G/TBT/N/PHL/322  
16 January 2024  
(24-0354) 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  
Director III, Policy and Planning Service  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: pps@fda.gov.ph  ; iffarinas@fda.gov.ph  ; rljgarcia@fda.gov.ph  ; BPS@dti.gov.ph  
www.fda.gov.ph  
3. Notified under Article 2.9.2 [  ], 2.10.1 [  ], 5.6.2 [X], 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):  Product 
and company certification. Conformity assessment (ICS code(s): 03.120.20)  
5. Title, number of pages and language(s) of the notified d ocument:  "Draft 
Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug 
Administration for Licensing, Registration and Other Authorizations and Regulatory 
Services Repealing Administrative Order No. 50s. 2001, entitled, "Revised 20 01 Schedule 
of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and 
Drugs"" and its Amendments"; (25 page(s), in English)  
6. Description of content:  The rate of fees and charges of the Food and Drug 
Administration has been referred to the Administrative Order No. 50 s.2001 or the Revised 
2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the 
Bureau of Food and Drugs. After more than twenty years, the FDA is restructuring its fees 
and charges at a level commensurate with the cost of regulating health products, 
establishments or facilities to protect consumer safety and public health.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Ord er aims to prescribe the schedule of fees and charges for the services 
rendered by the FDA and provide the guidelines for its implementation. Specifically, it 
shall aim to:  G/TBT/N/PHL/322  
 
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  A. Perform its given mandate by upgrading of its facilities, equipment outlay, huma n 
resource development, and expansion; acquisition of the appropriate office space, as well 
as purchases of laboratory equipment and motor vehicles; upgrading of its current 
facilities and equipment and maintenance; funding for operating expenses of the ce ntral 
office laboratory divisions and satellite laboratories; and other activities or services  
B. Meet and sustain the increasing demands of providing the FDA stakeholders quality 
and efficient services with the current innovations in technology and the im provement of 
its given regulatory function.  
8. Relevant documents:   
• Republic Act (RA) No. 3720, "Food, Drugs and Devices, and Cosmetics Act" as 
amended by Executive Order (EO) No. 175 and RA 9711  
• Republic Act (RA) No. 9711, ""Food and Drug Administration (FDA) Act of 2009".  
• Republic Act (RA) No. 9502, "Universally Accessible Cheaper and Quality 
Medicines Act of 2008".  
• DOF-DBM-NEDA Joint Circular No. 1 -2013, also known as the "Implementing 
Rules and Regulations of the Administrative Order No.  31 s. 2012 on the 
Rationalization of Rates of Fees and Charges, Increase in Existing Rates and 
Imposition of New Fees and Charges"  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  15 March 2024  
11. Texts available from:  National enquiry point [X] 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://members.wto.org/crnattachments/2024/TBT/PHL/24_00513_00_e.pdf  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_00513_01_e.pdf