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Annex AGENERAL REGULATORY FEES AND CHARGESAUTHORIZATION/CERTIFICATION1. Issuance of an Electronic Authenticated Copy of the DocumentFEEPhp2,500.002. Re-issuance of a Lost or Damaged Permit/Certificate2,500.003. Re-issuance of a Lost or Damaged LTO/CPR5,000.004. Reconstruction of CPR10,0005. Pre-Market Consultation Feei. Pre-Submission Consultation10,000/hr.ii. Pre-Market Product Development Consultation15,000/hr.6. Legal Consultation Fee10,000/hr.7. Bureau of Customs Clearancesi. Import Permit for Samplesii. Import Permit for Scientific Research, Education and Development7,50010,000iii. Customs Release for Radiation Device5,0008. Certificate of Donation5,0009. Compassionate Special Permit5,00010. Certificate of Free Sale2,50011. Certificate of No Pending FDA Administrative Case and UnpaidFees and Penalties2,50012. Permit to Carry/Mail (Personal Use)50013. Permit to Carry/Mail (R& D Use)10,00014. Other Special Permits10,000

Annex BFEES AND CHARGES FORAPPLICATIONS FORLICENSE TO OPERATEI. VALIDITY PERIODVALIDITY PERIODINITIALRENEWAL3 YEARS5 YEARS* Renewal Fee is equivalent to Seventy Percent (70%) of the Initial License Fee for each application** Annual Fees apply to both Initial and Renewal LTOII. CENTER FOR COSMETICS REGULATION AND RESEARCHA. MANUFACTURERSTYPEOF FACILITYLICENSE FEE1. Cosmetics Manufacturer60,000.00 12,0002. HUHS/Pesticides Manufacturer75,000.00 15,0003. Toys Manufacturer4. Toys Micro-Scale ManufacturerANNUAL FEE30,000.00 7,000TBATBATBATBA6. Cosmetics Micro-Scale Manu-facturer

B. DISTRIBUTORSTYPEOF FACILITYLICENSE FEEANNUAL FEE1. COSMETICS 0TBATBA15,0003,000Micro-Scale Wholesaler**On-Line Seller2. HUHS/PESTICIDES DISTRIBUTORSImporter60,000.00 12,000Wholesaler30,000 7,000Exporter15,000 3,000Importer/WholesalerOn-Line Seller75,000.00 15,00025,000 5,0003. TOYS lesalerMicro-Scale Wholesaler *On-Line Seller* Establishments with 100,000 capitalization30,000 7,00030,000 7,00015,000 3,00075,000.00 15,000TBA15,000 3,000TBA

C. VARIATIONSTYPE OF AUTHORIZATIONMAJOR VARIATIONFEE1. LTO for Cosmetics Manufacturers and Distributors2. LTO for HUHS/Pesticides Manufacturers and Distributors3. LTO for Toys Manufacturersand DistributorsMINOR VARIATIONFEE10,0005,00020,00010,00010,0005,000* Variations do not include change/adding of activitiesIII. CENTER FOR DRUG REGULATION AND RESEARCHA.MANUFACTURER, DISTRIBUTOR AND RETAILERTYPEOF FACILITYA. DRUG MANUFACTURERLICENSE FEEANNUAL FEE90,000.00 18,000B. DRUG DISTRIBUTORS1. Importer60,000 12,0002. Wholesaler30,000 7,0003. Exporter4. Importer/Wholesaler15,000 3,00075,000 15,000C. DRUG RETAILERS1. Retail Pharmacy20,000.00 5,0002. Retail Outlet for Non-PrescriptionDrugs10,000.00 2,0003. On-Line Pharmacy15,000.00 3,000

4. Compounding Pharmacy25,000.00 5,000D. OTHER DRUGESTABLISHMENTS1. Clinical Research Organisation60,000 12,0002. Sponsor60,000 12,000B. VARIATIONSTYPE OFAUTHORIZATIONLTO for Drug ManufacturersLTO for Drug DistributorLTO for Drug Retailer* Variations do not include change/adding of activitiesMAJORVARIATION FEEMINORVARIATION FEE20,000.0010,00015,0005,00010,0002,500

IV. CENTER FOR DEVICE REGULATION,RADIATION HEALTH AND RESEARCHA. MEDICAL DEVICE ESTABLISHMENTSTYPE OFFACILITYMedical Device ManufacturerLICENSE FEEANNUAL FEE75,000 15,000Medical Device Importer40,000 8,000Medical Device Wholesaler30,000 7,000Medical Device Exporter15,000 3,000Medical Device Importer/Wholesaler60,000 12,000Medical Device On-Line Seller15,000 3,000B. RADIATION FACILITIESTYPE OFFACILITYMedical X-Ray Facility*Non-Medical X-Ray Facility**Specialized Medical Radiation Facility***Therapeutic Medical Radiation FacilityLICENSE FEEANNUAL FEE(per device)15,000 3,00015,000 3,00025,000 5,00025,000 5,000*Medical X-Ray Facility Utilizing X-ray Devices such as : General Radiography and/or Fluoroscopy/Mobile C-Arm, Simulator,Lithotripsy, Bone Densitometry**Non-Medical X-Ray Facility Utilizing X-Ray Devices for : Industrial, Anti-Crime, Educational and Research, Veterinary, Dentalapplications***Specialized Medical Radiation Facility utilizing radiation devices such as : Computed Tomography (CT), Mammography,Interventional Radiology (Cardiac Catheterization) , Magnetic Resonance Imaging (MRI)

C. VARIATIONSTYPE OFAUTHORIZATIONMAJOR VARIATION FEEMINOR VARIATION FEELTO for Medical Device Establishments20,00010,000LTO for Radiation Facilities(per device)5,0002,000* Variations do not include change/adding of activities

V. CENTER FOR FOOD REGULATION AND RESEARCHA.MANUFACTURERS AND DISTRIBUTORSTYPE OFFACILITYLICENSE FEEANNUAL FEEA. FOOD MANUFACTURER (FM)a. Manufacturerb. Micro-Scale Manufacturers*75,000 15,000TBAN/AB. FOOD ,000 5,00015,000 3,000Importer/Wholesaler50,000 10,000On-Line Seller15,000 3,000* Establishments with 100,000 capitalizationB. VARIATIONSTYPE OFAUTHORIZATIONMAJORVARIATION FEEMINORVARIATION FEELTO of Food Manufacturer10,0005,000LTO of Food Distributor10,0005,000* Variations do not include change/adding of activities

Annex CFEES AND CHARGES FORAPPLICATIONS FORCERTIFICATE OF PRODUCT REGISTRATIONI.VALIDITY PERIODTYPE OF AUTHORIZATIONINITIALRENEWALCERTIFICATEFOR PRODUCTREGISTRATION3 YEARS5 YEARSCERTIFICATEFOR PRODUCTNOTIFICATION1 YEAR1 YEAR* Renewal Fee is equivalent to Seventy Percent (70%) of the Initial Application Fee for each application** Annual Fees apply to both Initial and Renewal CPR/CPNII. CENTER FOR COSMETICS REGULATION AND RESEARCHA. CERTIFICATE OF PRODUCT NOTIFICATIONTYPE OFPRODUCTAPPLICATION FEEANNUAL FEE(Charged per product)A. COSMETIC PRODUCTSSingle ProductPer Succeeding Variant2,5002,500500N/A1,000N/AB. TOYS AND CHILDCARE ARTICLESPer SKU

B. CERTIFICATE OF PRODUCT REGISTRATIONTYPE OF PRODUCTAPPLICATION FEEANNUAL FEEA. HUHS/PESTICIDESPer Product135,00027,000C. VARIATIONTYPE OFAUTHORIZATIONCPR for HUHS/PESTICIDESMAJORVARIATION FEE10,000MINORVARIATION FEE5,000

II. CENTER FOR DRUG REGULATION AND RESEARCHA.PRODUCT TYPENEW DRUG APPLICATIONAPPLICATIONFEEEVALUATIONFEEANNUAL FEE1. NEW CHEMICALENTITY100,000150,0002. VACCINES &BIOLOGICALS100,000150,00030,0003. INNOVATIVEPRODUCTS ANDTECHNOLOGIES *100,000150,00030,00030,0004. GENERICSA. PRESCRIPTIONImported10,00075,000 15,0005,00030,000 —Imported7,50050,000 10,000Locally Manufactured3,50020,000 —Locally ManufacturedB. NON- PRESCRIPTION5. TRADITIONAL and HERBAL MEDICINESA. PRESCRIPTIONImportedLocally Manufactured10,00075,000 15,0005,00030,000 —7,50050,000 10,0003,50020,000 —B. NON- PRESCRIPTIONImportedLocally Manufactured

6. OTHER DRUG PRODUCTS**Imported7,50050,000 10,000Locally Manufactured3,50020,000 —7. VETERINARY MEDICINES, VACCINES AND BIOLOGICALSA. PRESCRIPTION10,000Imported75,000 15,0005,00030,000 —Imported7,50050,000 10,000Locally Manufactured3,50020,000 —Locally ManufacturedB. NON- PRESCRIPTION* e.g. Radio-pharmaceuticals, Blood and Blood Products, Stem Cell, and Human Cell and Tissuebased products** e.g. Medical GasesB. VARIATIONSTYPE OFAUTHORIZATIONMAJOR VARIATION FEECPR of Imported Drug ProductsCPR for a Locally ManufacturedMINOR VARIATION FEE30,00010,00010,0005,000C. OTHER PERMITSPERMIT/CERTIFICATIONFEE1. Generic Labelling Exemption5,0002. Certificate of Pharmaceutical Product5,000

III. CENTER FOR DEVICE REGULATION,RADIATION HEALTH AND RESEARCHA.MEDICAL DEVICE PRODUCTSRISK CLASSAPPLICATION FEE EVALUATION FEE(PER DEVICE)(PER DEVICE)ANNUAL FEE(Per Device)CLASS A5,00010,000 2,000CLASS B10,00020,000 5,000CLASS C15,00045,000 9,00030,00060,000 12,000CLASS D (includesdevices incorporatingmedicinal/therapeutic products)B. VARIATIONSTYPE OFAUTHORIZATIONMAJORVARIATION FEEMINORVARIATION FEECPR for CLASS A Devices2,5001,000CPR for CLASS B Devices10,0005,000CPR for CLASS C Devices10,0005,000CPR for CLASS D Devices(includes devices incorporating medicinal/therapeuticproducts)20,0005,000

C.OTHER PERMITSPERMIT/CERTIFICATIONFEE5,0001. Quality System Certificate2. Safety Evaluation Report (Per Device)3. Certificate of Radiation Measurement forExtremely Low Frequency (ELF) and Radiofrequency Radiation (RFR) Facilities5,000 per facility/device14,000 / transmitter site plus transportation costof the FDA personnel10,000 per LINAC device4. Pre-Operational Permit for TherapeuticRadiation Facility Utilizing Linear Accelerator (LINAC)

IV. CENTER FOR FOOD REGULATION AND RESEARCHA.PRODUCT TYPEPRODUCT TYPEAPPLICATION FEEANNUAL FEE1. FOOD ADDITIVESImported3,000 700Locally Manufactured1,500 —2. RAW MATERIALS and OTHER LOW RISK FOOD PRODUCTSImported3,000 700Locally Manufactured1,500 —3. MEDIUM/HIGH RISK FOOD PRODUCTSImported5,000 1,000Locally Manufactured3,000 —3. FOOD SUPPLEMENTImported20,000 5,000Locally Manufactured10,000 —B.VARIATIONSTYPE OF VARIATIONVARIATION FEE2,500AmendmentC. OTHER PERMITSTYPE OF PERMIT/CERTIFICATIONHazard Analysis Critical Control Point(HACCP) Certification*Sangkap Pinoy Seal* Validity : Three (3) yearsFEE10,000/product8,000

Annex DGOOD MANUFACTURING PRACTICES (GMP)CONFORMITY ASSESSMENT OF MANUFACTURERS OF DRUG PRODUCTSI. GMP CONFORMITY ASSESSMENT OF OVERSEAS MANUFACTURERS OF DRUGPRODUCTASSESSMENT TYPE *FEENOTE1. Verification of GMP Standard (GMPEvidence Evaluation)50,000Per manufacturing site2. Quality System Dossier (QSD) Evaluation75,000Per manufacturing site(one-time payment)USD 7,000Per manufacturing siteB. Other Asian countriesUSD 10,000Per manufacturing siteC. Any other countryUSD 20,000Per manufacturing siteD. Listed Fee **USD 12,000Per manufacturing site3. On-site GMP audit of manufacturerlocated in:A. ASEAN country* All new overseas manufacturers who intend to register their drug products in the Philippines will be subjected to GMP Conformity Assessment. The service charge varies according to the geographical location of manufacturer. For the purpose of the application of inspection fees, ‘manufacturer’ encompasses all types of manufacturing, including: packaging, re-packaging, labeling and re-labeling. A fee is due only when manufacturer is notified that an inspection is being prepared. Listed fees includetravel and accommodation costs of the 2- or 3-member inspection team.** To cover costs and reasonable expenses by each inspector, including costs for travel/transportation fare, accommodation, andper diem/allowance.II. GMP CONFORMITY ASSESSMENT LOCAL/DOMESTIC MANUFACTURERS OFDRUG PRODUCTASSESSMENT TYPEFEEApplication for GMP Certificate50,000Domestic Manufacturing Inspection60,000* All local manufacturing facilities engaged in the manufacture or assembly of drug products must be licensed with the PhilippineFDA. The manufacturers are expected to comply with the relevant legislative and regulatory requirements, and GMP standard

Annex ELABORATORY FEES FOR CERTIFICATIONCERTIFICATIONFEEA. GENERAL PERMIT AND/OR APPROVALI. Sustainability Evaluation of Food Contact Materials2,500II. Evaluation of Test Results from Accredited Laboratories2,500B. LOT RELEASE CERTIFICATEI. Single Component3,000II. Multiple Component4,500C. BATCH NOTIFICATION CERTIFICATE6,500

1. FOOD ADDITIVES Imported 3,000 700 Locally Manufactured 1,500 — 2. RAW MATERIALS and OTHER LOW RISK FOOD PRODUCTS Imported 3,000 700 Locally Manufactured 1,500 — 3. MEDIUM/HIGH RISK FOOD PRODUCTS Imported 5,000 1,000 Locally Manufactured 3,000 — 3. FOOD SUPPLEMENT Imported 20,000 5,000 Locally Manufactured 10,000 — B.VARIATIONS