G/TBT/N/VNM/396

8 April 2026

(26-2735)

Committee on Technical Barriers to Trade

Original: English

1.

Notifying Member: VIET NAM

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

1. Drug Administration of Vietnam - Ministry of Health

No. 138A, Giang Vo, Ba Dinh, Hanoi

Telephone: (+84 24) 37366483

Fax: (+84 24) 38234758

Email: dangkythuoc.qld@moh.gov.vn

2. Administration of Science Technology and Training –Ministry of Health

Address: No. 138B Giang Vo – Ba Dinh – Hanoi

Phone: (+84 24) 33846688

Fax: (+84 24) 32373236

Email: cuck2dt@moh.gov.vn

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Drugs and medicinal ingredients

5.

Details of notified document(s) (title, number of pages and languages, means of access): Draft Circular amending and supplementing a number of articles of Circular No. 12/2025/TT-BYT dated 16 May 2025 of the Ministry of Health on registration of drugs and medicinal ingredients; (135 page(s), in Vietnamese)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://members.wto.org/crnattachments/2026/TBT/VNM/26_01946_00_x.pdf

Drug Administration of Vietnam - Ministry of Health

No. 138A, Giang Vo, Ba Dinh, Hanoi

Telephone: (+84 24) 37366483

Fax: (+84 24) 38234758

Email: dangkythuoc.qld@moh.gov.vn

6.

Description of content: This draft Circular amends and supplements a number of articles of Circular No. 12/2025/TT-BYT dated 16 May 2025 of the Ministry of Health on registration of drugs and medicinal ingredients, in particular:

- Article 22 on general regulations for administrative documents in drug and medicinal ingredients registration dossiers.

- Article 44 on supplementary documents and updates during the application review process.

7.

Objective and rationale, including the nature of urgent problems where applicable: - To promptly address difficulties and challenges in the registration of drugs and medicinal ingredients, including ensuring the availability of medicines for epidemic prevention and control and other urgent situations arising in practice.
- To continue administrative procedure reforms in drug registration activities, ensuring improved access to medicines for the public while creating more favorable conditions for enterprises.; Protection of human health or safety

8.

Relevant documents:

- The Law on Pharmacy dated 6 April 2016;

- The Law amending a number of articles of the Law on Pharmacy dated 21 November 2024;

- The Law on Technology Transfer dated 19 June 2017;

- Decree No. 69/2018/ND-CP dated 15 May 2018 of the Government detailing a number of articles of the Law on Foreign Trade Management;

- Decree No. 76/2018/ND-CP dated 15 May 2018 of the Government detailing and guiding the implementation of a number of articles of the Law on Technology Transfer;

- Decree No. 163/2025/ND-CP dated 26 June 2025 of the Government detailing a number of articles and measures for the implementation of the Law on Pharmacy;

- Decree No. 42/2025/ND-CP dated 27 February 2025 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health.

9.

Proposed date of adoption: May 2025

Proposed date of entry into force: July 2026

10.

Provision of comments

Final date for comments: 23 May 2026 (45 days from notification)

[ ] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

Drug Administration of Vietnam - Ministry of Health

No. 138A, Giang Vo, Ba Dinh, Hanoi City

Phone: (84-24) 37366483

Fax: (84-24) 38234758

Email:cqldvn@moh.gov.vn