  
  
G/TBT/N/VNM/253  
23 March 2023  
(23-2102) 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 (including 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 [  ], 2.10.1 [X], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other : Urgently amending and supplementing the contents of Decree No. 54 and Decree 
No. 155, which are not suitable with the actual situation, according to the shortened order 
and procedures to immediately remove difficulties and obstacles of the organiz ation, 
individuals in the production and trading of pharmaceutical products in order to ensure 
the timely and sufficient supply of quality drugs for the needs of disease prevention and 
treatment, and to strengthen the protection, care and improvement of th e people's 
health.  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Medicaments (ICS code(s): 11.120.10)  
5. Title, number of pages and language(s) of the noti fied document:  Draft Decree on 
amendments to some articles of Government's Decree No. 54/2017/ND -CP dated 08 May 
2017 providing guidelines for some articles and implementation of the law on pharmacy 
and Government's Decree No. 155/2018 dated 12 November 20 18 on amendments to 
some articles related to business conditions under state management of the Ministry of 
Health; (5 page(s), in Vietnamese)  
6. Description of content:  - Amendments to regulations on export, import, registration of 
herbal ingredients, exc ipients, capsule shells, semi -finished herbal ingredients in Clause 
1 Article 91, Article 93 of Decree No. 54 and point b Clause 47 Article 5 of Decree No. 155 
to simplify administrative dossiers and procedures for export, import, registration of 
herbal in gredients, excipients, capsule shells, semi -finished herbal ingredients, creating 
more favourable conditions for enterprises, including allowing to replace "the Pharmacy 
Business License for enterprises supplying herbal ingredients, semi -finished herbal 
ingredients" with "Business license or equivalent documents with the trading scope in 
herbal ingredients", and allows to replace "Certificate of Good Manufacturing Practice 
(GMP) for herbal ingredients, semi -finished herbal ingredients" with "Manufacturing 
License or equivalent documents with Good Manufacturing Practice Certificate (GMP) 
within the scope of manufacture of herbal ingredients, semi -finished herbal ingredients".  G/TBT/N/VNM/253  
 
- 2 - 
 
  - Amendment to Point a Clause 1 Article 97 of the Decree 54 on inspection of foreign  drug 
manufacturers in the direction of mandating the Advisory Council to consider and evaluate 
the conformity of exporting countries' GMP standards with GMP principles and standards 
prescribed by the Ministry of Health, if the exporting countries/territor ies apply GMP 
principles and standards that are not among the GMP principles and standards announced 
or promulgated by the Ministry of Health.  
- Amendment on review of stated drug prices and the composition of the intersectoral 
drug pricing Council  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Harmonization; Reducing trade 
barriers and facilitating trade  
8. Relevant documents:   
- Law on Food Safety  
- Decree 15/2018/ND -CP date d February 02, 2018 of the Government on the elaboration 
of some articles of the Law of Food Safety  
- Vietnam Pharmacopoeia V  
- TCVN 7924 -2:2008 (ISO 16649 -2:2001)  
- Circular 26/2012/TT -BKHCN dated December 12, 2012 of the Minister of Science and 
Technolog y on the state inspection of quality of goods in circulation  
- Circular 12/2017/TT -BKHCN dated September 28, 2017 of the Minister of Science and 
Technology on amendments and supplements to Circular 26/2012/TT -BKHCN dated 
December 12, 2012 of the Minister of Science and Technology on the state inspection of 
quality of goods in circulation  
- ASEAN Guidelines on Limits of Contaminants for Health Supplements (Annex III) at 
website: https://asean.org/wp -content/uploads/2017/09/ASEAN -Guidelines -on-Limts -
of-contaminants -HS-V2.0-with-disclaimer.pdf  
9. Proposed date of adoption:  The draft Decree is expected to be submitted to the 
Government in March 2023 to consider and approve.  
Proposed date of entry into force:  immediately after the date of promulgation.  
10. Final date for comments:  1 April 2023  
11. Texts available from:  National enquiry point [ ] 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/2023/TBT/VNM/23_8406_00_x.pdf  
 