(NAR) VOL. 12 NO. 2 / JANUARY - MARCH 2001
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 |