G/TBT/N/PHL/304  
3 July 2023  
(23-4510) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  PHILIPPINES  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
DR. SAMUEL A. ZACATE  
Director General  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notifi cation shall be indicated if different from above:   
IRENE V. FLORENTINO -FARIÑAS, RPh, MD, MNSA  
Officer -in-Charge – Director III  
Policy and Planning Service  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
E-mail: pps@fda.gov.ph  ; bps@dti.gov.ph  
www.fda.gov.ph   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Health 
care technology (ICS code(s): 11); Food technology (ICS code(s): 67); Chemical 
technology (ICS code(s): 71)  
5. Title, number of pages and language(s) of the notified document:  Updated 
Guidelines on the Application for License to Operate of Health Product Establishments with 
the Food and Drug Administration; (15 page(s), in English)  
6. Description of content:  The regulation aims to intro duce technical procedures on 
inspection and updated list of documentary requirements for the issuance of License to 
Operate aligned with international standards and automation of FDA licensing application 
systems. It also intends to repeal Administrative O rder No. 2020 -0017 (Revised 
Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug 
Administration Repealing AO No. 2016 -0003).  
The regulation provides the list of updated documentary requirements for LTO 
applications, in addit ion to other technical requirements that shall be presented during 
inspection of the FDA -covered establishments.  
Further, the FDA's intention to comply with international standards in terms of health 
shall be institutionalized in the agency's regulatory pr ocess. Hence, compliance with the 
World Health Organization – Global Benchmarking Tool (WHO -GBT) is necessary.  G/TBT/N/PHL/304  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  1. To further reengineer the FDA's processes and automate its system for 
initial, renewal, and variation applications for License to Operate (LTO) through the FDA 
available online application platforms; and,  
2. To update the list of documentary requirements for LTO applications, in addition to 
other technical req uirements that shall be presented during the inspection of the FDA -
covered establishments.  
8. Relevant documents:   
• Implementing Rules and Regulation (IRR) of RA No. 9711: Food and Drug 
Administration (FDA) Act of 2009  
• Administrative Order (AO) No. 2020-0017 "Revised Guidelines on the Unified 
Licensing Requirements and Procedures of the FDA Repealing AO No. 2016 -0003"  
9. Proposed date of adoption:  Third quarter of 2023  
Proposed date of entry into force:  15 days after newspaper publication  
10. Final date for comments:  21 July 2023  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Mr. Neil P. Catajay  
Director  
Bureau of Philippine Standards  
Department of Trade and Industry  
3F Trade and Industry Building  
361 Sen. Gil Puyat Avenue  
Makati City  
Philippines  
Tel: (632) 751 4700; (632) 7913128  
Email: bps@dti.gov.ph  
Website: http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/draft -for-comments -updated -guidelines -on-the-application -for-
license -to-operate -of-health -product -establishments -with-the-food-and-drug-
administration/  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_10750_00_e.pdf  
https://members.wto.org/crnattachments/2023/TB T/PHL/23_10750_01_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_10750_02_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_10750_03_e.pdf