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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
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 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.
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 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;
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 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
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 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
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 Annexes
Page 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 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
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 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
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 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