G/LIC/N/2/PHL/200  
 
26 January 2024  
(24-0632) 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  FDA Circular No.  2020-0030 – Guidelines for the Use of the FDA 
eServices Portal System for License to Operate (LTO) Application of 
Drug Distributors, Drug Traders, Drugstores, Retail Outlets for Non -
Prescription Drugs (RONPD), Clinical Research Organization (CRO), 
and Sponsors  
3 Date of Publication  16 October 2020  
4 Date of entry into force  16 October 2020  
5 Website link/Official 
publication of the new 
regulation/procedure  https://www.fda.gov.ph/wp -content/uploads/2020/10/FDA -Circular -
No.-2020-030-1.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  (a) Drug products, including vaccines, biologics, veterinary 
medicines and animal health products, medical gases, traditional 
medicine, and herbal medicines for commercial distribution  
(b) Drug products for personal use:  
• Over-the-counter (OTC) drugs – 50 g 
• Prescription drugs – the imported quantity or volume 
should correspond to the quantity or volume specified in 
the prescription with the corresponding physician's 
Professional Regulatory Commission (PRC) License 
Number, or its equivalent for prescriptions i ssued by 
foreign physicians.  
• Vitamins, supplements, and other health supplements 
intended as maintenance – 500 g in total.  
 
 
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/200  
 
- 2 - 
 
   Category  Notification details  
(c) Imports of FDA -DOH-regulated products may be brought into 
the Philippines without prior clearance from the FDA; provided 
that su ch products are:  
• For personal use;  
• In quantities not exceeding the limits  
• Brought into the Philippines in any of the following ways:  
i. In passenger baggage, whether accompanied or 
unaccompanied;  
ii. In balikbayan boxes; or  
iii. In parcels sent through mail or delivery services.  
 
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 provide guidelines on the new FDA eServices 
Portal System in applying for LTO  
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://eservices.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 Civi c Dr, Alabang, Muntinlupa, 1781 Metro Manila  
Website: https://eservices.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 was developed to provide a 
streamlined online platform for FDA Authorized Applications.  
 
Initial, renewal, and variation of License to Operate (LTO) applications 
for Drug Distributors (Importer/Exporter/Wholesaler), Drug Traders, 
Drug retailers (Drugstore and Retail Outlet for Non -Prescription 
Drugs), Clinical Research Organizations (CROs), and Sponsors . 
 
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;  G/LIC/N/2/PHL/200  
 
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   Category  Notification details  
 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)   
 
 
 
__________