G/TBT/N/VNM/290  
24 January 2024  
(24-0542) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  VIET NAM  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Drug Administration of Viet Nam  
Ministry of Health  
138A Giang Vo Street – Ba Dinh District – Ha Noi  
Tel: (84 -4) 37366483 - Fax: 38234758 - Email: cqldvn@moh.gov.vn  
Name and address (incl uding telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
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 or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
PHARMACEUTICAL PRODUCTS (HS code(s): 30)  
5. Title, number of pages and language(s) of the notified document:  Draft Law 
amending and supplementing a number of articles of the Law on Pharmacy; (23 page(s), 
in Vietnamese)  
6. Description of content:  This draft Law amends and supplements a number of articles 
of Law No. 105/2016/QH13 on Pharmacy.  
These Articles include 2, 4, 6, 7, 8, 10, 17, 24, 28, 32, 33, 34, 35, 37, 42, 43, 44, 46, 
47, 48, 49, 53, 54, 55, 56, 58, 59, 60, 61, 64, 65, 76, 78, 79, 87, 89, 107, 109, 110, 
112, 113;  
This draft Law abolishes point c and d, c lause 26, Article 2, point a, clause 10, Article 6, 
point b, clause 4, Article 7 of Law No. 105/2016/QH13 on Pharmacy.  
Transitional provisions:  
1. Certificates of drug information and advertising content issued under the provisions of 
Law No. 105/2016/QH13 on Pharmacy will continue to be used until the expiry of the 
Certificate's validity  
2. Dossier submitted before the entry into force of this draft Law and requesting the 
issuance, extension, amendment or supplementation of the registration ce rtificate for the 
circulation of drugs and medicinal ingredients shall be implemented in accordance with 
the provisions of Law No. 105/2016 /QH13 on Pharmacy, except in cases where the 
establishment requests to comply with the provisions of this draft Law.  
3. For dossiers applying for a License to import toxic drugs and toxic medicinal 
ingredients; drugs and medicinal ingredients that are on the list of substances whose use G/TBT/N/VNM/290  
 
- 2 - 
 
  is prohibited in a number of industries and fields used for testing, research, and 
manufacturing of drugs for export in accordance with the provisions of the 2016 Law on 
Pharmacy and its guiding Decrees.  
4. Chain pharmacy businesses that have had a chain pharmacy system prior to the 
effective date of this Law shall complete procedures to apply for a certificate of authority 
to do business as a chain within 45 days of the effective date of this draft Law.  
The regulations on granting, extending, amendment and supplementing circulation 
registration certificates for drugs and medicinal ingredi ents, except for regulations on 
issuing medical oxygen product declaration forms, shall be applied from January 1, 2025  
The Draft Law was formulated based on the basis of 05 policies submitted to the 
Government and the National Assembly of Vietnam in the p roposal No. 09/TTr -BYT dated 
on January 5th, 2023 as well as other difficulties and issues encountered during the 
implementation process, as follows:  
1. Policy 1: Further strengthen the sufficient and timely supply of quality -assured 
medicines to meet peop le's need for disease prevention and treatment.  
2. Policy 2: Ensure sufficient and timely supply of drugs that meet the demands of 
security, national defense, coping with the consequences of natural disasters, and 
preventing epidemics and diseases in the n ew situation  
3. Policy 3: Improve the efficiency of import/export management of drugs/medicinal 
materials to the socio -economic development situation and international practice  
4. Policy 4: Promote the development of the pharmaceutical industry with emphas is on 
research, technology transfer and production of high -tech drugs, biological 
drugs/medicinal materials, standardized herbal medicines, and raw materials from 
domestically available pharmaceutical sources.  
5. Policy 5: Organize and rearranging the busi ness and distribution system for 
drugs/medicinal materials to cope with socio -economic development and international 
integration.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Reducing trade barriers and facilitatin g trade  
8. Relevant documents:   
Law No. 105/2016/QH13 on Pharmacy  
9. Proposed date of adoption:  October 2024  
Proposed date of entry into force:  1 July 2025  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Drug Administration of Viet Nam  
138A Giang Vo Street – Ba Dinh District – Ha Noi  
Tel : (84 -4) 37366483 - Fax: 38234758 - Email: cqldvn@moh.gov.vn  
https://members.wto.org/crnattachments/2024/TBT/VNM/24_00694_00_x.pdf