G/LIC/N/2/PHL/201  
 
26 January 2024  
(24-0627) 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 submission, originally received on 13 December 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  [ ] (a) New licensing regulation/procedure2; (please answer question  
8 to 14 ) 
 
[X] (b) Changes to a regulation/procedure which has been 
previously notified in document: G/LIC/N/2/PHL/189 ; (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 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;  
 
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 which are in force but being notified for the first time to the Committee.  
 G/LIC/N/2/PHL/201  
 
- 2 - 
 
   Category  Notification details  
(g)  Regulate imports of arms, ammunition or fissionable 
materials and safeguard national security;  
(h)  Other:  _______________  
11 Administrative body(ies) for  
submission of applications   
 Ministry/authority and Department: Food and Drug Administration  
Address:   
Website:   
Telephone:  
E-Mail:  
12 Contact point for 
information on eligibility  Ministry/authority and Department: Food and Drug Administration  
Address:   
Website:   
Telephone:  
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:  Inclusion of drug products in the coverage as it has 
the same procedural guidelines as the medical devices 
following DOH AO No. 2020 -0017.  
 
16  Please elaborate the 
changes in detail (in one of 
the WTO official languages)  
 DOH AO No. 2020 -0017 was already notified to the WTO for medical 
devices. Since the procedural guidelines for drug products and 
medical devices are similar, there is a need to update the N2 
Notification for DOH AO No. 2020 -0017 to include drug products as 
follows:  
 
Drugs  
HS 30 Pharmaceutical products  
 
Initial, renewal and variation to License to Opera te applications of 
Manufacturers (including packers/repackers ), Traders, Distributors 
(as importers, exporters, and/or wholesalers), drug outlets such as  G/LIC/N/2/PHL/201  
 
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   Category  Notification details  
  drugstores, pharmacies (community, hospital or institutional) or 
boticas, and retail outlets for non -prescription drugs (RONPDs) of all 
drugs including vaccine s, biologics, veterinary medicines, and animal 
health products, medical gases, traditional medicine, and herbal 
medicine.  
 
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