License to Operate

For a company to be able to import, distribute, market, advertise or manufacture their products here in the Philippines.
+63 (02) 856 9631
+63 (02) 551 9012-13
info@tripleiconsulting.com
Metro Manila Head Office

Address: 12F Sagittarius Building,
111, H.V. Dela Costa Street Salcedo Village, Makati City 1227
Tel: +63 (02) 856 9631
+63 (02) 551 9012-13
Email: info@tripleiconsulting.com

For a company to be able to import, distribute, market, advertise or manufacture their products here in the Philippines, they must first secure a License to Operate (LTO) as Importer/Distributor/Wholesaler, for products imported from different countries, or as Manufacturer, for locally manufactured products. After obtaining an LTO companies may then proceed to apply for a Certificate of Product Registration (CPR), which states that the product has been evaluated and officially registered with the Philippine FDA.

Establishments under industries requiring a License to Operate as manufacturer, importer, distributor, wholesaler, or exporter:

  • Food
  • Drugs
  • Cosmetics
  • Household Hazards
  • Veterinary Products
  • Medical Devices (to be submitted to the Department Of Health – Center for Device, Regulation, Radiation Health and Research)
Requirements:
  • Accomplished and duly notarized Petition Form and Joint Affidavit of Undertaking;
  • List of products to be distributed, identified by generic names and brand names intended for use;
  • Copies of Pharmacist Board Registration Certificate, PRC ID, valid PTR, ID picture, and Duties and Responsibilities;
  • Certificate of Attendance of owner or pharmacist to an FDA seminar on Licensing of Drug Establishments;
  • Certificate of Registration with SEC and Articles of Incorporation/Partnership (for corporations or partnerships);
  • Certificate of Business Name Registration with DTI (for single proprietorships);
  • Locational plan and floor plan (office and storage room) with dimensions; and
  • Contract of lease for the space to be occupied.

If Importer

  • Foreign Agency Agreement (FAA) from each supplier, duly authenticated by the Territorial Philippine Consulate
  • Certificate of Registration of manufacturer and its conformity with the Good Manufacturing Practices From Health Authority authenticated by the Philippine Consulate

If Wholesaler

  • Valid current contract with FDA licensed supplier/manufacturer
  • Certificate of product registration from FDA
  • Copy of LTO from supplier/manufacturer

If Exporter

  • Valid current contract with FDA licensed supplier/manufacturer
  • Certificate of product registration from FDA
  • Copy of LTO from supplier/manufacturer

Requirements for verification during inspection:

  • Reference materials:
    • Philippine National Drug Formulary (latest edition)
    • R.A. 3720: Foods, Drugs, Devices & Cosmetics Act
    • R.A. 6675: Generics Act of 1988 and Relevant Implementing Rules and Regulations
    • R.A. 5921: Pharmacy Law as amended and Relevant Implementing Rules and Regulations
    • Latest edition of United State Pharmacopoeia/National Formulary (USP/NF), or Remington’s Pharmaceutical Sciences, or Goodman & Gilman’s The Pharmacological Basis of Therapeutics
  • Batch Distribution Record Book
Procedure:
  1. Submit application requirements to FDA;
  2. Proceed with interview with the Food and Drug Registration Office (FDRO);
  3. Review of completion of requirements and application by the Licensing Department;
  4. Receive Order for Payment and complete application;
  5. Request for schedule of inspection;
  6. Physical inspection of office and facility by the FDRO;
  7. Approval of the LTO by the Director; and
  8. Release of documents to applicant.
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12F Sagittarius Building,
111, H.V. Dela Costa Street Salcedo Village, Makati City 1227
Contact Us : +63 (02) 551 9012-13; +63 (02) 856 9631

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