Commodity

Commodity Details

For Imports

Regulating Agencies

Legal Basis

• Administrative Order No. 2020-0017 – Administrative Order No. 2020-0017 || Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003
• DOH Department Circular No. 2011-0101 – DOH Department Circular No. 2011-0101 The Rules and Regulations Implementing RA No. 9711- The Food and Drug Administration Act of 2009
• Republic Act No. 10611 – Republic Act No. 10611 An Act To Strengthen The Food Safety Regulatory System In the Country To Protect Consumer Health And Facilitate Market Access Of Local Foods And Food Products And For Other Purposes
• Republic Act No. 7394 dated April 13, 1992 – Republic Act No. 7394 dated April 13, 1992 The Consumer Act of the Philippines
• Republic Act 9711 dated August 18, 2009 – Republic Act 9711 dated August 18, 2009 An Act Strengthening And Rationalizing The Regulatory Capacity Of The Bureau Of Food And Drugs (BFAD) By Establishing Adequate Testing Laboratories And Field Offices, Upgrading Its Equipment, Augmenting Its Human Resource Complement, Giving Authority To Retain Its Income, Renaming It The Food And Drug Administration (FDA), Amending Certain Sections Of RA No. 3720, As Amended, And Appropriating Funds Thereof

Permits, Clearances, Certifications

• License to Operate (LTO)
• Certificate of Product Registration (CPR)
• FDA Certification/Notification/Clearance (for those not requiring LTO and/or CPR)
• Certificate of Analysis (if applicable)

Requirements & Procedures

Documentary Requirements

Food and Drug Administration

The Philippine importer must use the e-registration system version using the valid user account holder . You must read carefully the new issuance of FDA Circular 2020-033 (Procedure for the use of a modified e-registration system for raw material and pre-packaged food products and its amendment 2020-033A).

There is an available video presentation on the FDA website for "Complete Guide on How to Apply for Food CPR version 2".

You may also see the Frequently Asked Questions of FDA for your other references.

Valid License to Operate (LTO) as Food Importer

Duly accomplished and notarized Integrated Application Form

Proof of Registration

1. If Single Proprietorship, valid Certificate of Business Name Registration with the DTI
2. If Corporation or Partnership, valid Registration with SEC and Articles of Incorporation or Partnership
3. If Cooperative, valid Certificate from Cooperative Development Authorities (CDA) and by laws

Proof of Occupancy

1. Valid notarized Contract of Lease/Sub-Lease/Certificate of Occupancy/ Warehousing Agreement (for third party logistics)
2. Transfer Certificate of Title (TCT)if owned and notarized Certificate of Occupancy (if owned by one of the incorporators
3. Clearance from the Condominium/ Building Administration allowing the use of the unit for business purposes - as necessary

Location Plan/Site/Google Map (indicate size, location, landmarks, immediate environment, type of building)

Floor Plan/Lay out with dimension (office and/or warehouse; manufacturing plant)

List of food products to be distributed

Sample label of product to be imported/distributed

Any of the following from each supplier

1. Foreign Agency Agreement
2. Certificate of Distributorship
3. Appointment Letter
4. Proforma Invoice
5. Memorandum of Agreement

Any one of the following documents for the status of manufacturer issued by the Regulatory/Health Authority from the country of origin

1. Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent
2. Phytosanitary Certificate/Health Certificate
3. Certificate of Free Sale
4. ISO 2200 Certification/FSSC 2200
5. HACCP Certificate as applicable

Valid Certificate of Product Registration (CPR)

Completely filled up Assessment Slip

Application Letter

Notarized Affidavit of Undertaking

Completely filled up Product List

Proforma/Sales Invoice declaring the products imported and applied for product registration

Actual loose label with sticker reflecting the complete name and address of the importer

Original copy of the Certificate of Free Sale (CFS) issued by the Government Regulatory Agency in the country of origin stating that the specific products applied for registration are freely sold in the country of origin and fit for human consumption.

Procedures

Food and Drug Administration

1. Application form id downloaded from www.fda.gov.ph
   • The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amendments 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. Application form is filled-up correctly.
   • The application form has six parts:
     1. General Information
     2. Establishment Information
     3. Product Information
     4. Supporting Information
     5. Sources and Clients
     6. 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. 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. 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 scheduled over separate days. Requests for specific schedules will not be accommodated. Receiving will be scheduled within 10 working days of receipt of application email.
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 accommodate 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. 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. Application is filed on schedule.
   • Only applications scheduled for the day will be accommodated. Hard copies will no longer be required at submission. Don'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.

NTMs

1. FDA – License to Operate
2. FDA – Certificate of Product Registration
3. FDA – Labelling Requirement

Import Status

Regulated

For Exports

Regulating Agencies

No Regulating Agencies

Status

The export of this commodity is currently regulated. Please contact the regulating agency above for export requirements and procedures.

NTMs

1. FDA – License to Operate
2. FDA – Certificate of Product Registration
3. FDA – Export Certification

Tariff Schedules

Visit the Philippine Tariff Commission (TC) through its Philippine Tariff Finder (PTF).

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