G/LIC/N/2/MMR/12  
 
11 October 2023  
(23-6818) Page: 1/2 
Committee on Import Licensing  Original: English  
 
  
AGREEMENT ON IMPORT LICENSING PROCEDURES  
NOTIFICATION UNDER ARTICLE 5.1 TO 5.4 OF THE AGREEMENT1 
MYANMAR  
The following submission , originally received  on 26 September  2023, is being circulated at the 
request of the delegation of Myanmar.  
 
 Category  Notification details  
1 Notifying Member  Myanmar  
2 Title of new 
legislation/procedure  Notification No. 3/1993: Drug Registration Notification  
3 Date of Publication  5 August 1993  
4 Date of entry into force  5 August 1993  
5 Website link/Official 
publication of the new 
regulation/procedure  https://www.mohs.gov.mm  
 
6 Have you attached a copy of 
the regulation (PDF) to the 
Secretariat  Yes [X]  
 
No  [ ]  
7 Type of notification  [x] (a) New licensing regulation/procedure; (please answer 
question 8 to 14)  
 
[ ] (b)Changes to a regulation/procedure which has been 
previously notified in document : (please answer question 15 and 
16) 
8 List of products subject to 
licensing  Detail HS code Product description (6 or 10 digit level)  
 
9 Nature of licensing  Automatic: [  ]  
Non-Automatic: [X]  
10 Administrative 
purpose/measure being 
implemented  (a)  Protect public morals;  
(b)  Protect human, animal or plant life or health;  
(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:  
 
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.  G/LIC/N/2/MMR/12  
 
- 2 - 
 
   Category  Notification details  
11 Administrative body(ies) for  
submission of applications  
 Ministry/authority and Department: Ministry of Health, 
Department of Food and Drug Administration  
Address: PyigyiZayyar Road, ZayyarThiri Ward, ZabuThiri 
Township, Nay Pyi Taw, Myanmar  
 
Website: www.fda.gov.mm   
Telephone: 0673 -403073  
Fax: 0673 -403073  
 
E-Mail: fdanpt1@gmail.com   
12 Contact point for 
information on eligibility  Ministry/authority and Department: Ministry of Health,  
Department of Food and Drug Administration  
Address: PyigyiZayyar Road, ZayyarThiri Ward, ZabuThiri  
Township, Nay Pyi Taw, Myanmar  
 
Website: www.fda.gov.mm   
Telephone: 0673 -403073  
Fax: 0673 -403073  
 
E-Mail: fdanpt1@gmail.com   
13 Expected duration of 
licensing procedure  Ongoing  
14 A summary of the 
notification in one of the 
WTO official languages  According to National Drug Law, Notification No. 3/1993  is 
concerned with registration of pharmaceuticals in Myanmar 
describing the requirements for drug registration.  
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 official WTO languages)   
 
 
__________