   
  
G/LIC/N/2/MMR/13  
 
11 October 2023  
(23-6809) Page: 1/3 
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. 161/2023: Amendment of the Drug Registration 
Notification  
3 Date of Publication  14 July 2023  
4 Date of entry into force  1 January 2024  
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  [ ] (a) New licensing regulation/procedure; (please answer 
question 8 to 14)  
 
[X] (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  - 
 
9 Nature of licensing  Automatic: [  ]  
Non-Automatic: [  ]  
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/13  
 
- 2 - 
 
   Category  Notification details  
11 Administrative body(ies) for  
submission of applications  
 Ministry/authority and Department:  
Website:  
Telephone:  
Fax:  
E-Mail:  
12 Contact point for information 
on eligibility  Ministry/authority and Department:  
Address:  
Website:  
Telephone:  
Fax:  
E-Mail:  
13 Expected duration of licensing 
procedure   
14 A summary of the notification 
in one of the WTO official 
languages   
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)  Article 1  
1.(a) According to the section 7 of the National Drug Law, a 
person who wants to register a drug must apply to the 
Department of Food & Drug Administration.  
(b) An application under sub-article (a) may be registered using 
e-submission system.  
(c)  When applying according to sub -article (b), the information 
in this system must be completed and applied correctly.  
(d) Submission of drug sample and specific documents must be 
complied with  Drug Registration Guideline by the 
Department of Food and Drug Administration.  
 
2. After the description of Article 6 of the Drug Registration 
Notification,  E-submission application to the Department of Food 
and Drug Administration must be made via onlin e payment 
system.  G/LIC/N/2/MMR/13  
 
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   Category  Notification details  
  3. Article10  
(a) For imported registered drugs, the prescribed annual fees 
must be paid regularly via online payment system during 
validity period of Drug Registration Certificate. If annual 
fees are dismissed for two consecutive years, the renewal 
registration will not be allowed.  
(b) Imported registered drugs must be submitted to the 
Depar tment  of Food and Drug Administration for laboratory 
testing, once every five years of registration, and the 
Laboratory analysis fee must be paid via online payment 
system.  
(c) For local registered drugs, an annual GMP inspection of 
plant by the Department  of Food and Drug Administration 
and random sampling and testing of high -risk drugs must 
be complied.  
 
4. Article 11  
A person who wishes to apply for renewal Registration certificate 
must apply in accordance with the specific requirements on 
6 months befor e the expiry of the drug registration certificate.  
 
5. The term "Myanmar Food and Drug Authority " stated in 
Articles 7, 8, 9, 10 and 13 of the Drug Registration Notification 
shall be replaced by "Department of Food and Drug 
Administration assigned by the Myanmar Food and Drug 
Authority ". 
 
 
__________  