G/LIC/N/2/PHL/191  
 
21 February 2023  
(23-1221) 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.2021-021 – Guidelines  on the Licensing of Retailers 
of Medical Devices in the Philippines  
3 Date of Publication  7 October 2021 
4 Date of entry into force  2 February 2022 
5 Website link/Official 
publication of the new 
regulation/procedure  https://www.fda.gov.ph/wp -content/uploads/2021/10/FDA -Circular -
No.2021 -021.pdf  
6 Have you attached a copy of 
the regulation (PDF) to 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 regulation/procedure" is understood to refer to any newly introduced law, regulation or 
procedure, and those wh ich are in force but being notified for the first time to the Committee.  
 G/LIC/N/2/PHL/191  
 
- 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 specify establishment classified as retailers of 
medical devices; to clarify the licensing of drug outlets 
which are also retailers of medical devices; to provide 
specific requirements for and responsibilities of 
qualified persons and for post licensing inspection 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   This FDA Circular was issued to provide specific guidelines 
supplementing the provisions of AO No. 2020 -0017 on the licensing 
of 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)   
 
 
__________