FDA CIRCULAR  
No. ___________  
 
 
 
TO               :  ALL MANUFACTURERS/ TRADERS/ IMPORTERS OF VAPOR 
PRODUCTS AND HEATED TOBACCO PRODUCTS.   
 
 
SUBJECT   :   APPLICATION PROCEDURE FOR PRODUCT MARKETING 
AUTHORIZATIONS THROUGH THE FDA ELECTRONIC PORTAL (E-
PORTAL) SYSTEM.  
 
 
I. BACKGROUND  
 
   Pursuant to Republic Act No. 9711, otherwise known as the “FDA Act of 2009”, 
Section 144  of Republic Act No. 11467, Section II of Executive Order No. 106 and 
consistent with the provision of Republic Act No. 11032, otherwise known as the “Ease 
of Doing Bu siness and Efficient Government Service Delivery Act of 2018” on the 
development of electronic versions of licenses, clearances, permits, certifications, or 
authorizations promoting transparency and reducing red tape in business and non -business 
transactio ns in government, the FDA hereby implements this Circular for the issuance of 
product marketing authorization to all vapor products  and heated tobacco products (HTPs)  
by establishments with a valid FDA -issued electronic license to operate (e -LTO) using t he 
FDA E -Portal System.  
 
II. OBJECTIVE  
 
The objective of this Circular is to provide the procedural guidelines and 
documentary requirements for the FDA product marketing authorization application 
through the FDA E -Portal System.   
III. SCOPE AND COVERAGE  
 
 This Circular shall cover all manufacturers, traders, and importers of vapor 
products and HTPs.  
IV.          GENERAL GUIDELINES  
1. Only those establishments with valid  e-LTO as manufacturer, trader or importer 
can apply for product marketing authorizations.  
 2. HTP refills, cartridges, and electronic delivery devices shall be filed under product 
registration application and shall be issued a Certificate of Product Registration 
(CPR) after compliance to set requirements.  
 
3. Vapor product refills and cartridges with or without the presence of nicotine, 
bearing therapeutic or health claims, and/or contains nicotine with concentrations 
above 20 mg/mL but not more than 65 mg/mL in its formulation shall be submitted 
for product registration, with the issuance of a CPR aft er compliance to set 
requirements.  
 
4. Vapor product refills and cartridges with or without the presence of nicotine, that 
are not marketed with therapeutic or health claims, provided that nicotine 
concentrations do not exceed 20 mg/mL, shall be submitted for  product 
notification, with the issuance of an FDA Electronic Registration Number (FERN) 
upon compliance to set requirements.  
 
5. Vapor product electronic delivery devices shall be submitted for notification, with 
the issuance of a FERN upon compliance to set  requirements.  
 
6. No vapor products and HTPs shall be distributed or sold in the Philippines without 
the appropriate product marketing authorizations from the FDA.  
 
7. Applicants are required to provide true, correct, updated, and complete 
information pertaining to their type of application.  
 
8. Submission of application shall be done using the FDA e -Portal system, accessible 
through  https://eportal2 .fda.gov.ph . To file an application, follow the procedure 
outline below. Please refer to Annex A  for the detailed procedural guidelines.  
 
9. Documents uploaded to the system must conform to the following specifications:  
 
9.1. Documents must be in PDF file format a nd .png (for images), free from 
bugs, viruses, and the like that may jeopardize the system of the FDA.  
9.2. Documents must be scanned and saved in PDF file format at 100 -150 dots -
per-inch (dpi).  
9.3. Document filenames of documents shall be less than 40 characters in 
length, and shall not contain the following characters: \ ? / : * “ > < |.”  
 
10. Incomplete and incorrect submissions shall immediately be disapproved.  
 
 V.           SPECIFIC GUIDELINES  
1.  Procedural Guidelines for Vapor Products and Heated Tobacco Products.  
 
1.1. Submission of Product Marketing Authorization Application  
 
1.1.1.  Log-in by entering the issued username and password.  
1.1.2.  On the home tab, under the navigation pane, select among the following 
options to proceed to the application form:  
1.1.2.1.  FERN - ENDS/ENNDS - E-liquid Registration (Initial Form)  
1.1.2.2.  CPR - ENDS/ENNDS - E-liquid Registration (Initial Form)  
1.1.2.3.  FERN - ENDS/ENNDS - Device Registration (Initial Form)  
1.1.2.4.  CPR - Heated Tobacco Products - Refills and Cartridges 
Registration (Initial Form)   
1.1.2.5.  CPR - Heate d Tobacco Products - Device Registration (Initial 
Form)  
1.1.3.  The product marketing authorization application form is divided into 
several parts as provided by the application wizards. These include:  
1.1.3.1.  Declaration of Undertaking  
1.1.3.2.  Local Company Responsible for Placi ng the Product in the Market  
1.1.3.3.  Product Source  
1.1.3.4.  Particulars of the Product (ENDS/ENNDS E -liquid, HTP Refills 
and Cartridges, and Electronic Delivery Devices)  
1.1.3.5.  Ingredient List and Complete Technical Specifications 
(ENDS/ENNDS E -Liquid)  
1.1.3.6.  Component List and Complet e Technical Specifications (Heated 
Tobacco Product Refills and Cartridges)  
1.1.3.7.  Upload Documents (Documentary Requirements)  
1.1.4.  Accomplish the application form as provided in parts.  
1.1.5.  An application summary will appear to review the provided information 
and the attac hed documentary requirements.  
1.1.6.  Assessment slip will be generated at the end of the step.  
1.1.6.1.  The computer -generated assessment slip will be viewed through a 
flash window.  
1.1.6.2.  Print and download the file as reference for payment.  
1.1.6.3.  To continue with the application, cl ick ‘Next’ to delegate the 
application to payment posting. The application will then move to 
the Processed folder in the navigation pane.  
1.1.6.4.  The status of the application may be checked in the Processed 
folder as indicated by the Task column.  1.1.7.  To complete the application submission, the applicant must delegate the 
application to the FDA Cashier/Accounting.  
 
1.2. Payment of Application  
 
The application may be paid through any payment options made available by the 
FDA.  
1.3. Results of Application  
 
The result of the application may either be approved (issuance of CPR or FERN) 
or disapproved. The result of the application shall be downloaded from the On -Process 
folder of the applicant.  
1.3.1.  Open the case number of the application and a flash window reflecting the 
output doc ument will appear.  
1.3.2.  Download and print the document and click ‘Next’ to end the task.  
 
VI.          PROCESSING TIME  
Applications will be processed within twenty (20) working days.  This timeline 
begins at the time the payment transaction reference number or the official receipt 
number has been verified by the FDA Accounting/Cashier, and ends at the time the result 
of the application has been forwarded to the On -Process folder of the applicant.  
 
VII.    FEES  
Applications shall be charged with the fee s pursuant to the schedule of fees stated 
under Annex C of this issuance.   
VIII.    EFFECTIVITY DATE  
This Circular shall take effect immediately.  
IX.      PENALTIES  
Violation to any provisions of this Circular shall be subject to the 
penalties/sanctions pr ovided under Book III, Article XI of the Rules and Regulations 
Implementing Republic Act No. 9711, The Food and Drug Administration Act of 2009, 
and other penalties provided by other applicable laws.                   
 
 
 X. SEPARABILITY CLAUSE  
 
If any provision in this Circular, or application of such provision to any 
circumstances, is held invalid, the remainder of the provisions in this Circular shall not be 
affected.  
  
 
 
                                                     ROLANDO ENRIQUE D. DOMINGO, MD  
 Director General  
 
 
 
 
 
  ANNEX A  
 
Submission of FERN Application Through the FDA e -Portal System V.2  
 
 
1. Access the FDA e -Portal V.2 
at 
https://eportal2.fda.gov.ph  
 
2. Log-in by entering the issued 
username and password.   
 
 
3. In the HOME tab, select 
New Application in the 
navigation pane and 
select among the 
following options to 
proceed to the 
application form:  
● FERN - 
ENDS/ENNDS - 
E-liquid 
Registration 
(Initial Form)  
● CPR - 
ENDS/ENNDS - 
E-liquid 
Registration 
(Initial Form)  
● FERN  - 
ENDS/ENNDS - 
Device 
Registration 
(Initial Form)  
● CPR - Heated 
Tobacco 
Products - 
Refills and 
Cartridges 
Registration 
(Initial Form)   
● CPR - Heated 
Tobacco  
 Products - 
Device 
Registration 
(Initial Form)  
 
4. Accomplish the application 
form as provided in parts by 
the application wizard. Fill -in 
the fields as completely as 
possible. Fields marked with 
a red asterisk (*) are required 
to be filled -in. Mark required 
fields with N/A, if not 
applicable.  
● Declaration - Proceed 
with the application by 
selecting your response 
using the drop -down list 
and click ‘Next’.   
● Local Company 
Responsible for Placing 
the Product in the 
Market - Select the LTO 
number specific for the 
FERN application. All 
relevant info rmation 
about the applicant 
establishment will 
automatically be 
reflected. Click ‘Next’ 
button.  
  
● Product Source - Fill-in 
the necessary 
information. Click 
‘Next’ button.  
 
 
 
 
 
 
 
 
  ● Particulars of the 
Product (E -liquid and 
Refill and Cartridges) – 
Provide the required 
information. Please note 
that once information 
has been submitted, it 
will no longer be 
modifiable. Hence, any 
change to the provided 
information would merit 
a new regis tration 
application. Click 
‘Next’ button.  
● Particulars of the 
Product (Device) - 
Provide the required 
information. Please note 
that once information 
has been submitted, it 
will no longer be 
modifiable. Hence, any 
change to the provided 
information would me rit 
a new registration 
application. Click 
‘Next’ button.  
 
  
 
● Ingredient List and 
Technical Specifications 
(ENDS/ENNDS E -
Liquid) – provide the 
full ingredient listing 
with function and 
amount in percentage of 
each ingredient. Click 
‘New’ to add new 
ingredient to the list. 
Click ‘Next’ button.  
● Component List (Heated 
Tobacco Product Refills 
and Cartridges) – 
provide the full 
component listing with 
function and theoretical  weight/ volume of each 
component. Click ‘New’ 
to add new component to 
the list. C lick ‘Next’ 
button.  
 
● Upload Documents – 
Upload the required 
document/s in PDF 
format  (Refer to Annex 
B) 
● Applicants may upload 
documents 
simultaneously.   
● Application Summary – 
It reflects all the 
declared information 
and uploaded 
documents. The 
applicant establishment 
may review and recheck 
the information. If there 
are corrections to be 
made, the applicant may 
revisit the pages of the 
application form by 
clicking ‘Previous 
Steps’. The applicant 
establishment may also 
view the attached 
document by clicking its 
file name.  
 
  
● Order of payment – A 
computer generated 
document will appear 
reflecting the 
appropriate fees and 
charges. The applicant 
establishment should 
save and print a copy of 
the document as 
reference for payment. 
Click ‘Next’ to continue 
and delegate the  
  applicati on to payment 
verification.  
 
5. The application will undergo 
evaluation, checking, quality 
assurance and final 
recommendation. The 
application may either be 
approved (issuance of CPR 
or FERN) or disapproved. 
The result may be 
downloaded through the On-
Process folder of the 
applicant establishment. 
Download and print the 
document and click ‘Next’ to 
end the task.   
 
  ANNEX B  
Documentary Requirements per Application Type  
 
1. FERN Application for Vapor Product Refills and Cartridges  
1.1 Technical Specifications of the Finished Product  
1.2 Certificate of Analysis of the Finished Product  
1.3 Safety Data Sheet of the finished product, following the Guidelines under the Globally 
Harmonized System for the Classification and Labelling of Chemicals (GHS) Annex 4 – 
Guidance on the Preparation of Safety Data Sheets (SDS)  
1.4 Primary and Secondary Commercial Label  
1.5 Stability Study (accelerated or real -time) per Packaging Type  
1.6 Front Panel of the Commercial Label (in .png format)  
 
2 CPR Application for Vapor Product Refills and Cartridges  
2.1 Pre-Market Authorization (PMA) Certificate  
2.2 Complete Product Information File (PIF)  
 
3 FERN Application for ENDS/ENNDS Electronic Delivery Devices  
 
3.1 Certificate of Conformity from DTI  
3.2 Technical Specifications of the Finished Product  
3.3 Certificate of Analysis for the Migration of Specific Metals  
3.4 Primary and Secondary Commercial Label  
 
4 CPR Application for HTP Refills and Cartridges  
4.1 Pre-Market Authorization  (PMA) Certificate  
4.2 Complete Product Information File (PIF)  
 
5 CPR Application for HTP Electronic Delivery Devices  
 
5.1 Pre-Market Authorization (PMA) Certificate  
5.2 Complete Product Information File (PIF)  
 
 
  ANNEX C  
Schedule of Fees for Registration  
 
Product Market Authorization  Annual Fees  
(in PhP)  
(Maximum of 2 
years)  Renewal per year  
 
(Maximum of 5 
years)  
Vapor Products Refills and Cartridges - 
FERN Application  6,000.00  4,800.00  
Vapor Product Electronic Delivery Device -  
FERN Application  12,000.00  9,600.00  
Vapor Products and Heated Tobacco Products  
Refills and Cartridges - CPR Application  150,000.00  120,000.00  
Heated Tobacco Products Electronic Delivery 
Device - CPR Application  150,000.00  120,000.00