FDA Consulting




June 17, 2020

BIR removes mayor’s permit as requirement in business registration

The Bureau of Internal Revenue (BIR) has taken out the mayor’s permit as one of the requirements in business registration.

Commissioner Cesar Dulay pointed out that the BIR aims to expedite the process of establishing businesses in the Philippines.

It is continuously making reforms to ease the burden of entrepreneurs in submitting required documents.

-PTV News

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)

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.