G/LIC/N/2/VNM/17  
 
16 December  2019 
(19-8722) Page: 1/3 
Committee on Import Licensing  Original: English  
 
 
AGREEMENT ON IMPORT LICENSING PROCEDURES  
NOTIFICATION UNDER A RTICLE 5.1 TO 5.4 OF  THE AGREEMENT1 
VIET NAM 
The following notification , dated 29 November 2019 , is being circulated at the request of the 
delegation of Viet Nam . 
 
 Category  Notification details  
1 Notifying Member  Viet Nam   
2 Title of new 
legislation/procedure  1. Decree No. 54/2017/ND -CP dated 8th May  2017 on guidelines for 
implementation of the law on pharmacy  
2. Decree No. 155/2018/ND -CP dated 12th November 2018 on 
amendments to some articles related to business conditions under 
state management of the Ministry of Health.  
3 Date of Publication  
 1. 8th May 2017  
2. 27th December 2017  
4 Date of entry into force  
 1. 1st July 2017  
2. 1 January 2018  
5 Website link/Official 
publication of the new 
regulation/procedure  1. http://vbpl.vn/TW/Pages/vbpq -
toanvan.aspx?ItemID=123255&Keyword=n%C4%91%2054%20201
7  
2. http://vbpl.vn/TW/Pages/vbpq -
toanvan.aspx?ItemID=127635&Keyword=n%C4%91%20155%2020
18 
6 Have you attached a copy of 
the regulation (PDF) to the 
Secretariat   Yes. ( Please attach a copy of the regulation to the notification. ) 
 
 No. 
7 Type of notification   (a) New licensing regulation/procedure2; (please answer question 
8 to 14)  
 
 (b) Changes to a regulation/procedure which has been pre viously 
notified in document: ______________ ;  ( please answer question 
15 and 16 ) 
8 List of products subject to 
licensing  See the attached Annex  
 
9 Nature of licensing  Automatic:  
 
Non-Automatic:  
10 Administrative 
purpose/measure being 
implemented  (a)  Protect public morals;  
(b)  Protect human, animal or plant life and health; protect 
environment;  
                                                
1 It is understood that the notifying Member has also completed its notification obligations under 
Article  1.4(a) and Article 8.2(b) regarding the relevant law/regulation/procedure notified for by filling this form 
in a full and complete manner.  
2 "New licensing regulation/procedure" is understood to refer to  any newly introduced law, regulation or 
procedure, and those which are in force but being notified for the first time to the Committee.  
 G/LIC/N/2/VNM/17  
 
- 2 - 
 
   Category  Notification details  
(c)  Collect trade statistics or market surveillance;  
(d)  Protection of patents, trademarks and copyrights, and 
the prevention of deceptive practices;  
(e)  Pursue obligations under the UN Charter and other 
international treaties ( i.e. CITES, Basel Convention, 
Rotterdam Convention, UNSC Resolutions etc.)  
(f)  Quota (including TRQ) administration;  
(g)  Regulate imports of arms, ammunition or fissionable 
materials and safeguard national security;  
(h)  Other: ______________ (please specify)  
 
11 Administrative body(ies) for  
submission of applications   
 Ministry/authority and Department: Pharmaceutical Business 
Management – Drug Administration of Viet Nam  
Address:  Building A, 138A Giang Vo street, Ba Dinh District, Ha Noi  
Website: https://dav.gov.vn/  
Telephone: +84 24 3846 2011  
E-Mail: chienpc.qld@moh.gov.vn  
12 Contact point for 
information on eligibility  Ministry/authority and D epartment: Pharmaceutical Business 
Management – Drug Administration of Viet Nam  
Address:  Building A, 138A Giang Vo street, Ba Dinh District, Ha Noi  
Website: https://dav.gov.vn/  
Telephone: +84 24 3846 2011  
E-Mail: chienpc.qld@moh.gov.vn  
13 Expected duration of 
licensing procedure  Ongoing  
 
14 A summary of the 
notification in one of the 
WTO official languages   Import licensing procedure of m edicines, pharmaceutical starting 
materials  
 
15 In the case of 7(b), please 
indicate the type of new 
change(s)  (a)  Termination  
(b)  Suspension  
(c)  Modification of specific details in existing  
procedures:  
 Product coverage;  
 Administrative purpose;  
 Automatic or Non -automatic;  
 Duration of licensing;  
 Change the nature of quantity/value restriction;  
 Eligibility of applicants;  
 Contact information on eligibility;  
 Administrative body(ies) for submission of application;  
 Documentation requirements (including application form);  
 Period for Application;  
 Administrative body(ies) to issue licence;  
 Processing time for issuing licence;  
 Licence fee/administrative charge;  
 Deposit/advance payment and relevant conditions;  
 Appeal regulations/procedures;  
 Validity of licence;  
 Other conditions of licence (extension, transferability, 
penalty of non -use etc.);  
 Foreign exchange requirements;  
 Other: __________ (please specify).  
 
 
16  Please elaborate the 
changes in detail (in one of 
the WTO official languages)  
  
 
 
 G/LIC/N/2/VNM/17  
 
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  ANNEX  
LIST OF MEDICINES, P HARMACEUTICAL STARTI NG MATERIALS  
SUBJECT TO IMPORT LI CENSING  
1. Medicines, pharmaceutical starting materials eligible for exemption of import licensing:  
 
Medicines, pharmaceutical starting materials that are pharmaceutical substances g ranted marketing 
authorization in Viet Nam, pharmaceutical starting materials that are pharmaceutical substances for 
manufacturing medicines in accordance with the drug registration dossier granted marketing 
authorization in Viet Nam, except for controlled  medicines, pharmaceutical starting materials.  
 
2. Medicines, pharmaceutical starting materials subject to import licensing:  
 
a) Medicines without marketing authorization in Viet Nam  
 
b) Pharmaceutical starting materials that are pharmaceutical substance s without marketing 
authorization in Viet Nam  
 
c) Controlled medicines, pharmaceutical starting materials   
 
3. Controlled medicines are specified as follows:  
 
a) The list of radioactive substances used in the health sector as provided in Annex IV in conjunction 
with Decree No. 54/2017/ND -CP 
 
b) The list of narcotic pharmaceutical substances specified in Annex I in conjunction with Circular 
No. 20/2017/TT -BYT dated 10 May 2017 of the Minister of Health detailing specific provisions in the 
Pharmacy Law and Decree No. 54/2017/ND -CP dated 8 May 2017 of the Government on controlled 
medicines and pharmaceutical starting materials;  
 
c) The list of psychotropic pharmaceutical substances specified in Annex II in conjunction with 
Circular No.20/2017/TT -BYT date d 10 May 2017 of the Minister of Health detailing specific provisions 
in the Pharmacy Law and Decree No.  54/2017/ND -CP dated 8 May 2017 of the Government on 
controlled medicines and pharmaceutical starting materials;  
 
d) The list of precursors for medicin e production specified in Annex III in conjunction with Circular 
No.20/2017/TT -BYT dated 10 May 2017 of the Minister of Health detailing specific provisions in the 
Pharmacy Law and Decree No.  54/2017/ND -CP dated 8 May 2017 of the Government on controlled 
medicines and pharmaceutical starting materials;  
 
e) The list of medicines, pharmaceutical substances in the list of substances the use of which is 
banned in specific sectors, areas as specified in Annex VII in conjunction with Circular No. 
20/2017/TT -BYT dated 10 May 2017 of the Minister of Health detailing specific provisions in the 
Pharmacy Law and Decree No. 54/2017/ND -CP dated 8 May 2017 of the Government on controlled 
medicines and pharmaceutical starting materials;  
 
f) The list of toxic medicines and  toxic pharmaceutical starting materials for medicine production 
issued in conjunction with Circular No. 06 /2017/TT -BYT dated 3rd May 2017 by the Minister of 
Health on the publication of List of toxic medicines and toxic pharmaceutical starting materials used 
in medicine production.  
 
4. The list of HS Code of all medicines, pharmaceutical starting materials:  
 
Circular No. 06 /2018/TT -BYT dated 6th April 2018 of the Minister of Health on publication of the 
List of medicines, pharmaceutical starting material s for human use and cosmetics for export, import 
with identified HS codes according to the List of Vietnamese goods for export, import (attached 
herewith).  
 
__________