G/TBT/N/PHL/251  
10 February 2021  
(21-1102) 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 ROLANDO ENRIQUE D. DOMINGO, DBPO  
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 
regar ding the notification shall be indicated if different from above:   
DR. OSCAR G. GUTIERREZ  
Officer -in-Charge  
Policy and Planning Service  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: oggutierrez@fda.g ov.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):  Health 
products under the DOH -Food and Drug Administration (e.g processed food, food 
supplements, food additives and ingredients, drugs or medicines, cosmetics, medical and 
health -related devices, including diagnostic kits and reagents, radiat ion emitting devices 
or equipment, household hazardous substances, including urban pesticides, cigarettes, 
toys and childcare articles, among other products as determined by the DOH -FDA) 
5. Title, number of pages and language(s) of the notified document:  AO 2020 -0017-
Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and 
Drug Administration Amending Administrative Order No. 2016 -0003 (15 page(s), in 
English)  
6. Description of content:  Consistent with Republic Act No. 9711 (Food and Drug 
Administration Act (FDA) Act of 2009)   and Republic Act No. 11032 (Ease of Doing 
Business (EODB) and Efficient Government Service Delivery (EGSD) Act of 2018) and the 
DOH-F1+ Strategic Goals, these guidelines are one of the continuing effort s of the FDA 
to streamline its processes and requirements and to automate and re -engineer its 
systems.   Main objectives of the issuance are to simplify the requirements and processes 
for initial, renewal and variation of   License to Operate (LTO) applicati ons and to re -
engineer FDA's system to comply with the maximum prescribed processing time 
depending on the complexity of transactions.  G/TBT/N/PHL/251  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safe ty; Reducing trade barriers and facilitating 
trade; Cost saving and productivity enhancement  
8. Relevant documents:   
RA 9711 (FDA Act of 2009)  
9. Proposed date of adoption:  Not applicable  
Proposed date of entry into force:  Not applicable  
10. Final date for comments:  Not applicable  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
DR. OSCAR G. GUTIERREZ  
Officer -in-Charge  
Policy and Planning Service  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: oggutierrez@fda.gov.ph ;  
www.fda.gov.ph  
https://www.fda.gov.ph/administrative -order -no-2020-0017-revised -guidelines -on-the-
unified -licensing -requirements -and-procedures -of-the-food-and-drug-administration -
repealing -administrative -order -no-2016-0003/