Commodity

Commodity Details

Chapter 30.04 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale.
Heading 3004.90 – Other :
Subheading 3004.90.90 – – Other :
Commodity 3004.90.93 – – – Containing sorbitol or salbutamol, in other forms

For Imports

Regulating Agencies

Department of Finance
  • 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

  • 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

  1. Valid LTO as Drug Importer

    1. Notarized duly accomplished Petition Form and Joint Affidavit of Undertaking

    2. Proof of Registration: If Single Proprietorship, Certificate of Business Name of Registration with the DTI

      • Valid Mayor's Business Permit or Barangay Business Permit bearing the exact registered business name and address

    3. If Corporation or Partneship, Registration with SEC and Articles of Incorporation; Secretary's Certificate when applicable

      • If the Corporate Name is different from the Business Address, secure either Mayor's Business Permit or Barangay Business Permit reflecting the exact registered business name and address

    4. If Franchisee, submit a copy of Franchise Agreement and proof of registration of franchisor

      • Pharmacist Clearance Copies of Pharmacist Board Certificate, PRC-ID, valid PTR, Duties and Responsibilities of the pharmacist and Certificate of Attendance of Owner/Pharmacist to an FDA sponsored/accredited Seminar on Licensing of Drug Establishments and Outlets (AO 56 s. 1989) and Seminar on EDPMS (NCPAM)

    5. List of Products to be distributed identified by their generic name and brand names, if any

    6. Notarized Contract of Lease of the space to be occupied (office and storage room/warehouse) if not owned or any proof of ownership if owned (e.g. Tax Declaration) or notarized Certificate of Occupancy

    7. Valid Homeowner's Association (HOA) Clearance when applicable

    8. Picture of establishment (facade) bearing the exact registered business name

    9. Location Plan (sketch with landmark) and Floor Plan with dimension (square meter) of the space to be occupied (office and storage room/warehouse)

    10. Foreign Agency Agreement from each suppleir duly authenticated by the Territorial Philippine Consulate

    11. Certificate of Registration of Manufacturer and its conformity with GMP from Health Authority (GMP Certificate

  2. Valid CPR

    1. Notarized Letter of Application

    2. Form 8

    3. Copy of valid agreement between the manufacturer and importer

    4. Unit Dose and Batch Formulation (in metric system)

    5. Technical Specification of all Raw Materials

    6. Certificate of Analysis of Active Raw Material(s)

      • From the manufacturer (supplier) of the active material

      • From the manufacturer of the finished product

    7. Certificate of Analysis of the Finished Product (from the same batch or lot of the representative sample submitted)

    8. Master Manufacturing Procedure, Production Equipment, Sampling and In-Process Controls, and Master Packaging Procedure

    9. Assay and other test procedures including Assay with Data Analysis e.g. chromatograms, if applicable (For Non-Official Formulation, assay validation report(s) for test procedure(s)

    10. Stability Studies

      • National Guidelines:

        1. Accelerated - 1 batch 3 elevated temperatures (400C, 500C, 600C) or

        2. Long-Term - 3 batches (300C /70% -+5% RH)

      • ASEAN Guidelines

        • Accelerated - 2 batches (3 batches for New Drug) at 400C/75% RH and

        • Long Term Stability Studies - 2 batches (3 batches for New Drug (300C/75% RH) as adopted in the 8th ACCSQ PPWG Meeting

        • In-Use Stability Studies (Additional requirements for Powder for Suspension)

          • 1 batch at 300C (7 days) and 2 to 80C (14 days)

          • 3 batches at 300C (7 days) and 2 to 800C (14 days)

            3 batches at 300C (7 days) and 2 to 800C (14 days)

    11. Labelling Materials

      • Facsimile labels with actual color text (3 copies)

      • Actual/Commercial labeling materials (3 copies)

    12. Bioavailability/Bioequivalence Studies (where applicable)

    13. Dissolution Profile for Drugs in List B Prime (12 units Test Procedure versus Reference including computation of similarity factor (f2) as per BC No. 13-A s. 1999

    14. For New Drug Application

      • Copy of ACB approval on pre-clinical, clinical and protocol for monitored release (MR)

      • Copy of ACB approval on the rationale of fixed dose combination product (if applicable)

      • Copy of ACB approval of post-marketing surveillance (PMS) or Letter of Extension of MR status (if applicable)

    15. For imported products (an english translation shall accompany any document not written in english)

        • Original Certificate of Pharmaceutical Product (issued at least 1 year from the date the application for registration was filed)

        • For Countries not issuing CPP, the following may be accepted:

          • Certificate of Free Sale from the country of origin, duly authenticated by the territorial Philippine Consulate

          • Government Certificate attesting the registration status of the manufacturer, duly authenticated by the territorial Philippine Consulate

        • For Products in Plastic Container

          • General Information

          • General Information

            Studies done on the plastic to substantiate claim that the products is safe to use

          • Test Procedures and Limits

          • Empty plastic container and closure with corresponding proof of payment for laboratory analysis

      • Additional requirements for Vaccines and Biological Products

        • Report on pre-clinical studies, if appropriate

        • Report on clinical trials, as appropriate

          • New Biological Product

            • Phase IV, Clinical trial protocol, or FDA approval

            • Phase I, II, and Clinical Studies

              • Dose Response Studies

              • Protective Efficacy (natural and artificial challenge)

              • Relationship between Immune Response and Protection

              • Rate of fall of response and loss of protection

              • Re-vaccination stuies, where applicable

              • Studies in relevant sub-groups

              • Lot-to-do consistency study (retrospective)

          • Established Biological Product

            • Phase IV Clinical Trial

          • Live

            • Transmission to contact studies

            • Vaccine induced disease studies

            • Effect on large scale vaccination on the natural history of the disease

            • Combination of biological product

              • Clinical data on efficacy

              • Interaction studies

            • Clinical data on safety

              • Comparison on local reactions (combination vs separate)

              • Comparison on combination with worst of separate vaccines

              • Names of the medical director of the importer/distributor who will monitor event/s reactions and prepare appropriate report to be submitted to FDA

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

Department of Finance
  • 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

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).

Edit