administrative order subject: new schedule of fees and ... or… · drug, ra 8976, s. 2000 (the...

Republic of the Philippines

Department of Health

FOOD AND DRUG ADMINISTRATION

Civic Drive, Filinvest Corporate City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751

Website: www.fda.gov.ph Email: [email protected]

ADMINISTRATIVE ORDER

No. _______________________

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

Administration for Licensing, Registration and Other

Authorizations and Regulatory Services, Amending

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”.

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.

This Administrative Order is an amendment to 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” to reflect the various changes in the organizational structure, scope

and coverage, number of personnel and regulatory operations of the Food and Drug

Administration (FDA) consistent with the various laws, rules and regulations implemented. The

FDA is rationalizing and streamlining its fee structure to make adjustments in order to first,

strengthen regulatory enforcement and post-marketing surveillance activities; second, address

rising operational costs and expenses for qualified personnel who have technical skills in the

evaluation of health products, inspection of establishments and laboratory testing; and third,

sustain the cost of development, maintenance and upgrading information and communication

technology and online systems.

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

resources, especially financial and human resources. These laws include the following: RA

3720, s. 1963 (Food, Drug and Cosmetic Act of 1963), Presidential Decree (PD) No. 881, s. 1972

(The Household Hazardous Act), PD 856, s. 1976 (The Code of Sanitation of the Philippines),

EO No. 51, s. 1986 (The Milk Code of the Philippines), RA 7394, s. 1992 (The Consumer’s Act

of the Philippines, RA 6675, s. 1988 (The Generics Act of 1988), RA 7581, s. 1992 (The Price

Act), RA 8172, s. 1995, (The ASIN Law), RA 8203, s. 1996 (The Special Law on Counterfeit

Drug, RA 8976, s. 2000 (The Food Fortification Law), RA 9165, s. 2002 (The

Comprehensive Dangerous Drugs Act, RA 9211, s. 2003, (The Tobacco Regulation Act), RA

9257, s. 2003, (The Expanded Senior Citizens Act), RA 9502, s. 2008 (The Universally

Accessible Cheaper Quality Medicine Act, RA 9711, s. 2009 (The FDA Act of 2009, RA 10354,

s. 2013 (The Responsible Parenthood and Reproductive Health Bill), RA 10623, s. 2013 (The

Price Act, amending RA 7581), RA 10620, s. 2013 (The Toy and Game Safety Labeling Act),

RA 10611, s. 2013 (The Food Safety Act), RA 10643, s. 2014 (The Tobacco Products Graphic

Health Warnings Law, RA 10918, s. 2016 (The Philippine Pharmacy Act of 2016), RA 10963,

s. 2017 (The TRAIN Act), RA 11032, s. 2018 (Ease of Doing Business and Efficient Government

Service Delivery Act), and RA Republic Act No. 11215, s. 2018 (An Act Institutionalizing a

National Integrated Cancer Control Program and Appropriating Funds Therefor).

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The FDA is mandated by law to license all the establishments 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. For

the protection of public health and consumer safety, FDA ensures through post-market

surveillance of health products and establishment to ensure that adulterated, unregistered or

misbranded health products are 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, cigarettes, toys and childcare articles, among other products as determined by the

DOH-FDA.

Section 31 of R.A. 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, authorizes the Food and Drug Administration (FDA) 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. 9711, however, states that the FDA shall cease to be allocated a

budget under the General Appropriations Act after it has become financially sustainable.

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

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.

With the upgrading of online services, the reform in its current fees and charges is one

way of sustaining the services. 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 and

establishments, sustain its post-market surveillance and sustain the development of the FDA to

protect consumer safety and public health.

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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

1. 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.

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 burdens 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.

4. Initial is the term used for a first-time application for any authorization, e.g. license,

certification, or permits issued by the FDA.

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 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-licensed changes in the status, circumstances,

conditions, claims, or activities of authorized establishments.

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V. GUIDELINES

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

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-assessment of received applications for product market authorizations;

3) 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

(g) Pharmacovigilance

4) Printing;

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 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 only.

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.

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E. 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) Council1.

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

considered Large.

V. VALIDITY

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

VI. 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

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.

VII. IMPLEMENTATION ARRANGEMENTS

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

the attached Annexes.

VIII. 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.

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IX. 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.

X. 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.

XI. EFFECTIVITY DATE

This Administrative Order shall take effect after fifteen (15) days following the

completion of publication in two newspapers of general circulation.

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. Certification / Clearance /

Verification/Special Permit*

500.00

3. 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

4. Issuance of Advertisement and Sales

Promotion Permit

for Pharmaceuticals, Processed Food

Products,

Cosmetics, Household/Urban Hazardous

Substances and

Household/Urban Pesticides

5. Good Manufacturing Practice (GMP)

Certification (excluding inspection)

6. Certificate of Free Sale 1,000.00

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

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

9. Major Variation of LTO (with inspection) 3,000.00

10. Minor Variation of LTO 1,000.00

*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)

Manufacturer/ Trader (Cosmetics, Household/Urban Hazardous Substances)

Micro –scale Enterprises (Total Assets)

Group I (<500,000)

Group II (500,001-1,500,000)

Group III (1,500,001-3,000,000)

7,500.00

11,250.00

15,000.00

12,000.00

17,833.33

23,750.00

Small 30,000.00 47,500.00

Medium 45,000.00 71,250.00

Large 60,000.00 95,000.00

Manufacturer/ Trader (Household/Urban Pesticides)

Micro Enterprises 15,000.00 14,250.00

Small 30,000.00 47,500.00

Medium 45,000.00 71,250.00

Large 60,000.00 95,000.00

Manufacturer (Toys and Childcare Articles)

Micro –scale Enterprises

Group I (<500,000)

Group II (500,000-1,500,000)

Group III (1,500,000-3,000,000)

7,500.00

11,250.00

15,000.00

12,000.00

17,833.33

23,750.00

Small 30,000.00 47,500.00

Medium 37,500.00 59,416.67

Large 52,500.00 83,333.33

Distributor 30,000.00 50,000.00

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

Certifications for Supervising Pesticide Handlers and

Pesticide Handlers 3,000.00 5,000.00

Accreditation of Training Providers 6,000.00 10,000.00

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

Application of ENDS/ENNDS

LICENSE TO OPERATE Fees (in PhP)

Per Year + LRF

Electronic Nicotine Delivery System (ENDS)/ Electronic Non-Nicotine Delivery System

(ENNDS)

Retailers (Retail Outlet, Online Seller) 5,000.00

Distributors (Importers, Exporters, Wholesalers) 10,000.00

Traders 10,000.00

Manufacturers 15,000.00

PRODUCT REGISTRATION/NOTIFICATION

Fees (in PhP)

Initial

( 5 years)

Renewal

(5 years)

Certificate of Product Registration

Household/Urban Pesticides 15,000.00

Amendments / Variants

Major Variation 3,000.00

Minor Variation 1,500.00

Notification Fees (in PhP)

(1 year)

a. Cosmetics/HUHS

Basic Notification Fee 1,000.00

Variants (per variant) 500.00

b. Toys and Childcare Articles (5 SKUs) 500.00

Electronic Registration (FERN)

Fees (in PhP) + LRF

Initial

(1 year)

Renewal Per

Year

(max. 5 years)

HUHS E-Liquids and Refills 5,000.00 3,000.00

Electronic Delivery Devices 10,000.00 8,000.00

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ANNEX C

CENTER FOR DRUG REGULATION AND RESEARCH

LICENSE TO OPERATE

Fees (in PhP)

Initial

(3 years)

Renewal

(5 years)

1. Manufacturer (Manufacturer, Packer, Repacker) 112,500.00 190,000.00

2. Manufacturer-Trader 45,000.00 60,833.33

3. Distributor (Exporter, Importer, Wholesaler) 45,000.00 60,833.33

4. Drugstore/ Pharmacy/Botica and Other Similar Outlets,

RONPD 6,750.00 10,833.33

5. Contract Research Organization / Sponsor 45,000.00 60,833.33

PRODUCT REGISTRATION

Fees (in PhP)

Initial

(5 years)

Renewal

(5 years)

1. New Chemical Entities 155,000.00

2. Generic Products 76,000.00 53,500.00

3. Biologicals and Vaccines 170,000.00 68,000.00

4. Other Drug Product Classification 76,000.00 53,500.00

VARIATIONS

Major Variation – A* 30,000.00

Major Variation – B 20,000.00

Minor Variation – Prior Approval 5,000.00

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. 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. Issuance of Foreign GMP Clearance (Desktop

Evaluation) – PIC/S

*Major Variation 1, 4, 5, 9, 10, 11, 12, 13 and Country Specific Major Variations as provided

in FDA Circular No. 2014-008. Categorization may later be updated by the FDA..

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ANNEX D

CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND RESEARCH

LICENSE TO OPERATE

(Medical and Non-Medical Radiation

Facilities)

Fees Per Machine (in Php)

Initial

(2 years)

Renewal

(3 years)

Renewal

(5 years)

1. Medical X-Ray Facility (General

Radiography and/or Fluoroscopy/Mobile C-

Arm, Simulator, Lithotripsy, Bone

Densitometry)

4,000.00 5,000.00 N/A

2. Specialized Medical X-ray Facility

(Computed Tomography, Mammography,

Interventional Radiography (Cardiac

Catheterization), MRI)

8,000.00 10,000.00 N/A

3. Therapeutic Radiation Facility Utilizing

Linear Accelerator (LINAC)

20,000.00 25,000.00 N/A

4. Non-Medical X-Ray Facility (Industrial,

Anti-Crime, Educational and Research,

Veterinary, Dental)

4,000.00 N/A 8,500.00

PRE-OPERATIONAL PERMIT Fees Per Machine

(in Php)

Therapeutic Radiation Facility Utilizing Linear

Accelerator (LINAC)

5,000.00

VARIATIONS Fees per

application

(in Php)

Major Variation 3,000.00/applicatio

n

Minor Variation 1,500.00 /

application

Field Radiation Measurement

TYPE OF RADIATION FACILITY Fees (in Php)

Extremely Low Frequency (ELF) and

Radiofrequency Radiation (RFR) Facilities 14,000.00 / transmitter site plus 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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LICENSE TO OPERATE

Fees (in PhP)

Initial

(3 years)

Renewal

(5 years)

Medical Device

1. Manufacturer/Repacker/Refurbisher 75,000.00 125,000.00

2. Distributor (Importers, Exporters and

Wholesalers) 22,500.00 37,500.00

3. Retailer of Medical Device 6,750.00 10,833.33

Water Purification/Treatment

Devices/System 0.00

4. Manufacturer, exporter, installer, importer

and distributor 10,500.00 8,333.33

Healthcare Waste Treatment Equipment

(equipment or devices used for treating

sharps, pathological and infectious waste)

and treatment, storage and disposal (TSD)

Facility Operator

5. Manufacturer, exporter, importer and

distributor 10,500.00 8,333.33


(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

Minor Variations 1,000.00

OTHER CERTIFICATIONS

Compassionate Special Permit (Institutional

Use) 6,000.00

Product Classification 1,500.00

Exemption Certificate 500.00

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(Water Purification/Treatment Device)

Fees (in Php)

Initial

(5 years)

Renewal

(5 years)

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

a. Manufacturers, distributors and Treatment

Storage and Disposal (TSD) facility

operators

i. Cost < Php 1,000,000.00 7,000.00 5,000.00

ii. Cost = Php 1,000,000.00 - Php

5,000,000.00 10,000.00 8,000.00

iii. Cost > Php 5,000,000.00 13,000.00 10,000.00

b. Healthcare waste generators 6,000.00 4,000.00

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

(2 years)

Renewal

(3 years)

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

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

Medium Enterprises (15,000,000.01-

100,000,000.00) 45,000.00 100,000.00

Large Enterprises (>100,000,000.00) 90,000.00 150,000.00

Food Distributor (Importer/ Exporter/Wholesaler) 22,500.00 50,000.00

Food Trader 22,500.00 50,000.00


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 Certificate

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

2. Inter-Agency Committee on EO 51 (Milk Code)

Certificate

2,020.00

3. IDOL (Initiative of DOH and DTI Operational

Livelihood Pilot Program)

4. Sangkap Pinoy Seal

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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

1.2 Cosmetics

pH 400.00

Single analyte 3,000.00

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



1.3 Food Products

Moisture 400.00

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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

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

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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

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

of 6

4. Microbial Limit Tests

Aerobic Plate Count 900.00

Proteolytic Plate Count 900.00

Bacterial Spore Count 900.00

Coliform Plate Count 900.00

Halophilic Yeast Count 900.00

Yeast and Mold Count 900.00

Coliforms /E. coli (MPN) 1,800.00

Psychotropic Bacteria 1,800.00

Lactic Acid Bacteria 1,800.00

Bacillus cereus 1,800.00

Staphylococcus aureus 1,800.00

Candida albicans 1,800.00

Clostridium perfringens 1,800.00

Cronobacter spp. 1,800.00

Enterobacteriaceae 1,800.00

Escherichia coli 1,800.00

Fecal streptococci 1,800.00

Listeria monocytogenes 1,800.00

Pseudomonas aeruginosa 1,800.00

Salmonella 1,800.00

Bacillus subtilis 1,800.00

Enterococci 1,800.00

Vibrio parahaemolyticus 1,800.00

Osmophilic Yeast 1,800.00



Other counting method 900.00

Other identification method 1,800.00

5. Bioassay Tests

Bacterial Endotoxin Test (LAL) 6,000.00

6. Toxicological Test

Bottled Water

Total package 5,550.00

Organoleptic (color, odor, taste, turbidity) 400.00

pH 400.00

Conductivity 400.00

Total dissolved solids 400.00

of 6

Nitrate 400.00

Cyanide 1,200.00

Heavy Metals (per metal) 1,800.00

Hypochlorite

Assay 800.00

Residual Chlorine 800.00

pH 400.00

Toys/ School Supplies

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

b. Additional element 1,200.00

Test for Packaging Materials

a. Migration Testing (package) 6,000.00

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

Evaluation for Suitability (food-contact) 2,000.00

Medical Devices

a. Water Leak Test (Condom) 1,000.00

b. Efficacy/ Reproducibility (In-Vitro

Diagnostic Reagents/ Kits)

1,000.00

COST OF CERTIFICATIONS

Permit and/or Approval (General)



a. Suitability evaluation of Food Contact

Materials

2,500.00

b. Evaluation of Test Results from Accredited

Laboratory

2,500.00

Lot Release Certificate



Batch Notification Certificate 6,500.00

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

of 6

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 visit

transportation and other allowable

expenses of PLSD health physics

team, to be shouldered by the

requesting agency

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 plus transportation and

other allowable expenses of PLSD

health physics team, to be shouldered

by the requesting agency

5. Rental fee for QA/QC measuring

instruments & test tools, radiotherapy

dosimeter

9,000.00/week (with accountability

contract)

administrative order subject: new schedule of fees and ... or… · drug, ra 8976, s. 2000 (the...

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