Page 1 of 22 
  
 
 
 
 
 
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 pr oblems.  
 
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 no t offered for sale or use. The scope of the health product s 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 severa l 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 S pecial 
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  a nd  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 Regulati ons 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 authorizati on. 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 Page 2 of 22 
 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 re sponsive 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  “Revis ed 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 “Impleme nting Rules and Regulations of Administrative Order No. 
31 s. 2012 on the Rationalization of Rates of Fees and Charges, Increase in Existing Rates and 
Imposi tion of New Fees and Charges”, the FDA is restructuring its fees and charges at a level 
commensurat e 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 d ifferent 
establishments.  Page 3 of 22 
  
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 charge s 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, tech nical 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;  Page 4 of 22 
 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 a uthorized 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 g eneral, 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 t o 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 Page 5 of 22 
 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 a pplication 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 pr ocedure  
 
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 ARR ANGEMENTS  
 
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  
 Page 6 of 22 
  
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 AnnexesPage 7 of 22 
  
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  Page 8 of 22 
 Certifications for Supervising Pesticide Handlers and 
Pesticide Handlers  3,000.00  5,000.00  
Accreditation of Training Providers  6,000.00  10,000.00  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
 
 
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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
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)  Page 9 of 22 
 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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
 
 
 
 
  
 
Page 10 of 22 
 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  
VARIATION (Minor – w/out 
inspection)  1,000.00 / variation  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
 
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   
 
Page 11 of 22 
 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)  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
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    
 
Page 12 of 22 
 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 
DSA + transportation cost   
 
Page 13 of 22 
 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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
 
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 indust rial 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 pre viously 
approved address; Change of location of the machine within the facility (includes the transfer of stationary  
 
Page 14 of 22 
 machine from one room to another or from one area or another); and Change of machine or inclusion of 
additional machine/s (includes replace ment 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 fa cility 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  
VARIATION  (Minor – w/out 
inspection)  1,000.00 / variation  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
PRODUCT REGISTRATION  
(Water Purification/Treatment Device)  Fees (in Php)*  
Initial  
(5 years)  Renewal  
(5 years)   
 
Page 15 of 22 
 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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
 
 
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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Page 16 of 22 
 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 
inspection)  1,000.00 / variation  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
* 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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
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   
 
Page 17 of 22 
 Diamond Seal  2,000.00/year  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
  
 
Page 18 of 22 
 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  
a. Single component  3,000.00  
b. Multiple component  4,800.00  
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   
 
Page 19 of 22 
 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   
 
Page 20 of 22 
 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   
 
Page 21 of 22 
      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  
* All fees  are subject to an additional 1% for Legal Research Fee (LRF)  
 
 
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 
DSA + transportation cost  
3. Countries outside Asia -Pacific  USD 10,500.00 + UNDP 
DSA + transportation cost  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
 
COST OF CERTIFICATIONS  
Classification  Fees (in PhP)*  
Suitability Evaluation of Food Contact Materials  2,500.00  
Evaluation of Test Results from Accredited Laboratory  2,500.00  
Lot Release Certificate   
a. Single component  3,000.00   
 
Page 22 of 22 
 b. Multiple component  4,500.00  
Lot Release Certificate Addendum  500.00  
Batch Notification Certificate  6,500.00  
Amendment of Certificates and Test Reports  500.00  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
COST OF LABORATORY BRED ANIMALS  
Classification  Fees (in PhP)*  
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  
* All fees are subject to an additional 1% for Legal Research Fee (LRF)  
 
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 reques ting 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 guid elines 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