republic of the philippines department of health … on... · 2016-06-03 · building 1, san lazaro...

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila • Trunk Line 651-7800 Direct Line: 711-9501

Fax: 743-1829; 743-1786 • URL: http://www.doh.gov.ph; e-mail: [email protected]

Republic of the Philippines

Department of Health

OFFICE OF THE SECRETARY

ADMINISTRATIVE ORDER No. _______________________

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

Administration for Licensing, Registration and Other

Certifications

I. BACKGROUND AND RATIONALE

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

is the responsibility of the State to establish and maintain an effective food and

drug regulatory system and to undertake research responsive to the country's

health needs and problems. Consistent with the national policy, the Congress of

the Philippines passed three landmark legislations, namely Republic Act (RA) No.

9502, (Universally Accessible Cheaper and Quality Medicine Act of 2008),

Republic Act No. 9711, (Food and Drug Administration Act of 2009) and

Republic Act 10611 (Food Safety Act of 2013), to ensure protection of public

health and welfare.

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

No. 9711, authorizes the Food and Drug Administration (FDA) to retain all fees,

fines, royalties and other charges under a Special Regulatory Fund and to use

them as follows: operations, which includes upgrading of its facilities, equipment

outlay, human resource development and expansion; acquisition of the

appropriate office space, , as well as purchase of laboratory equipment and

motor vehicles; upgrading of its current facilities and equipment and

maintenance; funding for operating expenses of the central office laboratory

divisions and satellite laboratories; and other activities or services of the FDA in

the performance of its mandate. Furthermore, R.A. No. 9711 stated that the

FDA shall cease to be allocated its budget under the General Appropriations Act

after it has established itself to be fiscally sustainable.

To ensure financial sustainability of the organization, increasing the fees

being collected, based on the corresponding direct and indirect costs of services

provided by FDA, through a cost recovery strategy, shall be implemented.

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

department head are authorized to revise their rates of fees and charges pursuant

to Section 54 (1), Chapter 12, Book IV of the Executive Order No. 292 or the

Administrative Code of 1987. The determination of new fees is based on the

DOF-DBM-NEDA Joint Circular No. 1 (s. 2013), also known as the

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Implementing Rules and Regulation of Administrative Order No. 31 (s.

2012) sets the guidelines on the rationalization of rates of fees and charges,

increase in existing rates, and imposition of new fees and charges with direct and

indirect cost has been the main basis.

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

with the cost of regulating health products to be able to sustain its operations and

be able to achieve its legal mandate.

II. OBJECTIVE

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

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

implementation.

III. SCOPE

The new schedule of fees and charges shall apply to all persons,

establishments and health products under FDA’s jurisdiction, including but not

limited to national and local government agencies, state colleges and universities,

public schools, private entities, and non-governmental organizations availing of

FDA’s services.

IV. DEFINITION OF TERMS

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

documents submitted upon payment of assessment fee. This process is only

applicable for the applications for Certificate of Product Registration (CPR).

B. “Assessment Fee” is the amount paid for the review process, prior to the

submission of the application for FDA Authorization.

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

a barcode, whether CPR or License to Operate (LTO), issued by the FDA for

special purposes, e.g. as part of the requirements to be submitted during

biddings in government agencies.

D. “Centers” shall refer to the Center for Cosmetic Regulation and Research

(CCRR), Center for Food Regulation and Research (CFRR), Center for Drug

Regulation and Research (CDRR) and Center for Device Regulation,

Radiation Health and Research (CDRRHR) of the FDA.

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

approval of applications.

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

authorization from the FDA.

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G. “Re-issuance” is the process of granting a duplicate copy of a valid

authorization upon the request of the Marketing Authorization Holder (MAH),

due to loss or damage of the original issuance.

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

approved authorization within the prescribed period1.

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

of the issued authorization by the FDA.

V. GUIDELINES

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

Annex “A” General Certification Fees

Annex “B” CCRR

Annex “C” CDRR

Annex “D” CDRRHR

Annex “E” CFRR

Annex “F” Sample of OnColl Payment Slip

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

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

when applicable:

1) Receiving of application documents;

2) Pre-marketing activities, including but not limited to assessment, technical

evaluation and pre-licensing inspection of establishment;

3) Post-marketing surveillance of products and establishments, but not

limited to the following:

(a) Collection of sample

(b) Laboratory testing

(c) Complaints and reports processing

(d) Safety monitoring

(e) Post-licensing inspection

(f) Routine inspection

4) Printing of one (1) original copy and issuance of additional nineteen (19)

electronic authenticated copies of the LTO and CPR;

5) Records management and archiving; and

6) Courier services to deliver the authorization.

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

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

or 1% of the application fee, whichever is higher, as imposed by RA 3870,

as amended by PD 200 and further amended by PD 1856, of which FDA is 1 Refer to Section V.I of this AO.

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

December 1981.

2) Other fees incurred from the use of payment collection facilities, such

as service fees charged by banks authorized by the FDA to collect its

fees.

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

whichever is higher shall also be collected.

E. Applications for renewal made as early as six (6) months to three (3) months

prior to expiration of LTO and CPR will be entitled to a discounted rate of ten

per cent (10%) of the renewal fee; provided that the applications are compliant

with the renewal requirements.

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

Administration shall be collected ONLY through the FDA Cashier and all

authorized FDA Satellite Cashiers.

Payments may also be made through:

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

2) BancNet System.

The FDA may issue additional guidelines regarding new payment modes and

methods.

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

for product registration, whichever is higher, shall be imposed along with the

resetting of timelines for applications that failed to meet the prescribed

timeline to comply with a Notice of Deficiency/Letter of Denial.

H. The categories for the size of the business operation used by CCRR and CFRR

for licensing purposes shall be in accordance with DTI Resolution No. 01

(Series of 2003 dated 16 January 2003) issued by the Small and Medium

Enterprise Development (SMED) Council2.

2 Sec. 3. Micro, Small and Medium Enterprises (MSMEs) as Beneficiaries. – MSMEs shall be defines as

any business activity or enterprise engaged in industry, agribusiness and/or services, whether single

proprietorship, cooperative, partnership or corporation whose total assets, inclusive of those arising from

loans but exclusive of the land on which the particular business entity’s office, plant and equipment are

situated, must have value falling under the following categories:

Micro Php 3,000,000.00 below

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

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

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

shall be considered Large.

I. Pursuant to Section 3, Paragraph (A) (2) and (B) (2) of Article 1, Book II on

Licensing of Establishments and Registration of Health Products of IRR of

RA 9711, the surcharge or penalty, which shall be imposed only for

applications for renewal of LTO or CPR registration received after the date of

their expiration, shall be assessed and imposed. This rule applies even in

succeeding renewal applications.

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

shall be subject to a surcharge or penalty equivalent to twice the renewal

licensing fee and an additional 10% per month or a fraction thereof of

continuing non-submission of such application up to a maximum of one

hundred twenty (120) days. Any application for renewal of license filed

thereafter shall be considered expired and the application shall be subject to a

fee equivalent to the total surcharge or penalty plus the initial filing fee and

the application shall undergo the initial filing and evaluation procedure.

For renewal applications filed within one hundred twenty (120) days from its

original expiry, the LTO shall be considered valid and existing until a decision

or resolution by the FDA is rendered on the application for renewal.

J. The validity of the License to Operate (LTO) shall be two (2) years for Initial

issuance and three (3) years for Renewal. On the other hand, the validity of

the Certificate of Product Registration (CPR) shall be five (5) years for both

initial and renewal applications. This is applicable for all the FDA Centers.

V. IMPLEMENTATION ARRANGEMENTS

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

otherwise specified in the attached Annexes.

B. The fees and charges shall be subject to regular review. The Committee on

Fees and Charges shall undertake periodic review, conduct consultations with

stakeholders, and recommend amendments to this Administrative Order, when

necessary, to the Office of the Director-General, for approval of the Secretary

of Health.

VI. REPEALING CLAUSE

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

2011-004 and other previous issuances inconsistent with this Administrative

Order are hereby repealed, rescinded and modified accordingly.

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VII. SEPARABILITY CLAUSE

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

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

and effective.

VIII. EFFECTIVITY DATE

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

following the completion of publication in two newspapers of general circulation.

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

Secretary of Health

Office of the Director General

Food and Drug Administration

Health Policy Development and Planning

Bureau Office for Health Regulation Office of the Secretary

Maria Lourdes C. Santiago, MSc, MM

OIC, Director General

Lilibeth C. David, MD, MPH, CESO III

Undersecretary

Kenneth Y. Hartigan-Go, MD

Undersecretary

Date: Date: Date: Date:

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Annex A

General Certification Fees (Common to all Centers)

Certification

Fees (in PhP)

1. Issuance of an Authenticated Copy of

the Document

(for the first 5 complete set)

for the succeeding – P50.00/copy)

500.00

2. Re-issuance of an Authorization or

License (Lost or Damaged Original) 2,000.00

3. Certification / Clearance /

Verification/Special Permit* 500.00

4. 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

1,000.00

5. Certificate of Free Sale 1,000.00

6. Permit to Carry/Mail (Personal Use) 50.00/transaction

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

*Except clearances specifically mentioned in other Annexes

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Annex B

CENTER FOR COSMETIC REGULATION AND RESEARCH

LICENSE TO OPERATE

Fees (in Php)

Initial

(2 years)

Renewal

(3 years)

Manufacturer/ Trader (Cosmetics, Household/Urban Pesticides)

Micro –scale Enterprises (Total Assets)

Group I (<500,000)

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

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

10,000.00

14,250.00

Small (3,000,001-15,000,000) 20,000.00 28,500.00

Medium (15,000,001-100,000,000) 30,000.00 42,750.00

Large (>100,000,000) 40,000.00 57,000.00

Manufacturer (Toys and Childcare Articles)

Micro –scale Enterprises

Group I (<500,000)

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

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

5,000.00

7,500.00

10,000.00

7,200.00

10,700.00

14,250.00

Small (3,000,001-15,000,000) 20,000.00 28,500.00

Medium (15,000,001-100,000,000) 25,000.00 35,650.00

Large (>100,000,000) 35,000.00 50,000.00

Distributor 20,000.00 30,000.00

Variations (Manufacturer/Trader/Distributor)

Major Variation 8,000.00

Minor Variation 4,000.00

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PRODUCT REGISTRATION/NOTIFICATION

Fees (in PhP)

Initial

( 5 years)

Renewal

(5 years)

Certificate of Product Registration

Household/Urban Pesticides

15,000.00

Notification Fees (in PhP)

(1 year)

a. Cosmetics/HUHS

Basic Notification Fee 1,000.00

Variants (per variant) 200.00

b. Toys and Childcare Articles (5 SKUs) 250.00

Amendments

Household/Urban Pesticides

i. Major Variation 3,000.00

ii. Minor Variation 1,500.00

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Annex C

CENTER FOR DRUG REGULATION AND RESEARCH

LICENSE TO OPERATE

Fees (in PhP)

Initial

(2 years)

Renewal

(3 years)

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

2. Manufacturer-Trader 30,000.00 36,500.00

3. Distributor (Exporter, Importer, Wholesaler) 30,000.00 36,500.00

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

RONPD 4,500.00 6,500.00

5. Contract Research Organization / Sponsor 30,000.00 36,500.00

Variations

Major Variation – Manufacturer 8,500.00

Major Variation – Manufacturer-Trader / Distributor /

CROs/Sponsors 6,500.00

Major Variation – Drugstore/ Pharmacy/Botica and Other

Similar Outlets, RONPD 3,500.00

Minor Variation – Notification 1,500.00

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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. Biotechnological Products 170,000.00 68,000.00

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

VARIATIONS

Major Variation – A* 35,000.00

Major Variation – B 25,000.00

Minor Variation – Prior Approval 6,500.00

Minor Variation – Notification 1,500.00

OTHER PERMITS AND CLERANCES

1. Generic Labelling Exemption Permit / year 1,500.00

2. Conversion to PCPR 1,500.00

3. Compassionate Special Permit (Institutional Use) 6,000.00

4. Donation Certificate 1,500.00

5. Export Certificate 1,500.00

6. Certificate of Pharmaceutical Product 1,500.00

7. Product Classification 1,500.00

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

FDA Circular No. 2014-008. For multiple variations on product registration with any major

variation enumerated herein, only the major variation fee will be collected.

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Annex D

CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND

RESEARCH

LICENSE TO OPERATE

(Medical and Non-Medical Radiation Facilities)

Fees Per Machine (in Php)

Initial

(2 years)

Renewal

(3 years)

1. Medical X-Ray Facility (General Radiography and/or

Fluoroscopy/Mobile C-Arm, Simulator, Lithotripsy,

Bone Densitometry)

4,000.00 5,000.00

2. Non-Medical X-Ray Facility (Industrial, Anti-Crime,

Educational and Research, Veterinary, Dental)

4,000.00 5,000.00

3. Specialized Medical Radiation Facility:

[Computed Tomography (CT), Mammography,

Interventional Radiology (Cardiac Catheterization)]

8,000.00 10,000.00

4. Therapeutic Radiation Facility Utilizing Linear

Accelerator (LINAC)

20,000.00 25,000.00

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/application

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

(Medical Device)

Fees (in Php)

Initial

(2 years)

Renewal

(3 years)

1. Manufacturer/Repacker 50,000.00 75,000.00

2. Distributor (Importers, Exporters and

Wholesalers) 15,000.00 22,500.00

VARIATIONS

Major Variations-Manufacturer 5,000.00

Minor Variations 1,000.00


(Medical Device)

Fees (in Php)

Initial

(5 years)

Renewal

(5 years)

1. Class A 15,000.00 15,000.00

2. Class B 30,000.00 30,000.00

3. Class C 40,000.00 40,000.00

4. Class D 60,000.00 60,000.00

VARIATIONS

Major Variations 1 3,000.00

Major Variations 2 6,000.00

Minor Variations 1,000.00

SERVICE

(Physics Laboratory)

Period of charging Fees (in Php)

1. Performance testing per x-ray machine

Per machine 20,000.00 per

machine plus

transportation cost

of the health

physics team

2. Calibration of radiotherapy dosimeter

(electrometer & ion chamber)

Per dosimeter 8,000.00 per

dosimeter

3. Rental of non-invasive kV meter and

related accessories as 1 set

Per day of use,

or fraction thereof 7,000.00/day

4. Rental of non-electronic x-ray QA

test tools

Per day of use,


5. Rental of selective frequency meter

for radio frequencies

Per day of use,


6. Rental of densitometers Per day of use,


7. Rental of sensitometers Per day of use,


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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)

2,000.00

6,000.00

9,000.00

3,000.00

9,000.00

13,500.00

Small Enterprises 15,000.00 30,000.00

Medium Enterprises 30,000.00 60,000.00

Large Enterprises 60,000.00 90,000.00

Food Distributor (Importer/ Exporter/Wholesaler)

15,000.00

30,000.00

Food Trader

15,000.00

30,000.00

VARIATIONS

Fees (in Php)

Major Variation 3,000.00

Minor Variation 1,500.00


Fees (in Php)

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

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ANNEX F

ONCOLL PAYMENT SLIP

0 3 9 2 2 2 2 0 0 6

NAME OF INDUSTRY

Notification Number (14 alphanumeric

characters)

republic of the philippines department of health … on... · 2016-06-03 · building 1, san lazaro...

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