G/TBT/N/PHL/271  
7 October 2021  
(21-7554) 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:   
Department of Health  
Food and Drug Administration Philippines  
Field Regulatory Operations Office  
 
DR. ROLANDO ENRIQUE D. DOMINGO  
Director -General  
 
DR. OSCAR G. GUTTIERREZ, JR. MPA  
Deputy Director General - Field Regulatory Operations Office (DDG -FROO)  
Field Regulatory Operations Office  
Email: oddgfroo@fda.gov.ph   
Phone: (02) 8857 1900 local 8309  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority d esignated to handle comments 
regarding the notification shall be indicated if different from above:   
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:  FDA CIRCULAR 
NO. ____ Subject: GUIDELINES FOR THE CLASSIFICATION OF DEFICIENCIES OBSERVED 
DURING INSPECTION OF DRUG DISTRIBUTORS AND DRUG RETAIL OUTLETS (8 page(s), 
in English)  
6. Description of content:  These guidelines shall apply to all drug Good Distribution and 
Storage Practice (GDSP) inspectorate a nd local drug establishments distributing and retail 
of drugs including: household remedy, medicinal gas, traditional and herbal medicines, 
non-sterile, sterile, vaccines and biologicals and active pharmaceutical ingredients for 
human and animal use.  
This Circular is issued to have uniform understanding in the classification of the noted 
non-conformances during inspection of drug distributors and drug retail outlets and 
provide guidelines to the drug GDSP inspectorate service of the FDA's Field Regulatory 
Operations Office. , as well as drug distributors and drug retail outlets for uniformity of 
regulatory understanding consistent with the provisions of RA No. 3720, as amended by 
RA No. 9711, RA No. 11032, and relevant national and international standards an d 
policies.  G/TBT/N/PHL/271  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Harmonization  
8. Relevant documents:   
• Administrative Order 2013 - 0027 "Adoption and Implementation of the WHO 
Annex 5 - Guide to Good Distribution Practices for Pharmaceutical Products and 
WHO Annex 9 -Guide to Good Storage Practices for Pharmaceutical"  
• FDA Circular No. 2021 -003 "Revised Guidelines on the Cold Chain Management 
for Pharmaceutical Products and Establishment"  
• FDA Circular No. 2019 -003 "Guidelines for the classification of deficiencies 
observed during inspection of Drug Manufacturers"  
9. Proposed date of adoption:  15 December 2021  
Proposed date of entry into force:  15 January 2022  
10. Final date for comments:  8 October 2021  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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) 7514700; (632) 7913128  
bps@dti.gov.ph  
http://www.bp s.dti.gov.ph  
Head of Organization  
https://www.fda.gov.ph/wp -content/uploads/2021/09/Revised -Draft-Circular -GDSP -
Deficiencies -with-list-22-September -2021.pdf