee

Ref #. 24/2022/UBTVQH15 dated Aug. 11, 2022

Ongoing payment of support for employees under the Resolution No. 03/2021/ UBTVQH15 dated Sep. 24, 2021 of the National Assembly’s Standing Committee

8.

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Ref #. 03/2021/UBTVQH15 dated Sep. 24, 2021

Adopting support policies for employees and employers afflicted by COVID-19  by using the Unemployment Insurance Fund

2. List of partially expired Resolutions of the National Assembly’s Standing Committee

No.

Type of document/Issuing body

Reference number/Symbol and Issuance Date

Citation

Invalidated contents

1.

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Ref #. 268/NQ-UBTVQH15 dated Aug. 6, 2021

Regarding consent granted to the Government to adopt Resolutions of which certain contents conflict with regulations of laws with the aim of meeting COVID-19 prevention and control requirements

All but clause 2 of Article 1

2.

Resolution of the National Assembly’s Standing Committee

Ref #. 12/2021/UBTVQH15 dated Dec. 30, 2021

Regarding grant of permission to enforce a number of healthcare regulatory mechanisms and policies for COVID-19 management activities

All but Article 2, Clause 1 and Clause 2 of Article 3, Clause 1 and Clause 2 of Article 4, and Article 8