G/TBT/N/PHL/278  
21 January 2022  
(22-0492) 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 OSCAR G. GUTIERREZ, JR., MPA  
OIC-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 notification shall be indicated if different from above:   
Irene Florentino -Fariñas, RPh., MD, MNSA  
OIC-Director, Policy and Planning Service  
Food and Drug Administration DEPARTMENT OF HEALTH  
Email: PPS@ fda.gov.ph ; iffarinas@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  
5. Title, number of pages and language(s) of the notified document:  Draft FDA 
Circular "Categorization of Identified Borderlin e Health Products under the Jurisdiction of 
the Food and Drug Administration (FDA)" (30 page(s), in English)  
6. Description of content:  This Circular aims to provide guidance in the categorization of 
borderline health products under the jurisdiction of th e FDA by:  
A. Providing the preliminary list of borderline products and their designated product 
categories;  
B. Reiterating the considerations in determining product classification; and,  
C. Providing the appropriate transitory period to allow the proper reclassification of 
borderline health products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
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  G/TBT/N/PHL/278  
 
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  9. Proposed date of adoption:  This Circular shall take effect fifteen (15) days following 
the completion of its publication in a newspaper of general circulation and/or fil ing of a 
copy of which to the University of the Philippines Office of the National Register.  
Proposed date of entry into force:  This Circular shall take effect fifteen (15) days 
following the completion of its publication in a newspaper of general circulat ion and/or 
filing of a copy of which to the University of the Philippines Office of the National Register.  
10. Final date for comments:  27 January 2022  
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 M akati City,  
Philippines 1200  
(632) 7751 4700; (632) 7751 4706  
Email: bps@dti.gov.ph   
http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/wp -content/uploads/2021/12/Draft_FC -Illustrative -List-of-
Borderline -Products.pdf