G/TBT/N/PHL/302  
26 May 2023  
(23-3618) Page: 1/3 
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 notific ation 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 Food and 
Drug Administration (FDA) Circular "Guidelines for the Importation and Exportation of 
Finished Drug Products and Raw Materials"; (6 page(s), in English)  
6. Description of content:  The proposed policy aims to provide detailed guidelines and 
clear procedures in the issuance of Clearance for Customs Release (CFCR) for finished 
drug products and raw materials and to conduct inspections of entry/exit ports autho rized 
by the Bureau of Customs (BOC) for finished drug products and raw materials. This 
proposed policy shall apply to all FDA -licensed drug establishments 
[Manufacturer/Trader/Distributor (Importer/Exporter)] involved in the manufacture, 
importation, and exportation of finished drug products and raw materials intended for 
distribution. However, it shall not cover drug products and raw materials used in clinical 
trials/product development/research, drug products for personal use, donations, and 
under Compas sionate Special Permit, and shall be processed based on existing rules and 
regulations.  G/TBT/N/PHL/302  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:   
Republic Act (RA) No. 9711, otherwise known as the "Food and Drug 
Administration (FDA) Act of 2009", mandates the FDA to regulate and 
subsequently issue appropriate authorizations to establishments engaged in the 
manufacture, distribution, importation, exportation and retailing of health 
products, among others.  
Article I  Section 6 (Requirements for Every Incoming Shipment of Health 
Products) of the Book II of the Implementing Rules and Regulation (IRR) of RA 
No. 9711, states that " The FDA in coordination with the Bureau of Customs, 
Bureau of Quarantine and other concerned agencies is mandated to undertake 
and adopt measures relating to importation of health products such as, but not 
limited to, sampling and examination, in accordanc e with relevant existing laws 
and regulations, of every incoming shipment of health products". The FDA hereby 
issued FDA Memorandum Circular (FMC) No. 2013 -032 wherein a valid License to 
Operate (LTO) and Certificate of Product Registration (CPR) are requi red for the 
release of drug products. However, there is a need to strengthen market control 
within the distribution chain through additional measures to ensure that the public 
only receive quality -assured drug products. The infiltration of substandard and 
falsified drug products into the supply system shall be prevented through risk -
based surveillance scheme and rigorous control. Therefore, as part of the FDA's 
powers and functions under RA No. 9711, issuance of appropriate authorization 
such as import/expo rt clearance is necessary to strengthen the FDA's overall 
market surveillance and control regulatory function.  
In the interest of public health, import/export activities related to drug products need to 
be controlled and under the proper oversight of the F DA. Issuance of this guidelines is 
imperative to ensure the consistency and effectiveness of these regulatory activities.  
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 for ce: To be determined  
10. Final date for comments:  23 June 2023  G/TBT/N/PHL/302  
 
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  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.p h/draft -for-comments -guidelines -for-the-importation -and-
exportation -of-finished -drug-products -and-raw-materials/  
https://members.wto.org/crnattachments/2023/T BT/PHL/23_09836_00_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_09836_01_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_09836_02_e.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_09836_03_e.pdf