G/TBT/N/PHL/303  
28 June 2023  
(23-4403) 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 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:  Guidelines on 
the Publishing of Package Insert and Patient Information Leaflet of Registered Drug 
Products in the Food and Drug Administration (FDA) Verification Portal S ystem; (3 
page(s), in English)  
6. Description of content:  The proposed policy aims to provide guidelines to all Marketing 
Authorization Holders (MAHs) of drug products on the publishing of the package insert 
and patient information leaflet of registered d rug products. This Circular shall also provide 
the healthcare professionals and consumers with the latest information on drug safety 
and use, through PI and PIL publication on the FDA Verification Portal System.  
7. Objective and rationale, including the n ature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/PHL/303  
 
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  8. Relevant documents:   
• Implementing Rules and Regulation (IRR) of RA No. 9711: Food and Drug 
Administration (FDA) Act of 2009  
• Administrative Order (AO) No. 2016-0008: Revised Rules and Regulations 
Governing the Generic Labeling Requirements of Drug Products for Human Use  
• AO No. 105 s. of 1991: Requirement for Labelling Materials of Veterinary Drugs 
and Products  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  This Circular shall take effect fifteen (15) days after 
its publication in a newspaper of general circulation and be filed with the University of the 
Philippines Law Center Office of the National Administrative  Register (ONAR).  
10. Final date for comments:  7 July 2023  
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  
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/wp -content/uploads/2023/06/Guidelines -on-the-Publishing -of-
Package -Insert -and-Patient -Information -Leaflet -of-Registered -Drug-Products -in-the-
Food-and-Drug-Admin istration -FDA-Verification -Portal -S.pdf  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_10615_00_e.pdf