Commodity

Commodity Details

For Imports

Regulating Agencies

Legal Basis

• Executive Order No. 245 dated July 24, 1987 – Executive Order No. 245 dated July 24, 1987 Implementing The Consolidation Of All Tobacco Agencies And The Creation Of The National Tobacco Administration, Prescribing Its Charter And For Other Purposes

Permits, Clearances, Certifications

• Permit to Operate as Excise Taxpayer
• Sanitary and Phytosanitary Import Clearance (SPSIC)
• License to Operate (LTO)
• Certificate of Product Registration (CPR)
• License a) Authority to Import b) Authority for Transshipment
• Commodity Clearance a) Import Commodity Clearance b) Transshipment Commodity Clearance

Requirements & Procedures

Documentary Requirements

Bureau of Plant Industry

Plant Quarantine Clearance:

1. Duly accomplished Application Form or BPI Q Form No. 1
2. Proforma Invoice
3. GM Certification
4. Certificate from Buyers
5. Research Outline

Phytosanitary Certificate

1. Duly accomplished Application Form or BPI Q Form No. 1

National Tobacco Administration

Issuance of Commodity Clearances

At least three working days prior to unloading of subject commodity, importer/transshipper shall file with the NTA, through the Regulation Department, a duly accomplished ECC(Export Commodity Clearance/ICC(Import Commodity Clearance))/TCC(Transshipment Commodity Clearance) Form, on a per shipment basis in four copies; The ECC/ICC/TCC Form must be supported by the following documents:

1. Import Declaration
2. Sale/Packing List/Purchase Invoice
3. Bill of Lading/ Airway Bill
4. Phytosanitary Inspection Certificate
5. Fumigation Certificate
6. Moisture Content Certificate
7. Certificate of Inspection (RD Form #26)
8. Request for Inspection (RD Form #11)
9. NTA Official Receipt (OR)
10. Certificate of Authenticity (COA), if required by importing country (RD Form no. 19)
11. Import/Export/Transshipment Clearance Form, duly accomplished (RD Form no. 17/18)
12. Other pertinent import documents as required by the Bureau of Customs (BOC), Bureau of Internal Revenue (BIR) and Department of Trade and Industry (DTI)

Note: Should be filed at least three working days prior to the date of unloading of the commodity

Bureau of Internal Revenue

1. Bill of Lading
2. Packing List
3. Commercial Invoice
4. Import Entry and Internal Revenue Declaration
5. Tax and Duty Declaration 'Valuation Computation' - Computation of Duties and Taxes
6. Material Safety Data Sheet (MSDS)
7. Product Information Sheet
8. DOE Permit or Certification of Compliance for Coal Importation
9. In case of salt, certification that the imported salt is extracted from sea water duly authenticated by the Philippine Embassy at the country of origin to qualify exemption from excise tax.

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

Bureau of Internal Revenue

1. Importer/Broker will login to www.nsw.gov.ph and fill up and submit application for ATRIG thru NSW System
2. Receiving Officer 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 to determine whether or not the application requires any of the following:
   1. Conduct of ocular inspection;
   2. Resolution of technical/factual issue (for referral to the Laboratory Unit);
   3. Resolution of legal issues (for referral to the Law Division).
4. Processing Officer prepares computation in excel format, prepares eATRIG and forward docket to Reviewing Officer.
5. Reviewing Officer reviews eATRIG. Forward docket to Approving Officer, if found in order. Otherwise, return docket to Processing Officer.
6. Approving Officer (Approve 1 & 2) reviews and approves eATRIG, if found in order, authorizes the transaction and electronically transmit eATRIG to BOC . Otherwise, return docket to Reviewing Officer

Bureau of Plant Industry

Application and Issuance of Plant Quarantine Clearance:

1. Fill up application form for Permit to Import for Plants and Plant products or Potential Animal Pests
2. Submit accomplished BPI 'Q' Form No. 1 or 5
3. Bring application form to cashier for payment
4. Return application form to PQS for processing
5. Receives Plant Quarantine Clearance
6. Fill up Feedback Form

Bureau of Plant Industry

Application and Issuance of Phytosanitary Certificate:

1. Fill up Application for Inspection and Phytosanitary Certification
2. Submit accomplished BPI ''Q'' Form No. 10
3. Present actual commodity for inspection
4. Receive Phytosanitary Certificate
5. Fill up Feedback Form

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.

National Tobacco Administration

1. Prior to the issuance of Commodity Clearance, the concerned exporter/importer/transshipper, must first apply for Authority to Export/Import/Transship, to the NTA, thru the Regulation Dept., by submitting the following documents, as per Checklist of
   Requirements and complying the following procedures:
   1. Properly accomplished NTA Application Form (RD Form # 16), duly supported by the following:
      1. Business Registration (Individual) or Articles of Incorporation & By-Laws (Corporation);
      2. ITR and/or latest Audited Financial Statement;
      3. List of Company officers and their designated authorized representative/s, signed by the Corporate Sec/Owner/President;
      4. Individual/Company Information Sheet (RD Form # 1); and
      5. Current business A1:L43
   2. And payment of assessed Permit/License Fee, and corresponding Official Receipt (OR), shall be issued by the NTA Cashier.
2. Procedures in the Issuance of Commodity Clearances
   1. At least three (3) working days prior to the loading(Exportation or Transshipment) /unloading(Importation) of the subject commodity, the exporter/importer/transshipper, shall file with the NTA, thru the Regulation Dept., a duly accomplished ECC(Export Commodity Clearance/ICC(Import Commodity Clearance))/TCC(Transshipment Commodity Clearance) Form, on a per shipment basis, in four (4) copies;
   2. The ECC/ICC/TCC form must be supported by the following documents:
      1. Export/Import Declaration;
      2. Sales/Packing List/Purchase Invoice;
      3. Bill of Lading/Airway Bill;
      4. Phytosanitary Inspection; Fumigation Certificate/Moisture Content Certificate;
      5. Certificate of Inspection (RD Form # 26)
      6. Request for Inspection (RD Form# 25); and
      7. NTA Official Receipt (OR) for full pay’t of fees.
   3. After assessment of subject for export/import/transship, the concerned exporter/importer/transshipper pays the assessed processing, regulation and inspection fees to NTA Cashier; and
   4. Inspection shall be conducted by NTA Designated Inspector.
3. Inspection Procedure
   Upon arrival of imported/transshipped commodity, the concerned importer/transshipper, must advice NTA of said arrival, and immediately, a NTA Designated Inspector shall conduct the requested inspection and get samples of the subject commodity to determine absence of chemical/pesticide residues, and the absence of pathogenic microbiological organisms or free from toxic constituents (trace Of metals, i.e. arsenic and mercury) and to determine whether the commodity conforms to the description indicated in the ICC/TCC-Inbound.
   1. When all requirements and procedures are complied, NTA issues duly approved ECC/ICC/TCC, to exporter/importer/transshipper; and
   2. Exporter/Importer/Transhipper, using the issued duly approved ECC/ICC/TCC, shall now enter/withdraw the commodity to/from customs territory.

NTMs

1. FDA – License to Operate
2. BIR – Permit to Operate as Excise Taxpayer
3. FDA – Certificate of Product Registration
4. BIR – Excise Tax
5. FDA – Labelling Requirement
6. BIR – Authority to Release Imported Goods (ATRIG)
7. BIR – Inspection Requirement
   

Import Status

Regulated

For Exports

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
4. NTA – Authority to Export
5. NTA – Export Commodity Clearance
6. NTA – Fee Payment
7. NTA – Pre-shipment Inspection

Tariff Schedules

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

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