FDA Citizen's Charter CFRR

FOOD AND DRUG ADMINISTRATION
Department of Health
CITIZEN’S CHARTER
2020 (1st Edition)
Profile
I. Mandate:
To protect the general public by ensuring the safety, efficacy, and quality of health
products.
II. Vision:
To be an internationally recognized center of excellence in health product regulation

by 2026.
III. Mission:
To guarantee the safety, quality, purity, efficacy of health products in order to protect
and promote the right to health of the general public.
IV. Service Pledge:
Ensure the safety, efficacy, quality, and purity of health products by fostering
integrity, transparency, and excellence-based standards and policies,
in a healthy and safe work environment.
2
CENTER FOR FOOD REGULATION AND RESEARCH
External Services
List of Health Products covered
Processed Food
List of Services
External Services
ISSUANCE OF USER ACCOUNT TO ACCESS FDA E-SERVICES/ PROVISION OF

APPOINTMENT SCHEDULE AND DOCUMENT TRACKING NUMBER (DTN) /
RECEIVING OF APPLICATION FOR LICENSE TO OPERATE LODGE AT THE E-
SERVICES AND OTHER AUTHORIZATIONS / RECEIVING OF LETTERS AND
OTHER DOCUMENTS IN RELATION TO CLIENTS APPLICATION............................. 5
ISSUANCE OF OFFICIAL RECEIPTS AND POSTING OF PAYMENT........................... 7
LICENSE TO OPERATE OF ESTABLISHMENT

I. LICENSE TO OPERATE – INITIAL APPLICATION FOR MANUFACTURERS OF
PROCESSED FOOD ............................................................................................... 10
II. LICENSE TO OPERATE – INITIAL APPLICATION FOR TRADERS,
DISTRIBUTORS (IMPORTER, EXPORTER, WHOLESALER) OF PROCESSED
FOOD ....................................................................................................................... 14
III. LICENSE TO OPERATE – RENEWAL APPLICATION........................................... 19
IV. LICENSE TO OPERATE – VARIATION APPLICATION
(FROM E-LTO) ....................................................................................................... 23
A. E-REGISTRATION PORTAL USER ACCOUNT..................................................... 28
B. CERTIFICATE OF PRODUCT REGISTRATION (CPR)

I. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT
REGISTRATION (CPR) – INITIAL/ RENEWAL DATA CAPTURE/
AMENDMENT DATA CAPTURE/ REAPPLICATION DATA
CAPTURE ................................................................................................................ 30
II. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT
REGISTRATION (CPR) – AMENDMENT (APPLICATIONS PREVIOUSLY
APPROVED VIA E-REGISTRATION) ................................................................... 49
3
III. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT
REGISTRATION (CPR) – AUTOMATIC RENEWAL APPLICATION (INITIAL
APPLICATION APPROVED FROM E-REGISTRATION ........................................ 54
IV. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT
REGISTRATION (CPR) – RE-APPLICATION (INITIAL APPLICATION
DISAPPROVED VIA E-REGISTRATION) ............................................................. 57
V. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT
REGISTRATION (CPR) – FOR EXPORT MARKET ONLY................................... 59
C. OTHER CFRR AUTHORIZATIONS ........................................................................ 73

I. TITLE OF CERTIFICATION/PERMIT: SANGKAP PINOY SEAL/DIAMOND
SANGKAP PINOY SEAL ......................................................................................... 73
II. TITLE OF CERTIFICATION/PERMIT: GMP/HACCP
CERTIFICATE ......................................................................................................... 75
III.TITLE OF CERTIFICATION/PERMIT: BOC CLEARANCE/
IMPORT PERMIT ................................................................................................... 76
IV.TITLE OF CERTIFICATION/PERMIT: SALES PROMO PERMIT (INITIAL AND
AMENDMENT APPLICATION) ............................................................................... 80
FIELD REGULATORY OPERATIONS OFFICE INSPECTION

AGENDA...................................................................................................................... 83
A. SIMPLE .................................................................................................................... 83
Bureau of Customs – For Donation .......................................................................... 83
Bureau of Customs – For Personal Use .................................................................. 83
B. COMPLEX ............................................................................................................... 84
INSPECTION AGENDA – FOOD DISTRIBUTOR ................................................... 84
C. HIGHLY TECHNICAL ............................................................................................. 85
INSPECTION AGENDA – FOOD MANUFACTURER/ REPACKER/ BOTTLED
WATER
MANUFACTURER .................................................................................................. 85
FDAC……………… ...................................................................................................... 86
FEEDBACK AND COMPLAINT MECHANISM ............................................................. 92
4
ISSUANCE OF USER ACCOUNT TO ACCESS FDA E-SERVICES/ PROVISION OF
APPOINTMENT SCHEDULE AND DOCUMENT TRACKING NUMBER (DTN) / RECEIVING
OF APPLICATION FOR LICENSE TO OPERATE LODGE AT THE E-SERVICES AND
OTHER AUTHORIZATIONS / RECEIVING OF LETTERS AND OTHER DOCUMENTS IN
RELATION TO CLIENTS APPLICATION
Center/Office/Division : Food and Drug Action Center

Classification : Simple
Type of Transaction : G2B-Government to Business
Who May Avail : All Manufacturers, Traders, Distributors (Importer, Exporter,
Wholesaler) of Food, Drugs, Cosmetics, Household Urban
Hazardous Substances (HUHS), Toys and Child Care Articles
(TCCAs), Household Urban Pesticides (HUPs) and Medical
Devices
Fees to be Paid : AO 50 s.2001
CLIENT STEPS AGENCY ACTION PROCESSING TIME PERSON

RESPONSIBLE
1) USER ACCOUNT 1) FDAC checks 1-2 working days FDA Action Center
Sends email request email request and (FDAC)
to fdac@fda.gov.ph sends username
for e-LTO user and password to
account following FDA the client. Creates
Circular 2016-004 user account for
● Accesses the
client
FDA e-portal
● Logs in using
FDA-issued
user account
● Accomplish
application for
License to
Operate
● Uploads
documentary
requirements in
PDF format
● Prints Order of
Payment
generated
Completes
application process by
clicking the “NEXT
STEP” and
“CONTINUE “buttons
2) SCHEDULE/ 2) FDAC checks 1-2 working days FDA Action Center
5
APPOINTMENT email request and (FDAC)
Sends email request sends DTN for
to fdac@fda.gov.ph drug registrations
for schedule and other
authorizations to
the client
3) Pays the required 3) Receives payment 1 working day FDA Cashier
fee through any of the and issues Official
following: Receipt.
FDA Cashier at FDAC
Starmall Alabang
BancNet Posts payment
Online**Landbank
Branches using the
Online Collection
Payment Slip**
System routes
application to
appropriate
Center/Office
● Application from
Manufacturer is
routed to concerned
Field Regulatory
Office for review and
inspection
Applications from
Distributor, Retail
Outlets,
CRO/Sponsors are
forwarded to
appropriate Center for
review
4) CLIENT WITH 4) FDAC issues Processing Time is 3 Head and
SCHEDULE TO Acknowledgement Minutes. Information Officer
APPEAR Receipt with DTN, Transmission of II at Public
Gets queueing prepares documents is Before Assistance and
number for counter 3 transmittal and 12 noon of the next Complaints’ Desk
and submits endorses received working day (PACD)
documents with soft
applications to the
copies for
concerned Center/
registration, CAPA,
compliances, and Office.
other authorizations. ▪ Staff copies files
6
from client’s USB
Client may also and stores the files
submit documents at in FDAC’s external
FDA Ali Mall Cubao: hard drive. “USB is
Received documents returned to client.”
are transmitted to
FDAC Alabang every
Tuesday and Friday
and as deemed
necessary.
5) WALK-IN CLIENT 5) FDAC issues Processing Time is 3 Head and
Gets queueing Acknowledgement MINUTES. Information Officer
number for counter 2 Receipt with DTN, Transmission of II at Letters Section
and submits letters prepares documents is Before
and other documents, transmittal and 12 noon of the next
as deemed endorses received working day.
necessary, in relation
documents to the
to their application. At
concerned Office/
FDA Ali Mall Cubao:
Center
Received documents
are transmitted to
FDAC Alabang every
Tuesday and Friday
and Whenever
deemed necessary.
ISSUANCE OF OFFICIAL RECEIPTS AND POSTING OF PAYMENT

Center/Office/Division : AFS – Cashier
Classification : Complex
Type of Transaction : G2B – Government to Businesses, G2G –
Government to Government
Who May Avail : All Manufacturers, Traders, Distributors (Importers,
Wholesalers, Exporters) of Food, Drugs, Cosmetics,
Toys and Child Care Notification, Household Urban
Pesticides (HUSP), Medical Devices and
Drugstores/Retail Outlets for Non-Prescriptions Drugs
Fees to be Paid : AO 50 s. 2001
CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1. Order of Payment Form E-Services
2. Integrated Application FDAC Center/Regional Offices
Form/Document Tracking No.
3. Manual Assessment Form FDAC Center/Regional Offices
4. Corresponding cash/check for Applicant
payment
7
CLIENT STEPS AGENCY ACTION PROCESSING TIME PERSON
RESPONSIBLE
Collection of
Payment
1) Applicants with Applicant
Order of Payment,
Assessment form and
DTN scheduled for the
day will be
accommodated by the
FDA
Cashier
2) Get a number from 1) Priority number will Applicant
the Guard on Duty on be given to Senior
a first come first Citizens, Persons’with
served basis. Disability and
Pregnant Women.
3) Wait for your 2) Maximum of five (5)
number to be called. applications per
Otherwise the next transaction per client.
client will be served. In excess of 5
Clients who have applications, clients
waived their turn must must secure for
secure another another number to be
number and wait for called before he/she
their turn. can pay the remaining
applications.
4) Client 3) Receives and 1 minute FDAC SCO
submit/present the verifies the copy of the
Order of payment/DTN DTN /IAOPF
to FDAC Cashier (2 downloaded by the
copies) client or as filled up by
the client/s as
reference for
acceptance of
payment
4) Encodes the details 3-5 minutes FDAC SCO
of payment and Prints
the pre-numbered or
and affix signature
above the name of the
SCO and CO (Name is
currently pre-encoded
in the OR)
5) Payment in Cash/ 5) Release the original 1 minute FDAC SCO
Check/Combination of Official Receipt and
Cash and Check the DTN/ IAOPF with
8
stamped “PAID” in the
Client’s copy.
6) Attached copy of 1 minute FDAC SCO
the DTN/IAOPF and
file the duplicate and
triplicate copy of
Official Receipt
Posting of Payment
Verified payment 1 minute per Cashier Staff
through Over-the- application
counter report of
collection and for
Online Bancnet and
LBP OnColl payment
through Bank reports
Log in to FDA 1-2 minutes per Cashier Staff
Information System for application
DTN Posting or in FDA
E Portal System for
EPS Posting
Note:
Over-the-Counter Within 2 working days
payment
Online Bancnet Within 2-3 working
Payments days
LBP OnColl Payments Within 3-5 working
days
TOTAL: 2-5 working days
Disclosure Statement: Standard Processing Time is reckoned from the time the complete
properly filled up documents are received by the Special Collecting Officer until the
transaction of the customer is completed. Processing Time does not include waiting
time that may vary depending on the number of customers availing the FDA services or
systems maintenance
9
LICENSE TO OPERATE OF ESTABLISHMENT
I. LICENSE TO OPERATE – INITIAL APPLICATION FOR MANUFACTURERS OF

PROCESSED FOOD
Center/Office/Division : Center for Food Regulation and Research (CFRR)

Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Processed Food
Fees to be Paid Food Manufacturer:
1 Million and below – Php 1,000 + 1% LRF
over 1 Million but below 5 Million – Php 2,000 + 1% LRF
5 Million but below 10 Million - Php 3,000 + 1% LRF
10 Million but below 20 Million – Php 5,000 + 1% LRF
50 Million and above - Php 15,000 + 1% LRF
Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the
Corresponding Services Rendered by the Bureau of Food and
Drugs
FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No.
3870, as amended by PD 200 and further Amended by PD 1856

1)Basic Requirements based on the Administrative Order No.
2020-0017:
FDA e-Services
● Accomplished e-Application Form as prescribed by FDA (www.fda.gov.ph)
regulations. Completes the application process by clicking
the “NEXT STEP” and “CONTINUE” buttons. Applicant/Qualified person
● Location plan and Global Positioning System (GPS) Applicant/Qualified person
coordinates to be filled in the eApplication Form
● Name of the Qualified Person (refer to Annex A of AO 2020-
0017) depending on the type of health product
establishment (refer to Annex B of AO 2020-0017)
● Self-Declaration in the e-Application Form
2) Proof of Business Registration Applicant/Qualified person
Any one of the following shall be submitted as proof of business
name registration (in pdf):
10
● For single proprietorship, the Certificate of Business
Registration issued by the Department of Trade and Industry
(DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the
Certificate of Registration issued by the Securities and
Exchange Commission (SEC) and Articles of Incorporation (1
Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the
Cooperative Authority and Articles of Cooperation (1
Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law
creating the establishment, if with original charter, or its
Certificate of Registration issued by the Securities and
Exchange Commission (SEC) and Articles of Incorporation,
if without original charter (1 Scanned copy PDF)
When a business or establishment address is different from the

business name registration address, the applicant shall submit a
copy of the Business Permit (e.g. Mayor’s Permit)
3) Proof of income (Latest Audited Financial Statement with Applicant/Qualified person
Balance Sheet)
4) Proof of payment of fees as prescribed by current FDA FDA Cashier/Other FDA
regulations (AO 50 s. 2001). Authorized
Payment Portals or Banks
5) Additional Requirements for Applications of LTO as
Manufacturer of all health products
Risk Management Plan (RMP) (checking upon inspection) Applicant/Qualified person
This is required for all medium and large food manufacturers.
Site Master File(checking upon inspection) Applicant/Qualified person
This is required for all medium and large food manufacturers.
CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the online None 0 Authorized
application portal Representativ
through e/Qualified
(http://eservices.fda.g Person
ov.ph) “Applications
2. Select the product None Authorized
category (Food) and Representativ
the type of business e/Qualified
establishment Person
(Manufacturer)
before proceeding to
Initial Application
11
3. Click “I agree to the None Authorized
Declaration and Representativ
Undertaking”. e/Qualified
Declining the Person
declaration shall mean
forfeiture of the
opportunity to proceed
with the application
4. Upload the company’s None Authorized
proof of Business Representativ
Name Registration in e/Qualified
.pdf format. File size Person
should not be more
than 5MB
5. After providing the None Authorized
required information, Representativ
applicants can review e/Qualified
the duly-filled out form Person
in the Self-
Assessment Review.
By agreeing to the
Terms and Conditions,
the applicants confirm
the correctness of
information given
6. Print the Order of None 0 Authorized
Payment form with Representativ
Reference Number e/Qualified
sent through the Person
declared e-mail
address.
7. The applicant 1. FDA Cashier Food 0 FDA Cashier
company pays the receives the Manufac-
turer: Administrative
assessed fee as per payment for FDAC
1 Million and Finance
the system generated Cashier payments
and Service
Order of Payment
Form through FDAC below – (AFS)/General
Php Services
Cashier or any other Received 1,000 + Division
means prescribed by notification of 1% LRF (GSD)/Cashie
FDA (e.g. BANCNET, payment for bank over 1 r Section
LANDBANK payments; Million
ONCOLL). Timeline of but below
posting for each mode 5 Million
of payment: – Php
1.Over the counter (FDA 2,000+
Cashier) – the 1% LRF
12
payment will be posted 5 Million
after 2 days but below
10 Million
2. Bank payment - Php
3,000 +
1% LRF
Payment – the
10 Million
payment will be posted but below
after 5 days 20 Million
– the – Php
payment will be posted 5,000 +
1% LRF
after 2 days
20 Million
but below
50 Million
– Php
10,000 +
10% LRF
50 Million
and
above -
Php
15,000 +
10% LRF
2. Post payment in None 1 working FDA Cashier

eservices for day Administrative
confirmed and Finance
payments. This will Service (AFS)
prompt automatic
decking of
application to
respective Center
3. Receive application None 1 working day Administrative
and sort per product Officer
category (Field
Regulatory
Operations
Office)
4. Inspect None 11 working Regional Field
manufacturing days Officer/
facility Inspector
5. Endorse COC/RL to None 1 working day Regional Field
Center Officer/
Licensing
Officer
13
6. Evaluation of None 2 working FDA Evaluator
correctness of days (Center/Licens
submitted ing and
documentary Registration
requirements. Division)
Recommend pre-
license inspection of
the establishment.
7. Checking and None 3 working Technical
quality assurance of days Officer of
the documents specific
provided and Center of
compliance. jurisdiction
8. Approval of LTO None 1 working day Center
Director of
jurisdiction
If application is
disapproved, the
applicant will be
notified through email
and will receive the
Letter of Denial
8. The applicant Authorized
company receives Representativ
notification and link of e of the
LTO for printing Applicant
Company
TOTAL: 20 working days
II. LICENSE TO OPERATE – INITIAL APPLICATION FOR TRADERS, DISTRIBUTORS

(IMPORTER, EXPORTER, WHOLESALER) OF PROCESSED FOOD

Type of Transaction : G2B – Government to Business
Who May Avail : All Traders, Distributors (Importer, Exporter, Wholesaler) of
Processed Food
14
Fees to be Paid : Food Distributors:
Importer, Exporter, Wholesaler – Php 4,000 + 1% LRF
Iodized Salt Importer – Php 1,000 + 1% LRF

Corresponding Services Rendered by the Bureau of Food
and Drugs

Collection of Legal Research Fee Imposed by Republic Act
No. 3870, as amended by PD 200 and further Amended by
PD 1856

1)Basic Requirements based on the Administrative
Order No. 2020-0017:
FDA e-Services
● Accomplished e-Application Form as prescribed (www.fda.gov.ph)
by FDA regulations. Completes the application
process by clicking the “NEXT STEP” and Applicant
“CONTINUE” buttons. Applicant
● Location plan and Global Positioning System Applicant
(GPS) coordinates to be filled in the eApplication
Form
● Name of the Qualified Person (refer to Annex A
of AO 2020-0017) depending on the type of
health product establishment (refer to Annex B of
AO 2020-0017)
● Self-Declaration in the e-Application Form
2) Proof of Business Registration Applicant
Any one of the following shall be submitted as proof of

business name registration:
● For single proprietorship, the Certificate of
Business Registration issued by the Department
of Trade and Industry (DTI)
● For Corporation, Partnership and other Juridical
Person, the Certificate of Registration issued by
the Securities and Exchange Commission (SEC)
and Articles of Incorporation
● For Cooperative, the Certificate of Registration
issued by the Cooperative Authority and Articles
of Cooperation
15
● For Government-Owned or Controlled
Corporation, the law creating the establishment, if
with original charter, or its Certificate of
Registration issued by the Securities and
Exchange Commission (SEC) and Articles of
Incorporation, if without original charter include
Mayor’s Permit or Barangay Clearance provision
A copy of Business permit (i.e. Mayor’s Permit or

Barangay Clearance provision) will be submitted for
business or establishment address with different
business name registration address.
3) Proof of income (Latest Audited Financial Applicant/Qualified person
Statement with Balance Sheet)
4) Proof of payment of fees as prescribed by current FDA Cashier/Other FDA
FDA regulations (AO 50 s. 2001). Authorized
Payment Portals or Banks
CLIENT STEPS AGENCY FEES TO PROCESSING PERSON

ACTION BE PAID TIME RESPONSIBLE
application portal Representative
through / Qualified
(http://eservices.fd Person
a.gov.ph)
“Applications
2. Select the product None 0 Authorized
category (Food) Representative
and the type of / Qualified
business Person
establishment
(Distributor/
Trader) before
proceeding to
Initial Application
3. Click “I agree to None 0 Authorized
the Declaration Representative /
and Undertaking”. Qualified Person
Declining the
declaration shall
mean forfeiture of
the opportunity to
proceed with the
application
4. Upload the None 0 Authorized
company’s proof Representative
of Business Name / Qualified
Registration in .pdf Person
16
format. File size
should not be
more than 5MB
5. After providing the None 0 Authorized
required Representative
information, / Qualified
applicants can Person
review the duly-
filled out form in the
Self-Assessment
Review. By
agreeing to the
Terms and
Conditions, the
applicants confirm
the correctness of
information given.
Payment form with Representative
Reference Number / Qualified
declared e-mail
address
7. The applicant 1. FDA Cashier Food FDA Cashier
company pays the receives the Distributo Administrative
assessed fee as payment for rs: and Finance
per the system FDAC Cashier Importer, Service (AFS)
generated Order payments Exporter,
of Payment Form Wholesal
through FDAC Received er – Php
Cashier or any notification of 4,000 +
other means payment for 1% LRF
prescribed by FDA bank
(e.g. BANCNET, payments;
LANDBANK Iodized
ONCOLL). Salt
Importer
Timeline of posting – Php
for each mode of 1,000 +
payment: 1% LRF
1. Over the
counter (FDA
Cashier) – the
payment will be
posted after 2
days
2. Bank payment
OnColl Payment
17
– the payment will
be posted
after 5 days
– the
payment will
be posted after
2 days
2. Post payment None 1 working day FDA Cashier
in eServices Administrative
for confirmed and Finance
payments. Service (AFS)
This will
prompt
automatic
decking of
application to
respective
Center
3. Receive None 1 working day Administrative
application Officer (Center
and sort per of jurisdiction)
product
category
4. Checking and None 11 working Technical
quality days Officer of
assurance of specific Center
the documents of jurisdiction
provided and
compliance
5. Approval of None 1 working day Center
LTO Director of
jurisdiction
If application
is
disapproved,
the applicant
will be notified
through email
and will
receive the
Letter of
Denial
company receives Representative
notification and link of the
of LTO for printing Applicant
Company
TOTAL: 14 working
days
18
III. LICENSE TO OPERATE – RENEWAL APPLICATION

Wholesaler) of Processed Food
Fees to be Paid : Food Distributors:
Importer, Exporter, Wholesaler – Php 8,000 + 1% LRF
Iodized Salt Importer – Php 2,000 + 1% LRF
Food Manufacturer:
1 Million and below – Php 2,000 + 1% LRF
over 1 Million but below 5 Million – Php 4,000 + 1% LRF
5 Million but below 10 Million - Php 6,000 + 1% LRF
50 Million and above - Php 30,000 + 1% LRF

Corresponding
Services Rendered by the Bureau of Food and Drugs

PD 1856

Computation of Surcharge or Penalty Impossible in case of
Submission of Renewal Applications Covering License of
Establishments and Registration of Health Products After
Their Date of Expiration Pursuant to Section 3, Paragraphs
(A)(2) and (B)(2) of Article I of Book II of the RA 9711
Implementing Rules and Regulations, and Other Purposes

1)Basic Requirements based on the Administrative
Order No. 2020-0017:
FDA e-Services (www.fda.gov.ph)
● Accomplished e-Application Form as
prescribed by FDA regulations.. Applicant
● Declaration and Undertaking
19
2) Proof of payment of fees as prescribed by FDA Cashier/Other FDA
current FDA regulations (AO 50 s. 2001). Authorized Payment Portals or
Banks
CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
through / Qualified
(http://eservices.fd Person
a.gov.ph)
“Applications”.
category and the Representative
type of business / Qualified
establishment Person
before proceeding
to Renewal
Application
3. Click “I agree to None 0 Authorized
the Declaration Representative
and Undertaking”. / Qualified
Declining the Person
declaration shall
mean forfeiture of
the opportunity to
proceed with the
application.
4. Provide the None 0 Authorized
information / Qualified
completely and Person
accurately
detailing the
License to
Operate Number,
its validity and
security code
5. Update the contact None 0 Authorized
information Representative
/ Qualified
Person
information, / Qualified
applicants can Person
review the duly-
filled out form in the
Self-Assessment
20
Review. By
agreeing to the
Terms and
Conditions, the
applicants confirm
the correctness of
information given.
declared e-mail
address
8. The applicant 1. FDA Cashier Food 0 FDA Cashier
company pays the receives the Distribu- Administrative
assessed fee as payment for tors: and Finance
per the system FDAC Cashier Importer, Service (AFS)
generated Order of payments Exporter,
Payment Form Wholesal
through FDAC Received er – Php
Cashier or any notification of 8,000 +
other means payment for 1% LRF
prescribed by FDA bank payments.
(e.g. BANCNET, Iodized
LANDBANK Salt
ONCOLL). Importer
– Php
Timeline of posting 2,000 +
for each mode of 1% LRF
payment:
1. Over the counter Food
(FDA Manufact
Cashier) – the urer:
payment will be 1 Million
posted after 2 days and
2. Bank payment below –
Php
Payment – the 2,000 +
payment will be 1% LRF
posted after 5 days over 1
– the Million
payment will be but below
posted after 2 days 5 Million –
Php
4,000 +
1% LRF
5 Million
but below
10 Million
- Php
21
6,000 +
1% LRF
10 Million
but below
20 Million
– Php
10,000 +
1% LRF
20 Million
but below
50 Million
– Php
20,000 +
1% LRF
50 Million
and
above -
Php
30,000 +
1% LRF
2. Post payment None 1 working day FDA Cashier

in eservices for Administrative
payments. This Service (AFS/
will prompt
automatic
decking of
application to
respective
Center
LTO Director
If application is
disapproved, the
applicant will be
notified through
email and will
receive the Letter
of Denial
notification and link of the
of LTO for printing Applicant
Company
TOTAL: 7 working
days
22
IV. LICENSE TO OPERATE – VARIATION APPLICATION (FROM E-LTO)
Center/Office/Division : Center for Food Regulation and Research

(CFRR)
Wholesaler) of Food
Fees to be Paid : Amendment of LTO or Re-issuance (if lost) – Php 500
+1% LRF

Corresponding
Services Rendered by the Bureau of Food and Drugs

PD 1856

1)List of Requirements for Specific Variation based on the Authorized Representative
Amendment of Administrative Order No. 2020-0017: of the Applicant Company
A. Transfer of Location of Manufacturing Plant and Drug

Retailers
Documentary Requirement:
1. Business permit reflecting the new address
2. Updated Site Master File to be presented upon
inspection
B. Expansion of Manufacturer and/or Additional Product

Line; or Change of Manufacturing Activity
1. Updated Site Master File to be presented upon
inspection
C. Transfer of Location Offices
1. Business permit reflecting new location of office
A. Transfer of Location of Drug Retailers

23
1. Business permit reflecting new address
E. Change of Distributor Activity

1. Contract Agreements showing change in activity
F. Transfer or Addition of Warehouse

1. Business permit reflecting new warehouse
G. Additional Drugstore Activities

1. Additional Credentials of Pharmacist, as applicable
2. Other documents related or specific to the
additional activity (see Annex C of AO 2020-0017)
H. Expansion of Office Establishment

1. Expansion floor plan
I. Change of Ownership
1. Business name registration reflecting new
ownership
2. Any proof on the transfer of ownership (see Annex
C of AO 2020-0017)
J. Change of Business Name;

1. Business permit reflecting the new name
J. Zonal Change in Address

1. Certificate of Zonal Address
K. Change of Qualified Person

1. Name of new qualified person, with credentials
when applicable
24
2. Applicable requirements as specified in Annex B of
AO 2020-0017
A. Change of Authorized Person

2. Name of new qualified person
3. Updated contact details
2) Proof of payment of fees as prescribed by current FDA FDA Cashier/Other FDA
regulations (AO 50 s. 2001). Authorized Payment Portals
or Banks
CLIENT STEPS AGENCY ACTION FEES PROCESSING PERSON

TO BE TIME RESPONSIBLE
PAID
through / Qualified
(http://eservices.fda. Person
gov.ph) “Applications
category and the Representative
type of business / Qualified
establishment before Person
proceeding to
Variation
3. Click “I agree to the None 0 Authorized
Declaration and Representative
Undertaking”. of
Declining the the Applicant
declaration shall Company
mean forfeiture of
the opportunity to
proceed with the
application.
4. Upload the None 0 Authorized
documentary Representative
requirements / Qualified
depending on the Person
variation or
circumstances of the
establishment as
shown in Annex C
AO No. 2020-0017
25
required information, Representative
applicants can / Qualified
review the duly-filled Person
out form in the Self-
Assessment Review.
By agreeing to the
Terms and
Conditions, the
applicants confirm
the correctness of
information given
declared e-mail
address
7. The applicant 2 FDA Cashier See 0 FDA Cashier
company pays the receives the above Administrative
assessed fee as per payment for FDAC table and Finance
the system generated Cashier payments Service (AFS)
Order of Payment
Form through FDAC Received
Cashier or any other notification of
means prescribed by payment for bank
FDA (e.g. BANCNET, payments.
LANDBANK
ONCOLL).
Timeline of posting for

each mode of payment:
1. Over the counter
(FDA Cashier) – the
payment will be
posted after 2 days
2. Bank payment
Payment – the
payment will be
posted after 5 days
– the
payment will be
posted after 2 days
3. Post payment in None 1 working day FDA Cashier
eservices for Administrative
payments. This will Service (AFS)
prompt automatic
decking of
26
application to
respective Center
4. Receive None 1 working day FDA Evaluator
application and (Center/Licensi
sort per product ng and
category Registration
Division)
5. Evaluation of None 2 working FDA Evaluator
correctness of days (Center/Licensi
submitted ng and
documentary Registration
requirements. Division)
6. Checking and None 2 working FDA Evaluator
quality assurance days (Center/Licensi
of the documents ng and
provided and Registration
compliance. Division)
Variation Director of
jurisdiction
If application is
disapproved, the
applicant will be
notified through
email and will
receive the Letter
of Denial
notification and link of of the Applicant
LTO with appropriate Company
amendment for
printing
TOTAL: 7 working
days
Note:
1. The fees charged for manufacturers and traders of products regulated by
BFAD are based on the capital invested.
2. Renewal of LTO shall be on the anniversary of its issuance and shall be valid
for two years.
27
A. E-REGISTRATION PORTAL USER ACCOUNT

Classification : Government to Business
Type of Transaction : Simple
Who May Avail : All FOOD Manufacturers/Traders/Distributors (Importers/
Wholesalers/ Exporters)
Fees to be Paid : NONE
1. Submit one (1) scanned copy of the required

document.
A. FOR FOOD ESTABLISHMENTS WITH
VALID LTO UNDER THE MANUAL SYSTEM
1. Send a request for username and password

to cfrr@fda.gov.ph with Applicant company
SUBJECT: CFRR: E-Registration
(Body)
Email Address:
Last name:
First Name:
Middle Name:
Company Name:
LTO No.:
LTO validity:
FDA Website (www.fda.gov.ph)
2. The email must contain an attached scanned
copy notarized authorization letter (please see
Annex B of FDA Circular No. 2016-014 or
updated/existing issuance set by FDA) from
company with a valid License-to-Operate
(issued under the manual system).
B. FOR RE-VALIDATION OF ACCOUNT (FOR

THOSE INITIALLY GRANTED ACCESS
THROUGH
FDA
E-PORTAL FOR LICENSING PURPOSES)
1. If the issued username is cfrruser**, email

must be sent to fdac@fda.gov.ph
2. If the issued username is fdauser**, email
must be sent to cfrr@fda.gov.ph with
Subject: “CFRR E-Registration Revalidation”
(Body)
28
Authorized Representative:
Company name:
LTO number:
LTO validity:
Username:
FDA
C. FOR RENEWAL OF ACCOUNT
1. If the issued username is cfrruser**, email
must be sent to cfrr@fda.gov.ph with
subject “CFRR E-registration”
(Body)
Email Address:
Last name:
First Name:
Middle Name:
Company Name: FDA
Existing Username:
Existing Password:
2. If the issued username is fdauser**, email

must be sent to fdac@fda.gov.ph
CLIENT STEPS AGENCY ACTION PROCESSING FEES TO PERSON

TIME BE PAID RESPONSIBLE
1) The authorized 1) The FDA 3 Working Administrative
representative submits Personnel checks e- Days Staff, Center for
documents/information mail request. If Food
to the above- compliant, user Regulation and
mentioned e-mail name and password Research
address. will be issued to the (CFRR)
client, via e-mail.
Otherwise, the
personnel will send
e-mail to the
applicant to request
for lacking
document(s)/ clarify
information.
Total: 3 Working
Days
29
B. CERTIFICATE OF PRODUCT REGISTRATION (CPR)
I. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT

REGISTRATION (CPR) – INITIAL/ RENEWAL DATA CAPTURE/ AMENDMENT DATA
CAPTURE/ REAPPLICATION DATA CAPTURE

Type of Transaction : Highly Technical
Fees to be Paid : In accordance to Administrative Order 50 s. 2001 + Legal
Research Fee (LRF).
Low Risk Food (Category 1): Php 200.00/year of validity+

1% LRF
Medium Risk Food (Category 2): Php 250.00/year of validity
+ 1% LRF
High Risk Food: Php 1,000.00/year of validity + 1% LRF
Bottled Water: Php 1,000.00/year of validity + 1% LRF

document in the e-Registration Portal
2. Product labels and pictures of the product in
commercial presentation for upload should be scanned
in 200-dpi setting
3. Documents for upload should be scanned in 150-dpi
setting
4. Provide an appropriate file name for each scanned
copy of documents to be uploaded in the E-registration
system. For product labels, follow the format:
“Label_(Case Number)”
e.g. Label_12345.png or Label_12345.pdf
1. General Requirements based on Administrative
Order 2014-0029
 Accomplished Initial Application Form as FDA Website (www.fda.gov.ph)
prescribed by FDA regulations (e-Registration e-
Portal, refer to FDA Circular 2016-014).
 Proof of Payment of Fees as prescribed by FDA Cashier/Other FDA Authorized
current FDA regulations (A.O. 50 s. 2001). Payment Portals or Banks
 Clear and complete loose labels or artworks, as
applicable, of all packaging sizes, or equivalents Applicant Company/
as defined by FDA regulations (Refer to AO Manufacturer/Source/Supplier
2014-0030).
 Pictures of the product in all angles and in Applicant Company/

different packaging sizes, and from at least two Manufacturer/Source/Supplier
different perspectives allowing visual recognition
30
of a product as the same with the one being
registered. Applicant Company/
Manufacturer/Source/Supplier
 For FOOD SUPPLEMENT, a sample in actual For the Certificate of Analysis:
commercial presentation shall be submitted. a) Manufacturer/Supplier/Source
b) Laboratory analysis
 As applicable, documents to substantiate issued/conducted by FDA
claims, such as technical, nutritional or health accredited laboratories.
studies or reports, market-research studies,
Certificate of Analysis, quantitative analysis and
computations, scientific report or studies
published in peer-reviewed scientific journals,
certificates or certification to support use of
logo/seal on Sangkap Pinoy, Halal, Organic, or
Kosher food and in compliance with current
labeling regulations.
2) General Requirements based on FDA Circular Manufacturer/Source/Supplier
2016-007
• For Locally Manufactured Products: (in
cases when the source is not directly the
manufacturer) Distributorship agreement or
contract agreement, whichever is applicable,
signed by the duly authorized representative of
the establishment as reflected in the records of
CFRR (FDA Circular 2016-007).
• For Imported Products:

a. Any scanned copy of the original copy of
Distributorship agreement or contract
agreement Sales Invoice or Proforma Invoice,
or whichever is applicable, signed by the duly
authorized representative of the establishment
as reflected in the records of CFRR (FDA
Circular 2016-007).
b. Certified true copy or certified photocopy of
ANY of the following original documents issued
to the source by the regulatory or health
authority from the country of origin per source:
 Valid manufacturer’s certificate of
registration with GMP compliance or its
equivalent;
 Valid Phytosanitary Certificate/ Health
Certificate;
 Valid ISO 22000 Certification;
 Valid HACCP Certificate; or
 Certificate of Free Sale (CFS issued by a
regulatory agency or duly authenticated
by the Philippine consulate from the
country of origin)
31
3) ADDITIONAL REQUIREMENTS PER FOOD 1) For the Certificate of Analysis:
CATEGORY a) Applicant Company/
Manufacturer/Source/Supplier; or
1. LOW-RISK FOOD PRODUCTS b) Laboratory analysis
issued/conducted by FDA
accredited laboratories.
A.1. COOKING OIL (i.e. Coconut, Palm,
Soybean, Corn). 2) For other technical document(s):
• Certificate of Analysis for Vitamin A a) Applicant Company/
based on Republic Act 8976. Manufacturer/Source/Supplier
D.1. WHEAT FLOUR

• Certificate of Analysis for Vitamin A
and Iron based on Republic Act 8976.
G.1. REFINED SUGAR

• Certificate of Analysis for Vitamin A
based on Republic Act 8976.
I.1. IODIZED SALT & SALT

SUBSTITUTES
• Certificate of Analysis for Iodine
Content based on Republic Act 8172.
I.8. SOY SAUCE

• Certificate of Analysis for 3-MCPD
based on FDA Memorandum 2011-028.
D.6. PRE-PACKED RICE

• Certificate of Analysis for Iron based
on Republic Act 8976.
2. MEDIUM-RISK FOOD PRODUCTS
MRA1a. CONDENSED MILK

• Certificate of Analysis for
Microbiological parameters for Sweetened
Condensed Milk: Coliforms cfu/g, Yeast &
Mold Count cfu/g & SPC/APC cfu/g based
on FDA Circular 2013-010.
• Certificate of Analysis for Total Milk
Solids and Milk Fat based on
Administrative Order No. 132 s. 1970.
MRA2. MILK POWDER
32
Microbiological parameters for Milk
Powder (e.g. whole, nonfat, filled milk,
buttermilk, whey & whey protein and milk
intended for children more than 36 months
of age and adults): Salmonella/25g,
SPC/APC cfu/g & Enterobacteriaceae
cfu/g based on FDA Circular 2013-010.
• Certificate of Analysis for pH, Protein,
Fat, Milk Solids, Milk Fat and Moisture
(whichever is applicable) based on
MRA3. MILK PRODUCTS FOR SPECIFIC

TARGET AGE GROUP
• Certificate of Analysis for pH, Protein,
Fat, Milk Solids, Milk Fat and Moisture
(whichever is applicable) based on
• Certificate of Analysis to support
Nutrition Information declaration.
MRB2. EDIBLE ICES (POPSICLES)
Microbiological parameters for Flavored
Ice: SPC/APC cfu/g, Coliforms MPN/g,
YMC cfu/g & Salmonella/25g based on
FDA Circular 2013-010.
MRC1. TOMATO CATSUP
• Certificate of Analysis for Total Soluble
Solids and Titratable Acidity based on
MRC2. FROZEN FRUITS
Microbiological parameters for Frozen
Fruits: E. coli MPN/g based on FDA
Circular 2013-010.
MRC3. CANNED OR BOTTLED FRUITS
& VEGETABLE PRESERVE IN JUICE,
SYRUP & BRINE
Microbiological parameters for Fruits and
33
Vegetable Products in Hermetically
Sealed Containers: Commercial Sterility
based on FDA Circular 2013-010.
MRC7. FERMENTED VEGETABLES
Microbiological parameters for Fermented
Vegetable (Ready to Eat): YMC cfu/g,
Coliforms MPN/g, E. coli MPN/g,
Salmonella/25g & S. aureus cfu/g based
MRD. COCOA POWDER
Microbiological parameters for Cocoa
Powder: Molds cfu/g, Salmonella/25g,
Coliforms cfu/g & SPC/APC cfu/g based
MRD. CHOCOLATE PRODUCTS
Microbiological parameters for Chocolate
Products: Molds cfu/g, Salmonella/25g,
MRF1Ai. CURED (INCLUDING SALTED)
NON-HEAT TREATED PROCESSED
MEAT, POULTRY AND GAME
PRODUCTS
Microbiological parameters for Packaged
Cooked, Cured/Salted Meat: S. aureus
(coagulase +) cfu/g, Salmonella/25g &
Listeria monocytogenes/25g based on
Microbiological parameters for
Cured/Smoked Poultry: S. aureus
(coagulase +) cfu/g & Salmonella/25g
• Certificate of Analysis for Nitrate and
Nitrite Content (if utilized) based on
Administrative Order No. 154 s. 1971 and
Bureau Circular 2006-016.
MRF1Aii. CURED (INCLUDING SALTED)
DRIED NON-HEAT TREATED
PROCESSED MEAT, POULTRY AND
GAME PRODUCTS
34
MRF2Ai. FERMENTED NON-HEAT
TREATED PROCESSED MEAT,
POULTRY AND GAME PRODUCTS
Microbiological parameters for Fermented,
Comminuted Meat, not cooked (dry &
semi-dry fermented sausages): E. coli
MPN/g, S. aureus (coagulase +) cfu/g &
Salmonella/25g based on FDA Circular
2013-010.
MRJa. CAKES, COOKIES, PIES,
PASTRIES, DOUGHNUTS, SWEET
ROLLS, CONES, MUFFINES, WAFFLES-
PLAIN /WITHOUT FILLING
Microbiological parameters for Baked
Goods: S. aureus (coagulase +) cfu/g,
MYC cfu/g, SPC/APC cfu/g & Coliforms
cfu/g) based on FDA Circular 2013-010.
MRJa. FROZEN BAKERY PRODUCTS
Bakery Products: S. aureus (coagulase +)
cfu/g & Salmonella/25g based on FDA
Circular 2013-010.
MRjb. FROZEN DOUGH
Microbiological parameters for Frozen and
Refrigerated Doughs: Molds cfu/g, Yeast &
Yeastlike Fungi cfu/g, Coliforms cfu/g,
Psychrotrophic bacteria cfu/g & SPC/APC
MRK2a. EMULSIFIED SAUCES AND
DIPS (SALAD DRESSING- i.e.
MAYONNAISE, THOUSAND ISLAND,
RANCH, FRENCH)
Microbiological parameters for Salad
Dressing: SPC/APC cfu/g, YMC cfu/g,
35
Salmonella/25g & Listeria
monocytogenes/25g based on FDA
Circular 2013-010.
• For Mayonnaise: Certificate of Analysis
for Fat Content based on Administrative
Order No. 235 s. 1975.
MRL1a. FRUIT AND VEGETABLE
JUICES
Microbiological parameters for Non-
Alcoholic Beverages: YMC cfu/mL,
Coliforms cfu/mL & SPC/APC cfu/mL
MRL1c. SPORTS, ENERGY DRINK &
ELECTROLYTE DRINKS
• Certificate of Analysis for Caffeine and
Vitamin Assays based on Administrative
Order 2014-0029.
MRL1ci. CARBONATED WATER-BASED
FLAVORED DRINKS
• For Cola-type Beverage: Certificate of
Analyis for Caffeine Content based on
Administrative Order 88-A s. 1984.
MRL1cii. NON-CARBONATED WATER-
BASED FLAVORED DRINKS
MRL1ciii. FROZEN CONCENTRATE
Juice Concentrates: SPC/APC cfu/mL &
YMC cfu/mL based on FDA Circular 2013-
010.
MRL1d. POWDERED COCOA DRINK
MIXES
36
Microbiological parameters for Powdered
Beverage: SPC/APC cfu/g & YMC cfu/g
MRM1. VITAMINS, MINERALS & AMINO
ACIDS AS FOOD SUPPLEMENTS
• Shelf life study with stability data
based on Administrative Order 2014-0029.
• Certificate of Analysis of the physico-
chemical (Vitamins, Minerals & Amino
Acids Assays) and microbiological
parameters of the finished product based
on Administrative Order 2014-0029.
• Safety data (include but not limited to
acute toxicity test, safe history of use;
research studies on safety of the product)
• Clear and complete loose labels or
artworks declaring the term “Food
Supplement” and the phrase “NO
APPROVED THERAPEUTIC CLAIMS”
based on Bureau Circular No. 2 s 1999.
 Sample in actual commercial
presentation based on Administrative
Order 2014-0029.
For FOOD SUPPLEMENTS, one (1)

representative sample in commercial
presentation consistent with the E-
Registration application shall be
submitted to Food and Drug Action
Center (FDAC) at 3rd Floor Starmall,
Alabang, Muntinlupa City before
continuing the application to Pre-
Assessment through either the following
means:
i. Personal Delivery to FDAC, Starmall,
Alabang, Muntinlupa City or
ii. Delivery via registered courier that

must contain the following
information:
TO:
FOOD AND DRUG ACTION CENTER
(FDAC)
3rd Floor Starmall, Alabang,
Muntinlupa City
37
FROM: Company’s complete name &
address
SUBJECT: Food Product E-

Registration
Application (Case No.)
The proof of submission of sample

(Acknowledgement Receipt from
FDAC or Receipt from Registered
Courier) shall be uploaded together
with the other documentary
requirements.
3. HIGH-RISK FOOD PRODUCTS
HRA1a. MILK (PLAIN) AND BUTTERMILK

PLAIN
Microbiological parameters for Liquid Milk
(evaporated & ready to drink)-
UHT/Sterilized: Commercial Sterility based
Microbiological parameters for Pasteurized
Milk: Coliforms cfu/mL, Salmonella/25mL,
Listeria monocytogenes/25mL,
Psychrotrophic bacteria cfu/mL &
SPC/APC cfu/mL based on FDA Circular
2013-010.
HRA1b. DAIRY-BASED DRINKS,
FLAVORED AND/OR FERMENTED
2013-010.

Microbiological parameters for Yogurt and
Fermented Milk: S. aureus (coagulase +)
38
cfu/mL, Coliforms cfu/mL,
Salmonella/25mL & Lactic acid cfu/mL
HRA3a. PASTEURIZED CREAM
Cream: Coliforms cfu/g, Salmonella/25g,
Listeria monocytogenes/25g,
HRA3b. STERILIZED AND UHT
CREAMS, WHIPPING AND WHIPPED
CREAMS, AND REDUCED FAT CREAMS
(PLAIN)
Microbiological parameters for Cream
(UHT/Sterilized): Commercial Sterility
HRA4a. UNRIPENED CHEESE
Microbiological parameters for Cheese
and Cheese (moisture > 39% & pH): S.
aureus (coagulase +) cfu/g, E. coli MPN/g,
Coliforms MPN/g, Psychrotrophic bacteria
cfu/g, Salmonella/25g & Listeria
Circular 2013-010.
Microbiological parameters for All Raw
Milk Cheese: Campylobacter/25g,
Salmonella/25g, Listeria
monocytogenes/25g and S. aureus
(coagulase +) cfu/g based on FDA Circular
2013-010.
• Certificate of Analysis for Fat in Dry
Matter and Moisture Content based on
Administrative Order No. 200-A s. 1973
HRA4di. PLAIN PROCESSED CHEESE
Microbiological parameters for Processed
Cheese Spread: S. aureus (coagulase +)
cfu/g, Coliforms cfu/g & SPC /APC cfu/g
HRA4di. FLAVORED PROCESSED
CHEESE
39
HRA5. DAIRY BASED DESSERT (e.g.
Yogurt)
HRA8. DAIRY BASED FROZEN
DESSERT
Microbiological parameters for Ice Cream
& Sherbet (plain and flavored): Coliforms
cfu/g, Listeria monocytogenes/25g,
Salmonella/25g, SPC/APC cfu/g & S.
aureus (coagulase +) cfu/g based on FDA
Circular 2013-010.
with added ingredients (nuts, fruits, cocoa
etc.): Coliforms cfu/g, Listeria
monocytogenes/25g, Salmonella/25g,
SPC/APC cfu/g & S. aureus (coagulase +)
HRB1. DRIED FRUIT
Microbiological parameters for Sun Dried
Fruits: Mold cfu/g, OsmophilicYeasts cfu/g
& E. coli MPN/g based on FDA Circular
2013-010.
HRB1. DRIED VEGETABLE
Microbiological parameters for Dried
Vegetable: E. coli MPN/g based on FDA
Circular 2013-010.
HRB2. VEGETABLE, SEAWEED AND
NUT AND SEED- PUREES, SPREADS
Microbiological parameters for Peanut
Butter & Other Nut Spreads:
2013-010.
HRD. CHOCOLATE WITH NUTS
40
HRF1. FINE BAKERY PRODUCTS WITH
FILLINGS
Goods (microbiologically sensitive types
e.g. containing eggs & dairy products): S.
aureus (coagulase +) cfu/g, MYC cfu/g,
SPC/APC cfu/g & Coliforms cfu/g) based
Microbiological parameters for Coated or
Filled, Dried Shelf-Stable Biscuits:
Coliforms MPN/g & Salmonella/25g based
HRG1a./HRG2a. HEAT-TREATED
GAME PRODUCTS (CANNED)
Microbiological parameters for Meat
Products in Hermetically Sealed
Containers: Commercial Sterility based on
HRG2b. FROZEN PROCESSED MEAT,
(NUGGETS, PATTIES, DUMPLINGS,
SALAMI, MEAT LOAF, HOTDOG)
Microbiological parameters for Cold Cuts,
Frozen & Chilled Hotdogs: E. coli MPN/g,
Salmonella/25g, S. aureus (coagulase +)
cfu/g & SPC/APC cfu/g based on FDA
Circular 2013-010.
HRH1A. FROZEN FISH, FISH FILLETS
AND FISH PRODUCTS
Microbiological parameters for Fresh
Frozen Fish: E. coli MPN/g, S. aureus
(coagulase +) cfu/g, V. parahaemolyticus
cfu/g, Salmonella/25g & SPC/APC cfu/g
HRH1B. FROZEN BATTERED FISH,
FISH FILLETS AND FISH PRODUCTS,
41
INCLUDING MOLLUSCS,
CRUSTACEANS AND ECHINODERMS
Microbiological parameters for Pre-
Cooked Breaded Fish: E. coli MPN/g, S.
aureus (coagulase +) cfu/g & SPC/APC
HRH1DII. COOKED MOLLUSCS,
Cooked Crustaceans: E. coli MPN/g, S.
aureus (coagulase +) cfu/g, V.
parahaemolyticus cfu/g, Salmonella/25g &
SPC/APC cfu/g based on FDA Circular
2013-010.
HRH2. Fully preserved, including canned
or fermented fish and fish products
Microbiological parameters for Fish &
Shellfish Products in Hermetically Sealed
Containers (thermally processed):
commercial sterility based on FDA Circular
2013-010.
HRH2. FULLY PRESERVED, INCLUDING
CANNED OR FERMENTED FISH AND
FISH PRODUCTS (BAGOONG (FISH &
SHRIMP))
• Certificate of Analysis for Total Solids,
Protein and NaCl based on Administrative
Order No. 128 s. 1970
FISH PRODUCTS (BAGOONG
(COOKED))
2013-010.
HRIA. LIQUID EGG PRODUCTS
Egg Products (Liquid, Frozen, Dried):
Coliforms cfu/g, Salmonella/25g, YMC
cfu/g (for dried products) & SPC/APC cfu/g
42
HRJ1. INFANT FORMULA & FORMULAS
FOR SPECIAL MEDICAL PURPOSED
INTENDED FOR INFANTS (POWDER)
• Certificate of Analysis for Energy,
Protein, Total Fat, Linolenic Acid, Total
Carbohydrates per 100g, Vitamins and
Minerals, Trace Minerals and Other
Substances, Lauric/Mystiric/Trans Fatty
Acids, Optional Ingredients- Taurine, DHA
and Contaminants based on Codex Stan
72-1981 Rev. 2007.
Infant Formula with or without added
Lactic acid producing cultures:
Cronobacter spp./10g, Salmonella/25g,
SPC/APC cfu/g & Enterobacteriaceae/10g
artworks compliant with Department
Circular 2008-0006.
• For FSMP: Scientific Studies indicating
safety and benefits of the product for
intended medical condition based Codex
Stan 180-1991 and Administrative Order
2014-0029.
INTENDED FOR INFANTS (LIQUID)
Acids, Optional Ingredients- Taurine, DHA
and Contaminants based on Codex Stan
72-1981 Rev. 2007.
Microbiological parameters for Infant
Formula- Liquid (UHT/Sterilized) cultures:
2013-010.
Circular 2008-0006.
• For FSMP: Scientific Studies indicating
safety and benefits of the product for
intended medical condition based Codex
Stan 180-1991 and Administrative Order
2014-0029.
43
HRJ1. FOLLOW-UP FORMULA/MILK
SUPPLEMENT
Acids, Optional Ingredients- suitable for 6
months onwards and scientifically proven
based on Codex Stan 1561987.
Microbiological parameters for Follow-up
Formula/Milk Supplements:
Salmonella/25g, SPC/APC cfu/g &
Enterobacteriaceae/10g based on FDA
Circular 2013-010.
Circular 2008-0006.
HRJ2. CEREAL-BASED FOODS FOR
INFANTS & YOUNG CHILDREN
Protein, Carbohydrates, Lipids, Minerals
and Vitamins based on Codex Stan 074-
1981, Rev 1-2006.
Microbiological parameters for Cereal-
based Foods for Infants: Bacillus cereus
cfu/g, Clostridium perfringes cfu/g,
SPC/APC cfu/g, Salmonella/25g &
Coliforms MPN/g based on FDA Circular
2013-010.
artworks declaring the statement “Infants
six months onwards should be given fresh,
indigenous and natural food in
combination with continued breastfeeding
based on Department Circular 2008-0006.
HRJ2. CANNED BABY FOODS
Nutrition Information based on Codex Stan
73-1981 amended 1989.
Microbiological parameters for Baby
Foods in Hermetically Sealed Containers:
2013-010.
artworks declaring the statement “Infants
44
six months onwards should be given fresh,
indigenous and natural food in
combination with continued breastfeeding
based on Department Circular 2008-0006.
HRJ3. FOODS FOR SPECIAL MEDICAL
PURPOSES
• Scientific Studies indicating safety and
benefits of the product for intended
medical condition based Codex Stan 180-
1991 and Administrative Order 2014-0029.
180-1991.
artworks compliant with Codex Stan 180-
1991.
HRJ5. FOODS FOR SPECIAL DIETARY
USE
• Scientific Studies indicating safety and
suitability of the product to specific
disease and disorder to which it is
intended based on Codex Stan146-1985
and Administrative Order 2014-0029.
Nutrition Information based on Codex
Stan146-1985.
artworks compliant with Codex Stan146-
1985.
HRJ4. FORMULA FOODS FOR WEIGHT
CONTROL DIETS
181-1991.
artworks compliant with Codex Stan 181-
1991.
HRJ. BOTTLED WATER
• Certificate of Analysis for Physico-
Chemical Properties (Turbidity, Color,
Odor, Taste, pH, TDS, Conductivity,
Calcium. Magnesium, Sodium, Potassium,
Chloride, Sulfate), Contaminants (Nitrates,
Nitrites, Iron, manganese, Copper, Zinc,
Aluminum, Fluoride, organic Matter,
Surfactants), Toxic Contaminants
(Arsenic, Cadmium, Cyanide, Chromium,
Lead, Mercury, Selenium, Phenolic
Substances), Volatile Organic Compounds
45
(Carbon tetrachloride, Benzene,
Trihalomethanes), Pesticides & Related
Substances (Carbamates,
Organochlorines, Organophosphates,
Herbicides, Fungicides, PCB),
Radionuclides (Gross Alpha Activity,
Gross Beta Activity) and Microbiological
Parameters (Coliforms, Fecal Strepcocci,
Pseudomonas Aeruginosa, HPC) based
on Administrative Order No. 18-A s. 1993.
artworks compliant with Administrative
Order No. 39 s. 1996 and Administrative
Order No. 18-A s. 1993.
HRK1. HERBS AND BOTANICALS
AND/OR PRODUCTS WITH OTHER
NUTRITIONAL SUBSTANCES AND/OR
COMBINATION AS FOOD
SUPPLEMENTS
chemical and microbiological parameters
of the finished product based on
Administrative Order 2014-0029.
artworks declaring the term “Food
Supplement” and the phrase “NO
APPROVED THERAPEUTIC CLAIMS”
based on Bureau Circular No. 2 s 1999.
• For Dried Plants: Certificate of
Analysis for Heavy Metals in the finished
product based on Administrative Order
184 s. 2004.
• Sample in actual commercial
Order 2014-0029.

46
means:
iii. Personal Delivery to FDAC, Starmall,
iv. Delivery via registered courier that

information:
TO:
(FDAC)
Muntinlupa City

address

Registration

requirements.

NUTRITIONAL SUBSTANCES AS
CONVENTIONAL FOOD PRODUCT
 Certificate of Analysis for
Powdered Beverages: SPC/APC cfu/g
& Coliforms cfu/g.
CLIENT STEPS AGENCY PROCESSING FEES TO BE PERSON

ACTION TIME PAID RESPONSIBLE
1)The 1) FDA Day 0 None Food-Drug
authorized Personnel will Regulation
representative of pre-assess the Officer (FDRO)
47
the applicant completeness of or Nutritionist-
company fills out the submitted Dietitian (ND),
the on-line documents Center for Food
form/e- through e-Portal Regulation and
Registration https://eportal.fd Research
through the e- a.gov.ph. Result (CFRR)
Portal of Pre-
https://eportal.fd assessment will
a.gov.ph be received by
the account
holder. If found
complete, an
Order of
Payment will be
automatically
generated and
will be sent to
the email of the
account
holder/client. If
found
incomplete, the
application will
return to client’s
inbox to upload
lacking
documents.
2) The applicant Day 0 None
company
receives the
Order of
Payment
3) The applicant 2) FDA Cashier Day 0 Conventional Administrative
company pays receives the Food (Category Staff, Cashier-
the assessed Official Receipt 1): Php Administrative
fee as per the (OR) of 200.00/year of and Finance
system payment. validity + 1% Services (AFS)
generated Order LRF
of Payment Conventional
Form through Food (Category
FDAC Cashier 2): Php
or any other 250.00/year of
means validity + 1%
prescribed by LRF
FDA (e.g. Food
BANCNET, Supplement:
LANDBANK Php
ONCOLL). 1,000.00/year of
validity + 1%
LRF
Bottled Water:
Php
1,000.00/year of
48
validity + 1%
LRF
company
receives
Acknowledgeme
nt Receipt with
the application
and pre-
assessment
details.
3) FDA Cashier Day 0 None Administrative
posts payment Staff, Cashier-
and decks AFS
application to
CFRR.
4) Evaluation 8 Working Days None FDRO or ND,
(Days 1-8) CFRR
5) Checking 7 Working Days None FDRO or ND,
(Days 9-15) CFRR
6) Final 5 Working Days None Director IV,
Decision/Issuan Days 16-20) CFRR
ce
5) The applicant 7) The e-Portal None N/A
company generates
receives either electronically
Certificate of signed CPR or
Product LOD.
Registration
(CPR) or Letter
of Disapproval
(LOD)
TOTAL: 20 Working
Days
II. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT

REGISTRATION (CPR) – AMENDMENT (APPLICATIONS PREVIOUSLY
APPROVED VIA E-REGISTRATION)

Research Fee (LRF).
Change or Extension of Shelf-life: Php 1,000.00 + 1%

LRF
Other Types of Amendment: Php 200.00 + 1% LRF
49

in 200-dpi setting
setting
1) . General Requirements based on
Administrative Order No. 2014-0029
 Accomplished Initial Application Form as FDA Website (www.fda.gov.ph)

prescribed by FDA regulations (e-Registration
e-Portal, refer to FDA Circular 2016-014).
 Proof of Payment of Fees as prescribed by FDA Cashier/Other FDA
current FDA regulations (A.O. 50 s. 2001). Authorized Payment Portals or
Banks
 Scanned Application Letter stating the

intended changes (indicate Applicant Company
changes/amendments to be made)
2) Additional Requirements per Amendment Type 1) Applicant Company/

based on Administrative Order No. 2014-0029 Manufacturer/Source/Supplier
2) For the Certificate of Analysis:

2a. Change in Brand Name a) Applicant Company/
 Clear and complete loose labels or Manufacturer/Source/Supplier; or
artworks reflecting the change, as applicable, b) Laboratory analysis
of all packaging sizes, or equivalents as issued/conducted by FDA
defined by FDA regulations accredited laboratories.
 Authority from the source or the owner of
the brand (if imported)
 IPO registration, if available
2b. Change in Product Name
 Clear and complete loose labels or
artworks reflecting the change, as applicable,
of all packaging sizes, or equivalents as
defined by FDA regulations
2c. Change in Company Name/Business
Name
 Proof of change in business name (e.g.
License to Operate)
50
2d. Change in Supplier Details
 Any of the following scanned copy of the
original documents: Foreign Agency
Agreement or Certificate of Distributorship or
Appointment letter or Proforma Invoice or
Memorandum of Agreement from the new
supplier.
2e. Change in Packaging Material and/or
Additional Packaging Type
 Clear and complete proposed loose labels
or artworks, as applicable, of all packaging
sizes, or equivalents as defined by FDA
regulations
 Pictures of the product in all angles and in
different packaging sizes, and from at least
two different perspectives allowing visual
recognition of a product as the same with the
one being registered.
 Proof of suitability of packaging material
for food, including stability of the product in
the new packaging.
2f. Change of Packaging in Commercial
Presentation (Change/Additional Packaging
Size)
artworks, as applicable, of all packaging
sizes, or equivalents, reflecting the change/s,
as defined by FDA Regulations
2g. Change or extension in Shelf-Life
 Stability study results with conclusion to
support extension or change in shelf-life
2h. Change in/Additional Packaging design
2i. Transfer of Ownership of a Registered
Product
 Proof of Agreement between previous and
current owners of the product transferring
ownership
51
2j. Change in Importer/Distributor
 Termination of agreement/Deed of
assignment
 Agreement of new
manufacturer/importer/distributor or
Appointment letter
2k. Change in Company Address/Business
Address (Not Applicable to Manufacturer and
Repacker)
 Proof of change in business name (e.g.
License to Operate)
2l. Change in LTO Number and/or LTO
Validity
 Copy of updated License to Operate
2m. Exportation of Previously Registered
Product Initially for Local Distribution.
artworks as applicable, of all packaging sizes,
or equivalents as defined by FDA regulations
(if label is different from the approved one).
2n. Any types of Amendments (other than
stated in the list)
e.g. Change in Product Specification

 Copy of updated Product Specification
Sheet
e.g. Change in Lot Code and Interpretation

 Copy of updated Product Specification
Sheet
52
CLIENT STEPS AGENCY ACTION PROCESSING FEES TO BE PERSON
TIME PAID RESPONSIBLE
1)The authorized 1) FDA Personnel Day 0 None Food-Drug
representative of will pre-assess the Regulation
the applicant completeness of Officer (FDRO)
company fills out the submitted or Nutritionist-
the on-line documents through Dietitian (ND),
form/e- e-Portal
Center for
Registration https://eportal.fda.g
through the e- ov.ph. Result of Food
Portal Pre-assessment will Regulation and
https://eportal.fd be received by the Research
a.gov.ph account holder. If (CFRR)
found complete, an
Order of Payment
will be automatically
generated and will
be sent to the email
of the account
holder/client. If
found incomplete,
the application will
inbox to upload
lacking documents.
company
receives the
Order of
Payment
3) The applicant 2) FDA Cashier Day 0 Change or Administrative
company pays receives the Official Extension of Staff, Cashier-
the assessed fee Receipt (OR) of Shelf-life: Administrative
as per the payment, posts Php and Finance
system payment and decks 1,000.00 + Services (AFS)
generated Order the application to
1% LRF
of Payment Form CFRR.
through FDAC Other Types
Cashier or any of
other means Amendment:
prescribed by Php 200.00
FDA (e.g. + 1% LRF
BANCNET,
LANDBANK
ONCOLL).
company
receives
Acknowledgeme
nt Receipt with
the application
and pre-
53
assessment
details.
posts payment and Staff, AFS
decks application to
CFRR.
4) Evaluation 8 Working None FDRO or ND,
Days CFRR
(Days 1-8)
5) Checking 7 Working None FDRO or ND,
Days CFRR
(Days 9-15)
6) Final 5 Working None Director IV,
Decision/Issuance Days CFRR
(Days 16-20)
company generates
Product LOD.
Registration
(CPR) or Letter
of Disapproval
(LOD)
TOTAL: 20 Working
Days
III. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT

REGISTRATION (CPR) – AUTOMATIC RENEWAL APPLICATION (INITIAL
APPLICATION APPROVED FROM E-REGISTRATION)

Type of Transaction : Simple
Research Fee (LRF).
Conventional Food (Category 1): Php 1,000.00/5 years of

validity + 1% LRF
Conventional Food (Category 2): Php 1,250.00/5 year of
validity + 1% LRF
Food Supplement: Php 5,000.00/5 years of validity + 1%
LRF
Bottled Water: Php 5,000.00/5 years of validity + 1% LRF
54
1) Accomplished Application Form as prescribed by FDA Website (www.fda.gov.ph)
FDA regulations. Select “RENEWAL” as type of
application using the same case number used in
initial application in the e-Registration Portal.
2) Proof of payment of fees as prescribed by FDA Cashier/Other FDA
current FDA regulations (AO 50 s. 2001). Authorized Payment Portals or
Banks

1)The authorized 1) FDA Day 0 None Food-Drug
representative of Personnel will Regulation
the applicant pre-assess the Officer (FDRO)
company fills out completeness of and/or
the on-line the submitted Nutritionist-
form/e- documents
Dietitian (ND),
Registration through e-Portal
through the e- https://eportal.fd Center for Food
Portal a.gov.ph. Result Regulation and
https://eportal.fd of Pre- Research
a.gov.ph assessment will (CFRR)
be received by
the account
holder. If found
complete, an
Order of
Payment will be
automatically
generated and
will be sent to the
email of the
account
holder/client. If
found
incomplete, the
application will
inbox to upload
lacking
documents.
company
receives the
Order of
Payment
3) The applicant 2) FDA Cashier Day 0 In accordance to Administrative
company pays receives the Administrative Staff, Cashier-
the assessed fee Official Receipt Order 50 s. Administrative
as per the (OR) of payment, 2001 + Legal and Finance
system posts payment Research Fee Services (AFS)
generated Order and decks the (LRF).
55
of Payment Form application to
through FDAC CFRR. Conventional
Cashier or any Food (Category
other means 1): Php
prescribed by 1,000.00/5
FDA (e.g.
years of validity
BANCNET,
LANDBANK + 1% LRF
ONCOLL). Conventional
Food (Category
2): Php
1,250.00/5 year
of validity + 1%
LRF
Food
Supplement:
Php 5,000.00/5
years of validity
+ 1% LRF
Bottled Water:
Php 5,000.00/5
years of validity
+ 1% LRF
company
receives
Acknowledgeme
nt Receipt with
the application
and pre-
assessment
details.
posts payment Staff, AFS
and decks
application to
CFRR.
Decision/Issuanc (Days 1-3) CFRR
e
company generates
Product LOD.
Registration
(CPR) or Letter
of Disapproval
(LOD)
TOTAL: 3 Working Days
56
IV. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT
REGISTRATION (CPR) – RE-APPLICATION (INITIAL APPLICATION
DISAPPROVED VIA E-REGISTRATION)

Research Fee (LRF).
Re-application Fee PhP 200.00 + 1% LRF

in 200-dpi setting
setting
1. Accomplished Application Form as prescribed by FDA Website (www.fda.gov.ph)
FDA regulations.
Through the e-Registration Portal, upload/attach 1) For the Certificate of Analysis:

the compliance to the deficiencies stated in the a) Applicant Company/
previously issued Letter of Denial (LOD) within 6
months upon receipt of LOD, using the same case issued/conducted by FDA
number. (Administrative Order 2014-0029 & FDA accredited laboratories.
Circular 2016-014).
2) For other technical
document(s):
a) Applicant Company/
Manufacturer/Source/Supplier
2. Proof of Payment of Fees as prescribed by FDA Cashier/Other FDA

current FDA regulations. (Administrative Order 50 Authorized Payment Portals or
s. 2001) Banks

1)The authorized 1) FDA Day 0 None Food-Drug
representative of Personnel will Regulation
the applicant pre-assess the Officer (FDRO)
company fills out completeness of
57
the on-line the submitted or Nutritionist-
form/e- documents Dietitian (ND),
Registration through e-Portal Center for
through the e- https://eportal.fd Food
Portal a.gov.ph. Result Regulation and
https://eportal.fd of Pre-
Research
a.gov.ph assessment will
be received by (CFRR)
the account
holder. If found
complete, an
Order of
Payment will be
automatically
generated and
will be sent to the
email of the
account
holder/client. If
found
incomplete, the
application will
inbox to upload
lacking
documents.
company
receives the
Order of
Payment
3) The applicant 2) FDA Cashier Day 0 Re-application Administrative
company pays receives the Fee PhP Staff, Cashier-
the assessed fee Official Receipt 200.00 + 1% Administrative
as per the (OR) of payment. LRF and Finance
system Services (AFS)
generated Order
of Payment Form
through FDAC
Cashier or any
other means
prescribed by
FDA (e.g.
BANCNET,
LANDBANK
ONCOLL).
company
receives
Acknowledgeme
nt Receipt with
the application
and pre-
58
assessment
details.
posts payment Staff, Cashier-
and decks AFS
application to
CFRR.
4) Evaluation 8 Working Days None FDRO or ND,
(Day 1-8) CFRR
5) Checking 7 Working Days None FDRO or ND,
(Day 9-15) CFRR
Decision/Issuanc Day 16-20) CFRR
e
company generates
Product LOD.
Registration
(CPR) or Letter
of Disapproval
(LOD)
TOTAL: 20 Working
Days
V. TITLE OF CERTIFICATION/PERMIT: CERTIFICATE OF PRODUCT

REGISTRATION (CPR) – FOR EXPORT MARKET ONLY

Who May Avail : All FOOD Exporters
Research Fee (LRF).
Conventional Food (Category 1): Php 200.00/year of

validity + 1% LRF
Conventional Food (Category 2): Php 250.00/year of
validity + 1% LRF
Food Supplement: Php 1,000.00/year of validity + 1%
LRF
Bottled Water: Php 1,000.00/year of validity + 1% LRF

1) I. Basic Requirements based on Administrative
Order 2014-0029:
59
• Accomplished Initial Application Form as FDA Website (www.fda.gov.ph)
prescribed by FDA regulations (e-Registration
e-Portal, refer to FDA Circular 2016-014).
• Proof of Payment of Fees as prescribed by FDA Cashier/Other FDA

Authorized Payment Portals or
current FDA regulations (A.O. 50 s. 2001).
Banks
• Loose label/artwork/picture of the product
complaint with the existing regulations of the Applicant Company/
importing country. Manufacturer/Source/Supplier
• For FOOD SUPPLEMENT, a sample in

actual commercial presentation shall be
submitted.
2) For Locally Manufactured Products: (in cases Applicant Company/

when the source is not directly from the Manufacturer/Source/Supplier
manufacturer) Distributorship agreement or
contract agreement, whichever is applicable,
signed by the duly authorized representative of the
establishment as reflected in the records of CFRR.
(FDA Circular 2016-007).
3) Scanned copy of any of the following: Request Buyer/Recipient

for Quotation or valid notarized agreement signed
by importing and exporting parties whichever is
applicable, as supporting document that the
product is for export market.
4) ADDITIONAL REQUIREMENTS PER FOOD For the Certificate of Analysis:

CATEGORY 1) Applicant Company/
1. MEDIUM-RISK FOOD PRODUCTS 2) Laboratory analysis
MRA1a. CONDENSED MILK
• Certificate of Analysis for For other technical document(s):
Microbiological parameters for Sweetened 1) Applicant Company/
Condensed Milk: Coliforms cfu/g, Yeast & Manufacturer/Source/Supplier
Mold Count cfu/g & SPC/APC cfu/g based
MRA2. MILK POWDER
60
MRA3. MILK PRODUCTS FOR SPECIFIC
TARGET AGE GROUP
MRB2. EDIBLE ICES (POPSICLES)
Microbiological parameters for Flavored
Ice: SPC/APC cfu/g, Coliforms MPN/g,
YMC cfu/g & Salmonella/25g based on
MRC2. FROZEN FRUITS
Fruits: E. coli MPN/g based on FDA
Circular 2013-010.
MRC3. CANNED OR BOTTLED FRUITS
& VEGETABLE PRESERVE IN JUICE,
SYRUP & BRINE
Microbiological parameters for Fruits and
Vegetable Products in Hermetically
Sealed Containers: Commercial Sterility
MRC7. FERMENTED VEGETABLES
Microbiological parameters for Fermented
Vegetable (Ready to Eat): YMC cfu/g,
Coliforms MPN/g, E. coli MPN/g,
Salmonella/25g & S. aureus cfu/g based
MRD. COCOA POWDER
Microbiological parameters for Cocoa
Powder: Molds cfu/g, Salmonella/25g,
MRD. CHOCOLATE PRODUCTS
61
MRF1Ai. CURED (INCLUDING SALTED)
NON-HEAT TREATED PROCESSED
MEAT, POULTRY AND GAME
PRODUCTS
Cured/Smoked Poultry: S. aureus
(coagulase +) cfu/g & Salmonella/25g
MRF1Aii. CURED (INCLUDING SALTED)
DRIED NON-HEAT TREATED
GAME PRODUCTS
MRF2Ai. FERMENTED NON-HEAT
TREATED PROCESSED MEAT,
Microbiological parameters for Fermented,
Comminuted Meat, not cooked (dry &
semi-dry fermented sausages): E. coli
MPN/g, S. aureus (coagulase +) cfu/g &
2013-010.
MRJa. CAKES, COOKIES, PIES,
PASTRIES, DOUGHNUTS, SWEET
ROLLS, CONES, MUFFINES, WAFFLES-
PLAIN /WITHOUT FILLING
Goods: S. aureus (coagulase +) cfu/g,
MYC cfu/g, SPC/APC cfu/g & Coliforms
cfu/g) based on FDA Circular 2013-010.
MRJa. FROZEN BAKERY PRODUCTS
62
Bakery Products: S. aureus (coagulase +)
cfu/g & Salmonella/25g based on FDA
Circular 2013-010.
MRjb. FROZEN DOUGH
Microbiological parameters for Frozen and
Refrigerated Doughs: Molds cfu/g, Yeast &
Yeastlike Fungi cfu/g, Coliforms cfu/g,
MRK2a. EMULSIFIED SAUCES AND
DIPS (SALAD DRESSING- i.e.
MAYONNAISE, THOUSAND ISLAND,
RANCH, FRENCH)
Microbiological parameters for Salad
Dressing: SPC/APC cfu/g, YMC cfu/g,
Salmonella/25g & Listeria
Circular 2013-010.
MRL1a. FRUIT AND VEGETABLE
JUICES
MRL1c. SPORTS, ENERGY DRINK &
ELECTROLYTE DRINKS
MRL1ci. CARBONATED WATER-BASED
FLAVORED DRINKS
MRL1cii. NON-CARBONATED WATER-
BASED FLAVORED DRINKS
63
MRL1ciii. FROZEN CONCENTRATE
Juice Concentrates: SPC/APC cfu/mL &
YMC cfu/mL based on FDA Circular 2013-
010.
MRL1d. POWDERED COCOA DRINK
MIXES
Beverage: SPC/APC cfu/g & YMC cfu/g
MRM1. VITAMINS, MINERALS & AMINO
ACIDS AS FOOD SUPPLEMENTS
chemical (Vitamins, Minerals & Amino
Acids Assays) and microbiological
parameters of the finished product based
on Administrative Order 2014-0029.
 Sample in actual commercial
Order 2014-0029.

means:
i. Personal Delivery to FDAC, Starmall,


must contain the following information:
TO:
64
(FDAC)
Muntinlupa City

address

Registration

requirements.
2. HIGH-RISK FOOD PRODUCTS
HRA1a. MILK (PLAIN) AND BUTTERMILK

PLAIN
2013-010.
HRA1b. DAIRY-BASED DRINKS,
FLAVORED AND/OR FERMENTED
65
2013-010.
HRA3a. PASTEURIZED CREAM
Cream: Coliforms cfu/g, Salmonella/25g,
Listeria monocytogenes/25g,
HRA3b. STERILIZED AND UHT
CREAMS, WHIPPING AND WHIPPED
CREAMS, AND REDUCED FAT CREAMS
(PLAIN)
Microbiological parameters for Cream
(UHT/Sterilized): Commercial Sterility
HRA4a. UNRIPENED CHEESE
Microbiological parameters for Cheese
and Cheese (moisture > 39% & pH): S.
aureus (coagulase +) cfu/g, E. coli MPN/g,
Coliforms MPN/g, Psychrotrophic bacteria
cfu/g, Salmonella/25g & Listeria
Circular 2013-010.
Microbiological parameters for All Raw
Milk Cheese: Campylobacter/25g,
Salmonella/25g, Listeria
monocytogenes/25g and S. aureus
(coagulase +) cfu/g based on FDA Circular
2013-010.
HRA4di. PLAIN PROCESSED CHEESE
HRA4di. FLAVORED PROCESSED
CHEESE
66
HRA5. DAIRY BASED DESSERT (e.g.
Yogurt)
HRA8. DAIRY BASED FROZEN
DESSERT
& Sherbet (plain and flavored): Coliforms
cfu/g, Listeria monocytogenes/25g,
Salmonella/25g, SPC/APC cfu/g & S.
aureus (coagulase +) cfu/g based on FDA
Circular 2013-010.
with added ingredients (nuts, fruits, cocoa
etc.): Coliforms cfu/g, Listeria
monocytogenes/25g, Salmonella/25g,
SPC/APC cfu/g & S. aureus (coagulase +)
HRB1. DRIED FRUIT
Microbiological parameters for Sun Dried
Fruits: Mold cfu/g, OsmophilicYeasts cfu/g
& E. coli MPN/g based on FDA Circular
2013-010.
HRB1. DRIED VEGETABLE
Microbiological parameters for Dried
Vegetable: E. coli MPN/g based on FDA
Circular 2013-010.
HRD. CHOCOLATE WITH NUTS
HRF1. FINE BAKERY PRODUCTS WITH
FILLINGS
Goods (microbiologically sensitive types
67
e.g. containing eggs & dairy products): S.
aureus (coagulase +) cfu/g, MYC cfu/g,
SPC/APC cfu/g & Coliforms cfu/g) based
Microbiological parameters for Coated or
Filled, Dried Shelf-Stable Biscuits:
Coliforms MPN/g & Salmonella/25g based
HRG1a./HRG2a. HEAT-TREATED
GAME PRODUCTS (CANNED)
Microbiological parameters for Meat
Products in Hermetically Sealed
Containers: Commercial Sterility based on
HRG2b. FROZEN PROCESSED MEAT,
(NUGGETS, PATTIES, DUMPLINGS,
SALAMI, MEAT LOAF, HOTDOG)
Microbiological parameters for Cold Cuts,
Frozen & Chilled Hotdogs: E. coli MPN/g,
Salmonella/25g, S. aureus (coagulase +)
cfu/g & SPC/APC cfu/g based on FDA
Circular 2013-010.
HRH1A. FROZEN FISH, FISH FILLETS
AND FISH PRODUCTS
Microbiological parameters for Fresh
Frozen Fish: E. coli MPN/g, S. aureus
(coagulase +) cfu/g, V. parahaemolyticus
cfu/g, Salmonella/25g & SPC/APC cfu/g
HRH1B. FROZEN BATTERED FISH,
FISH FILLETS AND FISH PRODUCTS,
INCLUDING MOLLUSCS,
Microbiological parameters for Pre-
Cooked Breaded Fish: E. coli MPN/g, S.
aureus (coagulase +) cfu/g & SPC/APC
HRH1DII. COOKED MOLLUSCS,
Cooked Crustaceans: E. coli MPN/g, S.
68
aureus (coagulase +) cfu/g, V.
parahaemolyticus cfu/g, Salmonella/25g &
SPC/APC cfu/g based on FDA Circular
2013-010.
FISH PRODUCTS
2013-010.
FISH PRODUCTS (BAGOONG
(COOKED))
2013-010.
HRIA. LIQUID EGG PRODUCTS
Egg Products (Liquid, Frozen, Dried):
Coliforms cfu/g, Salmonella/25g, YMC
cfu/g (for dried products) & SPC/APC cfu/g
INTENDED FOR INFANTS (POWDER)
Infant Formula with or without added
Lactic acid producing cultures:
Cronobacter spp./10g, Salmonella/25g,
SPC/APC cfu/g & Enterobacteriaceae/10g
INTENDED FOR INFANTS (LIQUID)
Microbiological parameters for Infant
Formula- Liquid (UHT/Sterilized) cultures:
2013-010.
69
HRJ1. FOLLOW-UP FORMULA/MILK
SUPPLEMENT
Microbiological parameters for Follow-up
Formula/Milk Supplements:
Salmonella/25g, SPC/APC cfu/g &
Enterobacteriaceae/10g based on FDA
Circular 2013-010.
HRJ2. CEREAL-BASED FOODS FOR
INFANTS & YOUNG CHILDREN
Microbiological parameters for Cereal-
based Foods for Infants: Bacillus cereus
cfu/g, Clostridium perfringes cfu/g,
SPC/APC cfu/g, Salmonella/25g &
Coliforms MPN/g based on FDA Circular
2013-010.
HRJ2. CANNED BABY FOODS
Microbiological parameters for Baby
Foods in Hermetically Sealed Containers:
2013-010.
NUTRITIONAL SUBSTANCES AND/OR
COMBINATION AS FOOD
SUPPLEMENTS
chemical and microbiological parameters
of the finished product based on
Administrative Order 2014-0029.
• For Dried Plants: Certificate of
Analysis for Heavy Metals in the finished
product based on Administrative Order
184 s. 2004.
• Sample in actual commercial
Order 2014-0029.

70
means:
i. Personal Delivery to FDAC,
Starmall, Alabang, Muntinlupa City
or

information:
TO:
FOOD AND DRUG ACTION
CENTER (FDAC)
Muntinlupa City

address

Registration

requirements.

NUTRITIONAL SUBSTANCES AS
CONVENTIONAL FOOD PRODUCT
 Certificate of Analysis for
Microbiological
parameters for Powdered Beverages:
SPC/APC cfu/g & Coliforms cfu/g.
71
CLIENT STEPS AGENCY ACTION PROCESSING FEES TO BE PERSON
TIME PAID RESPONSIBLE
1)The authorized 1) FDA Personnel Day 0 None Food-Drug
representative of will pre-assess the Regulation
the applicant completeness of Officer (FDRO)
company fills out the submitted or Nutritionist-
the on-line form/e- documents through Dietitian (ND),
Registration e-Portal
Center for
through the e- https://eportal.fda.
Portal gov.ph. Result of Food
https://eportal.fda. Pre-assessment Regulation and
gov.ph will be received by Research
the account holder. (CFRR)
If found complete,
an Order of
Payment will be
automatically
generated and will
be sent to the
email of the
account
holder/client. If
found incomplete,
the application will
inbox to upload
lacking documents.
company receives
the Order of
Payment
3) The applicant 2) FDA Cashier Day 0 Convention Administrative
company pays the receives the al Food Staff, Cashier-
assessed fee as Official Receipt (Category Administrative
per the system (OR) of payment. 1): Php and Finance
generated Order of 200.00/year Services (AFS)
Payment Form
of validity +
through FDAC
Cashier or any 1% LRF
other means Convention
prescribed by FDA al Food
(e.g. BANCNET, (Category
LANDBANK 2): Php
ONCOLL). 250.00/year
of validity +
1% LRF
Food
Supplement
: Php
1,000.00/ye
ar of validity
+ 1% LRF
72
Bottled
Water: Php
1,000.00/ye
ar of validity
+ 1% LRF
company receives
Acknowledgement
Receipt with the
application and
pre-assessment
details.
posts payment and Staff, AFS
decks application
to CFRR.
4) Evaluation 8 Working Day None FDRO or ND,
(Day 1-8) CFRR
Days CFRR
(Day 9-15)
6) Final 5 Working None Director IV,
Decision/Issuance Days CFRR
(Day 16-20)
company receives generates
either Certificate of electronically
Product signed CPR or
Registration (CPR) LOD.
or Letter of
Disapproval (LOD)
TOTAL: s 20 Working
Day
C. OTHER CFRR AUTHORIZATIONS
I. TITLE OF CERTIFICATION/PERMIT: SANGKAP PINOY SEAL/DIAMOND

SANGKAP PINOY SEAL

Type of Transaction : Highly Technical Transaction
Who May Avail : All Food Manufacturers of Fortified Products
Fees to be Paid : P8,000.00 non-refundable fee for the use of the seal
(Regular Seal)
P500.00 processing fee for every application (Regular
Seal or Diamond Seal)
+ 1% LRF
73

document.
Basic Requirements based on RA 8976 (Food

Fortification Law of 2000), RA 8172 (ASIN Law),
the Sangkap Pinoy Seal Program Manual of
Operations (December 2000) and Administrative
Order No. 82 s. 2003 (Guidelines on the
Granting of Diamond Sangkap Pinoy Seal to
Manufacturers of Fortified Products):
• Duly accomplished application forms
FDA
• Copy of LTO issued by the FDA
FDA
• Results of product analysis for vitamin A, For the Certificate of Analysis:
Iron and Iodine from an FDA recognized a) Applicant Company/
laboratory. Manufacturer/Source/Supplier; or
Applicant Company/
• Sample label with Sangkap Pinoy Manufacturer/Source/Supplier
Seal/Diamond Sangkap Pinoy Seal
FDA Cashier/Other FDA
• Proof of payment
Banks (where payment was
made)
• Inspection report with Certificate of FDA Regional Field Office

Compliance

1) Receives document 1 Working Day P8,000.00 Food-Drug
requirements from FDA (Day 1) non- Regulation
Regional Field Office and refundable Officer (FDRO)
decks the same to CFRR fee for the or Nutritionist-
technical evaluators. use of the Dietitian (ND),
seal Center for
(Regular Food
Seal) Regulation
P500.00 and Research
processing (CFRR)
fee for
every
application
(Regular
Seal or
74
Diamond
Seal)
+ 1% LRF
Days CFRR
(Day 2-9)
Days CFRR
(Day 10-14)
4) Printing 1 Working Day None Administrative
(Day 15) Staff, CFRR
5) Signing of 4 Working None Director IV,
Certificate/Authorization Days CFRR
(Day 16-19)
6) The CFRR personnel 1 Working Day None Administrative
will forward the (Day 20) Staff, CFRR
Certificate/Authorization
to the Office of Director
General, for signature.
TOTAL: 20 Working
Days
II. TITLE OF CERTIFICATION/PERMIT: GMP/HACCP CERTIFICATE

Type of Transaction : Highly Technical Transaction
Who May Avail : All FOOD Manufacturers (Importer of raw material for
own use/Exporters)
Fees to be Paid : GMP – Php 500.00 + LRF per year; HACCP – Php1,000.00 +
LRF per year

document.
 Inspection report with certificate of FDA Regional Field Office
Compliance/ Recommendation Letter
from RFO
FDA
 Valid LTO
 Proof of payment FDA Cashier/Other FDA
made)

75
1) Receives document 1 Working Day GMP – Php Food-Drug
requirements from FDA (Day 1) 500.00 + Regulation
Regional Field Office LRF per Officer
and decks the same to year; (FDRO) or
CFRR technical HACCP – Nutritionist-
evaluators. Php1,000.00
Dietitian (ND),
+ LRF per
year Center for
Food
Regulation
and Research
(CFRR)

Days CFRR
(Days 2-9)
Days CFRR
(Days 10-14)
4) Printing 1 Working Day None Administrative
(Day 15) Staff, CFRR
5) Approval 4 Working None Director IV,
Days CFRR
(Days 16-19)
1) The applicant 6) The FDA personnel 1 Working Day None FDA
company receives the will forward the (Day 20) Personnel,
Certificate/Authorization Certificate/Authorization FDAC
to Food and Drug
Action Center (FDAC)
for release.
TOTAL: 20 Working
Days
III. TITLE OF CERTIFICATION/PERMIT: BOC CLEARANCE/ IMPORT PERMIT

Type of Transaction : Simple Transaction
Wholesalers/ Exporters) and Donee/Consignee
Fees to be Paid : In accordance to A.O. 50 s. 2001
BOC Clearance/ Import Permit: Php 500.00/invoice + 1% LRF

document.
For Release of Samples:
 Application Letter - No specific format, this
document is initiated by
applicant company
 Notarized Affidavit of Undertaking
76
- See sample template (Annex
A)
- Country of Origin or Source
 Certificate of Analysis/ Certificate of Free of Product to be imported
Sale - Product source/company
- Product source/company
 Pro Forma Invoice - Courier or Shipping
 Packing List Company
 Bill of Lading/Airway Bill (if available) - FDA Issued
 Valid License to Operate - FDA Cashier
 Payment
Additional requirement - From applicant company

Justification for importation of commercial quantity if
the imported products exceeded 1,000 kilograms
For release of donated food:
 BIHC Endorsement Letter - BIHC of DOH (Director Mar
Wynn Bello)
 Letter request from Donee - From Donee
 Certificate of Quality (should reflect the - Product Source/Company
expiration or last recommended date of
consumption) / Certificate of Free Sale
 Certificate of Donation - From Donor
 Deed of Acceptance - From Donee
 Invoice Packing List - From product
 Bill of Lading/Airway Bill (if available) source/company
- From product
 Payment (Php 510.00/inclusive of 1%
source/company
LRF)
- Courier or shipping
company
- FDA Cashier

1) The authorized 1) FDA Personnel Day 0 None FDA Personnel,
representative will pre-assess the Food Drug
submits documents completeness of the Action Center
to the Food and submitted (FDAC) or
Drug Action Center documents. If Center for Food
in Alabang for pre- complete, Order of Regulation and
assessment. Payment will be Research
generated and will (CFRR)
be given to the
client. Otherwise, all
the documents will
not be received and
will be returned to
the client for
compliance.
77
company receives
the Order of
Payment
3) The applicant 2) FDA Personnel Day 0 BOC FDA Personnel,
company pays the receives the Clearance/ FDAC or CFRR
assessed fee as per complete documents Import
the system and Official Receipt Permit: Php
generated Order of (OR) of payment. 500.00/invoi
Payment Form ce + 1%
through FDAC LRF
Cashier only.
company receives
Acknowledgement &
Official Receipt
stating the
completeness of the
submitted
documents and
payment.
posts payment and Staff, Cashier-
decks application to Administrative
CFRR. and Finance
Services (AFS)
4) Receives 4 Hours None FDA Personnel,
applications and (Day 1) FDAC
forwards the same
to CFRR receiving.
5) Receives 4 Hours None Administrative

applications and (Day 1) Staff, CFRR
forwards the same
to assigned CFRR
evaluators.
6) Evaluation 4 Hours None Food-Drug
(Day 2) Regulation
Officer (FDRO),
CFRR
7) Checking 4 Hours None FDRO, CFRR
(Day 2)
8) Final 4 Hours None Director IV,
Recommendation (Day 3) CFRR
5) The applicant 9) The FDA 4 Hours None FDA Personnel,
company shall claim personnel will (Day 3) FDAC
the IMPORT forward the
PERMIT /BOC Certificate/Authorizat
CLEARANCE ion to Food and
Drug Action Center
(FDAC) for release.
TOTAL: 3 Working
Days
78
ANNEX A
Affidavit of Undertaking
(Name of Applicant) of legal age, (Position in the Company) and/or duly authorized
representative of (Name of Company and Address), after having been sworn in
accordance with law, hereby declare that:
1. The aforementioned company has imported from (Country of Origin) the food
products: see attached product list.
2. The said importation is covered by Proforma Invoice No. ____ dated

____________ of (Source/Principal of the Importer), copy of which is cross-
checked with the original.
3. The applicant company has a valid License to Operate as an importer, with LTO
No. _____ covering the said shipment.
4. The products are not adulterated nor misbranded, and contain ingredients and
additives that are permitted for use in human and in accordance with relevant
regulations issued by FDA.
5. The said product is for use by (Company Name) for sampling purposes and product
development only. Moreover, it will not find its way in the market for sale or for
distribution.
6. The company understands and agrees that the products may be subjected to FDA
Laboratory examination at any time to verify the food product safety and quality and
that the cost of laboratory examination shall be charged to the importing company.
7. This Affidavit is executed to confirm the truth of the foregoing.
(Date) at (Place of Execution)
(Affiant)
Subscribed and sworn to before me this (date) day of (month), (year) at

_____________________.
Notary Public
79
IV. TITLE OF CERTIFICATION/PERMIT: SALES PROMO PERMIT (INITIAL AND
AMENDMENT APPLICATION)

Type of Transaction : Complex Transaction
Who May Avail : Food Manufacturers, Importers, Exporters,
Wholesalers/Distributors and Third Party Marketing
Agencies
Fees to be Paid : In accordance to DTI-DOH JAO NO. 1 s. 2000
Amount of Prizes: (Fees)

Php 150,000.00- below Php 300,000.00: Php 1,000.00.00
+ 1% LRF
Php 300, 001.00-Php 500,000.00: Php 2,000.00 + 1%
LRF
Php 500,001.00- Php 1,000,000.00: Php 3,000.00 + 1%
LRF
Above Php 1,000.000.00: Php 5,000.00 + 1% LRF
Coverage: (Fees)
NCR only or in several regions in NCR and Nationwide:
Php 1,000.00.00 + 1% LRF
More than one (1) region in NCR and Nationwide: Php
750.00 + 1% LRF
Several provinces/cities/municipalities within a single
region: Php 500.00 + 1% LRF
Single province/city/municipality: Php 250.00 + 1% LRF
Amendment/Extension: Php 300.00 + 1% LRF

document.
I. Initial Application:
• Integrated Application Form FDA Website (www.fda.gov.ph)
• Completely and accurately filled-up
Information Sheet and Mechanics of Sales
Promotion
FDA
• Valid Certificate of Product Registration
(CPR), Cosmetic Notification (NN) and LTO
(License to Operate) of the company Applicant company
• Advertising/Collateral Materials to be used
in the promotion FDA Cashier/Other FDA
• Proof of Payment of Fees Authorized Payment Portals or
made)
80
II. Amendment Application:
• Integrated Application Form FDA Website (www.fda.gov.ph)
• Letter of Intent stating the desired
• Photocopy of Approved Permit
• Additional Advertising/Collateral Materials to
be used in Promotion, if any.
FDA Cashier/Other FDA
• Proof of Payment of Fees made)
CLIENT STEPS AGENCY ACTION PROCESSING FEES PERSON

TIME TO BE RESPONSIBLE
PAID
1) The authorized 1) FDA Personnel will Day 0 None Administrative
representative submits pre-assess the Staff, Center
documents to the Food completeness of the for Food
and Drug Action Center submitted documents. If Regulation
(FDAC) in Alabang for complete, assessment and Research
pre-assessment. slip will be given to the
(CFRR)
authorized
representative.
Otherwise, all the
documents will not be
received and FDA
Personnel will note the
lacking documents for
the client to comply.
2) Applicant company Day 0 None
receives assessment
slip and proceeds to the
cashier for the payment
3) The applicant 2) FDA Cashier Day 0 Refer to Administrative
company pays the generates Official above Staff, Cashier-
indicated fee as per Receipt table Administrative
assessment slip and Finance
through FDAC Cashier Services
or any other means
(AFS)
prescribed by FDA (e.g.
BANCNET,
LANDBANK ONCOLL).
4) The applicant 3) FDA personnel 1 Working Day None FDA
company presents generates and updates (Day 1) Personnel,
Official Receipt and Document Tracking Food and
FDA Personnel Number (DTN) in the Drug Action
receives the documents FDA Inventory System
Center
through APDRA (FIS). FDAC Personnel
(FDAC)
forwards the application
to CFRR.
5) The applicant None
company receives
Acknowledgement &
81
Official Receipt stating
the completeness of the
submitted documents
and payment.
4) CFRR Database 1 Working Day None Administrative
controller receives the (Day 2) Staff, CFRR
Sales Promo Permit
Application and decks
the application to the
assigned evaluator.
5) Evaluation 1 Working Day None Food-Drug
(Day 3) Regulation
Officer
(FDRO) or
Nutritionist-
Dietitian (ND)
or
Administrative
Staff, CFRR
6) Checking 1 Working Day None FDRO or ND,
(Day 4) CFRR
7) Approval 1 Working Day None Director IV,
(Day 5) CFRR
8) CFRR Database 1 Working Day None Administrative
controller forwards the (Day 6) Staff, CFRR
Sales Promotion Permit
to FDAC and updates
the FIS indicating that
the Sales Promotion
Permit will be
forwarded to FDAC for
release.
6) The applicant 9) The FDA personnel 1 Working Day None FDA
company receives the will release the said (Day 7) Personnel,
Certificate/Authorization Certificate/Authorization FDAC
through courier. from the Releasing Unit
of Food and Drug
Action Center (FDAC),
through courier.
TOTAL: 7 working None
days
82
Field Regulatory Operations Office Inspection Agenda
A. SIMPLE
Bureau of Customs – For Donation
Certification Classification1 Type of Processing List of

Transaction2 Time3 Requirements
Inspection Report Simple Government- 3 days FDA
with recommendation to-Business upon Clearance
for release (G2B) receipt of issued by
(Upon request for Centers
validation/inspection inspection
of the products) from the
consignee
Legend:
1 Classify if Simple, Complex, or Highly Technical Transaction
2 Classify if Government-to- Citizens (G2C), Government-to-Business (G2B), and
Government-to-Government (G2G)
3 Based on Current Citizen’s Charter Timeline
Bureau of Customs – For Personal Use
Certification Classification1 Type of Processing List of

Transaction 1 Time2 Requirements
E-mail Reply Simple Simple 1 day upon E-mail Request
Government- receipt of
(citing Joint to-Business request from the
Circular No.1) (G2B) consignee
Legend:
1 Classify if Simple, Complex, or Highly Technical Transaction
2 Classify if Government-to- Citizens (G2C), Government-to-Business (G2B), and
Government-to-Government (G2G)
3 Based on Current Citizen’s Charter Timeline
83
B. COMPLEX
INSPECTION AGENDA – FOOD DISTRIBUTOR
Inspection Activity
I. Opening Meeting
II. Document Review
2.1 Organization, Management & Personnel

Organizational Chart /Job Description/ Duties and responsibilities
Training Plan/ Records/ Competency evaluation
2.2 QMS & Documentation

Authorization ( LTO & CPR )
Risk Management Plan (RMP)
Standard Operating Procedures
Records ( Importation/Distribution/Deliveries, complain, recall )
2.3 Contract activities

Quality Agreement with suppliers/sources
GMP Certificate/Free Sale /Phytosanitary Certificate and other equivalent
documents
III. Walk-through Inspection
3.1 Warehouse facilities ( Dry & Cold )

Premises (Sanitation: Sanitation Program/Pest Control
/housekeeping/ventilation/Lighting etc.)
Storage fixtures ( palettes, steel racks/cabinet )
Storage equipment ( Temperature monitors )
Storage area/segregated areas for recalled/damaged/expired/returned products
Storage condition ( Stock Rotation and arrangement )
Records ( temperature and RH, calibration, Stock Reconciliation/ Inventory, Dispatch )
3.2 Products ( physical examination / Collection of samples )
3.3 Transport & Dispatch of products

Vehicle Maintenance, Personnel, Compliance to Storage Requirements
IV. Report Writing (Consolidation of findings)
V. Exit Meeting (Discussion of findings)
84
C. HIGHLY TECHNICAL
INSPECTION AGENDA – FOOD MANUFACTURER/ REPACKER/ BOTTLED

WATER MANUFACTURER
Inspection Activity
OPENING MEETING
 Presentation of inspection agenda, attendance sheet
 Company presentation (plant layout, process flow, HACCP Plan, if any)
INSPECTION PROPER
 Storage of raw materials, packaging materials and finished products
 Processing area
 Laboratory facility (mandatory to bottled water)
 Sanitary facilities (gowning area, hand washing, toilet facilities)
DOCUMENTATION REVIEW
 Quality Control Procedures/Quality Manual, GMP Manual and/or HACCP
Manual
 Standard Operating Procedures
 Cleaning and Sanitation (production area, equipment, premises)
 Rejection/Returns/Disposal
 Product Recall
 Retention Sample
 QC Methods and Procedures / Sanitation & Hygiene Records / Preventive
Maintenance Records:
 In-house and third-party laboratory analysis (water, finished products)
 Production Record/Batch Manufacturing Records/Monitoring Records
 Quality audits (internal/external)
 Sanitation checklist
 List of approved suppliers, certificate of analysis of raw materials and
packaging materials
 Calibration of monitoring/measuring instruments/equipment
 Pest control program and records (including service reports and chemicals
used)
 Personnel training program and records (in-house/third party)
 Health certificates of personnel
REPORT WRITING
EXIT MEETING
85
1. Issuance of Electronic Portal (E-Portal) User Account
Center/Office/Division : FDAC Account Section
Type of Transaction : Government to Business (G2B)
Who may Avail : Manufacturer, traders, distributors, importers, exporters,
wholesalers, drug outlets, and other establishment and
facilities of health products, as determined by Food and
Drug Administration
Fees to be paid : No required payment
Food and Drug Administration
1.Signed and notarized Authorization Philippines Website
Letter (Annex B - FDA Circular No.
2016-004) (pdf format) FDA Circular No. 2016-004
“Procedure on the Use of the New
Application
Form for License to Operate (LTO) thru the
Food and Drug Administration (FDA)
Electronic Portal”
CLIENT STEPS AGENCY ACTION Fees PROCESSING PERSON
to be TIME RESPONSIBLE
Paid
1. Sends an email 1. Checks the FDAC
request to received email as to Staff
fdac@fda.gov.ph completeness and None 15 Minutes Informatio
appropriateness of n Officer II
the request
2. Received 2. Issue user FDAC
username and account (username Next Staff
None
password and password) to Working Informatio
the client Day n Officer II
TOTAL: None 2 Working Days
2. Issuance of Appointment Schedule and Document Tracking Number

Center/Office/Division : FDAC Account Section
Type of Transaction : Government to Business (G2B)
Who may Avail : Manufacturer, traders, distributors, importers,
exporters, wholesalers, drug outlets, and other
establishment and facilities of health products, as
determined by Food and Drug Administration
Fees to be paid : No required payment
1. Accomplished Integrated Application FDA Website
Form (IAF) (pdf format) FDA Circular No. 2014-003
2. Signed and Notarized Petition (pdf “Filling and Receiving of Registration, Licensing
format) and Other Application using the
Integrated Application Form”
86
Paid
1. Send 1.Checks the
application email received email as FDAC Staff
to to completeness None 15 Minutes Information
fdac@fda.gov.ph and Officer II
appropriateness
of the request
2. Receive 2.Issue
Document appointment FDAC Staff
Next
Tracking Log and schedule and Information
None Working
Appointment Document Officer II
Day
Schedule Tracking Log
(DTL) to the client
email
2 Working
TOTAL: None
Days
3. Filling of Complaint (Walk-in)
Filing of complaint through personal appearance at the Food and Drug Action
Center (FDAC)
Center/Office/Division : FDAC CSAT/E-Report Section
Type of Transaction : Government to Business, Citizen, or
Who may Avail : Government
All
Fees to be paid : None
Written letter addressed to Director General of
Food and Drug Administration (FDA)
 Full name
 Address
Food and Drug Action Center
 Contact details
 Details of the acts complained of
 Name of center/office of person(s)
charged, if applicable
 Evidence of such violation, if applicable
87
paid
1. Submits a written letter 1. Receive the
addressed to the Director written letter and
General of the Food and encode the details
Drug Administration in the FDA
(FDA) to E-Report Inventory System
Section of the Food and and generate None 5 Minutes
Drug Action Center Document Tracking
(FDAC) Number (DTN)
Address: 3Flr.
FDAC
Starmall Alabang,
E-Report
Alabang, Muntinlupa
Staff
(Administrativ
e Assistant III)
2. Receive an 2. Encode the DTN
acknowledgement and details of the in the
receipt. E- Report Database for
tracking and
None 5 Minutes
monitoring.
3. Print an
acknowledgement
receipt
4. Endorse the
received document/s None Day 1
to the concerned
center/office
1 Working Day,
TOTAL: None
10 Minutes
88
4. Filling of Complaint (Online)
Filling of complaint through email e-report@fda.gov.ph
Type of Transaction : Government to Business, Citizen, or
Who may Avail : Government
All
For complaint or feedback via email, kindly
include the following information if applicable:
 Full name:
 Address: Food and Drug Action Center
 Contact details:
 Details of the complaint/feedback
 Person(s) charged
 Evidence of such violation

paid
1. Check the FDAC
1. Send complaint via
received document E-Report
email with the detailed None 5 Minutes
along with other Staff
information at email to
attached documents (Administrativ
the
if available. e Assistant III)
Food and Drug 2. Encode the
Action Center complaint details and
(FDAC) generate Document None
Tracking Number
(DTN) in the FDA
Email: Inventory
3. EncodeSystem
the DTN
e-report@fda.gov.ph and compliant details
in the E-Report None
customersatisfactiontea Database for
m@ fda.gov.ph tracking and
monitoring.
4. Send an
acknowledgement None 5 Minutes
receipt including
2. Receive
DTN
acknowledgement
receipt and DTN 5. Endorse the
received document/s
None Day 1
to the concerned
center/office through
email
1 Working Day,
TOTAL: None
10 Minutes
89
5. Receiving of Application(s) and Other Documents of FDAC - Public
Assistance and Complaint Desk (PACD) and Letter Section
Center/Office/Division : FDAC PACD and Letter Section
Type of Transaction : Government to Business
Who may Avail : Manufacturer, traders, distributors, importers,
exporters, wholesalers, drug outlets, and other
establishment and facilities of health products, as
determined by Food and Drug Administration
Fees to be paid : Administrative Order No. 50 s. 2001
“Revised 2001 Schedule of Fees and Charges for
the Corresponding Services Rendered by the
Bureau of Food and Drugs”
1. Issued Document Tracking
Log (Scheduled Client)
2. Soft copies (PDF File format) of
the documents based on the
application requirements

paid
1. Submits 1. Checks the
AO FDAC
application and application and other
No. 5 Minutes Information
other documents documents if the
50 Officer II
to PACD or Letter payment has been
s. 2001
Section made
2. Received 2. Checks the
acknowledgeme received
nt receipt application/s and
other documents.
FDAC
3 minutes Information
3. Stamp the None
Officer II
client’s Document
Tracking Log as
an
acknowledgement
receipt of the
document/s
4. Routes the
Next FDAC Courier
received application
None Working Information
and/or other
Day (Before Officer II
document to the
12nn)
concerned
center/office
1 Working Day,
TOTAL: None
8 minutes
90
6. Assistance to Phone Callers
Center/Office/Division : FDAC Phone Operator Section
Type of Transaction : Government to Business, Citizen, or Government
Who may Avail : All
None None
1. Answer phone paid
calls and identify
the client’s concern
Calls the FDAC
designated
2. Acts on
landline numbers 10 Minutes FDAC
client’s concern
8-8211177 Depending Phone
None
8-8211176 on the Operators
3. Highly technical
8-8211159 complexity of Information
concerns are advise
8-8211220 the issue Officer II
to send an email to
8-8211162
the designated
center/office email
address
TOTAL: None 10 Minutes
7. Customer Satisfaction Survey (CSS) Form

Type of Transaction : Government to Business, Citizen, or Government
Who may Avail : All
CSS Form
Food and Drug Action Center (FDAC)
CLIENT STEPS AGENCY ACTION Fees PROCESSIN PERSON
to be G TIME RESPONSIBL
1. Consolidate all paid E
filled-out CSS form
1. Fill up the CSS at the end of the None 3 Minutes FDAC
form and drops it month E-Report Staff
at the designated (Administrative
suggestion box 2. Routes the Assistant III)
consolidated form
None Day 1
to the concerned
center/office
1 Working day,
TOTAL: None
3 Minutes
91
FEEDBACK AND COMPLAINT MECHANISM
How to send feedback Answer the Customer Satisfaction Survey
from in the receiving area and drop it in
the suggestion box
Food and Drug Action Center

(FDAC) Contact info: (8)821-1177,
(8)8211176,
How feedback are processed (8)8211159,
The (8)8211220,
admin verifies (8)8211162
the nature of feedback
after a month. The same will be referred to
the office concerned. Upon receiving the
response of the concerned center/office, the
client will be informed via email.
For follow-up, the contact information are

as follows: 8)821-1177, (8)8211176,
(8)8211159,
(8)8211220, (8)8211162
For queries, the contact information are as

follows: 8)821-1177, (8)8211176,
(8)8211159,
(8)8211220, (8)8211162
How to file a complaint info@fda.gov.ph

To file a complaint against the Food and
Drug Administration (FDA) or product
under jurisdiction of FDA, provide the
following details via email or walk-in
 Full name and contact
information of the complainant
 Narrative of the complaint
 Evidence, if applicable
 Name of the person being
complained, if applicable
Send all complaints against the FDA or

product to e-report@fda.gov.ph or through
walk-in at Food and Drug Action Center
How complaints are processed (FDAC)
All complaints received will be monitored
by the E-Report Section at the Food and
Drug Action Center (FDAC)
The FDAC shall coordinate with the

concerned Center or Office to answer the
complaint and shall investigate, if
necessary.
The E-Report Section or concerned

Center or Office shall give the feedback
to the client/complainant via email or
letter.
92

FDA Citizen&#39;s Charter CFRR

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

FDA Citizen&#39;s Charter CFRR

Uploaded by

Copyright:

Available Formats

FOOD AND DRUG ADMINISTRATION

To be an internationally recognized center of excellence in health product regulation

IV. Service Pledge:

ISSUANCE OF USER ACCOUNT TO ACCESS FDA E-SERVICES/ PROVISION OF

ISSUANCE OF OFFICIAL RECEIPTS AND POSTING OF PAYMENT........................... 7

LICENSE TO OPERATE OF ESTABLISHMENT

A. E-REGISTRATION PORTAL USER ACCOUNT..................................................... 28

B. CERTIFICATE OF PRODUCT REGISTRATION (CPR)

C. OTHER CFRR AUTHORIZATIONS ........................................................................ 73

FIELD REGULATORY OPERATIONS OFFICE INSPECTION

Center/Office/Division : Food and Drug Action Center

Fees to be Paid : AO 50 s.2001

CLIENT STEPS AGENCY ACTION PROCESSING TIME PERSON

ISSUANCE OF OFFICIAL RECEIPTS AND POSTING OF PAYMENT

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

I. LICENSE TO OPERATE – INITIAL APPLICATION FOR MANUFACTURERS OF

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Administrative Order 50 s. 2001*

FDA Circular No. 2011-003

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

When a business or establishment address is different from the

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

2. Post payment in None 1 working FDA Cashier

II. LICENSE TO OPERATE – INITIAL APPLICATION FOR TRADERS, DISTRIBUTORS

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Iodized Salt Importer – Php 1,000 + 1% LRF

Administrative Order 50 s. 2001*

FDA Circular No. 2011-003

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

Any one of the following shall be submitted as proof of

A copy of Business permit (i.e. Mayor’s Permit or

CLIENT STEPS AGENCY FEES TO PROCESSING PERSON

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Iodized Salt Importer – Php 2,000 + 1% LRF

Administrative Order 50 s. 2001*

FDA Circular No. 2011-003

FDA Circular No. 2011-004

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

2. Post payment None 1 working day FDA Cashier

Center/Office/Division : Center for Food Regulation and Research

Administrative Order 50 s. 2001*

FDA Circular No. 2011-003

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

A. Transfer of Location of Manufacturing Plant and Drug

B. Expansion of Manufacturer and/or Additional Product

C. Transfer of Location Offices

A. Transfer of Location of Drug Retailers

E. Change of Distributor Activity

F. Transfer or Addition of Warehouse

G. Additional Drugstore Activities

H. Expansion of Office Establishment

J. Change of Business Name;

J. Zonal Change in Address

K. Change of Qualified Person

A. Change of Authorized Person

CLIENT STEPS AGENCY ACTION FEES PROCESSING PERSON

Timeline of posting for

Center/Office/Division : Center for Food Regulation and Research (CFRR)

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1. Submit one (1) scanned copy of the required

1. Send a request for username and password

SUBJECT: CFRR: E-Registration

FDA Citizen's Charter CFRR

FDA Citizen's Charter CFRR