FDA Circular No. __________________  
 
 
TO:  ALL  VAPOR PRODUCT  AND HEATED  TOBACCO PRODUCT 
MANUFACTURERS, TRADERS, AND IMPORTERS  
 
SUBJECT:             Batch Notification of Vapor Products and Heated Tobacco Products 
(HTPs)  
 
I. BACKGROUND  
 
In 2005, the Philippines ratified the World Health Organization (WHO) Framework 
Convention on Tobacco Control (FCTC), implementing the comprehensive, effective, and 
practical tobacco control measures enshrined in the legally binding international treaty. A s 
a State Party to the treaty, the Philippines is compelled to develop and implement laws and 
strategies to combat illicit trade in tobacco products in accordance with the terms of Article 
15 of the WHO FCTC. Furthermore, the Philippines is obliged to esta blish an effective 
national tracking and tracing system for all tobacco products that are manufactured in or 
imported into the country, with the use of unique identification markings to allow the 
monitoring of movement of such products, thereby securing th e supply chain and assisting 
in the investigation of illegal trade.  
 
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 Business and Efficient Government Service Delivery Act of 2018” on the 
development of electronic versions of licenses, clearances, permits, certifications, or 
authorizations promoti ng transparency and reducing red tape in business and non -business 
transactions in government, the FDA hereby implements this Circular for the issuance of 
batch notification to all vapor products  and heated tobacco products (HTPs) to 
establishments with v alid FDA -issued electronic licenses to operate (e -LTOs) and product 
marketing authorizations using the FDA e -Portal System.  
 
II. OBJECTIVES  
 
This Circular is being issued to provide the guidelines on the submission of 
applications for batch notification of reg istered vapor products and HTPs.  
 
III. SCOPE  
 
This Circular shall apply to all manufacturers, traders, and importers of vapor 
products and HTPs.  
 
 
 
 IV. GENERAL GUIDELINES  
 
1. Vapor products and HTPs with valid certificate of product registration (CPR)  can 
apply for batch notifications.  
 
1.2.Marketing authorization holders shall be allowed to submit a maximum of ten (10) 
batch notification applications per day.  
 
2.3.Imported products of the same batch/lot number but of separate shipment should be 
applied individually (single payment per shipment).  
 
3.4.Submission of application shall be done using the FDA e -Portal system 
(https://eportal2.fda.gov.ph ).  
 
4.5.Documents uploaded to the system must conform to the following specifications:  
 
4.1.5.1.  Documents must be in PDF format, while images must be in .png format. 
Files should be free from bugs and viruses that may pose risk in the FDA system.  
 
5.2. Documents must be scanned and saved in PDF file format at 100-150 dots -per-
inch (dpi).       
 
4.2.5.3.  Filenames of documents must contain less than 40 characters. Filenames 
must not contain the following characters \ ? / : * “ > < |.”  
 
5.6.Incomplete and incorrect submissions shall immediately be disapproved.  
 
6.7.The Regional Field Offices shall collect samples of particular batches of the vapor 
products or heated tobacco products which need further assessment. A minimum of 
units shall be required for sample collection.  
 
V. SPECIFIC GUIDELINES  
 
1.  Procedural Guidelines the application of batch notification.  
 
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.  BN - ENDS/ENNDS - E-liquid Registration (Initial Form)  
1.1.2.2.  BN - Heated Tobacco Products - Refills and Cartridges 
Registration (Initial Form)   
1.1.2.3.  BN - Heated Tobacco Products - Device Registration 
(Initial Form)  1.1.3.  Click on the dropdown icon and select the correct product’s CPR 
number for batch notification.  
1.1.4.  The batch number application form is divided into several parts as 
provided below:  
1.1.4.1.  Declaration of Undertaking  
1.1.4.2.  Company and Product Information (pre -filled)  
1.1.4.3.  Particulars of the Product Batch  
1.1.4.3.1.  Batch/Lot Number  
1.1.4.3.2.  Date of Manufacture  
1.1.4.3.3.  Date of Importation (for imported products)  
1.1.4.3.4.  Batch Size (Quantity)  
1.1.4.3.5.  Expiration Date  
1.1.4.3.6.  Target Market (For Local Distribution or for 
Exportation)  
1.1.4.4.  Uploading of Documents (Documentary Requirements)  
1.1.4.4.1.  Certificate of Analysis  
1.1.4.4.2.  Picture of Actual Commercial Label  
1.1.4.4.3.  For imported products:  
1.1.4.4.3.1.  Clear copy of the commercial invoice and/or 
packaging list reflecting the batch/lot number 
and expiry date, or any proof of the actual 
volume of importation (Note that the actual 
volume of importation must correspond to 
the actual volume stated in the application 
form.)  
1.1.4.4.3.2.  Airway bill/bill of lading for the particular 
shipment  
1.1.5.  An application summary will appear to review the provided 
information and the attached documentary requiremen ts. 
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, click ‘Next’ to dele gate 
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 Batch 
Notification Certificate) 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 document will appear.  
1.3.2.  Download and print the document and click ‘Next’ to end the task.  
 
VI. EFFECTIVITY  
 
This Circular shall take effect immediately.  
 
VII. PENALTIES  
 
Violation to any provisions of this Circular shall be subject to the 
penalties/sanctions provided 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.                   
 
VIII.  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  