Permission to extend the drug registration certificate that expires up until December 31, 2024 in Vietnam

Below is the content at Resolution 80/2023/QH15 dated 09/01/2023 on continuing to implement the policy in the prevention and control of Covid-19 epidemic and using the certificate of circulation registration of drugs and medicinal ingredients, which expire from January 1, 2023 to December 31, 2024 promulgated by the National Assembly of Vietnam.

Cho phép gia hạn giấy đăng ký lưu hành thuốc hết hạn đến ngày 31/12/2024

Permission to extend the drug registration certificate that expires up until December 31, 2024 in Vietnam (Internet image)

Permission to extend the drug registration certificate that expires up until December 31, 2024 in Vietnam

According to Article 3 of Resolution 80/2023/QH15, the use of circulation registration papers for drugs and medicinal ingredients, which expire from January 1, 2023 to December 31, 2024, is regulated as follows:

- The certificate of registration for the circulation of drugs and medicinal ingredients, which expires on January 1, 2023, and has been submitted for extension by the registration establishment, and the certificate of circulation of drugs and medicinal ingredients, which are extended in accordance with the provisions of Clause 5 and Article 6 of Resolution 12/2021/UBTVQH15 but have not been extended in time in accordance with the provisions of the Law on Pharmacy.

+ Drugs and medicinal ingredients are recalled in accordance with the law on pharmacy;

+ Drugs showing signs of being unsafe for users but being suspended from trading, using, and being sealed and preserved in accordance with the law on pharmacy;

+ The drug has a certificate of circulation registration with a term of 3 years according to the provisions of the law on pharmacy.

- The Ministry of Health shall announce the list of drugs and medicinal ingredients with circulation registration certificates that can be continued to be used in accordance with the above-mentioned regulations.

03 policies on COVID-19 prevention and control will continue to be implemented until the end of 2023 in Vietnam

Pursuant to Article 2 of Resolution 80/2023/QH15, the following COVID-19 prevention and control policies will continue to be implemented from January 1, 2023 to the end of December 31, 2023, including:

- Expenses for COVID-19 prevention and control of medical facilities, COVID-19 collection and treatment facilities and regimes and policies for people mobilized to participate in the prevention and control of the COVID-19 epidemic that were implemented before December 31, 2022 but have not yet paid, they may continue to pay according to the provisions of Article 2, Clause 1 and Clause 2, Article 3, Clauses 1 and 2, Article 4, Article 8 of Resolution 12/2021/UBTVQH15 and detailed regulations, implementation instructions.

Funds for the implementation of these costs, regimes, and policies will be transferred to 2023 for payment, accounting, and settlement in the 2023 budget.

- Payment of expenses for COVID-19 prevention and control to medical facilities and expenses for medical examination and treatment for COVID-19 patients shall continue to comply with the provisions of Clause 2, Article 1 of Resolution 268/NQ-UBTVQH15 dated August 6, 2021, Article 2, Clauses 1 and 2, Article 3, Clauses 1 and 2, Article 4, Article 8 of Resolution 12/2021/UBTVQH15 and detailing and guiding the implementation.

- Goods stored at duty-free shops, warehouses of duty-free enterprises, and goods stored in bonded warehouses whose storage period has been extended in accordance with the provisions of National Assembly Standing Committee Resolution 10/2021/UBTVQH15 dated December 8, 2021 on extending the storage time of goods at duty-free shops, warehouses of duty-free enterprises, and goods stored in bonded warehouses meeting the requirements of COVID-19 epidemic prevention and contingency planning.

Goods stored in bonded warehouses that are entitled to an extension of the storage period as prescribed in this Clause must be exported through international border gates or main border gates upon export.

Resolution 80/2023/QH15 takes effect from the date of its adoption.

Resolutions of the National Assembly Standing Committee of Vietnam implementing Resolution 30/2021/QH15 in the Appendix issued together with Resolution 80/2023/QH15 expire from January 1, 2023, except for regulations in Clause 2, Article 1 of Resolution 268/NQ-UBTVQH15, Article 2, Clauses 1 and 2 Article 3, Clauses 1 and 2 Article 4, Article 8 Resolution 12/2021/UBTVQH15 and detailed regulations and implementation guidelines that will continue to be implemented from January 1, 2023 until the end of December 31, 2023.

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