BFD Administrative Order No. 40 (2000)

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

[ 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 DrugsP1,000.00 P2,000.00 only 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 P500 (for every additional han five (5) suppliers/source 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 Laboratory9.1 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 P1,500.006. 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 500.00Viscosity 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 500.00Plastic 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- P2,000/organism chemical reaction) Commercial Sterility of Thermally P1,000.00 Processed Foods in Thermetically Sealed Containers E. Bioassay Test P5,000.00 Depressor Substances Test 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 P 20.00 copy) 1.2.4 Foreign documents (per page) ( FSC, CGMP, Mfg. P 20.00 Agreement)1.2.5 BFAD issued FSC or CGMP (per P 20.00 page) 2. Certifications: 2.1 Free Sale/CGMP (Certificate of P 200.00 Pharmaceutical Product) 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 P 500.00 lost CPR or LTO) 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 1,500.002. 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. Immunization1.1 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 HealthSource: Supreme Court E-Library