G/TBT/N/PHL/323  
26 January 2024  
(24-0591) 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:   
MS. IRENE V. FLORENTINO -FARIÑAS, RPh., MD, MNSA  
Director III, Policy and Planning Service  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: pfpid@fda.gov.ph ; iffarinas@fda.gov.ph ; BPS@dti.gov.ph ; BPS.SMD@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):  Domestic 
safety (ICS code(s): 13.120)  
5. Title, number of pages and language(s) of the notified document:  Guidelines on 
the Recall of Health Products Regulated by the Food and Drug Administration; (13 
page(s), in English)  
6. Description of content:  The regulatory landscape of health products has changes 
significantly that the initially issued Guidelines on Product Recall needs to be revised. This 
Circular is hereby promulgated to create an updated framework for the recall of products 
in pursuit of public health and safety.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  This Circular intends to e stablish a guideline on the recall of health products 
and effectively contribute in ensuring the safety and protection of the general public which 
present a substantial risk of injury, illness, and/or gross deception. Specifically, this 
Circular aims to: A . Strengthen the recall system for health products under the jurisdiction 
of the FDA; B. Specify the responsibilities and reporting obligations of the MAH in the 
conduct of product recall; and C. Provide guidance to MAH in conducting effective recalls.; 
Protection of human health or safety  G/TBT/N/PHL/323  
 
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  8. Relevant documents:   
• Republic Act (RA) No. 9711 or the "Food and Drug Administration Act of 2009" 
and its Implementing Rules and Regulations (IRR)  
• FDA Circular (FC) No. 2016 -012 or the "Guidelines on Product Recall"  
9. Proposed date of adoption:  1 April 2024  
Proposed date of entry into force:  This Circular shall take effect after fifteen (15) days 
following the publication in the Official Gazette or in a newspaper of general circulation 
and filing with the Of fice of the National Administrative Register of the UP Law Center.  
10. Final date for comments:  24 February 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://www.fda.gov.ph/draft -for-comments -guidelines -on-the-recall -of-health -
products -regulated -by-the-food-and-drug-administration/  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_00744_00_e.pdf  
https://members.wto.org/ crnattachments/2024/TBT/PHL/24_00744_01_e.pdf  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_00744_02_e.pdf  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_00744_03_e.pdf