PHILIPPINES FDA License to Operate SERVICE

PHILIPPINES FDA License to Operate SERVICE

License to Operate

For a company to be able to import, distribute, market, advertise or manufacture their products here in the Philippines.

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.


BGC and Co. CPAs is a mid-sized progressive auditing firm providing comprehensive set of cost effective solutions to organizations like yours.

Our services include auditing, accounting, bookkeeping, business management, and HR consulting. Further, we provide other business services like VISA processing in Bureau of Immigration (BI), Philippine Retirement Authority (PRA).

We are equipped with state of art tools and techniques along with dedicated professional to evaluate potential opportunities and risks effective auditing and assurance services. We understand a value adding auditing and assurance service focus on scope of business improvement rather than merely preparing financial statements and reporting on figures.

The firm was formed to assist clients on the preparation of compliances relating to tax, financial management, forecasting and accounting software and system installation. Assist clients in tax investigations, internal auditing procedures and provide on financial, taxation, accounting and auditing matters when needed. Processing of business registration, cancellation / termination.

Our Mission

Deliver reliable cost effective professional services in time meeting specific customer requirements.

Our Vision

To become one of the best auditing and accounting firm in the Philippines providing the utmost satisfaction to all the clients. We would like to be known as one of the finest company to partnered with in all the aspects.

Our Team

Our teams of dedicated professionals led by senior qualified accountants are obliged to give you quality services which will enable you to serve your clients better and there by improve your business. We together with our associates enable to give you the best in the industry.

ABOUT OUR SERVICES

Auditing and Assurance

We are equipped with state of art tools and techniques along with dedicated professional to evaluate potential opportunities and risks delivering effective auditing & assurance services. We understand value adding auditing and assurance service focus on scope of business improvement rather than merely preparing financial statements and reporting on figures.


Our expertise in analyzing accounting systems, designing better systems with proper internal controls and management information reporting help our clients to adequately plan their business building strategy and give them the confidence to pace up with the rapidly growing economy.

Accounting and Bookkeeping


Accounting and bookkeeping is a necessity of every organization irrespective of its size. Our professionally qualified and experienced accountants understand and analyze business transactions and ensure compliance with the accounting standards. BGC has well trained staff familiar with many of the accounting system and most especially to the rapid changes in the BIR rules and regulations. Qualitative and timely accounting reports are crucial for the success of any business organization. BGC ensures relevant and reliable financial reports are delivered on regular intervals to assess performance and to facilitate decision making. Outsourcing of accounts department helps you to get professional expertise at lower cost and BGC provides the most efficient and effective bookkeeping solutions.

We assist you with below services:

• Accounts preparation and supervision
• Preparation and presentation of financial reports
• Bookkeeping services
• Payroll processing
• Training of accounting staff

Business Set-up and Termination

We do assist in setting up different types of business organizations through registrations to different government agencies such as:

• Securities and Exchange Commission (SEC);
• Bureau of Internal Revenue (BIR);
• Local Government Unit (LGU);
• Department of Trade and Industry (DTI);
• Social Security System (SSS);
• Philippine Health Insurance (Philhealth);
• Pag ibig;
• Food and Drug Administration (FDA)

We also assist our foreigner clients for the following:

• VISA extension;
• Bureau of Internal Revenue (BIR);
• 9g VISA;
• Special Resident Retiree’s VISA (SRRV)
• Social Security System (SSS);
• Passport Renewal


SERVICES
CONTACT US
ADDRESS

    •  7TH FLOOR, PCCI CORPORATE CENTER, L.P. LEVISTE ST., SALCEDO VILLAGE, BRGY. BEL-AIR MAKATI, PHILIPPINES 1209
    •  Info@bgcco.ph
    •  lconvento@bgcco.ph
    •  Working Hours : 8:00 a.m - 5:00 p.m
PROFILE


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