G/TBT/N/PHL/287  
29 April 2022  
(22-3389) 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  
Officer -in-Charge 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: jjncirunay@fda.gov.ph  / cdrr.sds@fda.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); Drug products under Maximum Retail Price (MRP)  
5. Title, number of pages and  language(s) of the notified document:  Guidelines on 
Labeling Requirements of Drug Products under Maximum Retail Price (MRP); (4 page(s), 
in English)  
6. Description of content:  The proposed issuance aims to provide streamlined and rational 
application pro cess for the change of labeling materials under MRP including drug 
molecules or drug formula that will be included in succeeding Executive Orders of MRP.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Streamlining pr ocess for the change of labeling materials of drug products 
under MRP and exhaustion period of old labeling materials at the manufacturing level.; 
Reducing trade barriers and facilitating trade  G/TBT/N/PHL/287  
 
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  8. Relevant documents:   
• Republic Act No. 9502 "Universally Accessible Cheaper and Quality Medicines Act 
of 2008"  
• Executive Order No. 821 s. 2009 "Prescribing the Maximum Drug Retail Prices for 
Selected Drugs and Medicines that Address Diseases that Account for the Leading 
causes of Morbidity and Mortality"  
• Executive Order No. 104 s. 2020 "Improving Access to Healthcare through the 
Regulation of Prices in the Retail of Drugs and Medicines"  
• Executive Order No. 155 s. 2021 "Further Improving Access to Healthcare through 
the Regulation of Prices in th e Retail of Drugs and Medicines"  
• Administrative Order No. 2016 -0008 "Revised Rules and Regulations Governing 
the Generic Labeling Requirements of Drug Products for Human Use"  
• Administrative Order No. 2020 -0039 "Guidelines in the Implementation of 
Maximum R etail Price (MRP) on Drugs and Medicines"  
• FDA Circular No. 2016 -017 "Additional Post -Approval Changes for Pharmaceutical 
Products  
9. Proposed date of adoption:  This Circular shall take effect fifteen (15) calendar days 
after publication in one (1) newspaper of general circulation and upon filing with the 
University of the Philippines, Office of the National Administrative Register (ONAR)  
Proposed date of entry into force:  Upon effectivity  
10. Final date for comments:  6 May 2022; This is considered as an urgent policy as this 
will help to reduce regulatory burden in the application and approval of the inclusion or 
update of the MRP statement to the labeling materials of drug products especially that 
these drug products are lifesaving drugs . 
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/wp -content/uploads/2022/04/FDA -Circular -MRP-Variation -on-
Labelings -DRAFT_For -posting.pdf  
https://members.wto.org/crnattachments/2022/TBT/PHL/22_3098_00_e.pdf