administrative order subject: new schedule of fees and

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ADMINISTRATIVE ORDER No. 2020-___________

SUBJECT: New Schedule of Fees and Charges of the Food and Drug

Administration for Licensing, Registration and Other

Authorizations and Regulatory Services, Repealing

Administrative Order No. 50 s. 2001, entitled, “Revised

2001 Schedule of Fees and Charges for the Corresponding

Services Rendered by the Bureau of Food and Drugs”

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.

The Food and Drug Administration (FDA) is mandated by law to license all the

establishments or facilities and issue product market authorization on all health products prior

to manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-

consumer use, promotion, advertising, or sponsorship. Accordingly, to protect public health

and uphold consumer safety, the FDA conducts post-market surveillance of health products

and establishment or facilities to ensure that adulterated, unregistered or misbranded health

products are not offered for sale or use. The scope of the health products regulated by the FDA

include processed food, food supplements, food additives and ingredients, drugs or medicines,

cosmetics, medical- and health-related devices, including diagnostic kits and reagents,

radiation emitting devices or equipment, household hazardous substances, including urban

pesticides, novel tobacco and other similar products, toys and childcare articles, among other

products, as determined by the Department of Health (DOH) - FDA.

Currently, the FDA is mandated by law to implement several national laws which

require resources, especially financial and human resources. Pursuant to Section 31 of the

Republic Act No. 9502, otherwise known as the Universally Accessible Cheaper and Quality

Medicine Act of 2008, and Section 18 of RA No. 9711, otherwise known as the FDA Act of

2009, the FDA is authorized to retain all fees, fines, royalties and other charges under a Special

Regulatory Fund and to be used for its 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.

Republic Act No. 11032, otherwise known as the Ease of Doing Business (EODB) and

Efficient Government Service Delivery (EGSD) Act of 2018, which was signed into law on

May 28, 2019, and the issuance of the Implementing Rules and Regulations on July 17, 2019

mandated all government agencies to re-engineer and streamline its services, institutionalize

regulatory impact assessment and automate its system to reduce the processing time in issuing

licenses, permits, certificates and authorization. It amended RA No. 9485, otherwise known as

the Anti-Red Tape Act (ARTA) of 2007, and seeks to create an efficient and unified licensing

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applications across the bureaucracy to make it easier to put up or renew businesses in the

Philippines and to spare people of intolerable queuing time or unnecessary waiting time. The

EODB and EGSD Act is consistent with the Universal Healthcare Law and the Department of

Health (DOH) F1+ Strategic Goals that are geared towards better health for all Filipinos and

more responsive health systems by developing innovative regulatory mechanisms for equitable

distribution of quality and affordable health goods and services.

This Administrative Order effectively repeals the Administrative Order No. 50 s. 2001,

entitled “Revised 2001 Schedule of Fees and Charges for the Corresponding Services

Rendered by the Bureau of Food and Drugs” in order to rationalize and streamline its fee

structure to maintain efficient and effective regulatory control/management and oversight

functions related to the following; (a) strengthening of regulatory enforcement and post-

marketing surveillance activities; (b) address rising operational costs and expenses for learning

and development activities of personnel, and (c) sustain the cost of development, maintenance

and upgrading information and communication technology and online systems.

In the interest of the service and pursuant to the DOF-DBM-NEDA Joint Circular No.

1-2013, also known as the “Implementing Rules and Regulations of Administrative Order No.

31 s. 2012 on the Rationalization of Rates of Fees and Charges, Increase in Existing Rates and

Imposition of New Fees and Charges”, the FDA is restructuring its fees and charges at a level

commensurate with the cost of regulating health products, establishments or facilities to protect

consumer safety and public health.

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 or

facilities and health products under FDA’s jurisdiction whether public or private, including but

not limited to national and local government agencies, state colleges and universities, and

schools, availing of FDA’s services.

IV. DEFINITION OF TERMS

1. Center shall refer to any of the following: 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.

2. Evaluation is a process of reviewing submitted regulatory documents by applicants based

on existing standards, rules, and regulations of the FDA.

3. Risk-based Regulation is an approach to regulating health products by targeting activities

that pose the highest risk to the public well-being, and in turn lowers the burden for a

variety of lower-risk sectors and firms. Lowering burdens improves compliance and

allows firms to benefit from a more level playing field. By directing the government

resources towards the highest-risk areas, risk-based approaches also make the most of

limited public resources, and further improves accountability by enhancing transparency

and predictability of requirements in given sectors and as applied to different

establishments.

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4. Initial application is the term used for a first-time or original application for any

authorization as defined by RA 9711.

5. Micro Small Medium Enterprises (MSMEs) shall be defined according to Republic Act

No. 9501 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: a. Micro, not more than P3M, b. Small, above P3M

but not more than P15M, and c. Medium, above P15 but not more than P100M. More than

P100M is considered a large enterprise.

6. Re-issuance is the process of granting a duplicate copy of a valid authorization due to loss

or damage of the original authorization. This is only applicable when the document is

issued by the FDA is a hardcopy, and not an electronic copy.

7. Renewal is the process of filing an application for the extension of the validity of an

authorization within the prescribed period.

8. Variation and/or Amendment refer to post-license changes in the status, circumstances,

conditions, claims, or activities of authorized establishments. Major variations include

changes affecting the establishment or the health product which may require inspection to

ensure public health protection. Minor variations include administrative changes.

V. GUIDELINES

A. The new schedule of fees and charges is attached as Annexes A to F, as follows:

Annex “A” Fees on General Certification (Common to all Centers)

Annex “B” Center for Cosmetic Regulation and Research (CCRR)

Annex “C” Center for Drug Regulation and Research (CDRR)

Annex “D” Center for Device Regulation Radiation Health and

Research (CDRRHR)

Annex “E” Center for Food Regulation and Research (CFRR)

Annex “F” Common Services Laboratory (CSL)

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

the expenses of all or any of the following activities:

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/special inspection;

g. Pharmacovigilance;

h. Post evaluation;

i. Product verification;

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j. Advertisement monitoring;

4. Printing

5. Records management and archiving; and

6. Courier services to deliver the authorization, if applicable.

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 Republic Act (RA) No. 3870,

as amended by Presidential Decree (PD) No. 200 and further amended by PD 1856,

of which FDA is 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. Fees either in Cash or Manager’s Check, payable to Food and Drug Administration, shall

be paid directly to the FDA Cashier.

Payments may also be made through:

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

2. BancNet System.

The FDA shall issue updated guidelines regarding new payment modes and methods as

necessary.

E. The following categories for the size pf business operation used by CCRR and CFRR for

licensing purposes (by asset) shall be in accordance with the Small and Medium Enterprise

Development (SMED) Council Resolution No. 1 s. of 2003 dated 16 January 2003 viz:

Micro – Up to PhP 3,000,000.00

Small – PhP 3,000,001.00 – PhP 15,000,000.00

Medium – PhP 15,000,001 – PhP 100,000,000.00

Large – above PhP 100,000,000.00

VI. VALIDITY

The validity of the License to Operate (LTO) shall be three (3) years for Initial

Application and subsequently for five (5) years for Renewal. On the other hand, the validity

of the Certificate of Product Registration (CPR) and Notification shall be, in general, five (5)

years for both initial and renewal applications, unless otherwise prescribed in the Annexes of

this AO.

The validity of Foreign Good Manufacturing Practice (GMP) Clearance will depend

on the GMP evidence presented by the establishment. Moreover, GMP Clearance issued by

other listed National Regulatory Agencies under the ASEAN-Mutual Recognition

Arrangements (MRA) on GMP will be recognized. GMP Certificate issued to local

manufacturers shall be effective up to the validity of the current LTO.

VII. PENALTY OR SURCHARGE

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

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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 filed beyond the allowable time

of filing shall be considered expired. Thus, it shall be treated as initial application and shall

undergo to corresponding 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.

VIII. IMPLEMENTATION ARRANGEMENTS

The revised fees and charges shall be implemented in 2020, except as otherwise specified

in the attached Annexes.

IX. MANDATORY REVIEW

The fees and charges shall be subject to mandatory review every three (3) years. The

Policy and Planning Service shall undertake periodic review, conduct consultations with

stakeholders, and recommend amendments to this Administrative Order to the Office of the

Director-General for approval of the Secretary of Health.

X. REPEALING CLAUSE

Provisions of Administrative Order No. 50 series 2001, FDA Circular No. 2011-004

and other previous issuance inconsistent with this Administrative Order are hereby repealed,

rescinded and modified accordingly.

XI. 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.

X. EFFECTIVITY DATE

This Administrative Order shall take effect after fifteen (15) days after its publication

in at least two (2) national papers of general circulation and upon filing at the Office of the

National Administrative Register (ONAR) at the UP Law Center, Diliman, Quezon City.

FRANCISCO T. DUQUE III, MD, MSc

Secretary of Health

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ANNEX A

FEES ON GENERAL CERTIFICATION

(Common to all Centers)

Certification

Fees (in PhP)*

1. Re-issuance of an Authorization or

License (Lost or Damaged Original)

2,000.00

2. Bureau of Customs Clearances

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

iv. Clearance for Donated Foods

1,000.00

3. Advertisements and Sales Promotion Permits

3.1. Discount scheme type of promotion

NCR only or in several regions

including NCR or nationwide

1,000.00

More than one region but excluding

NCR

750.00

Several

provinces/cities/municipalities within

a single region

500.00

Single province/city/municipality 250.00

3.2. Non-discount scheme type of promotion

Amount of Prize/s

Up to P50,000.00

250.00

P50,001.00 - P150,000.00 500.00

P150,001.00 - P300,000.00 1,000.00

P300,001.00 - P500,000.00 2,000.00

P500,001.00 - P1,000,000.00 3,000.00

Above P1,000,000.00 5,000.00

4. GMP Certificate (Local Manufacturer) 1,000.00/year

5. Reapplication (as determined by the

Center)

10% of application fee

6. Certificate of Free Sale 1,500.00

7. Permit to Carry/Mail (Personal Use) 100.00/transaction

8. Permit to Carry/Mail (R& D Use) 500.00/transaction

9. Authentication/ CTC 1,000.00/ authorization

10.Other Certification / Clearance/

Verification/ Permit**

1,000.00

* All fees are subject to an additional 1% for Legal Research Fee (LRF)

**Except clearances specifically mentioned in other Annexes

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ANNEX B

CENTER FOR COSMETIC REGULATION AND RESEARCH

LICENSE TO OPERATE

Fees (in PhP)*

Initial

(3 years)

Renewal

(5 years)

Variation

(Major –

w/

inspection)

Manufacturer/ Trader (Cosmetics, Household/Urban Hazardous

Substances)

Micro–Scale Enterprises (Total

Assets)

Group I (<Php500,000)

Group II (Php500,001-

1,500,000)

Group III (Php1,500,001-

3,000,000)

7,500.00

11,250.00

15,000.00

12,000.00

17,500.00

23,750.00

2,500.00

3,750.00

5,000.00

Small 30,000.00 47,500.00 10,000.00

Medium 45,000.00 71,250.00 15,000.00

Large 60,000.00 95,000.00 20,000.00

Manufacturer/ Trader (Household/Urban Pesticides)

Micro–Scale Enterprises 15,000.00 14,250.00 5,000.00

Small 30,00

0.00

47,500

.00

10,000

.00

Medium 45,00

0.00

71,250

.00

15,000

.00

Large 60,00

0.00

95,000

.00

20,000

.00

Manufacturer (Toys and Childcare Articles)

Micro–Scale Enterprises (Total

Assets)

Group I (<Php500,000)

Group II (Php500,000-

1,500,000)

Group III (Php1,500,000-

3,000,000)

7,500.00

11,250.00

15,000.00

12,000.00

17,500.00

23,750.00

2,500.00

3,750.00

5,000.00

Small 30,000.00 47,500.00 10,000.00

Medium 37,500.00 60,000.00 12,500.00

Large 52,500.00 85,000.00 17,500.00

Distributor 30,000.00 50,000.00 10,000.00

Variation - Minor (w/out inspection) 1,000.00 / variation ● Variation (Major and Minor) is paid per application of variation

Pest Control Operators/ Applicators/ Handlers/

Training Providers

Initial

(3 years)

Renewal

(5 years)

Pest Control Operators 6,000.00 10,000.00

Variation/s (Pest Control Operators) 1,000.00

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Certifications for Supervising Pesticide Handlers and

Pesticide Handlers 3,000.00 5,000.00

Accreditation of Training Providers 6,000.00 10,000.00


Schedule of Fees for the Licensing and FDA Electronic Registration Number (FERN)

Application of ENDS/ENNDS

LICENSE TO OPERATE

Fees (in PhP)*

Initial

(1 Year)

Renewal

(3 Years)

Variation

(Major –

w/

inspectio

n)

Vapor Products (VP) and Novel Tobacco Products (NTP) Establishment:

Retailers (VP + NTP) 5,000.00 15,000.00 2,500.00

Wholesaler/Exporter (VP + NTP) 10,000.00 30,000.00 5,000.00

Importer (VP) 12,000.00 36,000.00 6,000.00

Importer (NTP) 25,000.00 75,000.00 12,500.00

Traders (VP) 12,000.00 36,000.00 5,000.00

Traders (NTP) 25,000.00 75,000.00 12,500.00

Manufacturers (VP) 15,000.00 45,000.00 7,500.00

Manufacturers (NTP) 40,000.00 120,000.00 20,000.00

VARIATION (Minor – w/out

inspection)

2,000.00 / variation


PRODUCT

REGISTRATION/NOTIFICATION

Fees (in PhP)*

Initial

( 5 years)

Renewal

(5 years)

Certificate of Product Registration

Household/Urban Pesticides 15,000.00

Amendments / Variation

1. Major Variation 3,000.00/variation

2. Minor Variation 1,500.00/variation

Notification Fees (in PhP)*

(1 year validity)

a. Cosmetics/HUHS

1. Basic Notification Fee 1,000.00

2. Variants 500.00/variant

b. Toys and Childcare Articles (5 SKUs) 250.00

Electronic Registration (FERN)

Fees (in PhP)*

Initial per

year

(max of 2

years)

Renewal per

year

(max of 5

years)

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Vapor Products 6,000.00 4,800.00

Vapor Product Heating Devices 12,000.00 9,600.00

Heated Tobacco Products 150,000.00 120,000.00

Heated Tobacco Product Devices 150,000.00 120,000.00


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ANNEX C

CENTER FOR DRUG REGULATION AND RESEARCH

LICENSE TO OPERATE

Fees (in Php)*

Initial

(3

years)

Renewal

(5 years)

Variation

(Major – w/

inspection)

1. Manufacturer (Manufacturer,

Packer, Repacker)

112,50

0.00 190,000.00

37,500.00

2. Manufacturer-Trader 45,000.

00 75,000.00 15,000.00

3. Distributor (Exporter, Importer,

Wholesaler)

45,000.

00 75,000.00 15,000.00

4. Drugstore/ Pharmacy/Botica and

Other Similar Outlets, RONPD

6,750.0

0 11,250.00 2,250.00

5. Contract Research Organization /

Sponsor

45,000.

00 75,000.00 15,000.00


inspection) 1,000.00 / variation


CERTIFICATE OF PRODUCT REGISTRATION

Fees (in Php)*

Initial

(per years)

Renewal

(5 years)

1. New Chemical Entities (MR) – 3 years 31,0000.00 -

2. New Chemical Entities (MRE) – per years max of

2 years - 31,000.00

3. Generic Products 76,000.00 53,500.00

4. Biologicals and Vaccines 170,000.00 68,000.00

5. MR – 3 years 102,000.00

6. MRE - – per years max of 2 years 34,000.00

7. Initial 170,000.00 68,000.00

8. Human Influenza 40,000.00

(1 year

validity)

34,000.00

(1 year

validity [if

applicable

])

9. Other Drug Product Classification 76,000.00

53,500.00

VARIATIONS

Major Variation (turned initial) 30,000.00

Major Variation (others) 20,000.00

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Major Variation – Strain Clearance (MaV-SC) 25,000.00

Minor Variation – Prior Approval 5,000.00

Minor Variation – Notification 1,500.00

OTHER PERMITS AND CLEARANCES

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. Compassionate Special Permit (Personal Use) 500.00

5. Donation Certificate 1,500.00

6. Export Certificate 1,500.00

7. Certificate of Pharmaceutical Product 1,500.00

8. Product Classification 1,500.00

9. Issuance of Animal Feeds Certificate

10. Foreign GMP Clearance (excluding inspection) 10,000.00

11. Foreign Drug Manufacturer GMP Inspection (As per AO No. 2013-0022 and its

amendments)

Application Fee for Inspection 3,000.00

Inspector’s Fees

● ASEAN

USD 3,500.00 + UNDP

DSA

● Asia Pacific USD 7,000.00 + UNDP

DSA

● Others USD 10,500.00 + UNDP

DSA

Airfare and transportation expenses, translator (if

necessary), and other incurred fees

Shall be shouldered by

importer (s)/ foreign

manufacturer(s)


ACCREDITATION OF BIOEQUIVALENCE

TESTING CENTERS AND PRIVATE TESTING

LABORATORY

Fees (in PhP)*

1. Accreditation of Bioequivalence Testing Center (3-

year validity) 20,000.00/ year

Audits and Inspections

I. GCP/GLP audit of clinical trial sites/ Bioavailability/

Bioequivalence Testing Centers (minimum of 2

auditors)

A. Local

1. Within NCR 15,000.00 + transportation

cost

2. Outside NCR

15,000.00 + per diem/

inspector + transportation

cost

B. Overseas

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1. ASEAN Countries

USD 500/ man-day +

UNDP DSA +

transportation cost

2. Asia Pacific Countries (other than ASEAN) USD 7,000.00 + UNDP

DSA + transportation cost

3. Countries outside Asia-Pacific USD 10,500.00 + UNDP


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ANNEX D

CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND RESEARCH

I. RADIATION FACILITIES

LICENSE TO

OPERATE

Fees (in Php)*

Initial

(3 years)

Renewal

(5 years)

Variation3

(Major –

with

inspection)

Medical and Non-

Medical Radiation

Facilities1

9,500.00 per

machine

12,500 per

machine

3,000.00 per

machine

Therapeutic Medical

Radiation Facilities

25,000.00 per

machine

30,000 per

machine

8,000.00 per

machine

FACILITY

REGISTRATION Fees (in Php)*

Medical and Non-

Medical Radiation

Facilities2

5,500.00 per

machine

6,500.00 per

machine

1,800.00 per

machine

VARIATION3 (Minor –

w/out inspection) 1,000.00/variation


OTHER AUTHORIZATIONS - RADIATION FACILITIES

Certification / Permit Category Fees (in Php)*

Certificate of Safety Evaluation (CSE) for Non-Ionizing

Radiation Facility (Extremely Low Frequency (ELF) and

Radiofrequency Radiation (RFR) Facilities

2,500.00 per site

facility

Certificate of Radiation Measurement for ELF and RFR

Facilities

14,000.00 per site

facility

Pre-Operational Permit for Therapeutic Radiation Facility

Utilizing Linear Accelerator (LINAC)/Tomotherapy

machine and/or emerging devices used in radiation

oncology

6,000.00 per machine


1General Radiography/Fluoroscopy, Transportable X-ray facility, Computed Tomography (CT) for medical and

industrial applications, Mammography, Interventional X-ray (Cardiac Catheterization), Lithotripsy, Linear

Accelerator for anti-crime and industrial application, Open-type industrial radiography, Non-destructive testing,

Dental Panoramic/Cephalometric, Dental Cone Beam CT, Veterinary X-ray facility, Magnetic Resonance

Imaging (MRI) facility, X-ray facility for education, training and research

2Bone Densitometry (DEXA), Security and Baggage Inspection System, closed-type industrial radiography,

dental periapical/intraoral x-ray

3Variation:

Major Variation: Physical transfer/change of location of the facility that may entail changes in the previously

approved address; Change of location of the machine within the facility (includes the transfer of stationary

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machine from one room to another or from one area or another); and Change of machine or inclusion of

additional machine/s (includes replacement of x-ray tube assembly, x-ray generator and/or control console)

Minor Variation: Change in Business Name; Change of Management of Ownership; Change of Authorized

Personnel; Removal of Machine from Issued Authorization; and Change in the radiation facility service category

(includes the upgrading of service/s)

II. MEDICAL DEVICES AND HEALTH-RELATED DEVICES

LICENSE TO OPERATE

Fees (in PhP)*

Initial

(3 years)

Renewal

(5 years)

Variation

(Major – w/

inspection)

Medical Device

1. Manufacturer/Repacker/Refur

bi-sher 75,000.00 125,000.00

25,000.00

2. Distributor (Importers,

Exporters and Wholesalers) 22,500.00 37,500.00

7,500.00

3. Retailer of Medical Device 6,750.00 11,250.00 2,250.00

Water Purification/Treatment Devices/System

1. Manufacturer, exporter,

installer, importer and

distributor

10,500.00 17,500.00 3,500.00

Healthcare Waste Treatment Equipment (equipment or devices

used for treating sharps, pathological and infectious waste) and

treatment, storage and disposal (TSD) Facility Operator

1. Manufacturer, exporter,

importer and distributor 10,500.00 17,500.00 3,500.00




PRODUCT REGISTRATION

(Medical Device)

Fees (in Php)*

Initial

(5 years)

Renewal

(5 years)

1. Class A (Notification) 15,000.00 15,000.00

2. Class B (Registration) 30,000.00 30,000.00

3. Class C (Registration) 40,000.00 40,000.00

4. Class D (Registration) 60,000.00 60,000.00

5. Device Listing 2,000.00

VARIATIONS

Major Variations 6,000.00 / variation

Minor Variations 1,000.00 / variation


PRODUCT REGISTRATION

(Water Purification/Treatment Device)

Fees (in Php)*

Initial

(5 years)

Renewal

(5 years)

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1. Water purification/treatment device 2,500.00 2,500.00

2. Water purification/treatment system 6,000.00 6,000.00

3. Healthcare waste treatment equipment 10,000.00 10,000.00


OTHER CERTIFICATIONS Fees (in PhP)*

1. Compassionate Special Permit

(Institutional Use)

6,000.00

2. Product Classification 1,500.00

3. Exemption Certificate 500.00


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ANNEX E

CENTER FOR FOOD REGULATION AND RESEARCH

LICENSE TO OPERATE

Fees (in Php)*

Initial

(3 years)

Renewal

(5 years)

Variation

(Major)

Food Manufacturer

Micro Enterprises (Total

Assets)

Group I (<500,000)

Group II (500,001-

1,500,000)

Group III (1,500,001-

3,000,000)

3,000.00

9,000.00

13,500.00

5,000.00

15,000.00

22,500.00

1,000.00

3,000.00

4,500.00

Small Enterprises

(3,000,000.01-15,000,000.00) 22,500.00 50,000.00 7,500.00

Medium Enterprises

(15,000,000.01-

100,000,000.00)

45,000.00 100,000.00 15,000.00

Large Enterprises

(>100,000,000.00) 90,000.00 150,000.00 30,000.00

Food Distributor (Importer/

Exporter/Wholesaler) 22,500.00 50,000.00 7,500.00

Food Trader 22,500.00 50,000.00 7,500.00

Variation - Minor (w/out



* Variation (Major and Minor) is paid per application of variation

CERTIFICATE OF PRODUCT

REGISTRATION

Fees (in Php)*

Initial

(5 years)

Renewal

(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 Product

1. Hazard Analysis Critical Control Point

(HACCP)

3,000.00

2. Inter-Agency Committee on E.O. 51 (Milk

Code) Certificate

2,020.00

3. Sangkap Pinoy Seal (A.O. 15-A)

Initial Fee (Valid for 1 year) 8,500.00

Renewal Fee 5,000.00/year

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Diamond Seal 2,000.00/year


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ANNEX F

COMMON SERVICES LABORATORY

COST OF LABORATORY ANALYSIS

Classification Fees (in PhP)*

1. Physico-chemical Analysis

1.1 Drugs and Antibiotics

Visual Examination 400.00

Assay/Potency (Single Component) 3,000.00

Assay/Potency (Multi Component) 4,800.00

Dissolution Test

a. Single component 4,800.00

b. Multiple component 7,200.00

Disintegration Test 400.00

Hardness Test 400.00

Identification Test



Test for Impurities Test / Related Substances 6,000.00

Moisture content 1,200.00

Loss on Drying 2,400.00

pH 400.00

Vitamins

a. Vitamin A 4,800.00

b. Vitamin B1, B2, B6 4,800.00

c. Vitamin C (Ascorbic Acid) 1,200.00

d. Vitamin E 3,000.00

e. Other Vitamins 3,000.00

Minerals 2,400.00

Weight per tablet 400.00

Weight Variation 600.00

Minimum fill 600.00

Content Uniformity 5,000.00

Amino Acids 3,000.00 / per Amino Acid

content

1.2 Cosmetics

pH 400.00

Single analyte 3,000.00

Multiple analyte (max. of 3 analytes) 5,000.00

Multiple analyte (4 to 6 analytes) 10,000.00

1.3 Food Products

Moisture 400.00

Protein 2,400.00

Fat / Oil 900.00

Starch 900.00

Glucose 900.00

Sucrose 900.00

Lactose 900.00

Crude Fibers 900.00

Dietary Fibers 3,000.00

Total Solids 400.00

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Soluble Solids 400.00

Water-Insoluble Solids 400.00

Ash 400.00

Peroxide Value 900.00

Free Fatty Acids 900.00

Permanganate Oxidation Number (PON) 900.00

Total Acidity 600.00

Minerals 2,400.00

Amino Acids (LC) 4,800.00

Proline 900.00

Additives / Preservatives

a. Nitrate 2,400.00

b. Nitrite 2,400.00

c. Sodium Benzoate 2,400.00

d. Sorbic Acid 2,400.00

e. Two-component preservative 4,200.00

f. Food color (per color) 1,500.00

g. Sodium metabisulfite 2,400.00

h. Bromates 750.00

i. BHT 2,400.00

j. BHA 2,400.00

k. Aspartame 2,400.00

l. Acesulfame K 2,400.00

m. Saccharin 2,400.00

n. Two-component artificial sweetener 4,200.00

o. Monosodium Glutamate 2,400.00

p. Cyclamates 2,400.00

Micronutrients

a. Beta Carotene 3,000.00

b. Iodine 2,400.00

c. Iron 2,400.00

Vitamins

a. Vitamin A 4,800.00

b. Vitamin E 3,000.00

c. Vitamin C 1,200.00

d. Vitamin B1, B6, Niacin 4,800.00

Contaminants

a. Borax 400.00

b. Cyanide 1,200.00

c. Histamine 2,400.00

d. Filth 900.00

e. Formalin 1,500.00

f. Mycotoxins (per mycotoxin) 7,500.00

g. Melamine 7,500.00

h. 3-MCPD 7,500.00

i. DEHP 7,500.00

Heavy Metals

a. Lead 1,200.00

b. Cadmium 1,200.00

c. Chromium 1,200.00

d. Arsenic 1,200.00

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e. Mercury 1,200.00

f. Tin 1,200.00

Alcohol Content 2,400.00

Gas Volume 600.00

Total Soluble Solids (Brix) 600.00

pH 400.00

Caffeine 2,400.00

2. Microbiological Assay (Potency of Antibiotics) 4,800.00

3. Sterility Test

(Injectables, Medical Devices and Large Volume

Parenteral)

4,800.00

4. Microbial Limit Tests-

Aerobic Halophilic Count 900.00

Aerobic Plate Count / Heterotrophic Plate Count 900.00

Aerobic Thermophilic Count 900.00

Bacillus cereus 1,800.00

Bacillus subtilis 1,800.00

Bacterial Spore Count 900

Bile Tolerant Gram Negative Bacteria 1,800.00

Candida albicans 1,800.00

Clostridia 1,800.00

Clostridium perfringens 1,800.00

Coliform Plate Count 900.00

Coliforms/E.coli (MPN) 1,800.00

Commercial Sterility 1,800.00

Cronobacter spp. 1,800.00

Enterobacteriaceae 900.00

Enterococci 900.00

Escherichia coli 1,800.00

Fecal streptococci 1,800.00

Halophilic Yeast Count 900.00

Lactic Acid Bacteria (Lactobacilli) 1,800.00

Listeria monocytogenes 1,800.00

Osmophilic Yeast 900.00

Preservative Efficacy Test (PET) 1,800.00

Proteolytic Plate Count 900.00

Pseudomonas aeruginosa 1,800.00

Psychrotropic Bacteria 900.00

Salmonella 1,800.00

Staphylococcus aureus 1,800.00

Vibrio parahaemolyticus 1,800.00

Yeast and Mold Count 900.00

Other counting method 900.00

Other identification method (confirmatory test) 1,800.00

5. Bioassay Tests

Bacterial Endotoxin Test (LAL) 6,000.00

6. Toxicological Test

6.1 Bottled Water

Total package 5,550.00

Organoleptic (color, odor, taste, turbidity) 400.00

pH 400.00

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Conductivity 400.00

Total dissolved solids 400.00

Nitrate 400.00

Cyanide 1,200.00

Heavy Metals (per metal) 1,800.00

6.2 Hypochlorite

Assay 800.00

Residual Chlorine 800.00

pH 400.00

6.3 Toys/ School Supplies

a. Migration of Certain Elements (3 elements) 5,000.00

b. Additional element 1,200.00

6.4 Test for Packaging Materials

a. Migration Testing (package) 6,000.00

b. Material testing (Pb and Cd) 4,200.00

6.5 Medical Devices

a. Water Leak Test (Condom) 1,000.00

b. Efficacy/ Reproducibility (In-Vitro

Diagnostic Reagents/ Kits) 1,000.00


ACCREDITATION OF PRIVATE TESTING

LABORATORY

Fees (in PhP)*

Accreditation of Testing Laboratories 20,000.00/ year

Audits and Inspections

I. GLP/Accreditation Audit of Testing

Laboratories

A. Local

1. Within NCR 10,000.00 + transportation

cost

2. Outside NCR

10,000.00 + per diem/

auditor + transportation

cost

B. Overseas

1. ASEAN Countries USD 3500 + UNDP DSA

+ transportation cost

2. Asia Pacific Countries (other than ASEAN) USD 7,000.00 + UNDP


3. Countries outside Asia-Pacific USD 10,500.00 + UNDP



COST OF CERTIFICATIONS


Suitability Evaluation of Food Contact Materials 2,500.00

Evaluation of Test Results from Accredited Laboratory 2,500.00

Lot Release Certificate


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Lot Release Certificate Addendum 500.00

Batch Notification Certificate 6,500.00

Amendment of Certificates and Test Reports 500.00


COST OF LABORATORY BRED ANIMALS


Mouse

4-5 weeks 40.00

6-8 weeks 60.00

9-10 weeks 80.00

10+ weeks/breeder 100.00

Rat

4-5 weeks 100.00

6-8 weeks 150.00

9-10 weeks 180.00

10+ weeks/breeder 200.00


SERVICE

(Physics Laboratory Support Division) Fees (in Php)*

1. Performance testing of radiological

(diagnostic and therapeutic) equipment

10,000.00/machine + transportation

and other allowable expenses** of

PLSD health physics team, to be

shouldered by the requesting party

2. Calibration of radiotherapy dosimeters 5,000.00/dosimeter

3. Evaluation of new radiological products &

accessories

2,000.00/product & accessories

4. Inter-comparison of QA/QC measuring

instruments

2,000.00/unit + transportation and

other allowable expenses** of

PLSD health physics team, to be

shouldered by the requesting party

5. Rental fee for QA/QC measuring

instruments & test tools, radiotherapy

dosimeter

9,000.00/week (with accountability

contract***)

*All fees are subject to an additional 1% for Legal Research Fee (LRF)

** DOH AO No. 29, s. 2000 dated 30 March 2000 "Amendment to Administrative Orders

No. 23, s. 1999 and No. 50, s. 1999 prescribed the fees and charges to be collected by the

Radiation Health Service, DOH. The transportation and other allowable expenses is based on

E.O. No. 77 and implementing guidelines issued by the DOH

***Accountability Contract – a written agreement between the FDA and the borrower to

hold accountable for the borrowed measuring instrument, test tools, and radiotherapy

dosimeter

administrative order subject: new schedule of fees and

Documents