Commodity

Commodity Details

For Imports

Regulating Agencies

• Civic Drive, Filinvest Corporate City Alabang, Muntinlupa City
• 88571999, 8857-1900, 8877 0259
• None
• cdrr.od@fda.gov.ph (drugs) , cchuhsrr@fda.gov.ph (cosmetics & HUHS), cfrr@fda.gov.ph (food), cdrrhr@fda.gov.ph (medical device), info@fda.gov.ph, pps@fda.gov.ph
• http://www.fda.gov.ph

• FPA Bldg, B.A.I Compound Visayas Ave, Diliman, Quezon City, Metro Manila
• 8426-1572
• None
• fpa.oedgeneralinfo@gmail.com, fpa.oed@gmail.com, fpacentral77@gmail.com
• http://fpa.da.gov.ph

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
• FPA IRR No. 1, Series 1977 – FPA IRR No. 1, Series 1977 FPA Rules And Regulations Governing The Importation, Manufacture, Formulation, Repacking, Distribution, Delivery, Sale, Storage And Use Of Pesticides
• 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
• Presidential Decree No. 1144 dated May 30, 1977 – Presidential Decree No. 1144 dated May 30, 1977 Creating the Fertilizer and Pesticide Authority and Abolishing the Fertilizer Industry Authority
• 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 No. 7716 – Republic Act No. 7716 'An Act Restructing The Value Added Tax (VAT) System, Widening Its Tax Base And Enhanching Its Administration, And For These Purposes Amending And Repealing The Relevant Provisions Of The National Internal Revenue Code, As Amended, And For Other Purposes'
• 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)
• Certificate Authorizing Importation of Pesticide (CAIP)

Requirements & Procedures

Documentary Requirements

Fertilizer and Pesticide Authority

The following are no longer under the purview of this authority as per FPA Memorandum Circular No. 10 Series of 2023:

1. Pesticides and chemicals intended for industrial and household use
2. Urban pest control products
3. Veterinary medicine and products directly applied to animals

LIST OF REQUIREMENTS

1. Duly accomplished online Application Form

Accomplish the form and upload the supporting documents through the FPA Trade System at https://fpa.intercommerce.com.ph/

2. For:
   1. Corporation/Partnership – SEC registration and Articles of Incorporation [activities on "fertilizer" must be explicitly specified on Purpose]
   2. Cooperative - Copy of CDA Registration
   3. Single Proprietorship – certificate of business name registration with DTI
3. Company Profile, including officers, office and establishment location map with geotagged photos
4. Notarized Certificate of Capitalization - for DTI and CDA-registered companies only (New)

Audited Financial Statements & Income Tax Return from the previous year (DTI & CDA-Renewal)/(SEC-New/Renewal)

5. BOC Registration Certificate
6. Distributorship Agreement/Certificate from the Manufacturer/Supplier
7. Recommendation from the FPA Field Officer on the area of coverage
8. Risk Appraisal Checklist for Warehouse/Store [FPA-FOCU-F09]
9. Warehouse Registration Certificate
10. Special Power of Attorney (DTI) / Board Resolution (SEC & CDA) / Secretary’s Certificate (SEC & CDA) and Company Identification Card- for applicants represented by its authorized representative
11. Filing Fee and License Fee based on capitalization (New) and Equity/ Capital Deficiency (Renewal)

License Fee

1. Over P5M capitalization - 1st activity is P8,400 and succeeding activity is P4,800
2. Over P1M to P5M capitalization - 1st activity is P5,400 and succeeding activity is P3,600
3. Over P500T to P1M capitalization - 1st activity is P3,600 and succeeding activity is P1,800
4. P500T and below capitalization - 1st activity is P1,800 and succeeding activity is P850

Filing Fee

1. Manufacturer, Processor, Formulator, Repacker, Institutional User, Bulk Handler, Bulk Blender - P3,600
2. Importer, Distributor, Exporter, Indentor, Importer-End-User - P1,800

Note:

1. Applicant must register the product
2. Processing of License shall only commence upon submission of complete requirements
3. Renewal should be done within three (3) months before the expiry date

Turnaround time: 7 working days

Validity of Registration: 1 year

Food and Drug Administration

*COSMETICS

1. Valid LTO as Cosmetic Importer
   1. Completely accomplished notarized Integrated Application Form withd ID picture of both the Owner/Incorporator/General Manager and the Authorized Person(refer to FDA Circular No. 2014-003, only for NCR and CHD IV-A)
   2. Notarized Accomplished Form with 2 x 2 ID picture of Owner/Incorporator/Authorized Representative (see annex A)(except for NCR and CHD IV-A) - Notarized Secretary's Certificate/Special Power of Attorney (if authorized representative is not the owner in the DTI business registration or one of the incorporators in the SEC)
   3. Proof of Business Registration
      • Valid certificate of business name registration with the DTI, (for single proprietorship)
      • Valid registration with the SEC and Articles of Incorporation or Partnership (for corporation or partnership)
        • If the business name is different from the corporate name, SEC Certificate must reflect ''Doing business under the name and style of (Name of Establishment)''
      • Certificate of Cooperative Development Authority (CDA), (for cooperatives)
   4. Proof of Occupancy (Office, Manufacturing and Warehouse)
      • Transfer Certificate of Title (TCT) as proof of ownership
      • Notarized Certificate of Occupancy, if owned by one of the incorporators,
      • Notarized valid contract of lease/sublease, if the space/building being occupied is not owned
      • Valid Clearance from Homeowner's Assocation (HOA) / Condominium/Building Administration, if within a residential area/condiminium
      • Valid notarized warehousing agreement for third party logistics,
      • Floor plan/lay-out in meters and proper identification of areas (office and warehouse)
      • Vicinity/Location map with landmarks (ie google map, sketch of the area)
   5. Pertinent documents for authorized person (pharmacist or any allied health science professional with relevant trainings:
      • Notarized Joint Affidavit of Undertaking with 2 x 2 ID picture of authorized person (see Annex B)(except NCR and CHD IV-A)
      • PRC Board Certificate
      • Valid PRC ID
      • Current Professional Tax Receipt (PTR)
      • Duties and responsibilities signed by the authorized person and teh immediate supervisor
      • Certificate of Attendance to Qualified Person in Industry Regulatory Affairs (QPIRA) for CCRR or promisory letter to attend with proof of scheduled day of attendance and payment
   6. List of products indicating the name adn address of source/supplier/manufacturer, country of origin (if imported)
   7. Valid Foreign Agency Agreement or any form of authorization from each source/supplier duly authenticated by the Territorial Philippine Consulate
   8. If the source/suppler has appointed another logistc/involving any of the following:
      • Valid Supply Agreement between the foreign source/supplier and manfuacturer
      • Valid Tripartite Agreement duly authenticated by the Territorial Philippine Consulate
      • Proof of GMP Compliance of Manufacturer (any of the following)
      • Valid GMP Certificate of manufacturer issued by the government agency or accredited business association (WHO, ECC/EU, COLIPA) in the country of origin
      • Self-declaration of compliance of GMP if manufacturer is from an ASEAN Member State
      • Certificate of Free Sale issued by the government agency (National Regulatory Authority or Chamber of Commerce) in the country of origin
      • ISO Certificate in compliance to GMP
      • Valid manufacturer's license
2. Valid Notification

*H/UHS

1. Valid LTO as H/UHS Importer
   1. Accomplished Petition Form duly notarized with 2 x 2 ID picture of Owner/Incorporator/ Authorized Representative
      • Secretary's Certificate/Special Power of Attorney for authorized representative
      • Signed Duties and Responsibilities
      • Certificate of Attendance to FDA sponsored seminar on licensing of establishment or promisorry letter to attend
   2. Proof of Business 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 and other pertinent documents
      • if Cooperative, Certificate of Cooperative Development Authoity (CDA)
      • Valid Mayor's Business Permit/ Barangay Business Permit, if the business name and address is different from the registered name and address in the DTI or SEC
      • For change of Ownership: Deed of Sale
      • For Merging/Bu-out: Deed of Assignment
   3. Proof of Occupancy
      • Notarized valid Contract of Lease/Sublease (if the space/ building being occupied is not owned)
      • Transfer Certificate of Title (if owned)
      • Notarized Certificate of Occupancy (if owned by one of the incorporators)
      • Valid and duly notarized warehousing agreement (third pary logistics)
      • Valid Homeowner's Association (HOA) and Clearance if the establishment is located inside a subdivision or residential condominium
      • Floor plan, vicinity map and pictue with signage
   4. List of products distributed in matrix format indicating the name of raw material and/or product, manufacturer, supplier/trader, country of origin
      • Valid Foreign Agency Agreement from each supplier duly authenticated by the Territorial Philippine Consulate
      • Additional requirement, if the supplier is not the manufacturer
        • Valid Supply Agreement between the foreign source & manufacturer
        • Valid Tripartite Agreement duly Authenticated by the Territorial Philippines Consulate
        • For raw materials, an ISO/Business License/Manufacturer's License may be submitted in lieu of GMP Certificate
2. Valid CPR / Notification

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.

Fertilizer and Pesticide Authority

Steps in the Processing of VAT Exemption Clearance (VEC) for Importation of Fertilizer

1. Ensure that the product being applied for VAT exemption is duly registered with the FPA. This can be verified from the List of Registered Fertilizer Products through FPA website.
2. The importer must be a licensed fertilizer importer/importer end-user. This can also be a verified from the List of Fertilizer Handlers through FPA website. (https://fpa.da.gov.ph/resources/reports/registered-products/)
3. NSW application form and other supporting/shipping document must be emailed to fpa.frd.vat@gmail.com for proper evaluation of application. The following shipping documents are as attachments:
   1. Bill of Lading
   2. Commercial Invoice
   3. Packing List
   4. Certificate of Product Registration (CPR) & License to Operate (LTO)
   5. Laboratory analysis of sample taken from the country of origin prior to its shipment to the Philippines. This must be conducted by SGS or any independent laboratory from the country of origin and neither the Importer must not be affiliated nor connected the Laboratory company. For ease of reference and traceability, the test report should include any of the following as additional details: Bill of Lading No., Invoice No. or Batch/Lot Number of the product to be shipped.
   6. For potassium nitrate, nitrate-containing fertilizer product and other explosive ingredients, the following additional documents must also be submitted:
      1. Permit/Clearance issued by the Philippines National Police- Firearms and Explosive Office/ PNP-FEO; and,
      2. Disposition report of the previous shipment stating the names of customers and quantity sold,
4. If all the above-listed documents have been submitted, then the VEC will be prepared.
5. Per Administrative Order No. 13 (as signed by Sec. Edgardo J. Angara, effective May 16, 2000, the processing fee for VEC is six hundred pesos (P600.00).
6. The Turnaround time for VEC Application is four (4) working days.

PROCEDURES

Fertilizer and Pesticide Authority

1. Importer/Broker will login to www.nsw.gov.ph, fill up and submit application for VAT Exemption Clearance (VEC) through NSW System.
2. Receiving Officer (RO) checks the completeness of the basic documentary requirements. If found complete, RO receives the application thru NSW system, assigns Office Control Code and forward documents to concerned Processing Officer. If application is rejected/ hold, importer will be notified thru email that application was rejected or in pending state.
3. Processing Officer (Revenue Officer) evaluates the submitted documentary requirements.
4. Processing Officer prepares computation in excel format, prepares VEC and forward docket to Reviewing Officer.
5. Reviewing Officer reviews VEC. Forward docket to Approving Officer, if found in order. Otherwise, return docket to Processing Officer.
6. Approving Officer (Authorize 1 & 2) reviews and approves VEC, if found in order, authorizes the transaction and electronically transmit VEC. Otherwise, return docket to Reviewing Officer.

NTMs

Import Status

Regulated

For Exports

Regulating Agencies


• FPA Bldg, B.A.I Compound Visayas Ave, Diliman, Quezon City, Metro Manila
• 8426-1572
• None
• fpa.oedgeneralinfo@gmail.com, fpa.oed@gmail.com, fpacentral77@gmail.com
• http://fpa.da.gov.ph

Status

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

NTMs

1. FPA – FPA License
2. FPA – Export Permit
3. FPA – Product Registration

Tariff Schedules

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

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