G/LIC/N/2/PHL/192  
 
21 February 2023  
(23-1224) 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 
PHILIPPINES  
The following notification dated 14 February 2023 , is being circulated at the request of the delegation 
of the Philippines . 
 
 Category  Notification details  
1 Notifying Member  Philippines  
2 Title of new 
legislation/procedure  FDA Circular No.2022-007 – Guidelines  on the Use of the Food and 
Drug Administration eServices Portal System for License to Operate 
(LTO) Application of Retailers of Medical Devices  
3 Date of Publication  9 September 2022 
4 Date of entry into force  1 February 2022 
5 Website link/Official 
publication of the new 
regulation/procedure  https://www.fda.gov.ph/fda -circular -no-2022-007-guidelines -on-
the-use-of-the-food-and-drug-administratione -services -portal -
system -for-license -to-operate -lto-application -of-retailers -of-
medical -devices/   
6 Have you attached a copy of 
the regulation (PDF) t o the 
Secretariat  [ X ] Yes. ( Please attach a copy of the regulation to the notification. ) 
 
[    ] No. 
7 Type of notification  [ X ] (a) New licensing regulation/procedure2; (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  Retailers of medical devices  
 
9033.00.00 - Parts and accessories (not specified or included  
elsewhere in Chapter 90) for machines, appliances,  instruments or 
apparatus of Chapter 90  
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 and health; protect 
environment;  
(c)  Collect trade statistics or market surveillance;  
(d)  Protection of patents, trademarks and copyrights, and 
the prevention of deceptive practices;  
 
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 r egulation/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/PHL/192  
 
- 2 - 
 
   Category  Notification details  
(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:  To provide guidelines on the use of the FDA 
eServices Portal System for the application of  retailers 
of medical devices   
11 Administrative body(ies) for  
submission of applications  Ministry/authority and Department: Food and Drug Administration  
Address:  1781 Civic Dr, Alabang, Muntinlupa, 1781 Metro Manila  
Website: https://www.fda.gov.ph   
Telephone: +632 8 857 -1900 
E-Mail: info@fda.gov.ph  
12 Contact point for information 
on eligibility  Ministry/authority and Department: Food and Drug Administration  
Address: 1781 Civic Dr, Alabang, Muntinlupa, 1781 Metro Manila  
Website:  https://www.fda.gov.ph   
Telephone: +632 8 857 -1900 
E-Mail: info@fda.gov.ph   
13 Expected duration of 
licensing procedure  Ongoing  
14 A summary of the 
notification in one of the 
WTO official languages   The FDA eservices Portal System has been developed to provide a 
streamlined online platform for FDA authorization application s for 
retailers of medical devices.  
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)   
 
 
__________