OBJECTIVES

 To provide stakeholders engaged in the manufacturing

processes for ENDS/ENNDS products a general overview of
FDA’s regulation for manufacturers and traders

 To ensure that all concerned stakeholders understand the

process for the application of a license to operate and the
regulatory requirements during operations
 MANUFACTURER

means an establishment engaged in any and all

operations involved in the production of health
products including preparation, processing,
compounding, formulating, filling, packing,
repacking, altering, ornamenting, finishing and
labeling with the end in view of its storage, sale or
distribution. A trader shall be categorized a
manufacturer.
 TRADER

means any establishment which is a registered owner

of a health product and procures the raw materials and
packing components and provides the production
monographs, quality control standards and procedures,
but subcontract the manufacture of such product to a
licensed manufacturer. In addition, a trader may also
engage in the distribution and/or marketing of its
products.
 Manufacturing Process

Formulation The same process can apply for

traders, with the exemption of the
Procurement
Delivery / and production process that is
Distribution preparation of
raw materials subcontracted to a manufacturer.

Manufacturer The coverage of the contract

between a trader and a
Storage / Production
Warehousing Process manufacturer vary, depending on
the agreement between the two
Testing and establishments.
Inspection
 Operational Requirements

Quality System
These are the key areas that a
Documentation
manufacturer needs to establish
Personnel and maintain for its operation.
Premise
Equipment The FDA shall be issuing a
detailed guideline for all areas
Sanitation and Hygiene
and shall be discussed during
Production the QPIRA Seminar
Quality Control
 QUALITY SYSTEM

 A comprehensively designed and

correctly implemented system to
ensure the attainment of the Quality
company’s objectives Manual

Quality
 A company’s quality system must be Procedures
appropriate for its current activity
Work Instructions
 The company must at least establish
its quality manual, organizational
structure, procedures, controls, work
instructions, forms, and other records.
Records

Site Master File
Raw Material Specifications
Master Formula, Procedures,
and Standards
Standard Operating Procedures
Records
DOCUMENTATION
A document providing a general overview of the structure and activities
of the manufacturer.
Describe in detail the requirements with which the materials used or
obtained during manufacture have to conform. They serve as a basis for
quality evaluation.
This contains all information about the manufacturing process for the
product and the expected output. This document is kept and controlled
by the QA personnel.
Written instructions of the performance of specific activities.
Provide evidence of various actions taken to demonstrate compliance
with instructions, e.g. activities, events, investigations, and in the case of
manufactured batches a history of each batch of product, including its
distribution. Records include the raw data which is used to generate other
records. For electronic records regulated users should define which data
are to be used as raw data. At least, all data on which quality decisions are
based should be defined as raw data.
 DOCUMENTATION

SITE MASTER FILE

I. Table of Contents V. Documentation
II. Company Overview SOPs and Forms
General Information VI. Contract Manufacturing and Analysis
Site Overview Toll Manufactured Products
Products Produced Analysis Contracted Out
III. Personnel VII. Internal Quality Audit and FDA Reporting and
Organizational Chart Inspection
Employees with Job Description Inspections Conducted
Training Requirements Compliance History
Health and Hygiene Requirements
IV. Premise and Equipment
General Location of Site
Detailed Site Layout (with dimensions)
Personnel, Material, and Product Flow
List of Manufacturing Equipment
Maintenance and Calibration
 Standard Operating Procedures
• Training of personnel
• Handling of Raw Materials
 Acceptance of Incoming
 Dispensing
 Disposal of Expired & Reject
• Handling of Raw Materials
 Acceptance of Incoming
 Dispensing
 Expired & Reject
• Production Procedure
 Pre-production preparation
 Dispensing
 Mixing
 Packaging & Labelling
 Checking
 Storage
• Batch Numbering System
• Handling of Finished Products
 Approval and Release
 Returned, Expired & Reject
• Storage
 Raw Materials
 Finished Products
• Distribution of Finished Products
• Handling of Complaints
• Product Recall
• Laboratory Analysis of Finished Products
• Records Keeping
 PERSONNEL

General Requirements:
1. Organizational chart showing the hierarchy of responsibilities
General Manager / President

Head of Admin and Sales Production Manager Quality Assurance Manager

Admin Sales Warehouse Processing Quality Control

 PERSONNEL

General Requirements:
2. Personnel File
• Qualifications and background
• Job description
• Duties and responsibilities
• Training records
• Medical records
 KEY PERSONNEL

PRODUCTION MANAGER
Develop and establish SOPs in production

Ensure proper implementation of SOPs within the production area

at all times

Ensure production personnel are capacitated prior to deployment in

the production area

Ensure all areas of the production facility are well maintained

 KEY PERSONNEL
QUALITY ASSUARANCE MANAGER
• Must be an Allied Health Science Professional (e.g. PRC registered pharmacist, chemist, chemical
engineer, nurse, med tech, etc.)
• Establish standard operating procedures for inspection, testing and clearance of starting materials,
packaging materials, intermediate, bulk and finished products;
• Ensure all starting materials, packaging materials, intermediate, and finished products are of quality
and within current standards
• Ensure all critical processes of the company are followed accordingly based on written procedures
and policies
• Keep and maintain all documents and records of the company
• Approve and monitor 3rd party testing laboratories
• Lead the conduct of internal quality audits and investigations.
 KEY PERSONNEL
QUALIFIED PERSON
Ensure that all operations of the company are in accordance with
current national standards and regulations

Ensure that all the necessary marketing authorizations are secured

and up-to-date prior to operation and/or distribution of products

Shall act as the point person of the company in relation to FDA-

related processes
Note: The Quality Assurance Manager can also serve as the Qualified Person
SAMPLE PREMISE
SAMPLE PREMISE
 PRODUCTION PROCESS FLOWCHART
Quarantined Storage
Raw Material

Return to Supplier or Failed

QC Check
Disposal

Passed
Approved Storage
Raw Material

Customer Production QA Master

Order Dept. Formula

Weighing Yes

Failed Can be
Bulk Processing / Mixing QC Check
reworked?

Passed No
Filling and Packaging
Reject / Dispose
Warehouse
Reconciliation

Quarantine Storage
Yes Finished Product

Failed Passed
Reject / Disposal Can be Approved Storage
QC Check Distribution
Warehouse reworked? Finished Product
BATCH MANUFACTURING RECORD
BATCH MANUFACTURING RECORD
 PRODUCT PACKAGING AND LABELING
Primary Packaging
shall mean any material,
including printed material,
employed in the packaging
of product, excluding any
outer packaging used for
transportation or shipment,
that is in direct contact with
the electronic cigarette refill
solution
Secondary Packaging
shall mean any material,
including printed material,
employed in the packaging
of product, excluding any
outer packaging used for
transportation or shipment,
that is not in direct contact
with the electronic
cigarette refill solution
(e.g. product inserts, tags,
etc.)
 LABELING REQUIREMENTS

Restrictions Samples of Restricted Content

All Health Claims Smoking Cessation Claims
Harm Reduction Claims
Terms such as:
1. Light; Lites; Ultra lite
2. Supreme
Potentially Misleading Content 3. No.1
4. Leading
5. Most
6. Finest
Terms such as:
1. FDA-approved
Explicit/Implicit Conveyance of FDA
2. Any mention of FDA or
Endorsement
3. Any mention of Philippine FDA
4. Any imitation of such words and initials
FDA Logo
Any imitation of the FDA Logo
 PRIMARY LABELING REQUIREMENTS
Article Required
1. The declared commercial name of the product (transliterated into the English alphabet)
a. Brand name
b. Name of Product Variant

2. The term “ENDS/ENNDS solution” OR “single-use electronic cigarette,” as applicable, to describe the
product.
3. The exact statement, “Keep out of the reach of children.”

4. Electronic cigarette liquid solution volume in mL, rounded to the nearest 0.1mL. (e.g. 10.0 mL)

5. Nicotine concentration expressed in mg/mL nicotine or the words “nicotine-free,” as applicable,

rounded to the nearest one mg/mL.
6. Batch/Lot number(s)
7. Expiry date
8. FDA Electronic Registration Number
SECONDARY LABELING REQUIREMENTS

1. The declared commercial name of the product (transliterated into the English
alphabet)
a)Brand name
b)Name of Product Variant
2. The term “ENDS/ENNDS solution” OR “single-use electronic cigarette,” as applicable,
to describe the product.
3. Nicotine concentration expressed in mg/mL or the words “nicotine-free,” as applicable
4. Electronic cigarette liquid solution volume in mL, rounded to the nearest 0.1mL.

5. Marketing Authorization Holder Information

a)Company Name
b)Company Address
c)Company Contact Details
d)LTO Number
6. Country of Origin
 SECONDARY LABELING REQUIREMENTS
7. List of ingredients contained in the product, in descending order of concentration, with
potential allergens emphasized in bold characters. The declaration should follow the
succeeding format, inclusive of the Chemical Abstracts Service Registry Number [CAS
No.]: Chemical/Ingredient CAS No.

Propylene glycol 57-55-6

Vegetable Glycerin 56-81-5

Nicotine 56-81-5

[potential allergen] [as appropriate]

8. FDA Electronic Registration Number

9. Instructions on the handling, use, and storage of the ENDS/ENNDS solutions
10. Usage cases to be avoided (in the context of current medications, health conditions, and
interactions with other drugs and other substances)
11. Instructions for the disposal of the ENDS/ENNDS solutions and container
 SECONDARY LABELING REQUIREMENTS
12. Directions in case of ingestion or skin contact
13. GHS Pictogram, Signal Word, and Hazard Statement
14. Undesirable adverse health effects
15. Warning statements:
a) Do not swallow
b) Keep out of the reach of children
c) Avoid prolonged contact with the skin
d) Nicotine is an addictive substance.
e) Not suitable for pregnant women, nursing mothers, children, persons with respiratory or
cardiovascular diseases.
f) Call the poison center or the hospital near you in case of accidents, injury, or illness
arising from the use of this product.
16. The updated contact information of University of the Philippines, National Poison Control and
Information Service, as of the time of manufacture
17. The exact statement: “For any complaints or reports on product quality and safety, please
contact the Food and Drug Administration by email: ccrr@fda.gov.ph.”
 LICENSING PROCEDURE
1. Request for a user account by going to this link and accomplishing the online form:
• https://eportal2.fda.gov.ph/syseportal/en/neoclassic/2025723735d4504e361dde4030330943/2656580155d4641ea8aa1d
9091841768.php
 LICENSING PROCEDURE

Authorization Letter

or

Proof of Ownership
 LICENSING PROCEDURE
Trader and Distributors
Accomplished online application form for
Traders/Distributors
Proof of Business Name Registration
Business Permit/Barangay Permit
FDA QPIRA (Qualified Personnel in
Regulatory Affairs) Certificate for
ENDS/ENNDS
Government Issued ID of authorized
person and qualified personnel
Payment (PhP 10,000.00 + LRF)
Note: A notarized commitment letter shall be submitted in lieu of the QPIRA Certificate
Manufacturer
Accomplished application form for
Manufacturers
Proof of Business Name Registration
Business Permit/Barangay Permit
Attendance FDA QPIRA (Qualified
Personnel in Regulatory Affairs) Seminar
for ENDS/ENNDS
Government Issued ID of authorized
person and qualified personnel
(Allied Health Science Professional)
Site Master File
Payment (PhP 15,000.00 + LRF)
 LICENSING PROCEDURE
2. Log-in to E-portal Account at https://eportal2.fda.gov.ph
 LICENSING PROCEDURE

3. In the HOME tab, select

New Application in the
navigation pane and click
e-License to Operate
(Initial Application) to
proceed to the LTO
application form.
 LICENSING PROCEDURE
4. Read and understand the Declaration of Undertaking before selecting “Yes, I agree”
Declaration of Undertaking
I, duly authorized officer/s or representative/s of the Establishment hereby voluntarily and categorically declare, undertake, and
agree that all data and information contained and provided in the attached application, together with all other submissions,
including amendments, are true and correct based on my knowledge and are based on existing records, legal documents and
available information.
I, likewise declares, undertakes and agree that:

•I. The said establishment shall be open during its business hours under the supervision of a PRC registered professional (e.g.
Pharmacists), designated qualified personnel or authorized personnel at all times;

•II. The pharmacist/s and the other appropriate allied health professionals, upon and during employment in the establishment, is/are
not and will not in any way be connected to, employed by or engaged with any other FDA-regulated establishment;

•III. The approved and valid License to Operate shall be displayed in a conspicuous place in the establishment visible to my
customers;

•IV. The establishment will change its business name, and/or brand name in the case of products, in the event that there is a similar,
same, or confusingly similar name registered with the Food and Drug Administration, or if the FDA rules later that such name is
misleading, offensive, against the law, customs, public morals, public policy or otherwise violative of relevant rules and
regulations;
 LICENSING PROCEDURE

•V. The electronic copy of the files, documents, or information submitted in relation to this application are the exact duplicate
or scanned copy of the same and, any discrepancy, prejudicial contents, false claims or misrepresentation on any of the data
therein shall be a ground for the disapproval of application, or if discovered post-approval shall be a ground for the
appropriate sanctions including the revocation of the license or, and/or the filing of the appropriate legal action against me,
the owner, its officers or the establishment whenever possible;

•VI. If applying for automatic renewal, the establishment has filed the application, and have paid the complete & appropriate
renewal fee before expiry date and in which case there are no changes or variations in the establishment since last renewal of
LTO specifically but not limited to a change of location, change of ownership, change of business name, change of qualified
person, change in warehouse site, additional supplier and product lines, change in activity, change in key personnel;

•VII. The products that my establishment manufacture, distribute and/or sell are registered or to be registered with FDA prior
to distribution or sale, and that we assume primary responsibility and/or stewardship over the product in case of liability,
adverse events, and/or other public health & safety issues;

•VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized
representatives at any reasonable time and the establishment and its personnel and officers undertake to respond and
cooperate fully with the FDA as regards any subsequent post-marketing activity;
 LICENSING PROCEDURE
•IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in business address,
business name, ownership, or any other circumstances in relation to the approval of this application is a ground for the
revocation of the License to Operate;

•X. The above declarations and undertakings which are based on existing regulations are deemed conditions for the approval
of the LTO and therefore non-compliance or defiance after approval can be a cause for SUSPENSION, CANCELLATION,
REVOCATION of the License to Operate which shall be guided by the provisions of Republic Act 3720 as amended by
Republic Act 9711 and other relevant laws, rules and regulations;

•XI. This document is executed in full knowledge and awareness of Republic Act 3720, as amended by Republic Act 9711,
otherwise known as the Food and Drug Administration Act of 2009, other relevant laws and their implementing rules and
regulations; and

•XII. I and the establishment herein represented grants authority to the Food and Drug administration to verify through
government and private resources the veracity of the information provided in all submissions and the authenticity of all the
documents attached or submitted.
LICENSING PROCEDURE

5. Fill up online application form

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6. Upload Documentary Requirements

 LICENSING PROCEDURE

7. Check and Double Check Application

 LICENSING PROCEDURE
7. Download and print Order of Payment then click next until the end of the form
 LICENSING PROCEDURE

8. Finish submission of application

LICENSING PROCEDURE

9. Pay Fee