(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: | 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 |