License to Operate

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, 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)

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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

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Procedure:

• Submit application requirements to FDA;
• Proceed with interview with the Food and Drug Registration Office (FDRO);
• Review of completion of requirements and application by the Licensing Department;
• Receive Order for Payment and complete application;
• Request for schedule of inspection;
• Physical inspection of office and facility by the FDRO;
• Approval of the LTO by the Director; and
• 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 2 566 5240
+63 2 551 9013
+63 905 3130064
Fax: +63 2 551 8052
Email: info@tripleiconsulting.com