Food and Drug Administration

A. Processed Food and Food Products

A.1. Finished Product - CATEGORY I

Bakery and Bakery Related Products, Non-alcoholic Beverages & Beverage mixes, Candies and Confectionery Products, Cocoa and Cocoa Related Products, Coffee, Tea and non-dairy creamer, Condiments, Sauces and Seasonings, Culinary Products, Gelatin, Dessert Preparation and Mixes, Dairy Products, Dressings and Spreads Common in the Philippines, Flour/Flour Mixes and Starch, Fish and Other Marine Products, Fruits, Vegetable and Edible Fungi, Meat and Poultry Products, Noodles, Pastas and Pastry Wrapper, Nut and Nut Products, Native and Delicacies, Oils, Fats and Shortening, Snack Foods and Breakfast Cereal, Sugar and Other Related Products

  • Legal Basis
  • Import Permit / Clearance / Certification
  • Importation
  • Contact

Legal Basis is given to the Dangerous Drug Board to regulate this commodity via Republic Act 9711 – FDA Act of 2009 and Republic Act 3720 as amended by EO 175 s. 1987 Foods, Drugs and Devices, and Cosmetics Act.

  1. A. License to Operate (LTO)
  2. B. Certificate of Product Registration (CPR)
  3. C. Notification Number (NN)
  4. D. Certification / Clearance ( for those not requiring LTO, CPR, NN)
Documentary Requirements Procedure Lead Time Processing Fee
  1. 1. Valid LTO as Food Importer
    1. a) Duly accomplished and notarized Integrated Application Form
    2. b) Proof of Registration
      • - If Single Proprietorship, valid Certificate of Business Name Registration with the DTI
      • - If Corporation or Partnership, valid Registration with SEC and Articles of Incorporation or Partnership
      • - If Cooperative, valid Certificate from Cooperative Development Authorities (CDA) and by laws
    3. c) Proof of Occupancy
      • - Valid notarized Contract of Lease/Sub-Lease/Certificate of Occupancy/ Warehousing Agreement (for third party logistics)
      • - Transfer Certificate of Title (TCT)if owned and notarized Certificate of Occupancy (if owned by one of the incorporators
      • - Clearance from the Condominium/ Building Administration allowing the use of the unit for business purposes - as necessary
    4. d) Location Plan/Site/Gooble Map (indicate size, location, landmarks, immediate environment, type of building)
    5. e) Floor Plan/Lay out with dimension (office and/or warehouse; manufacturing plant)
    6. f) List of food products to be distributed
    7. g) Sample label of product to be imported/distributed
    8. h) Any of the following from each supplier
      • - Foreign Agency Agreement
      • - Certificate of Distributorship
      • - Appointment Letter
      • - Proforma Invoice
      • - Memorandum of Agreement
    9. i) Any one of the following documents for the status of manufacturer issued by the Regulatory/Health Authority from the country of origin
      • - Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent
      • - Phytosanitary Certificate/Health Certificate
      • - Certificate of Free Sale
      • - ISO 2200 Certification/FSSC 2200
      • - HACCP Certificate as applicable
  2. 2. Valid CPR
    1. a) Completely filled up Assessment Slip
    2. b) Application Letter
    3. c) Notarized Affidavit of Undertaking
    4. d) Completely filled up Product List
    5. e) Proforma/Sales Invocie declaring the products imported and applied for product registration
    6. f) Actual loose label with sticker reflecting the complete name and address of the importer
    7. g) Original copy of the Certificate of Free Sale (CFS) issued by the Government Regulatory Agency in the county of origin stating that the specific products applied for registration are freely sold in the country of origin and fit for human consumption
    8. h) Additional requirements for Category II
      • - List of ingredients in decreasing order of proportion. For additives with prescribed limit, the amount must be indicated
      • - Safety Certificate from flavor supplier
      • - Finished product specification (physical, chemical and microbiological)
      • - Certificate of Analysis of the finished product (indicate the analytical method used. Submit the test results, which are critical to the product)
      • - Flow diagram of method of manufacture, packaging and quality control
      • - Packaging certification of suitability for food use
      • - Estimated shelf life, parameters used and method for determining shelf life complete with the the following: product name, batch number, production date and date of analysis, tabulated data & results in terms of physical, chemical and/or microbiological, conclusion as to the shelf life of the product, name and signature of the QA analyst and QA manager
      • - justification of label claim ( if applicable)
      • - for bottled water, refer to AO 18-A s. 1993 for additional test to be submitted
    9. i) Additional requirement for Wheat Flour registration
      • - Certificate of Analysis (*CoA)-per batch specific shipment

      Remarks:

      Wheat Flour
      Vit. A;
      3.0 mg to 6.5 mg/Kg
      Vitamin A as Retinol
      Palmitate or Acetate

      Iron (Fe):
      70 mg to 105 mg
      Elemental Fe/Kg or 50 mg to 75 mg Fe as Sulfate/Kg
      Cooking Oil:
      Vit. A Retinol
      Palmitate
      125 mg to 23 mg RE/L

    10. j) Additional requirement for Iodized Salt registration
      • - Certificate of Analysis

      70 mg to 150 mg
      Iodine/Kg

  1. 1. Application form id dowloaded from www.fda.gov - The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amemndments and other certifications. Promos and advertisements are also now covered in the application from. Remember that a valid LTO is required for a CPR.
  2. 2. Application form is filled-up correctly. - The application form has six parts:
    1. a) General Information
    2. b) Establishment Information
    3. c) Product Information
    4. d) Supporting Information
    5. e) Sources and Clients
    6. f) Applicant Information
    If the part is appropriately filled up, a green 'PROCEED' will be indicated. Required fields will appear sequentially. If the form is appropriately filled up, the composed body text (in the green box) will appear.
  3. 3. Send an email to pair at pair@fda.gov.ph - In the XLS application form, the worksheet 'Email' composes the subject and bosy of the email that should be sent to pair@fda.gov.ph. Copy and paste the appropriate fields onto the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be required during submission. Any attachment will lead to rejection of schedule request. Up to ten applications in a single email are acceptable.
  4. 4. Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission. - The FDA will determine the schedule of applications according to the priority of the Centers. A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be secheduled over separate days. Requests for specific schedules will not be accomodated. Receiving will be scheduled within 10 working days of receipt of application email.
  5. 5. Fees are paid either at Land Bank branches or at the main FDA cashier. - Once a DTL is received, payment can be made immediately through any branch of the Land Bank of the Philippines. The main FDA cashier will only accomodate those scheduled to be received for the day. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the tracking number provided. Check that the tracking number indicated in the DTL is indicated in the proof of payment.
  6. 6. Check if all requirements are in order. - Be sure that you have a checklist of requirements and that you have all the necessary documents. Don't forget to have the petition or declaration form notarized. A softcopy of all requirements should be stored in a USB device to facilitate transfer. Include an XLS or XLSX copy of the accomplished application form. Please keep your USB devices free of malicious software. A copy of the OnColl Payment Slip is also required at the point of submission.
  7. 7. Application is filed on schedule. - Only applications scheduled for the day will be accomodated. Hard copies will no longer be required at submission. Dont't forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through pair@fda.gov.ph. Should you fail to complete submission on the set date, queue for another schedule through pair@fda.gov.ph using RSN.

Require importers to present valid LTO and CPR or NN, as appropriate, prior release of shipment.

Issuance of Licence to Operate (Initial, Regular Renewal, Re-issuance - 25 working per compliant application / 40 working days for Inspection

Issuance of Licence to Operate - Amendment (Inclusion/Deletion of Product, Sources, Activity/ Change of Name of Sources) - 14 working days (per compliant application)

Issuance of GMP/HACCP Certification - 25 working days (per compliant application)

Fees for Licensing of Establishments regulated by FDA (LTO)

Initial (1 year validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 4,000
  2. 2. Iodized Salt Importer - 1,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 1,000
  5. 3.2 Over 1 Million but below 5 Million - 2,000
  6. 3.3 5Million but below 10Million - 3,000
  7. 3.4 10Million but below 20Million - 5,000
  8. 3.5 20Million but below 50Million - 10,000
  9. 3.6 50Million and above - 15,000

Renewal (2 years validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 8,000
  2. 2. Iodized Salt Importer - 2,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 2,000
  5. 3.2 Over 1 Million but below 5 Million - 4,000
  6. 3.3 5Million but below 10Million - 6,000
  7. 3.4 10Million but below 20Million - 10,000
  8. 3.5 20Million but below 50Million - 20,000
  9. 3.6 50Million and above - 30,000

Note: A surcharge of 25% of annual fee shall be charged per quarter (every three months) of delay in filing an application for renewal of the LTO.

Fees for Registration of Products Regulated by FDA (CPR)

INITIAL (FOR ONE YEAR)

  1. 1. Food
  2. 1.1 Category 1 - Php 200
  3. 1.2 Category 2 - Php 250
  4. 1.3 Food Supplement - Php 1,000
  5. 1.4 Bottled Water - Php 1,000

RENEWAL (FOR 5 YEARS)

  1. 1. Food
  2. 1.1 Category 1 - Php 1,000
  3. 1.2 Category 2 - Php 1,250
  4. 1.3 Food Supplement - Php 5,000
  5. 1.4 Bottled Water - Php 5,000

Php 200

Contact Positon Contact Details
Center for Food Regulation and Research (CFRR) MARIA VICTORIA PINION

A.1. Finished Product - CATEGORY II

Food Supplements, Bottled Drinking Water, Alcoholic Beverages, Tea (Herbal), Bottled Drinking Water, Food for Infant and Children, Food for Special Dietary Use, Transgenic Food Products (use of generic engineering/biotechnology), Ethnic Food products with Indigenous Ingredient(s), Wheat Flour, Cooking Oil, Refined Sugar, and Iodized Salt

  • Legal Basis
  • Import Permit / Clearance / Certification
  • Importation
  • Contact
  1. A. License to Operate (LTO)
  2. B. Certificate of Product Registration (CPR)
  3. C. Notification Number (NN)
  4. D. Certification / Clearance ( for those not requiring LTO, CPR, NN)
Documentary Requirements Procedure Lead Time Processing Fee
  1. 1. Valid LTO as Food Importer
    1. a) Duly accomplished and notarized Integrated Application Form
    2. b) Proof of Registration
      • - If Single Proprietorship, valid Certificate of Business Name Registration with the DTI
      • - If Corporation or Partnership, valid Registration with SEC and Articles of Incorporation or Partnership
      • - If Cooperative, valid Certificate from Cooperative Development Authorities (CDA) and by laws
    3. c) Proof of Occupancy
      • - Valid notarized Contract of Lease/Sub-Lease/Certificate of Occupancy/ Warehousing Agreement (for third party logistics)
      • - Transfer Certificate of Title (TCT)if owned and notarized Certificate of Occupancy (if owned by one of the incorporators
      • - Clearance from the Condominium/ Building Administration allowing the use of the unit for business purposes - as necessary
    4. d) Location Plan/Site/Gooble Map (indicate size, location, landmarks, immediate environment, type of building)
    5. e) Floor Plan/Lay out with dimension (office and/or warehouse; manufacturing plant)
    6. f) List of food products to be distributed
    7. g) Sample label of product to be imported/distributed
    8. h) Any of the following from each supplier
      • - Foreign Agency Agreement
      • - Certificate of Distributorship
      • - Appointment Letter
      • - Proforma Invoice
      • - Memorandum of Agreement
    9. i) Any one of the following documents for the status of manufacturer issued by the Regulatory/Health Authority from the country of origin
      • - Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent
      • - Phytosanitary Certificate/Health Certificate
      • - Certificate of Free Sale
      • - ISO 2200 Certification/FSSC 2200
      • - HACCP Certificate as applicable
  2. 2. Valid CPR
    1. a) Completely filled up Assessment Slip
    2. b) Application Letter
    3. c) Notarized Affidavit of Undertaking
    4. d) Completely filled up Product List
    5. e) Proforma/Sales Invocie declaring the products imported and applied for product registration
    6. f) Actual loose label with sticker reflecting the complete name and address of the importer
    7. g) Original copy of the Certificate of Free Sale (CFS) issued by the Government Regulatory Agency in the county of origin stating that the specific products applied for registration are freely sold in the country of origin and fit for human consumption
    8. h) Additional requirements for Category II
      • - List of ingredients in decreasing order of proportion. For additives with prescribed limit, the amount must be indicated
      • - Safety Certificate from flavor supplier
      • - Finished product specification (physical, chemical and microbiological)
      • - Certificate of Analysis of the finished product (indicate the analytical method used. Submit the test results, which are critical to the product)
      • - Flow diagram of method of manufacture, packaging and quality control
      • - Packaging certification of suitability for food use
      • - Estimated shelf life, parameters used and method for determining shelf life complete with the the following: product name, batch number, production date and date of analysis, tabulated data & results in terms of physical, chemical and/or microbiological, conclusion as to the shelf life of the product, name and signature of the QA analyst and QA manager
      • - justification of label claim ( if applicable)
      • - for bottled water, refer to AO 18-A s. 1993 for additional test to be submitted
    9. i) Additional requirement for Wheat Flour registration
      • - Certificate of Analysis (*CoA)-per batch specific shipment

      Remarks:

      Wheat Flour
      Vit. A;
      3.0 mg to 6.5 mg/Kg
      Vitamin A as Retinol
      Palmitate or Acetate

      Iron (Fe):
      70 mg to 105 mg
      Elemental Fe/Kg or 50 mg to 75 mg Fe as Sulfate/Kg
      Cooking Oil:
      Vit. A Retinol
      Palmitate
      125 mg to 23 mg RE/L

    10. j) Additional requirement for Iodized Salt registration
      • - Certificate of Analysis

      70 mg to 150 mg
      Iodine/Kg

  1. 1. Application form id dowloaded from www.fda.gov - The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amemndments and other certifications. Promos and advertisements are also now covered in the application from. Remember that a valid LTO is required for a CPR.
  2. 2. Application form is filled-up correctly. - The application form has six parts:
    1. a) General Information
    2. b) Establishment Information
    3. c) Product Information
    4. d) Supporting Information
    5. e) Sources and Clients
    6. f) Applicant Information
    If the part is appropriately filled up, a green 'PROCEED' will be indicated. Required fields will appear sequentially. If the form is appropriately filled up, the composed body text (in the green box) will appear.
  3. 3. Send an email to pair at pair@fda.gov.ph - In the XLS application form, the worksheet 'Email' composes the subject and bosy of the email that should be sent to pair@fda.gov.ph. Copy and paste the appropriate fields onto the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be required during submission. Any attachment will lead to rejection of schedule request. Up to ten applications in a single email are acceptable.
  4. 4. Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission. - The FDA will determine the schedule of applications according to the priority of the Centers. A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be secheduled over separate days. Requests for specific schedules will not be accomodated. Receiving will be scheduled within 10 working days of receipt of application email.
  5. 5. Fees are paid either at Land Bank branches or at the main FDA cashier. - Once a DTL is received, payment can be made immediately through any branch of the Land Bank of the Philippines. The main FDA cashier will only accomodate those scheduled to be received for the day. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the tracking number provided. Check that the tracking number indicated in the DTL is indicated in the proof of payment.
  6. 6. Check if all requirements are in order. - Be sure that you have a checklist of requirements and that you have all the necessary documents. Don't forget to have the petition or declaration form notarized. A softcopy of all requirements should be stored in a USB device to facilitate transfer. Include an XLS or XLSX copy of the accomplished application form. Please keep your USB devices free of malicious software. A copy of the OnColl Payment Slip is also required at the point of submission.
  7. 7. Application is filed on schedule. - Only applications scheduled for the day will be accomodated. Hard copies will no longer be required at submission. Dont't forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through pair@fda.gov.ph. Should you fail to complete submission on the set date, queue for another schedule through pair@fda.gov.ph using RSN.

Require importers to present valid LTO and CPR or NN, as appropriate, prior release of shipment.

Issuance of Licence to Operate (Initial, Regular Renewal, Re-issuance - 25 working per compliant application / 40 working days for Inspection

Issuance of Licence to Operate - Amendment (Inclusion/Deletion of Product, Sources, Activity/ Change of Name of Sources) - 14 working days (per compliant application)

Issuance of GMP/HACCP Certification - 25 working days (per compliant application)

Fees for Licensing of Establishments regulated by FDA (LTO)

Initial (1 year validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 4,000
  2. 2. Iodized Salt Importer - 1,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 1,000
  5. 3.2 Over 1 Million but below 5 Million - 2,000
  6. 3.3 5Million but below 10Million - 3,000
  7. 3.4 10Million but below 20Million - 5,000
  8. 3.5 20Million but below 50Million - 10,000
  9. 3.6 50Million and above - 15,000

Renewal (2 years validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 8,000
  2. 2. Iodized Salt Importer - 2,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 2,000
  5. 3.2 Over 1 Million but below 5 Million - 4,000
  6. 3.3 5Million but below 10Million - 6,000
  7. 3.4 10Million but below 20Million - 10,000
  8. 3.5 20Million but below 50Million - 20,000
  9. 3.6 50Million and above - 30,000

Note: A surcharge of 25% of annual fee shall be charged per quarter (every three months) of delay in filing an application for renewal of the LTO.

Fees for Registration of Products Regulated by FDA (CPR)

INITIAL (FOR ONE YEAR)

  1. 1. Food
  2. 1.1 Category 1 - Php 200
  3. 1.2 Category 2 - Php 250
  4. 1.3 Food Supplement - Php 1,000
  5. 1.4 Bottled Water - Php 1,000

RENEWAL (FOR 5 YEARS)

  1. 1. Food
  2. 1.1 Category 1 - Php 1,000
  3. 1.2 Category 2 - Php 1,250
  4. 1.3 Food Supplement - Php 5,000
  5. 1.4 Bottled Water - Php 5,000

Php 200

Contact Positon Contact Details
Center for Food Regulation and Research (CFRR) MARIA VICTORIA PINION

A.2. Raw Materials, food ingredients, additives for own use

  • Legal Basis
  • Import Permit / Clearance / Certification
  • Importation
  • Contact
  1. A. License to Operate (LTO)
  2. B. Certificate of Product Registration (CPR)
  3. C. Notification Number (NN)
  4. D. Certification / Clearance ( for those not requiring LTO, CPR, NN)
Documentary Requirements Procedure Lead Time Processing Fee
  1. Valid LTO as Food Manufacturer
    1. a) Duly accomplished and notarized Integrated Application Form
    2. b) Proof of Registration
      • - If Single Proprietorship, valid Certificate of Business Name Registration with the DTI
      • - If Corporation or Partnership, valid Registration with SEC and Articles of Incorporation or Partnership
      • - If Cooperative, valid Certificate from Cooperative Development Authorities (CDA) and by laws
    3. c) Proof of Occupancy
      • - Valid notarized Contract of Lease/Sub-Lease/Certificate of Occupancy/ Warehousing Agreement (for third party logistics)
      • - Transfer Certificate of Title (TCT)if owned and notarized Certificate of Occupancy (if owned by one of the incorporators
      • - Clearance from the Condominium/ Building Administration allowing the use of the unit for business purposes - as necessary
    4. d) Location Plan/Site/Gooble Map (indicate size, location, landmarks, immediate environment, type of building)
    5. e) Floor Plan/Lay out with dimension (office and/or warehouse; manufacturing plant)
    6. f) List of food products to be manufactured
    7. g) Sample label of product to be manufactured) Any of the following from each supplier
      • - Foreign Agency Agreement
      • - Certificate of Distributorship
      • - Appointment Letter
      • - Proforma Invoice
      • - Memorandum of Agreement
    8. i) Any one of the following documents for the status of manufacturer issued by the Regulatory/Health Authority from the country of origin
      • - Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent
      • - Phytosanitary Certificate/Health Certificate
      • - Certificate of Free Sale
      • - ISO 2200 Certification/FSSC 2200
      • - HACCP Certificate as applicable
  1. 1. Application form id dowloaded from www.fda.gov - The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amemndments and other certifications. Promos and advertisements are also now covered in the application from. Remember that a valid LTO is required for a CPR.
  2. 2. Application form is filled-up correctly. - The application form has six parts:
    1. a) General Information
    2. b) Establishment Information
    3. c) Product Information
    4. d) Supporting Information
    5. e) Sources and Clients
    6. f) Applicant Information
    If the part is appropriately filled up, a green 'PROCEED' will be indicated. Required fields will appear sequentially. If the form is appropriately filled up, the composed body text (in the green box) will appear.
  3. 3. Send an email to pair at pair@fda.gov.ph - In the XLS application form, the worksheet 'Email' composes the subject and bosy of the email that should be sent to pair@fda.gov.ph. Copy and paste the appropriate fields onto the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be required during submission. Any attachment will lead to rejection of schedule request. Up to ten applications in a single email are acceptable.
  4. 4. Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission. - The FDA will determine the schedule of applications according to the priority of the Centers. A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be secheduled over separate days. Requests for specific schedules will not be accomodated. Receiving will be scheduled within 10 working days of receipt of application email.
  5. 5. Fees are paid either at Land Bank branches or at the main FDA cashier. - Once a DTL is received, payment can be made immediately through any branch of the Land Bank of the Philippines. The main FDA cashier will only accomodate those scheduled to be received for the day. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the tracking number provided. Check that the tracking number indicated in the DTL is indicated in the proof of payment.
  6. 6. Check if all requirements are in order. - Be sure that you have a checklist of requirements and that you have all the necessary documents. Don't forget to have the petition or declaration form notarized. A softcopy of all requirements should be stored in a USB device to facilitate transfer. Include an XLS or XLSX copy of the accomplished application form. Please keep your USB devices free of malicious software. A copy of the OnColl Payment Slip is also required at the point of submission.
  7. 7. Application is filed on schedule. - Only applications scheduled for the day will be accomodated. Hard copies will no longer be required at submission. Dont't forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through pair@fda.gov.ph. Should you fail to complete submission on the set date, queue for another schedule through pair@fda.gov.ph using RSN.

Require importers to present valid LTO and CPR or NN, as appropriate, prior release of shipment.

Issuance of Licence to Operate (Initial, Regular Renewal, Re-issuance - 25 working per compliant application / 40 working days for Inspection

Issuance of Licence to Operate - Amendment (Inclusion/Deletion of Product, Sources, Activity/ Change of Name of Sources) - 14 working days (per compliant application)

Issuance of GMP/HACCP Certification - 25 working days (per compliant application)

Fees for Licensing of Establishments regulated by FDA (LTO)

Initial (1 year validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 4,000
  2. 2. Iodized Salt Importer - 1,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 1,000
  5. 3.2 Over 1 Million but below 5 Million - 2,000
  6. 3.3 5Million but below 10Million - 3,000
  7. 3.4 10Million but below 20Million - 5,000
  8. 3.5 20Million but below 50Million - 10,000
  9. 3.6 50Million and above - 15,000

Renewal (2 years validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 8,000
  2. 2. Iodized Salt Importer - 2,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 2,000
  5. 3.2 Over 1 Million but below 5 Million - 4,000
  6. 3.3 5Million but below 10Million - 6,000
  7. 3.4 10Million but below 20Million - 10,000
  8. 3.5 20Million but below 50Million - 20,000
  9. 3.6 50Million and above - 30,000

Note: A surcharge of 25% of annual fee shall be charged per quarter (every three months) of delay in filing an application for renewal of the LTO.

Fees for Registration of Products Regulated by FDA (CPR)

INITIAL (FOR ONE YEAR)

  1. 1. Food
  2. 1.1 Category 1 - Php 200
  3. 1.2 Category 2 - Php 250
  4. 1.3 Food Supplement - Php 1,000
  5. 1.4 Bottled Water - Php 1,000

RENEWAL (FOR 5 YEARS)

  1. 1. Food
  2. 1.1 Category 1 - Php 1,000
  3. 1.2 Category 2 - Php 1,250
  4. 1.3 Food Supplement - Php 5,000
  5. 1.4 Bottled Water - Php 5,000

Php 200

Contact Positon Contact Details
Center for Food Regulation and Research (CFRR) MARIA VICTORIA PINION

A.3. Raw Materials, food ingredients, additives for local sale/ distribution

  • Legal Basis
  • Import Permit / Clearance / Certification
  • Importation
  • Contact
  1. A. License to Operate (LTO)
  2. B. Certificate of Product Registration (CPR)
  3. C. Notification Number (NN)
  4. D. Certification / Clearance ( for those not requiring LTO, CPR, NN)
Documentary Requirements Procedure Lead Time Processing Fee
  1. 1. Valid LTO as Food Importer
    1. a) Duly accomplished and notarized Integrated Application Form
    2. b) Proof of Registration
      • - If Single Proprietorship, valid Certificate of Business Name Registration with the DTI
      • - If Corporation or Partnership, valid Registration with SEC and Articles of Incorporation or Partnership
      • - If Cooperative, valid Certificate from Cooperative Development Authorities (CDA) and by laws
    3. c) Proof of Occupancy
      • - Valid notarized Contract of Lease/Sub-Lease/Certificate of Occupancy/ Warehousing Agreement (for third party logistics)
      • - Transfer Certificate of Title (TCT)if owned and notarized Certificate of Occupancy (if owned by one of the incorporators
      • - Clearance from the Condominium/ Building Administration allowing the use of the unit for business purposes
      • - as necessary
    4. d) Location Plan/Site/Gooble Map (indicate size, location, landmarks, immediate environment, type of building)
    5. e) Floor Plan/Lay out with dimension (office and/or warehouse; manufacturing plant)
    6. f) List of food products to be distributed
    7. g) Sample label of product to be imported/distributed
    8. h) Any of the following from each supplier
      • - Foreign Agency Agreement
      • - Certificate of Distributorship
      • - Appointment Letter
      • - Proforma Invoice
      • - Memorandum of Agreement
    9. i) Any one of the following documents for the status of manufacturer issued by the Regulatory/Health Authority from the country of origin
      • - Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent
      • - Phytosanitary Certificate/Health Certificate
      • - Certificate of Free Sale
      • - ISO 2200 Certification/FSSC 2200
      • - HACCP Certificate as applicable
  2. 2. Valid CPR
    1. a) Completely filled up Assessment Slip
    2. b) Application Letter
    3. c) Notarized Affidavit of Undertaking
    4. d) Completely filled up Product List
    5. e) Proforma/Sales Invocie declaring the products imported and applied for product registration
    6. f) Actual loose label with sticker reflecting the complete name and address of the importer
    7. g) Original copy of the Certificate of Free Sale (CFS) issued by the Government Regulatory Agency in the county of origin stating that the specific products applied for registration are freely sold in the country of origin and fit for human consumption
  1. 1. Application form id dowloaded from www.fda.gov - The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amemndments and other certifications. Promos and advertisements are also now covered in the application from. Remember that a valid LTO is required for a CPR.
  2. 2. Application form is filled-up correctly. - The application form has six parts:
    1. a) General Information
    2. b) Establishment Information
    3. c) Product Information
    4. d) Supporting Information
    5. e) Sources and Clients
    6. f) Applicant Information
    If the part is appropriately filled up, a green 'PROCEED' will be indicated. Required fields will appear sequentially. If the form is appropriately filled up, the composed body text (in the green box) will appear.
  3. 3. Send an email to pair at pair@fda.gov.ph - In the XLS application form, the worksheet 'Email' composes the subject and bosy of the email that should be sent to pair@fda.gov.ph. Copy and paste the appropriate fields onto the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be required during submission. Any attachment will lead to rejection of schedule request. Up to ten applications in a single email are acceptable.
  4. 4. Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission. - The FDA will determine the schedule of applications according to the priority of the Centers. A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be secheduled over separate days. Requests for specific schedules will not be accomodated. Receiving will be scheduled within 10 working days of receipt of application email.
  5. 5. Fees are paid either at Land Bank branches or at the main FDA cashier. - Once a DTL is received, payment can be made immediately through any branch of the Land Bank of the Philippines. The main FDA cashier will only accomodate those scheduled to be received for the day. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the tracking number provided. Check that the tracking number indicated in the DTL is indicated in the proof of payment.
  6. 6. Check if all requirements are in order. - Be sure that you have a checklist of requirements and that you have all the necessary documents. Don't forget to have the petition or declaration form notarized. A softcopy of all requirements should be stored in a USB device to facilitate transfer. Include an XLS or XLSX copy of the accomplished application form. Please keep your USB devices free of malicious software. A copy of the OnColl Payment Slip is also required at the point of submission.
  7. 7. Application is filed on schedule. - Only applications scheduled for the day will be accomodated. Hard copies will no longer be required at submission. Dont't forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through pair@fda.gov.ph. Should you fail to complete submission on the set date, queue for another schedule through pair@fda.gov.ph using RSN.

Require importers to present valid LTO and CPR or NN, as appropriate, prior release of shipment.

Issuance of Licence to Operate (Initial, Regular Renewal, Re-issuance - 25 working per compliant application / 40 working days for Inspection

Issuance of Licence to Operate - Amendment (Inclusion/Deletion of Product, Sources, Activity/ Change of Name of Sources) - 14 working days (per compliant application)

Issuance of GMP/HACCP Certification - 25 working days (per compliant application)

Fees for Licensing of Establishments regulated by FDA (LTO)

Initial (1 year validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 4,000
  2. 2. Iodized Salt Importer - 1,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 1,000
  5. 3.2 Over 1 Million but below 5 Million - 2,000
  6. 3.3 5Million but below 10Million - 3,000
  7. 3.4 10Million but below 20Million - 5,000
  8. 3.5 20Million but below 50Million - 10,000
  9. 3.6 50Million and above - 15,000

Renewal (2 years validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 8,000
  2. 2. Iodized Salt Importer - 2,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 2,000
  5. 3.2 Over 1 Million but below 5 Million - 4,000
  6. 3.3 5Million but below 10Million - 6,000
  7. 3.4 10Million but below 20Million - 10,000
  8. 3.5 20Million but below 50Million - 20,000
  9. 3.6 50Million and above - 30,000

Note: A surcharge of 25% of annual fee shall be charged per quarter (every three months) of delay in filing an application for renewal of the LTO.

Fees for Registration of Products Regulated by FDA (CPR)

INITIAL (FOR ONE YEAR)

  1. 1. Food
  2. 1.1 Category 1 - Php 200
  3. 1.2 Category 2 - Php 250
  4. 1.3 Food Supplement - Php 1,000
  5. 1.4 Bottled Water - Php 1,000

RENEWAL (FOR 5 YEARS)

  1. 1. Food
  2. 1.1 Category 1 - Php 1,000
  3. 1.2 Category 2 - Php 1,250
  4. 1.3 Food Supplement - Php 5,000
  5. 1.4 Bottled Water - Php 5,000

Php 200

Contact Positon Contact Details
Center for Food Regulation and Research (CFRR) MARIA VICTORIA PINION

A.4. Finished bulk for packing into its final product presentation for retail

  • Legal Basis
  • Import Permit / Clearance / Certification
  • Importation
  • Contact
  1. A. License to Operate (LTO)
  2. B. Certificate of Product Registration (CPR)
  3. C. Notification Number (NN)
  4. D. Certification / Clearance ( for those not requiring LTO, CPR, NN)
Documentary Requirements Procedure Lead Time Processing Fee
  1. 1. Valid LTO as Food Importer
    1. a) Duly accomplished and notarized Integrated Application Form
    2. b) Proof of Registration
      • - If Single Proprietorship, valid Certificate of Business Name Registration with the DTI
      • - If Corporation or Partnership, valid Registration with SEC and Articles of Incorporation or Partnership
      • - If Cooperative, valid Certificate from Cooperative Development Authorities (CDA) and by laws
    3. c) Proof of Occupancy
      • - Valid notarized Contract of Lease/Sub-Lease/Certificate of Occupancy/ Warehousing Agreement (for third party logistics)
      • - Transfer Certificate of Title (TCT)if owned and notarized Certificate of Occupancy (if owned by one of the incorporators
      • - Clearance from the Condominium/ Building Administration allowing the use of the unit for business purposes
      • - as necessary
    4. d) Location Plan/Site/Gooble Map (indicate size, location, landmarks, immediate environment, type of building)
    5. e) Floor Plan/Lay out with dimension (office and/or warehouse; manufacturing plant)
    6. f) List of food products to be distributed
    7. g) Sample label of product to be imported/distributed
    8. h) Any of the following from each supplier
      • - Foreign Agency Agreement
      • - Certificate of Distributorship
      • - Appointment Letter
      • - Proforma Invoice
      • - Memorandum of Agreement
    9. i) Any one of the following documents for the status of manufacturer issued by the Regulatory/Health Authority from the country of origin
      • - Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent
      • - Phytosanitary Certificate/Health Certificate
      • - Certificate of Free Sale
      • - ISO 2200 Certification/FSSC 2200
      • - HACCP Certificate as applicable
  2. 2. Valid CPR
    1. a) Completely filled up Assessment Slip
    2. b) Application Letter
    3. c) Notarized Affidavit of Undertaking
    4. d) Completely filled up Product List
    5. e) Proforma/Sales Invocie declaring the products imported and applied for product registration
    6. f) Actual loose label with sticker reflecting the complete name and address of the importer
    7. g) Original copy of the Certificate of Free Sale (CFS) issued by the Government Regulatory Agency in the county of origin stating that the specific products applied for registration are freely sold in the country of origin and fit for human consumption
  1. 1. Application form id dowloaded from www.fda.gov - The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amemndments and other certifications. Promos and advertisements are also now covered in the application from. Remember that a valid LTO is required for a CPR.
  2. 2. Application form is filled-up correctly. - The application form has six parts:
    1. a) General Information
    2. b) Establishment Information
    3. c) Product Information
    4. d) Supporting Information
    5. e) Sources and Clients
    6. f) Applicant Information
    If the part is appropriately filled up, a green 'PROCEED' will be indicated. Required fields will appear sequentially. If the form is appropriately filled up, the composed body text (in the green box) will appear.
  3. 3. Send an email to pair at pair@fda.gov.ph - In the XLS application form, the worksheet 'Email' composes the subject and bosy of the email that should be sent to pair@fda.gov.ph. Copy and paste the appropriate fields onto the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be required during submission. Any attachment will lead to rejection of schedule request. Up to ten applications in a single email are acceptable.
  4. 4. Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission. - The FDA will determine the schedule of applications according to the priority of the Centers. A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be secheduled over separate days. Requests for specific schedules will not be accomodated. Receiving will be scheduled within 10 working days of receipt of application email.
  5. 5. Fees are paid either at Land Bank branches or at the main FDA cashier. - Once a DTL is received, payment can be made immediately through any branch of the Land Bank of the Philippines. The main FDA cashier will only accomodate those scheduled to be received for the day. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the tracking number provided. Check that the tracking number indicated in the DTL is indicated in the proof of payment.
  6. 6. Check if all requirements are in order. - Be sure that you have a checklist of requirements and that you have all the necessary documents. Don't forget to have the petition or declaration form notarized. A softcopy of all requirements should be stored in a USB device to facilitate transfer. Include an XLS or XLSX copy of the accomplished application form. Please keep your USB devices free of malicious software. A copy of the OnColl Payment Slip is also required at the point of submission.
  7. 7. Application is filed on schedule. - Only applications scheduled for the day will be accomodated. Hard copies will no longer be required at submission. Dont't forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through pair@fda.gov.ph. Should you fail to complete submission on the set date, queue for another schedule through pair@fda.gov.ph using RSN.

Require importers to present valid LTO and CPR or NN, as appropriate, prior release of shipment.

Issuance of Licence to Operate (Initial, Regular Renewal, Re-issuance - 25 working per compliant application / 40 working days for Inspection

Issuance of Licence to Operate - Amendment (Inclusion/Deletion of Product, Sources, Activity/ Change of Name of Sources) - 14 working days (per compliant application)

Issuance of GMP/HACCP Certification - 25 working days (per compliant application)

Fees for Licensing of Establishments regulated by FDA (LTO)

Initial (1 year validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 4,000
  2. 2. Iodized Salt Importer - 1,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 1,000
  5. 3.2 Over 1 Million but below 5 Million - 2,000
  6. 3.3 5Million but below 10Million - 3,000
  7. 3.4 10Million but below 20Million - 5,000
  8. 3.5 20Million but below 50Million - 10,000
  9. 3.6 50Million and above - 15,000

Renewal (2 years validity)

  1. 1. Food Distributors (Importer, Exporter, Wholesaler) - 8,000
  2. 2. Iodized Salt Importer - 2,000
  3. 3. Food Manufacturer
  4. 3.1 1 Million and below - 2,000
  5. 3.2 Over 1 Million but below 5 Million - 4,000
  6. 3.3 5Million but below 10Million - 6,000
  7. 3.4 10Million but below 20Million - 10,000
  8. 3.5 20Million but below 50Million - 20,000
  9. 3.6 50Million and above - 30,000

Note: A surcharge of 25% of annual fee shall be charged per quarter (every three months) of delay in filing an application for renewal of the LTO.

Fees for Registration of Products Regulated by FDA (CPR)

INITIAL (FOR ONE YEAR)

  1. 1. Food
  2. 1.1 Category 1 - Php 200
  3. 1.2 Category 2 - Php 250
  4. 1.3 Food Supplement - Php 1,000
  5. 1.4 Bottled Water - Php 1,000

RENEWAL (FOR 5 YEARS)

  1. 1. Food
  2. 1.1 Category 1 - Php 1,000
  3. 1.2 Category 2 - Php 1,250
  4. 1.3 Food Supplement - Php 5,000
  5. 1.4 Bottled Water - Php 5,000

Php 200

Contact Positon Contact Details
Center for Food Regulation and Research (CFRR) MARIA VICTORIA PINION