Draft amendments to Pharmacy Law Decree 163/2025/ND-CP: consultation closed on 2 November 2026
Official Letter 8000/BYT-QLD circulated the draft Decree amending Decree 163/2025/ND-CP to ministries, business associations and pharmaceutical companies. The comment period ended on 2 November 2026. The Ministry of Health will now consolidate comments and finalise the draft for appraisal and submission to the Government; no issue date has been announced.
Update, 8 November 2026: the comment deadline (2 November 2026) has passed. The summary of the letter is kept for reference; the recommendations have been revised.
The Ministry of Health has issued Official Letter 8000/BYT-QLD (posted on 23 October 2026 on the Drug Administration of Vietnam website). The letter circulates a draft Decree amending and supplementing several articles of Decree 163/2025/ND-CP of 29 June 2025, which details and guides the implementation of the Pharmacy Law. Agencies, business associations and pharmaceutical companies were asked to send comments to the Ministry of Health (Drug Administration of Vietnam) before 2 November 2026. That window has now closed. The letter covers only the legal basis, the contents of the dossier and how to comment. The actual amendments are in the draft documents posted on moh.gov.vn and dav.gov.vn.
What the document is and who issued it This is a consultation letter, not a legal normative document, so it creates no new obligations by itself. It was signed by Deputy Minister of Health Do Xuan Tuyen on behalf of the Minister. The Drug Administration of Vietnam is the contact point for comments.
According to the letter, the Ministry drafted the amending Decree in order to:
- implement Government Resolution 66.7/2025/NQ-CP of 15 November 2025 on cutting and simplifying administrative procedures based on data;
- implement Government Resolution 66.16/2026/NQ-CP of 7 April 2026 on cutting and simplifying administrative procedures and regulations related to production and business activities;
- guide the Pharmacy Law provisions being amended by the draft Law amending several articles of the Law on Children, the Law on Persons with Disabilities, the Law on Medical Examination and Treatment, the Pharmacy Law, the Law on the Elderly and the Law on Health Insurance;
- promptly resolve difficulties and obstacles in applying Decree 163/2025/ND-CP.
The consultation is carried out under the Law on Promulgation of Legal Normative Documents.
What the draft dossier contains
- Draft Submission to the Government;
- Draft Decree and Annex(es);
- Summary report on implementation;
- Comparison and explanation table of the draft Decree.
The letter does not summarise which articles change. To see the specific changes for registration, manufacturing, import, trading or other procedures, companies need to read the draft and the comparison table directly.
Who is being consulted The annexed recipient list includes: ministries, ministerial-level agencies and Government agencies; the Central Committee of the Vietnam Fatherland Front; the Ethnic Council; provincial People's Committees; departments of the Ministry of Health, the National Health Information Center and the National Centralized Drug Procurement Center; the Administrative Procedure Control Agency of the Government Office (for the administrative procedures in the draft); provincial Departments of Health; the Vietnam Chamber of Commerce and Industry (VCCI); institutes and hospitals; pharmacy universities; the Vietnam Pharmaceutical Companies Association, the Vietnam Pharmaceutical Association, PharmaGroup, EuroCham, AmCham, InCham and USABC; and pharmaceutical companies.
Deadline, effective date and transition
- The comment deadline was 2 November 2026 and has passed. Comments were to be sent to the Ministry of Health (Drug Administration of Vietnam), with a Word version emailed to dav_moh@moh.gov.vn.
- Any recipient that has not commented by then will be treated as agreeing with the draft dossier.
- The letter states no effective date or transitional provisions for the amending Decree. If there are any, they will be in the draft Decree itself. The current Decree 163/2025/ND-CP keeps applying until an amending decree is issued and takes effect.
- Note: the number and date fields at the top of the signed PDF are blank. The number 8000 and the date 23 October 2026 come from the listing on the Drug Administration of Vietnam website.
What affected companies should do
- Download the draft dossier from moh.gov.vn or dav.gov.vn. Start with the comparison and explanation table, which shows which provisions change.
- Check which of your procedures currently rely on Decree 163/2025/ND-CP and assess the impact.
- Watch moh.gov.vn, dav.gov.vn and the Government portal for the finalised draft or the issued amending decree.
- Companies that still have concerns about the draft can raise them through the listed associations (Vietnam Pharmaceutical Companies Association, PharmaGroup, EuroCham, AmCham, InCham, USABC) or VCCI.
Sources
- Drug Administration of Vietnam announcement: https://dav.gov.vn/cong-van-so-8000byt-qld-ve-viec-xin-y-kien-ve-ho-so-du-thao-nghi-dinh-sua-doi-bo-sung-mot-so-dieu-cua-nghi-dinh-so-1632025nd-cp-n5544.html
- Official Letter 8000/BYT-QLD (signed PDF): https://dav.gov.vn/upload_images/files/8000_BYT_QLD_signed.pdf
