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