Revised 2000 Schedule of Fees and Charges for the corresponding services rendered by the Bureau of Licensing and Regulation, Bureau of Research and Laboratories, Bureau of Food and Drugs and National Quarantine Office.

The Department of Health pursuant to Executive Order No. 197 Section 1: œAll departments, bureaus  offices, agencies and units, including government owned or controlled corporations are hereby directed to review and upgrade their rates of fees and charges by not less than twenty percent (20%) hereby prescribes the revised 2000 schedule of fees and charges for compliance.

I.          BUREAU OF FOOD AND DRUGS

A.        Fee for License to Operate establishments dealing with products regulated by BFAD.

CLASSIFICATION					FEES
				Initial	Renewal
				(1 year validity)	(2 years validity)
1.	Drug Outlets
	1.1 Drugstores, Hospital Pharmacy			P2,000.00	P4,000.00
	1.2 Chinese Drugstore			P1,000.00	P2,000.00
	1.3 Retail Outlet for Non-Prescription Drugs only			P1,000.00	P2,000.00
2.	Drug Distributors:			P5,000.00	P10,000.00
	(Importer/Wholesaler)
3.	Cosmetic Distributor			P4,000.00	P8,000.00
	(Importer/Wholesaler/Exporter)
4.	Medical Devices Distributors			P4,000.00	P8,000.00
	(Importer/Wholesaler/Exporter)
5.	Food Distributors			P5,000.00	P10,000.00
	(Importer/Wholesaler/Exporter)
6.	Household Hazardous Substances Distributors
	(Importer/Wholesaler/Exporter)			P4,000.00	P8,000.00
7.	Drug manufacturer
	7.1 P20M and below			P10,000.00	P20,000.00
	7.2 Over P30M but below P50M			P15,000.00	P30,000.00
	7.3 P50M and above			P20,000.00	P40,000.00
8.	Drug Traders
	8.1 P20M and below			P3,000.00	P6,000.00
	8.2 Over P20M but below P50M			P5,000.00	P10,000.00
	8.3 P50M and above			P7,000.00	P14,000.00
9.	Cosmetic Laboratory
	9.1 P20M and below			P5,000.00	P10,000.00
	9.2 Over 20M but below P50M			P10,000.00	P20,000.00
	9.3 P50M and above			P15,000.00	P30,000.00
10.	Cosmetic Trader
	10.1 P20M and below			P3,000.00	P6,000.00
	10.2 Over P20M but below P50M			P5,000.00	P10,000.00
	10.3 P50M and above			P7,000.00	P14,000.00
11.	Medical Device Manufacturer
	11.1 P20M and below			P5,000.00	P10,000.00
	11.2 Over P20M but below P50M			P7,000.00	P14,000.00
	11.3 P50M and above			P10,000.00	P20,000.00
12.	Medical Device Trader
	12.1 P20M and below			P3,000.00	P6,000.00
	12.2 Over P20M but below P50M			P5,000.00	P10,000.00
	12.3 Over P50M			P7,000.00	P14,000.00
13.	Food Manufacturer
	13.1 P10M and below			P3,000.00	P6,000.00
	13.2 Over P10M but below P20M			P5,000.00	P10,000.00
	13.3 Over P20M but below P50M			P10,000.00	P20,000.00
	13.4 P50M and above			P15,000.00	P30,000.00
14.	Household Hazardous Substances Manufacturers
	14.1 P10M and below			P3,000.00	P6,000.00
	14.2 Over P10M but below P20M			P5,000.00	P10,000.00
	14.2 Over P20M but below P50M			P10,000.00	P20,000.00
	14.3 P50M and above			P15,000.00	P30,000.00
B.	FEES FOR PRODUCT REGISTRATION
				FEES
				Initial	Renewal
				(5 years validity)	(5 years validity)
1.	Drugs
	1.1 Monitored release for New Drug			P20,000.00 (3 years)
	1.2 Unbranded Application			P10,000.00	P7,500.00
	1.3 Branded Application			P15,000.00	P10,000.00
	1.4 Re-application Fee for Drug			P1,000.00
2.	Medical Device			P1,500.00 (1 year)	P5,000.00
3.	Diagnostic Reagents			P1,500.00 (1 year)	P5,000.00
4.	Food
	4.1 Category I			P1,000.00 (2 years)	P3,000.00 (3 years)
	4.2 Category II			P3,000.00 (2 year)	P4,500.00 (3 years)
	4.3 Food Supplement			P3,000.00 (2 years)	P4,500.00 (3 years)
	4.4. Bottled Water			P2,000.00 (2 years)	P3,000.00 (3 years)
5.	Household Hazardous Substances			P1,500.00 (2 years)	P2,250.00 (3 years)
6.	Cosmetics
	6.1 Listing			P1,500.00 (2 years)	P2,250.00 (3 years)
	6.2 Regular			P1,500.00 (2 years)	P4,750.00 (5 years)
7.	Re-application fee for all products			1,000.00
C.	COST OF LABORATORY ANALYSIS
	CLASSIFICATION				FEES
A.	Physico-Chemical Analysis
	a.1 Drugs and Antibiotics
		Visual Examination			P 300.00
		Assay/Potency (Single Component)			P1,500.00
		Assay/Potency (Multi Component)			P2,000.00
		Dissolution Test			P2,000.00
		Disintegration Test			P 350.00
		Hardiness Test			P 350.00
		Identification Test			P 500.00
		Purity Test/Related Substances			P 500.00
		Moisture Content			P 300.00
		Loss on Dying			P 300.00
		PH
		Vitamins			P 300.00
			Vitamins A		P1,000.00
			Vitamin B1, B2, B6		P2,000.00
			Vitamin C (Ascorbic Acid)		P 500.00
			Vitamin E		P 500.00
			Other Vitamins		P 500.00
			Minerals		P 800.00
	a.2 Diagnostic Reagents				P1,000.00
	a.3 Medical Devices				P1,500.00
	a.4 Cosmetic
		Assay			P1,200.00
		Identification Test			P 500.00
		Volatile/Non-Volatile Matters			P 500.00
	a.5 Food Products
		Moisture			P 300.00
		Protein			P1,000.00
		Fat/Oil			P 500.00
		Starch			P 500.00
		Glucose			P 500.00
		Sucrose			P 500.00
		Lactose			P 500.00
		Crude Fiber			P 500.00
		Dietary Fiber			P2,000.00
		Total Solids			P 300.00
		Soluble Solids			P 300.00
		Water Insoluble Solids			P 300.00
		Ash			P 300.00
		Acid Insoluble Ash			P 500.00
		Saponification Number			P 500.00
		Viscosity			P 300.00
		Refractive Index			P 300.00
		Peroxide Value			P 500.00
		Free Fatty Acids			P 500.00
		Permanganate Oxidation No (PON)			P 500.00
		Total Acidity			P 300.00
		Water Acidity			P 300.00
		Vacuum			P 300.00
		Minerals			P1,000.00
		Amino Acids (LC)			P2,000.00
		Proline			P 500.00
	Additives
		Nitrates			P 500.00
		Nitrite			P 500.00
		Sodium Benzoate			P 500.00
		Sorbic Acid			P 500.00
		Food Color			P 300.00/color
		Sodium Metabisulfite			P 500.00
		Bromates			P 500.00
		BHT			P 500.00
		BHA			P 500.00
		Aspartame			P 500.00
		Saccharin			P 500.00
		Monosodium Glutamate			P 300.00
	Micronutrients
		Vitamin A			P1,000.00
		Vitamin E			P1,000.00
		Beta Carotene			P1,000.00
		Vitamin C			P 500.00
		Vitamin B1B6			P1,000.00
		Vitamin B2B6 Niacin			P1,000.00
		Iodine			P 500.00
		Iron			P 500.00
	Contaminants
		Borax			P 300.00
		Aflatoxin			P2,000.00
		Total Heavy Metals			P 500.00
		Lead			P 500.00
		Cadmium			P 300.00
		Chromium			P 300.00
		Arsenic			P 300.00
		Mercury			P 300.00
		Tin			P 300.00
		Cyanide			P 300.00
		Histamine			P1,500.00
		Filth			P 500.00
		Formalin			P 500.00
		Pesticide			P2,000.00
		Alcohol Content			P1,000.00
		Gas Volume			P 300.00
		Total Soluble Solids (Brix)			P 300.00
		pH			P 300.00
		Caffeine			P 500.00
	a.6 Food Supplements				P4,000.00
	a.7 Beverages
		Alcohol content			P1,000.00
		Gas Volume			P 300.00
		Total Soluble Solids (Brix)			P 300.00
		pH			P 300.00
		Caffeine			P 500.00
	a.8 Bottled Water				P2,000.00
	a.9 Food Chemicals/Additives
		Direct			P1,000.00
		Indirect			P 500.00
	a.10 Containers/Wrappers
		Migratable Substances			P1,000.00
		Plastic Additives			P 500.00
		Cellulosic Materials for Pesticide Residue			P1,500.00
		Materials Testing			P 500.00
B.	Microbiological Assay
	(Potency of Antibiotics)				P2,500.00
C.	Sterility Test
	(Injectables, Medical Devices and Large Volume Parenterals				P2,500.00
D.	Microbial Limit Tests
		Aerobic Plate Count			P 500.00
		Aerobic Halophilic Count			P 500.00
		Aerobic Psychhrophillic Count			P 500.00
		Aerobic Thermophilic Spore Count			P 500.00
		Coliform Plate Count			P 500.00
		Coliform/E Coli (MPN)			P 500.00
		Fecal Streptocci			P 600.00
		Yeast and Mold Count			P 500.00
		Halophilic Yeast Count			P 500.00
		Staphylococcus Aureus Count			P 600.00
		Pseudomonas Aeruginosa			P 600.00
		Identification of Microorganisms
			Presumptive Test		P 600.00
			Confirmatory Test (complete Bio-chemical reaction)		P2,000/organism
			Commercial Sterility of Thermally Processed Foods in Hermetically Sealed Containers		P1,000.00
E.	Bioassay Test
		Depressor Substances Test			P5,500.00
		Skin Irritation Test			P5,500.00
		Eye Irritation Test			P5,700.00
		Paralytic Shellfish Poisoning Test (red tide)			P1,000.00
		Safety test			P1,500.00
		Acute Toxicity Test (rat)			P22,000.00
		Acute Toxicity Test (mouse)			P10,000.00
		Pyrogen Test			P5,200.00
		Bacterial Endoxin Test (LAL)			P4,000.00
F.	Others
	1. Authentication Fees:
		1.1 Express Lane (per copy)			P 100.00
		1.2 Regular Lane			P 50.00
2.	Certifications/Re-issuances/Clearances
		2.1 Free Sale/CGMP (Certificate of Pharmaceutical Product)			P 500.00
		2.2 Non Registrable			P 500.00
		2.3 GMP Certificate			P 500.00
		2.4 Products/Raw Materials for Exports			P 500.00
		2.5 Re-issuance of Valid CPR/LTO (for lost CPR or LTO)			P 500.00
		2.6 Products for Mailing/Hand-carry			P50.00/certificate
		2.7 Medical Director			P 500.00
		2.8 Permit to Import/Export			P 500.00
		2.9 Clearances			P 500.00
		2.10 All other Certificates			P 500.00
3.	Amendments:
		3.1 Amendments of CPR ™s/LTO			P 500.00
		3.2 Extension of Shelf Life			P1,000.00
4.	Additional source of supplier for LTO (For Importer/wholesaler/Distributor having more than 5 sources per supplier)				P 200.00
5.	Pre-site inspection				P500 + additional cost of transport & per diem
II.	BUREAU OF LICENSING AND REGULATION
A.	Hospital
		Category		License Fees
				Initial	Renewal
P	Primary			P750.00	P375.00
	Secondary			P1,100.00	P500.00
	Tertiary			P3,000.00	P1,500.00
				Fees
	Registration Fee (all categories)			P200.00
		Certification Fee		P 50.00
B.	PERMIT TO CONSTRUCT
	Category			Fees
	Primary			P300.00
	Secondary			P500.00
	Tertiary			P1,000.00
C.	DENTAL PROSTHETIC LABORATORIES
	Category			License Fees
				Initial	Renewal
	Primary			P600.00	P300.00
	Secondary			P800.00	P400.00
	Tertiary			P2,000.00	P1,000.00
D.	ACCREDITATION AND AUTHENTICATION
				Fees
1.	Application for accreditation			P 1,500.00
2.	Accreditation			P 1,500.00
3.	Cash Bond			P50,000.00
4.	Authentication per document			P 50.00
E.	FREE STANDING
	Application for LTO			P600.00
	License			P2,000.00
F.	AMBULATORY SURGICAL CLINICS
	Application			P800.00
	Accreditation			P800.00
G.	HEALTH MAINTENANCE ORGANIZATIONS
	CLASSIFICATION			CLEARANCE TO OPERATE FEES
				Initial	Renewal
	Stock			P50,000.00	P10,000.00
	Non-Stock			P10,000.00	P2,000.00
III.	BUREAU OF RESEARCH AND LABORATORIES
A.	Clinical Laboratory
	Category			License Fees
				Initial	Renewal
	Primary			P400.00	P200.00
	Secondary			P600.00	P300.00
	Tertiary			P1,000.00	P500.00
B.	Blood Service Facility (Blood Bank/Blood Center)
	A & B			P600.00	P400.00
C.	Accreditation Fees
	HIV Testing Laboratory
	CL and BSF			P1,000.00	P500.00
	Med. Tech. Interns Training Laboratory
	CL and BSF			P2,000.00	P1,000.00
	Water Testing Laboratory
	FB and HB			P500.00	P250.00
IV.	NATIONAL QUARANTINE OFFICE
A.	Fees
	Category				Fees
1.	Immunization
		1.1 Yellow Fever			P600.00
		1.2 Certification of Waiver			P 60.00
		1.3 Duplicate Certificate of Vaccination			P 60.00
		1.4 Validation			P 40.00
B.	Medical Examination Fees of Aliens for Immigration Purposes
		Category			Fees
1.	Physical Examination and Document Fees				P200.00
2.	Chest X-ray Examination				P200.00
3.	Serological Test (VDRL/RPR)				P150.00
4.	Routine Fecalysis				P 50.00
5.	Routine Urinalysis				P 50.00
6.	Certification for Board of Investment				P100.00
C.	Medical Examination Fees of Stewards and Foodhandlers (Subsidized)
	Category				Fees
1.	Chest X-ray Examination				P100.00
2.	Routine Urinalysis				P 20.00
3.	Routine Fecalysis				P 20.00
4.	Serologic Test (VDRL/RPR)				P 50.00
D.	Derating Certification Fees
1.	Deratting Certificate				P250.00
2.	Deratting Extension Certificate				P400.00
E.	Derrating Exemption Certificates
1.	Vessels 1000 tons or less				P400.00
2.	Vessels 1001 tons to 2000 tons				P600.00
3.	Vessels 2001 tons to 3000 tons				P1,000.00
4.	Vessels 3001 tons to 4000 tons				P1,200.00
5.	Vessels 4001 tons to 5000 tons				P1,500.00
6.	Vessels above 5001 tons				P1,800.00
F.	Miscellaneous Fees
1.	Laboratory Examination for Cholera Vibrio				P250.00

Existing issuances and orders related to the subject which are inconsistent with this Administrative Order are hereby rescinded or revoked.

This Order shall take effect on October 16, 2000.

Adopted: 17 April 2000

(SGD.) ALBERTO G. ROMUALDEZ, JR. MD
Secretary of Health