2000 / Apr
BFD ADMINISTRATIVE ORDER NO. 104-A, 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 (AMENDMENT TO ADMINISTRATIVE ORDER NO. 40, S. 2000) April 17, 2000
[ BFD ADMINISTRATIVE ORDER NO. 104-A, 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 (AMENDMENT TO 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.
The Department of Health pursuant to Executive Order No. 197 Section 1: “All 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.
Existing issuances and orders related to the subject which are inconsistent with this Administrative Order are hereby rescinded or revoked.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
The Department of Health pursuant to Executive Order No. 197 Section 1: “All 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