G/TBT/N/PHL/302/Rev.1  
3 May 2024  
(24-3550) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
Revision  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member:  PHILIPPINES  
If applicable, name of local government involved (Articles 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 notification shall be indicated if different from above:   
Jesusa Joyce N. Cirunay, RPh  
Director IV  
Center for Drug Regulation and Research  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: cdrr.od@fda.gov.ph  ; cdrr.sds@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):  
Pharmaceutics (ICS code(s): 11.120)  
5. Title, number of pages and language(s) of the notified document:  Draft Foo d and 
Drug Administration (FDA) Circular "Guidelines on the Importation and Exportation 
Notification for Pharmaceutical Products and Raw Materials"; (7 page(s), in English)  
6. Description of content:  FDA Memorandum Circular (FMC) No. 2013 -032, entitled 
"Requirements for the Immediate Release of Products Covered by the FDA at the Bureau 
of Customs", was issued, wherein only valid FDA License to Operate (LTO) and Certificate 
of Product Registration (CPR) were required to be presented to the Bureau of Customs  
(BOC) for the release of pharmaceutical products. However, there is a need to strengthen 
market control within the distribution chain through measures to ensure that the public 
only receives quality -assured pharmaceutical products. The infiltration of sub standard and 
counterfeit pharmaceutical products into the supply system shall be prevented through 
risk-based surveillance schemes and rigorous control. Therefore, as part of the FDA's 
powers and functions under RA No. 9711, requiring the concerned pharmac eutical 
establishments to notify each importation/exportation of pharmaceutical products and raw G/TBT/N/PHL/302/Rev.1  
 
- 2 - 
 
  materials is necessary to strengthen the FDA's overall market surveillance and control 
regulatory function.  
In the interest of public health, importation and exportation activities relative to 
pharmaceutical products and raw materials shall be regulated and monitored by the FDA. 
Hence, issuance of this Circular is imperative in ensuring consistency and effectiveness of 
these regulatory activitie s. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety   
8. Relevant documents:   
• Implementing Rules and Regulation (IRR) of RA No. 9711: Food and Drug 
Administration (FDA) Act of 2009 
• FDA Memorandum Circular (FMC) No. 2013 -032: Requirements for the Immediate 
Release of Products covered by the FDA at the Bureau of Customs  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  20 May 2024  
11. Texts available from:  National enquiry point [X] or address, telephone or fax 
numbers  and email and website address es, 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  
Webs ite: http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/draft -for-comments -guideline s-on-the-importation -and-
exportation -notification -for-pharmaceutical -products -and-raw-materials/  
https://members.wto.org/crna ttachments/2024/TBT/PHL/24_02967_00_e.pdf  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_02967_01_e.pdf  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_02967_02_e.pdf  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_02967_03_e.pdf  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_02967_04_e.pdf