Commodity

Commodity Details

Chapter 40.14 Hygienic or pharmaceutical articles (including teats), of vulcanised rubber other than hard rubber, with or without fittings of hard rubber.
Heading 4014.90 – Other :
Commodity 4014.90.40 – – Stoppers for pharmaceutical use

For Imports

Regulating Agencies

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

Legal Basis

  • DOH Administrative Order No. 2016-0003 – DOH Administrative Order No. 2016-0003Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration
  • 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

*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.

NTMs

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

Import Status

Regulated

For Exports

Regulating Agencies

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

Status

NTMs

Tariff Schedules

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

Edit