BGC & Co. CPA's | FDA Consulting

FDA Consulting

August 05, 2022

BGC & CO CPAS has officialy joined OneSMP LPP

OneSMP LPP is pleased to announce that BGC & CO CPAS. has joined the progressive ASEAN collaboration network of independent accounting , consulting and legal firms.

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
• Medical Devices (to be submitted to the Department Of Health – Center for Device, Regulation, Radiation Health and Research)

• 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

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.