Republic of the Philippines  
Department of Health  
FOOD AND DRUG ADMINISTRATION   
 
 
 
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines  
Trunk Line +63 2 857 1900                   Fax  +63 2 807 0751  
Website: www.fda.gov.ph              Email: info@fda.gov.ph  
                                                                                                     
 
FDA CIRCULAR  
No. ___________  
 
 
 SUBJECT  : Guidelines on the Publishing  of Package Insert and Patient 
Information Leaflet of Registered Drug Products in the Food 
and Drug Administration  (FDA)  Verification Portal System  
    
 
I. BACKGROUND  
 
Article I Section 2 of the Implementing Rules and Regulations (IRR) of Republic Act 
(RA) No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 
2009” states the declaration of the policy  to establish and improve processes that are 
designed  to protect and promote the right to health of the Filipino people . Such 
processes shall include ensuring immediate access to the list of approved drug product 
information, including but not  limited to approved indications, and known adverse 
effects, among others.  
 
Administrative Order (AO) No. 2016 -0008 e ntitled “Revised Rules and Regulations 
Governing the Generic Labeling Requirements of Drug Products for Human Use”  and 
AO No. 105 s. of 1991 entitled “Requirement for Labelling Materials of Veterinary 
Drugs and Products”  provide comprehensive guideline s for labeling requirement s, such 
as contents, formats and mandatory information required in  labeling  materials [e.g., 
package insert  (PI) and patient information leaflet  (PIL)] for human and veterinary drug 
products . These PI and PIL are public documents readily available and intended to be 
accessed by Healthcare Professionals  (HCPs)  and general consumers  as primary 
sources of information about the drug.  They provide useful information such as those 
dealing with the safe and effective use of a drug product ( e.g., indication(s), 
pharmacologic class and dosage), and information dealing with quality . 
 
The FDA, in its commitment to provide stakeholders with improved government 
services and access to registered drug product information, hereby issues this Circular 
to further guide all HCPs  and general consumers of the Summary of Product 
Characteristics (S PC) – like information of registered drugs. Thus, publication of SPC -
like information shall ensure accessibility, transparency, and promotion of improved 
patient safety to the general public.  
 
II. OBJECTIVES   
 
This Circular shall provide guidelines to all Marketing Authorization Holders (MAHs) 
of drug products on the publishing of the package insert  and patient information leaflet  
of registered drug products .  
 Page 2 of 3 
 
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 . 
 
III. SCOP E 
 
This Circular shall apply to the following:  
 
1. Marketing Authorization Holders  and other drug establishments ; 
2. Healthcare professionals;  
3. Patients  and Consumers  
 
IV. DEFINITION OF TERMS  
For the purpose of this issuance, the following terms shall be defined as follows:  
 
A. Package Insert  (PI) is the document defining information that is supplied with 
prescript ion drug products by the MAH. The PI is intended for use by healthcare 
professionals.  
 
B. Patient Information Leaflet  (PIL)  is the document defining information that is 
supplied with non -prescription drug products by the MAH. The PI L is intended for 
use by patien ts and is written in layman’s language.  
 
C. Summary of Product Characteristics (SPC)  is the product information as approved 
rsby the  regulatory authority . It also serves as the source of information for 
healthcare professionals  as well as for consumer information on labels and leaflets 
of drug products, and for control of ad vertising.  
 
D. SPC-like Information  refers to documents such as package insert  and patient 
information leaflet .  
 
E. FDA Verification Portal is online portal that provides comprehensive list of 
establishments and health products with License to Operate (LTO) and Certificate 
of Product Registration/Notification (CPR/NN) respectively. This is the public ’s 
access to safe and quality commodities in the market.  
 
V. GUIDELINES  
 
A. Approved PI and PIL of all registered drug products shall be published by the FDA 
in the Verification Portal System at https://verification.fda.gov.ph  and shall be 
updated regularly . 
B.  All MAHs of existing registered drug products prior to the effectivity of this Circular 
shall submit the facsimile/soft copy of the latest approved package insert or patient 
information le aflet through email at cdrr.label@fda.gov.ph  with the following 
details:  
1. Subject of email: PI/PIL for Posting [Drug Registration No. ] 
2. PI/PIL in readable pdf format  
3. Date of  Revision of the PI/PIL  Page 3 of 3 
 
C. The MAH shall  ensure that the format of the Summary of Product Characteristics 
(SPC) -like information shall be compliant with AO No. 2016 -0008 and AO No. 105 
s. 1991 and/or any amendment or new issuances.  
D. Upon effectivity of this Circular, t he FDA shall p ublish the  PI/PIL of the newly 
approved drug products.    
 
VI. TRANSITION PERIOD  
 
MAHs of all existing registered drug products upon the effectivity of this Circular shall 
submit the latest approved facsimile/soft copy of PI and PIL following the respective 
schedules provided below:  
A.  Monitored Release Status  – within 2 month s from the effectivity  of this Circular  
B.  Generic Prescription drug  – within the 3rd to 8th month from the effectivity  of this 
Circular  
C.  Biologicals  – within  the 9th month from the  effectivity of this Circular  
D.  Over-the-counter drug  – within  the 10th to 12th from the  effectivity of this Circular  
E.  Traditional Medicine /Herbal  Medicine /Home Remedy /Veterinary drug  – within  
the 13th month from the effectivity of this Circular  
 
VII. PENALTY CLAUSE  
 
Any establishment found to be in violation of the provision of this issuance shall be 
subject to sanctions and penalties as prescribed under RA No. 9711 otherwise known 
as “Food and Drug Administration (FDA) Act of 2009”, and its Implementing Rules  
and Regulations”  
 
VIII.  SEPARABILITY CLAUSE  
 
If any part, term of provision of this Circular shall be declared invalid or unenforceable, 
the validity or enforceability of the remaining of the remaining portions or provisions 
shall not be affected and this Circular shall be construed as if it did not contain the 
particular invalid or unenforceable or unconstitutional part, term or provision.  
 
IX. EFFECTIVITY  
 
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).  
 
 
 
 
DR. SAMUEL A. ZACATE  
Director General