BFD ADMINISTRATIVE ORDER NO. 40, S. 2000 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. April 17, 2000

The Department of  Health pursuant to Executive Order No. 197 Section 1 : “All departments, bureaus, offices, agencies and units, including government owned and 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.

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: (Importer/Wholesaler)	P5,000.00	P10,000.00
3. Cosmetic Distributor	P4,000.00	P8,000.00
4. Medical Devices Distributors	P4,000.00	P8,000.00
5. Food Distributors	P4,000.00	P8,000.00
6. Household Hazardous Substances Distributors	P2,000.00	P4,000.00
	6.1 For distributors with more t han five (5) suppliers/source	P500 (for every additional supplier/source
7. Drug manufacturer
	7.1 P30M and below	P10,000.00	P20,000.00
	7.2 Over P30M but below P50M	P15,000.00	P30,000.00
	7.3 Over P50M	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 Over P50M	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 Over P50M	P15,000.00	P30,000.00
10. Cosmetic Trader
	10.1 P20M and below	P1,000.00	P2,000.00
	10.2 Over P20M but below P50M	P3,000.00	P6,000.00
	10.3 Over P50M	P5,000.00	P10,000.00
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 Over P50M	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 P20M and below	P3,000.00	P6,000.00
	13.2 Over P20M but below P50M	P5,000.00	P10,000.00
	13.3 Over P50M	P10,000.00	P20,000.00
14. Household Hazardous Substances Manufacturers
	14.1 P20M and below	P2,000.00	P4,000.00
	14.2 Over P20M but below P50M	P4,000.00	P8,000.00
	14.3 Over P50M	P6,000.00	P12,000.00
B. FEES FOR PRODUCT REGISTRATION
1. Drugs
	1.1 Monitored release for New Drug	P20,000.00
		(3 years)
	1.2 Unbranded Application	P10,000.00	P7,500.00
		(5 years)	(5 years)
	1.3 Branded Application	P15,000.00	P7,500.00
		(5 years)	( 5years)
	1.4 Re-application fee for drug food	P1,000.00	(5 years)
2. Medical Device	P1,500.00	P5,000.00
		(1 year)	(5 years)
3. Diagnostic Reagents	P1,500.00	P5,000.00
4. Food
	4.1 Category I	P1,000.00	P2,000.00
		(1 year)	(2 years)
	4.2 Category II	P1,500.00	P3,000.00
		(1 year)	(2 years)
	4.3 Food Supplement	P1,500.00	P3,000.00
		(1 year)	(2 years)
	4.4. Bottled Water	P1,000.00	P2,000.00
		(1year)	(2 years)
5. Household Hazardous Substances	P750.00	P1,500.00
6. Cosmetics
	6.1 Listing	P750.00	P1,500.00
		(1 year)	(2 years)
	6.2 Regular	P1,500.00	P3,000.00
		(2 years)	(5 years)
C. COST OF LABORATORY ANALYSIS
	CLASSIFICATION		FEES
A. Physico-Chemical Analysis
	a.1 Drugs and Antibiotics
		Assay/Potency (Single Component)		P1,200.00
		Assay/Potency (Multi Component)		P1,600.00
		Dissolution Test		P2,000.00
		Disintegration Test		P 300.00
		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		P 300.00
		Vitamins
			Vitamins A		P 600.00
			Vitamin B1, B2, B6		P1,400.00
			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		P 500.00
		Fat/Oil		P 500.00
		Starch		P 500.00
		Glucose		P 500.00
		Surcose		P 500.00
		Lactose		P 500.00
		Crude Fiber		P 500.00
		Dietary Fiber		P1,500.00
	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 Activity		P 300.00
	Vacuum		P 300.00
	Minerals		P 500.00
	Amino Acids (LC)		P1,500.00
	Proline		P 500.00
		Additives		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		P1,500.00
	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 500.00
	Histamine		P1,500.00
	Filth		P 500.00
	Formalin		P 500.00
	Pesticide Residue		P2,000.00
	a.6 Food Supplements		P1,500.00
	a.7 Bottled Water		P2,000.00
	a.8 Food Chemicals/Additives
		Direct		P1,000.00
		Indirect		P 500.00
	a.9 Containers/Wrappers
		Migratable Substances		P 500.00
		Plastic Additives		P 500.00
		Cellulosic Materials for Pesticide Residue		P1,500.00
		Materials Testing		P 500.00
B. Microbiological Assay		P2,000.00
	(Potency of Antibiotic)
C. Sterility Test
	(injectibles, Medical Devices and Large Volume Parenterals	P2,500.00
D. Microbiological Analysis
		Aerobic Plate		P 500.00
		Aerobic Halophilic Count		P 500.00
		Aerobic Psychrophillic Count		P 500.00
		Aerobic Thermophilic Spore Count		P 500.00
		Coliform Plate Count		P 500.00
		Coliforms/E Coli (MPN)		P 600.00
		Fecal Streptocci		P 500.00
		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 Thermetically Sealed Containers		P1,000.00
E. Bioassay Test
		Depressor Substances Test		P5,000.00
		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
Others
	1. Authentication Fees:
		1.1 Express Lane (per page)		P 50.00
F. Others
	1. Authentication Fees:
		1.1 Express Lane (per copy)		P 50.00
		1.2 Regular Lane
			1.2.1 LTO’s/CPR’s/CPL’s per copy)		P 20.00
			1.2.2 Batch Certification (per page)		P 20.00
			1.2.3 Certification/Affidavit of Loss (per copy)		P 20.00
			1.2.4 Foreign documents (per page) ( FSC, CGMP, Mfg. Agreement)	P 20.00
			1.2.5 BFAD issued FSC or CGMP (per page)		P 20.00
2. Certifications:
	2.1 Free Sale/CGMP (Certificate of Pharmaceutical Product)		P 200.00
	2.2 Amendment of CPR/LTO		P 200.00
	2.3 Non Registrable		P 200.00
	2.4 Extension of Shelf-Life		P1,000.00
	2.5 All other Certification for Products/LTO		P 500.00
	2.6 GMP Certificate		P 500.00
	2.7 Products/Raw Materials for Exports		P 500.00
	2.8 Validity of LTO		P 200.00
	2.9 Re-issuance of Currently Valid CPR/LTO (for lost CPR or LTO)		P 500.00
	2.10 Drugs for Mailing/Hand carry		P20.00/certificate
	2.11 Medical Director		P 500.00
II. BUREAU OF LICENSING AND REGULATION
A.	HOSPITAL FEES
	Category	License fees
		Initial	Renewal
	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 DIALYSIS CLINICS
	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	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
	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		P600.00
	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.

Adopted: 17 April 2000

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