BFD Administrative Order No. 104-A (2000)

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

[ 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. 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 P1,000.00 P2,000.00 only 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) Household Hazardous Substances 6. 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 Household Hazardous Substances 14. 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. Drugs1.1 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 P3,000.00 (3 4.1 Category I P1,000.00 (2 years) years) P4,500.00 (3 4.2 Category II P3,000.00 (2 year) years) P4,500.00 (3 4.3 Food Supplement P3,000.00 (2 years) years) P3,000.00 (3 4.4. Bottled Water P2,000.00 (2 years) years) P2,250.00 (3 5. Household Hazardous Substances P1,500.00 (2 years) years) 6. Cosmetics P2,250.00 (3 6.1 Listing P1,500.00 (2 years) years) P4,750.00 (5 6.2 Regular P1,500.00 (2 years) 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 P2,000.00Vitamin 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 500.00Vitamin 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 P2,500.00 Volume Parenterals D. Microbial Limit Tests Aerobic Plate Count P 500.00 Aerobic Halophilic Count P 500.00 Aerobic Psychhrophillic Count P 500.00Aerobic 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 P1,000.00 Hermetically Sealed Containers 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 Additional source of supplier for LTO (For 4. Importer/wholesaler/Distributor having more than 5 sources per P 200.00 supplier) 5. Pre-site inspection P500 + additional cost of transport & per diemII. 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 ACCREDITATION AND D. 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 HEALTH MAINTENANCE G. ORGANIZATIONS CLASSIFICATION CLEARANCE TO OPERATE FEESInitial Renewal Stock P50,000.00 P10,000.00 Non-Stock P10,000.00 P2,000.00 BUREAU OF RESEARCH AND III. 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 Blood Service Facility (Blood Bank/Blood B. 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 Medical Examination Fees of Aliens for B. 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 Medical Examination Fees of Stewards and C. 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