   
  
G/LIC/N/2/PHL/189  
 
21 February 2023  
(23-1220) 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 
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  DOH Administrative Order No.2020 -0017 – Revised  Guidelines on the 
Unified Licensing Requirements and Procedures of the Food and Drug 
Administration Repealing AO No.2016 -0003 
3 Date of Publication  
 21 May 2020 
4 Date of entry into force  
 5 June 2020 
5 Website link/Official 
publication of the new 
regulation/procedure  https://www.fda.gov.ph/wp -
content/uploads/2020/05/Administrative -Order -No.2020 -0017.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  9033.00.00  - Parts and accessories (not specified or included  
elsewhere in Chapter 90 ) for machines, appliances,  
instruments or apparatus of Chapter 90.  
 
Initial, renewal and variation to License to Operate f or Traders and 
Distributors (Wholesalers/Importers/Exporters)  of: 
 
All medical devices,  
Radiation -emitting devices,  
In-vitro diagnostic device and reagents,  
Refurbished medical devices,  
Equipment or devices used for treating sharps,  
Pathological and infectious waste,  
Water treatment devices/systems,  
 
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/189  
 
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   Category  Notification details  
And other health -related devices as determi ned by the FDA.  
 
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;  
(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 simplify the requirements and processes for 
initial, renewal and variation to License to Operate  
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 said issuance redefined the coverage of activities and 
establishment regulated by the FDA and repealed AO No. 2016 -0003. 
 
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;  G/LIC/N/2/PHL/189  
 
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   Category  Notification details  
 Other: __________ (please specify).  
 
 
16  Please elaborate the 
changes in detail (in one of 
the WTO official languages)  
  
 
 
 
__________  