G/TBT/N/VNM/268  
31 July 2023  
(23-5194) 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):  HS code: 
30 - Pharmaceutical Products  
5. Title, number of pag es and language(s) of the notified document:  Draft Circular 
regulating the registration of toll manufactured medicines and technology transfer 
medicines in Vietnam; (23 page(s), in Vietnamese)  
6. Description of content:  This draft Circular provides genera l provisions on the 
registration of toll manufactured medicines and technology transfer medicines in Vietnam;  
This draft Circular also regulates the dossiers and procedures for granting, extending, 
amending, supplementing and withdrawing registration docum ents of toll manufactured 
medicines and technology -transferred medicines (pharmaceutical drugs, vaccines, 
biological products, herbal drugs) in Vietnam.  
This draft Circular shall amend, supplement or repeal some provisions of Circular 
23/2013/TT -BYT and ha s been updated in accordance with the following legal texts in the 
field of pharmaceuticals, toll manufacturing and technology transfer  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements  
8. Relevant documents:   
Pharmaceutical Law No. 105/2016/QH13 dated 06/4/2016;  
Commercial Law No. 36/2015/QH11 dated 14 June 2005;  
Foreign Trade Management Law No. 05/2017/QH14dated 12 June 2017;  
Technology Transfer Law No. 07/ 2017/QH14dated 19 June 2017;  G/TBT/N/VNM/268  
 
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  Decree No. 69/2018/ND -CP dated 15 May 2018 of the Government detailing a number of 
articles of the Foreign Trade Management Law;  
Decree No. 95/2022/ND -CP dated 15 November 2022 of the Government defining the 
roles, responsibilities, jurisdiction and organizational structure of the Ministry of Health;  
Decree no 54/2017/ND -CP dated 8 May 2017 of the Government detailing a number of 
articles and measures for implementing Pharmaceutical Law 2016;  
Decree No. 155/2018/ND -CP dated 12 November 2018 of the Government amending and 
supplementing a number of regulations related to business investment conditions under 
the scope of state management of the Ministry of Health.  
9. Proposed date of adoption:  26 September 2023  
Proposed date of entry into force:  10 November 2023  
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:   
https://members.wto.org/crnattachments/2023/TBT/VNM/23_11384_00_x.pdf  
https://members.wto.org/crnattachments/2023/TBT/VNM/23_11384_01_x.pdf  
https://members.wto.org/crnattachments/2023/TBT/VNM/23_11384_02_x.pdf