G/TBT/N/PHL/282  
17 March 2022  
(22-2354) 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  
OIC-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:   
DR OSCAR G. GUTIERREZ, JR., MPA  
OIC-Director General  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: odg@fda.gov.ph ; oddgfroo@fda.gov.ph   
www.fda.gov.ph  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Pharmaceutical Products; Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Draft FDA 
Circular No .__: Guidelines on the Issuance of License to Operate for Drug Establishments 
Engaged in E -Pharmacy (8 page(s), in English)  
6. Description of content:  This Circular aims to set guidelines on the License to Operate 
(LTO) application of drug establishments engaged in online pharmacy (E -Pharmacy) 
thereby ensuring the safety, health and welfare protection of the public.  
These guidelines shall cover the licensing of establishments, including drug outlets, 
RONPD, and other entities that will engage in online ret ailing of over -the-counter or non -
prescription drug products as additional activity or as pure E -Pharmacy. It shall not cover 
prescription drug products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Reducing trade barriers and facilitating 
trade  G/TBT/N/PHL/282  
 
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  8. Relevant documents:   
· Republic Act (RA) No. 9792, "E -Commerce Act"  
· RA 7394, "Consumer Act of the Philippines"  
· RA 9711, "FDA Act of 2009"  
· RA 10918, "Philippine Pharmacy Act"  
· DOH AO no. 2020 - 0017 or the "Revised Guidelines on the Unified Licensing and 
Procedures of the Food and Drug Administration Repealing AO 2016 -0003 and FDA 
Circular No. 2020 -0030 or the  "Guideline for the Use of FDA eServices Portal System for 
License to Operation (Application) of Drug Distributors, Drug Traders, Drugstores, Retail 
Outlets for Non -Prescription Drugs (RONPDs, Clinical Research Organizations (CRO), and 
Sponsors"  
9. Propos ed date of adoption:  15 July 2022  
Proposed date of entry into force:  1 August 2022  
10. Final date for comments:  2 May 2022  
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 1200 (632) 7791 3127  
Email: bps@dti.gov.ph   
http://www.bps.dti.gov.ph  
https://members.wto.org/crnattachments/2022/TBT/PHL/22 _2295_00_e.pdf