License to Operate from FDA

Pharmacy

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 and for locally manufactured products, an LTO as a Manufacturer. Only after obtaining an LTO companies may then proceed for to process an application for Certificate of Product Registration (CPR) or a certificate that the product has been evaluated and officially registered in the Philippine FDA. However for Exporters the product must first be registered initially before applying for an LTO as an exporter.

Triple i Consulting has a team of pharmacists on staff to consult with FDA, one of the most stringent government offices in the Philippines. Contact Us to arrange an initial consultation with our Pharma Division.


License to Operate for the following organizations:

• As Drugstore / Retail Outlet Non-Prescription Drugs / Hospital Pharmacy
• As Food Importer / Distributor / Wholesaler / Exporter
• As Drug Importer / Distributor / Wholesaler / Exporter
• As Cosmetics Importer / Distributor / Wholesaler /Exporter
• As Household Hazardous I /D / W/ E
• As Veterinary Products I/ D/ W/ E
• As Medical Device I / D /W /E (submitted at Dept. Of Health Center for Device, Regulation, Radiation Health and Research)

Requirements for License to Operate

Please see our guide on License to Operate

  • Accomplished Petition Form/Joint Affidavit of Undertaking Duly Notarized
  • 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, Duties and Responsibilities
  • Certificate of Attendance of Owner/Pharmacist to a FDA seminar on Licensing of Drug Establishments and Outlets in the Philippines
  • Locational Plan and Floor Plan (Office and Storage Room) with dimensions.
  • If a corporation, Certificate of Registration with SEC and Articles of Incorporation/Partnership
  • If single proprietorship, a Certificate of Business Name Registration with Bureau of Trade Regulation and Consumer Protection (BTRCP)
  • Contract of Lease for the space to be occupied

If Importer

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

If Wholesaler

  • A Valid current contract with FDA licensed supplier/manufacturer
  • A certificate that the products supplied are registered with FDA
  • Copy of LTO from supplier/manufacturer

If Exporter

  • A Valid current contract with FDA licensed supplier/manufacturer
  • A certificate that the product supplied are registered with BFAD
  • Copy of LTO from supplier/manufacturer

 

The Following Must also be Presented During the Inspection Required when Applying for LTO

  • Reference materials:
  • Philippine National Drug Formula
  • - R.A. 3720, Food, Drugs, Devices & Cosmetic 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.
  • Any one of the following reference books:
  • - United State Pharmacopoeia/National Formulary (USP/NF) latest edition
  • Remington’s Pharmaceutical Sciences (latest edition)
  • - Goodman & Gilman Pharmacological Basis of Therapeutics (latest edition)
  • Batch Distribution Record Book

Procedure for Securing LTO

  • Gather application and all requirements and submit to FDA registration department
  • Interview with Food and Drug Registration Office FDRO
  • Licensing Department will review requirements and application to make sure complete
  • Receive Order for Payment to FDRO and receive completed application
  • Request for a schedule of inspection
  • Physical inspection of office and facility by the FDRO. Submit report to licensing section of FDA
  • Director Approval of LTO
  • Release of documents to applicant

Metro Manila Head Office

Address: 18th Floor Salcedo Tower
169 HV Dela Costa, Salcedo Village 1227 Makati City, Philippines
Tel: +63 2 513 7947
+63 2 551 9013
+63 905 3130064
Fax: +63 2 551 8052
Email: info@tripleiconsulting.com