G/TBT/N/PHL/232  
24 March 2020  
(20-2377) 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 Rolando Enrique D. Domingo , DBPO  
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 th e notification shall be indicated if different from above:   
Dr. Oscar G. Gutierrez  
Officer -in-Charge  
Policy and Planning Service  
Food and Drug Administration  
Department of Health  
Email: oggutierrez@fda.gov.p h; cmcverga@fda.gov.ph  
www.fda.gov.ph    
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Health 
products under the DOH -Food and Drug Administration (e.g processed food, food 
supplements, food additives and ingredients, drugs or medicines,  cosmetics, medical and 
health -related devices, including diagnostic kits and reagents, radiation emitting devices or 
equipment, household hazardous substances, including urban pesticides, cigarettes, toys 
and childcare articles, among other products as de termined by the DOH -FDA) 
5. Title, number of pages and language(s) of the notified document:  New Schedule of 
Fees and Charges of the Food and Drug Administration for Licensing, Registration and 
Other Authorizations and Regulatory Services, Amending Admini strative Order 
No. 50 s. 2001, "Revised 2001 Schedule of Fees and Charges for the Corresponding 
Services Rendered by the Bureau of Food and Drugs". (22 page(s), in English)  
6. Description of content:  Additional guidelines on the FDA services particularly on fees and 
charges, validity of License to Operate (LTO), Certificate of Product Registration (CPR), 
Foreign Good Manufacturing Practice Certificate (FGMP), among others.   
Provides guidelines on fees and charges on FDA services including   those 
processes/ services in issuing licenses and  product market authorizations on all health 
products prior to manufacture, importation, exportation, sale, offering for sale, 
distribution, transfer, non -consumer use, promotion, advertising, or sponsorship.  G/TBT/N/PHL/232  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Administrative Order is issued to prescribe the new schedule of fees and 
charges for the services rendered by FDA, and provide the guidelines for its 
implementation inc luding  validity of License to Operate (LTO), Certificate of Product 
Registration (CPR), Foreign Good Manufacturing Practice Certificate (FGMP), among others  
8. Relevant documents:   
• Republic Act No. 9502 - Universally Accessible Cheaper and Quality Medicine Act of 
2008 
• RA No. 9711 - FDA Act of 2009  
9. Proposed date of adoption:  This Administrative Order shall take effect after fifteen 
(15) days after its publication in at least two (2) national papers of general circulation and 
upon filing at the Office of the National Administrative Register (ONAR) at the UP Law 
Center, Diliman, Quezon City.  
Proposed date of entry into force:  This Administrative Order shall take effect after 
fifteen (15) days after its publication in at least two (2) national pape rs of general 
circulation and upon filing at the Office of the National Administrative Register (ONAR) at 
the UP Law Center, Diliman, Quezon City.  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2020/TBT/PHL/20_2131_00_e.pdf