Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

ADMINISTRATIVE ORDER
No. _______________________

SUBJECT: New Schedule of Fees and Charges of the Food and Drug
Administration for Licensing, Registration and Other
Certifications

I. BACKGROUND AND RATIONALE

Enshrined in Section 12, Article XIII of the 1987 Philippine Constitution it

is the responsibility of the State to establish and maintain an effective food and
drug regulatory system and to undertake research responsive to the country's
health needs and problems. Consistent with the national policy, the Congress of
the Philippines passed three landmark legislations, namely Republic Act (RA) No.
9502, (Universally Accessible Cheaper and Quality Medicine Act of 2008),
Republic Act No. 9711, (Food and Drug Administration Act of 2009) and
Republic Act 10611 (Food Safety Act of 2013), to ensure protection of public
health and welfare.

Section 31 of R.A. No. 9502, which is consistent with Section 18 of RA

No. 9711, authorizes the Food and Drug Administration (FDA) to retain all fees,
fines, royalties and other charges under a Special Regulatory Fund and to use
them as follows: operations, which includes upgrading of its facilities, equipment
outlay, human resource development and expansion; acquisition of the
appropriate office space, , as well as purchase of laboratory equipment and
motor vehicles; upgrading of its current facilities and equipment and
maintenance; funding for operating expenses of the central office laboratory
divisions and satellite laboratories; and other activities or services of the FDA in
the performance of its mandate. Furthermore, R.A. No. 9711 stated that the
FDA shall cease to be allocated its budget under the General Appropriations Act
after it has established itself to be fiscally sustainable.

To ensure financial sustainability of the organization, increasing the fees

being collected, based on the corresponding direct and indirect costs of services
provided by FDA, through a cost recovery strategy, shall be implemented.

Heads of bureaus, offices or agencies, upon approval of the concerned

department head are authorized to revise their rates of fees and charges pursuant
to Section 54 (1), Chapter 12, Book IV of the Executive Order No. 292 or the
Administrative Code of 1987. The determination of new fees is based on the
DOF-DBM-NEDA Joint Circular No. 1 (s. 2013), also known as the

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila • Trunk Line 651-7800 Direct Line: 711-9501
Fax: 743-1829; 743-1786 • URL: http://www.doh.gov.ph; e-mail: osec@doh.gov.ph
 Implementing Rules and Regulation of Administrative Order No. 31 (s.
2012) sets the guidelines on the rationalization of rates of fees and charges,
increase in existing rates, and imposition of new fees and charges with direct and
indirect cost has been the main basis.

As such, FDA is restructuring its fees and charges at a level commensurate

with the cost of regulating health products to be able to sustain its operations and
be able to achieve its legal mandate.

II. OBJECTIVE

This Administrative Order is issued to prescribe the new schedule of fees

and charges for the services rendered by FDA, and provide the guidelines for its
implementation.

III. SCOPE

The new schedule of fees and charges shall apply to all persons,
establishments and health products under FDA’s jurisdiction, including but not
limited to national and local government agencies, state colleges and universities,
public schools, private entities, and non-governmental organizations availing of
FDA’s services.

IV. DEFINITION OF TERMS

A. “Assessment” is the process of initial review on the completeness of the

documents submitted upon payment of assessment fee. This process is only
applicable for the applications for Certificate of Product Registration (CPR).

B. “Assessment Fee” is the amount paid for the review process, prior to the
submission of the application for FDA Authorization.

C. “Electronic Authenticated Copy” is a valid scanned copy of authorization with

a barcode, whether CPR or License to Operate (LTO), issued by the FDA for
special purposes, e.g. as part of the requirements to be submitted during
biddings in government agencies.

D. “Centers” shall refer to the Center for Cosmetic Regulation and Research
(CCRR), Center for Food Regulation and Research (CFRR), Center for Drug
Regulation and Research (CDRR) and Center for Device Regulation,
Radiation Health and Research (CDRRHR) of the FDA.

E. “Evaluation” is a technical review of the required documents submitted for

approval of applications.

F. “Initial” is the term used for a first-time application for an LTO or any market
authorization from the FDA.

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 G. “Re-issuance” is the process of granting a duplicate copy of a valid
authorization upon the request of the Marketing Authorization Holder (MAH),
due to loss or damage of the original issuance.

H. “Renewal” is the process of filing a new application for a previously

approved authorization within the prescribed period1.

I. “Variation” refers to post approval changes in the status, condition or activity

of the issued authorization by the FDA.

V. GUIDELINES

A. The new schedule of fees and charges is attached as Annexes A to G:

Annex “A” General Certification Fees

Annex “B” CCRR
Annex “C” CDRR
Annex “D” CDRRHR
Annex “E” CFRR
Annex “F” Sample of OnColl Payment Slip

B. The application fees for granting an authorization prescribed in this issuance

shall cover the expenses of the following activities, including post-approval,
when applicable:

1) Receiving of application documents;

2) Pre-marketing activities, including but not limited to assessment, technical
evaluation and pre-licensing inspection of establishment;
3) Post-marketing surveillance of products and establishments, but not
limited to the following:
(a) Collection of sample
(b) Laboratory testing
(c) Complaints and reports processing
(d) Safety monitoring
(e) Post-licensing inspection
(f) Routine inspection
4) Printing of one (1) original copy and issuance of additional nineteen (19)
electronic authenticated copies of the LTO and CPR;
5) Records management and archiving; and
6) Courier services to deliver the authorization.

C. The applications fees shall not cover the following expenses:

1) UP Law Center’s Legal Research Fee (LRF) which is equivalent to P10.00

or 1% of the application fee, whichever is higher, as imposed by RA 3870,
as amended by PD 200 and further amended by PD 1856, of which FDA is
1
Refer to Section V.I of this AO.

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 only the collecting agent as per Letter of Instruction No. 1182 dated 16
December 1981.

2) Other fees incurred from the use of payment collection facilities, such
as service fees charged by banks authorized by the FDA to collect its
fees.

D. An assessment fee of P500.00 or 1% of the total product registration fee,

whichever is higher shall also be collected.

E. Applications for renewal made as early as six (6) months to three (3) months
prior to expiration of LTO and CPR will be entitled to a discounted rate of ten
per cent (10%) of the renewal fee; provided that the applications are compliant
with the renewal requirements.

F. Fees either in Cash or Manager’s Check payable to Food and Drug

Administration shall be collected ONLY through the FDA Cashier and all
authorized FDA Satellite Cashiers.

Payments may also be made through:

1) OnColl payment thru Landbank of the Philippines (LBP); and

2) BancNet System.

The FDA may issue additional guidelines regarding new payment modes and
methods.

G. A re-application fee equivalent to P500.00 or 1% of the current application fee

for product registration, whichever is higher, shall be imposed along with the
resetting of timelines for applications that failed to meet the prescribed
timeline to comply with a Notice of Deficiency/Letter of Denial.

H. The categories for the size of the business operation used by CCRR and CFRR
for licensing purposes shall be in accordance with DTI Resolution No. 01
(Series of 2003 dated 16 January 2003) issued by the Small and Medium
Enterprise Development (SMED) Council2.

2
Sec. 3. Micro, Small and Medium Enterprises (MSMEs) as Beneficiaries. – MSMEs shall be defines as
any business activity or enterprise engaged in industry, agribusiness and/or services, whether single
proprietorship, cooperative, partnership or corporation whose total assets, inclusive of those arising from
loans but exclusive of the land on which the particular business entity’s office, plant and equipment are
situated, must have value falling under the following categories:

Micro Php 3,000,000.00 below

Small Php 3,000,000.01 to 15,000,000.00
Medium Php 15,000,000.01 to 100,000,000.00

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 Any business activity or enterprise with total asset above Php 100,000,000.00
shall be considered Large.

I. Pursuant to Section 3, Paragraph (A) (2) and (B) (2) of Article 1, Book II on
Licensing of Establishments and Registration of Health Products of IRR of
RA 9711, the surcharge or penalty, which shall be imposed only for
applications for renewal of LTO or CPR registration received after the date of
their expiration, shall be assessed and imposed. This rule applies even in
succeeding renewal applications.

An application for renewal of an LTO received after its date of expiration

shall be subject to a surcharge or penalty equivalent to twice the renewal
licensing fee and an additional 10% per month or a fraction thereof of
continuing non-submission of such application up to a maximum of one
hundred twenty (120) days. Any application for renewal of license filed
thereafter shall be considered expired and the application shall be subject to a
fee equivalent to the total surcharge or penalty plus the initial filing fee and
the application shall undergo the initial filing and evaluation procedure.

For renewal applications filed within one hundred twenty (120) days from its
original expiry, the LTO shall be considered valid and existing until a decision
or resolution by the FDA is rendered on the application for renewal.

J. The validity of the License to Operate (LTO) shall be two (2) years for Initial
issuance and three (3) years for Renewal. On the other hand, the validity of
the Certificate of Product Registration (CPR) shall be five (5) years for both
initial and renewal applications. This is applicable for all the FDA Centers.

V. IMPLEMENTATION ARRANGEMENTS

A. The revised fees and charges shall be implemented in 2016, except as

otherwise specified in the attached Annexes.

B. The fees and charges shall be subject to regular review. The Committee on
Fees and Charges shall undertake periodic review, conduct consultations with
stakeholders, and recommend amendments to this Administrative Order, when
necessary, to the Office of the Director-General, for approval of the Secretary
of Health.

VI. REPEALING CLAUSE

Provisions of Administrative Order No. 50 series 2001, FDA Circular No.

2011-004 and other previous issuances inconsistent with this Administrative
Order are hereby repealed, rescinded and modified accordingly.

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 VII. SEPARABILITY CLAUSE

If any provision is declared unauthorized or rendered invalid by any court of law

or competent authority, those provisions not affected thereby shall remain valid
and effective.

VIII. EFFECTIVITY DATE

This Administrative Order shall take effect after fifteen (15) days
following the completion of publication in two newspapers of general circulation.

JANETTE P. LORETO-GARIN, MD, MBA-H

Secretary of Health

Office of the Director General Health Policy Development and Planning

Office for Health Regulation Office of the Secretary
Food and Drug Administration Bureau

Maria Lourdes C. Santiago, MSc, MM Lilibeth C. David, MD, MPH, CESO III Kenneth Y. Hartigan-Go, MD
OIC, Director General Undersecretary Undersecretary
Date: Date: Date: Date:

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 Annex A

General Certification Fees (Common to all Centers)

Certification Fees (in PhP)

1. Issuance of an Authenticated Copy of 500.00

the Document
(for the first 5 complete set)
for the succeeding – P50.00/copy)
2. Re-issuance of an Authorization or 2,000.00
License (Lost or Damaged Original)
3. Certification / Clearance / 500.00
Verification/Special Permit*
4. Bureau of Customs Clearances 1,000.00
i. Import Permit for Samples of
Products for Registration
ii. Import Permit for Clinical Trial Use
iii. Clearance from Customs Release of
Radiation Emitting Device
5. Certificate of Free Sale 1,000.00
6. Permit to Carry/Mail (Personal Use) 50.00/transaction
7. Permit to Carry/Mail (R& D Use) 500.00/transaction

*Except clearances specifically mentioned in other Annexes

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 Annex B

CENTER FOR COSMETIC REGULATION AND RESEARCH

Fees (in Php)

LICENSE TO OPERATE Initial Renewal

(2 years) (3 years)

Manufacturer/ Trader (Cosmetics, Household/Urban Pesticides)

Micro –scale Enterprises (Total Assets)
Group I (<500,000)
10,000.00 14,250.00
Group II (500,001-1,500,000)
Group III (1,500,001-3,000,000)
Small (3,000,001-15,000,000) 20,000.00 28,500.00
Medium (15,000,001-100,000,000) 30,000.00 42,750.00
Large (>100,000,000) 40,000.00 57,000.00
Manufacturer (Toys and Childcare Articles)
Micro –scale Enterprises
7,200.00
Group I (<500,000) 5,000.00
10,700.00
Group II (500,000-1,500,000) 7,500.00
14,250.00
Group III (1,500,000-3,000,000) 10,000.00
Small (3,000,001-15,000,000) 20,000.00 28,500.00
Medium (15,000,001-100,000,000) 25,000.00 35,650.00
Large (>100,000,000) 35,000.00 50,000.00
Distributor 20,000.00 30,000.00
Variations (Manufacturer/Trader/Distributor)
Major Variation 8,000.00
Minor Variation 4,000.00

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 Fees (in PhP)
PRODUCT REGISTRATION/NOTIFICATION Initial Renewal
( 5 years) (5 years)
Certificate of Product Registration

Household/Urban Pesticides 15,000.00

Fees (in PhP)

Notification
(1 year)
a. Cosmetics/HUHS
Basic Notification Fee 1,000.00
Variants (per variant) 200.00
b. Toys and Childcare Articles (5 SKUs) 250.00
Amendments
Household/Urban Pesticides
i. Major Variation 3,000.00
ii. Minor Variation 1,500.00

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 Annex C

CENTER FOR DRUG REGULATION AND RESEARCH

Fees (in PhP)

LICENSE TO OPERATE Initial Renewal

(2 years) (3 years)

1. Manufacturer (Manufacturer, Packer, Repacker) 75,000.00 114,000.00

2. Manufacturer-Trader 30,000.00 36,500.00
3. Distributor (Exporter, Importer, Wholesaler) 30,000.00 36,500.00
4. Drugstore/ Pharmacy/Botica and Other Similar Outlets, 4,500.00 6,500.00
RONPD
5. Contract Research Organization / Sponsor 30,000.00 36,500.00
Variations
Major Variation – Manufacturer 8,500.00

Major Variation – Manufacturer-Trader / Distributor /

6,500.00
CROs/Sponsors

Major Variation – Drugstore/ Pharmacy/Botica and Other

3,500.00
Similar Outlets, RONPD

Minor Variation – Notification 1,500.00

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 Fees (in PhP)
PRODUCT REGISTRATION Initial Renewal
(5 years) (5 years)
1. New Chemical Entities 155,000.00
2. Generic Products 76,000.00 53,500.00
3. Biotechnological Products 170,000.00 68,000.00
4. Other Drug Product Classification 76,000.00 53,500.00
VARIATIONS

Major Variation – A* 35,000.00

Major Variation – B 25,000.00
Minor Variation – Prior Approval 6,500.00
Minor Variation – Notification 1,500.00
OTHER PERMITS AND CLERANCES

1. Generic Labelling Exemption Permit / year 1,500.00

2. Conversion to PCPR 1,500.00
3. Compassionate Special Permit (Institutional Use) 6,000.00
4. Donation Certificate 1,500.00
5. Export Certificate 1,500.00
6. Certificate of Pharmaceutical Product 1,500.00
7. Product Classification 1,500.00

*Major Variation 1, 4, 5, 9, 10, 11, 12, 13 and Country Specific Major Variations as provided in
FDA Circular No. 2014-008. For multiple variations on product registration with any major
variation enumerated herein, only the major variation fee will be collected.

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 Annex D

CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND

RESEARCH

Fees Per Machine (in Php)

LICENSE TO OPERATE
Initial Renewal
(Medical and Non-Medical Radiation Facilities)
(2 years) (3 years)
1. Medical X-Ray Facility (General Radiography and/or 4,000.00 5,000.00
Fluoroscopy/Mobile C-Arm, Simulator, Lithotripsy,
Bone Densitometry)
2. Non-Medical X-Ray Facility (Industrial, Anti-Crime, 4,000.00 5,000.00
Educational and Research, Veterinary, Dental)
3. Specialized Medical Radiation Facility: 8,000.00 10,000.00
[Computed Tomography (CT), Mammography,
Interventional Radiology (Cardiac Catheterization)]
4. Therapeutic Radiation Facility Utilizing Linear 20,000.00 25,000.00
Accelerator (LINAC)

PRE-OPERATIONAL PERMIT Fees Per Machine

(in Php)
Therapeutic Radiation Facility Utilizing Linear Accelerator 5,000.00
(LINAC)
VARIATIONS Fees per application
(in Php)
Major Variation 3,000.00/application
Minor Variation 1,500.00 / application

Field Radiation Measurement

TYPE OF RADIATION FACILITY Fees (in Php)

Extremely Low Frequency (ELF) and 14,000.00 / transmitter site plus
Radiofrequency Radiation (RFR) Facilities transportation cost of the health
physicist team

Radiation Safety Evaluation Report for Non Ionizing Radiation Devices/Facilities

TYPE OF DOCUMENT Fees (in Php)

Safety Evaluation Report 2,500/site

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 Fees (in Php)
LICENSE TO OPERATE
(Medical Device) Initial Renewal
(2 years) (3 years)
1. Manufacturer/Repacker 50,000.00 75,000.00
2. Distributor (Importers, Exporters and
15,000.00 22,500.00
Wholesalers)
VARIATIONS
Major Variations-Manufacturer 5,000.00
Minor Variations 1,000.00

Fees (in Php)

PRODUCT REGISTRATION
(Medical Device) Initial Renewal
(5 years) (5 years)
1. Class A 15,000.00 15,000.00
2. Class B 30,000.00 30,000.00
3. Class C 40,000.00 40,000.00
4. Class D 60,000.00 60,000.00
VARIATIONS
Major Variations 1 3,000.00
Major Variations 2 6,000.00
Minor Variations 1,000.00

SERVICE Period of charging Fees (in Php)

(Physics Laboratory)
Per machine 20,000.00 per
machine plus
1. Performance testing per x-ray machine transportation cost
of the health
physics team
2. Calibration of radiotherapy dosimeter Per dosimeter 8,000.00 per
(electrometer & ion chamber) dosimeter
3. Rental of non-invasive kV meter and Per day of use,
7,000.00/day
related accessories as 1 set or fraction thereof
4. Rental of non-electronic x-ray QA Per day of use,
7,000.00/day
test tools or fraction thereof
5. Rental of selective frequency meter Per day of use,
15,000.00/day
for radio frequencies or fraction thereof
Per day of use,
6. Rental of densitometers 6,000.00/day
or fraction thereof
Per day of use,
7. Rental of sensitometers 6,000.00/day
or fraction thereof

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 Annex E

CENTER FOR FOOD REGULATION AND RESEARCH

Fees (in Php)

LICENSE TO OPERATE
Initial Renewal
(2 years) (3 years)

Food Manufacturer

Micro Enterprises (Total Assets)

Group I (<500,000) 2,000.00 3,000.00
Group II (500,001-1,500,000) 6,000.00 9,000.00
Group III (1,500,001-3,000,000) 9,000.00 13,500.00
Small Enterprises 15,000.00 30,000.00
Medium Enterprises 30,000.00 60,000.00
Large Enterprises 60,000.00 90,000.00

Food Distributor (Importer/ Exporter/Wholesaler) 15,000.00 30,000.00

Food Trader 15,000.00 30,000.00

VARIATIONS Fees (in Php)

Major Variation 3,000.00
Minor Variation 1,500.00

Fees (in Php)

PRODUCT REGISTRATION
Initial Renewal
(5 years) (5 years)
1. Raw Materials/Low-Risk Food 2,500.00 2,500.00
2. Medium-Risk Food 3,000.00 3,000.00
3. High-Risk Food 3,000.00 3,000.00
4. Food Supplement 15,000.00 15,000.00

VARIATIONS 500.00

CERTIFICATION Fees (in Php)

per Certificate
1. Hazard Analysis Critical Control Point (HACCP) 3,000.00

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 ANNEX F

ONCOLL PAYMENT SLIP

0 3 9 2 2 2 2 0 0 6

NAME OF INDUSTRY
Notification Number (14 alphanumeric
characters)

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