How to Apply for a License to Operate (LTO)

Applying for a License to Operate (LTO) for food establishment with the Food and Drug Administration (FDA) formerly Bureau of Food and Drug (BFAD) is among the initial steps for those who intend to set up a business as a food manufacturer, importer, exporter, trader, repacker or distributor, before they could start to operate their business in the Philippines.

I prepared below a step-by-step guide on how to get a license to operate for those who intend to do it on their own. Note that this is quite a tedious and time consuming task especially since there are several requirements and the location of the main FDA office is in Alabang.

Who are required to apply for a License to Operate (LTO) as a Food Establishment?

All food establishments should first secure a License to Operate (LTO) before engaging in food manufacturing, importation, exportation, offering for sale or consumption, distribution and transport, for food trade and exhibition, promotion, advertising, donation, or sponsorship of any health product.

Are food supplements covered by these requirements?

Yes. Food supplements and companies dealing with food supplements are covered by these requirements.

Where to file the application for License to Operate?

An application may be filed with the Center for Food in the FDA central office or respective regional field offices having jurisdiction over the establishment, or on-line once operational or a designated establishment or government agency by the FDA.

How long is the validity period for the License to Operate?

Initial– Initial LTO/CPR issued shall be valid for one (1) year from date of issuance reflected as such.

Renewal- Renewed LTO shall be valid for two (2) years and renewed CPR shall be valid for five (5) years from date of issuance reflected as such

What are the general requirements?

  1. Notarized accomplished Application for Authorization Form
  2. Proof of registration
  3. Proof of occupancy – office
  4. Proof of occupancy – warehouse
  5. Proof of occupancy – manufacturer
  6. Photocopy of Notarized Fixed Asset & Operating Capital or Financial Statement (new requirement)
  7. Location Plan
  8. Floor Plan
  9. Tentative list of food products to be manufactured or distributed identified on its classification and category
  10. Facsimile of Proposed Label (for local manufacturer) / sample label of product to be imported or a digital image of the document in an FDA-approved file type.

What are the specific requirements?

A. Food Repacker

Photocopy of notarized valid contract/ agreement with the manufacturer, with attached LTO of the manufacturer

B. Food Importer for Raw Materials

  1. List of sources for raw materials
  2. List of materials to be imported

C. Food Importer for Finished Products in Bulk

  1. Photocopy of Foreign Agency Agreement duly authenticated by the Territorial Philippine Consulate
  2. Photocopy of Certificate of Status of Manufacturer (cGMP Certificate) issued by a Government Health Agency Duly authenticated by the Territorial Philippine Consulate.

D. Food Manufacturer

  1. Organizational Chart Indicating qualification of key personnel in production and quality control
  2. List of Products and brands to be manufactured/repacked
  3. List of production equipment with specification
  4. List of quality control facilities and equipment (if any)
  5. Flowchart of manufacturing process with emphasis on identification of critical control points
  6. Detailed description of manufacturing process
  7. Quality control procedures / sanitation standard operating procedures enforced in the plant
  8. Certification with current laboratory analysis
  9. Name and address of suppliers of raw materials and packaging materials
  10. 10. HACCP Program

E. Importer of Finished Products

  1. Any one of the following from each supplier – Foreign Agency Agreement/ Certificate of Distributorship/ Appointment Letter Proforma Invoice
  2. Any one of the following documents for the status of Manufacturer issued by the Regulatory/ Health Authority from the country of origin:
    • Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent;
    • Phytosanitary Certificate;
    • Certificate of Free Sale;
    • HACCP Plan/Certificate as applicable;

F. Food Exporter

  1. LTO of Supplier/ Manufacturer;
  2. Notarized Distributorship agreement/Letter of Appointment with FDA Licensed Supplier/Manufacturer to distribute their products outside of the Philippines
  3. List of products with registration number and validities

G. Wholesaler

a. Locally Procured Raw Materials in Bulk and Finished:

       i.         LTO of Supplier/ Manufacturer

    ii.         Notarized Distributor Agreement or Letter of Appointment with FDA licensed Supplier/    Manufacturer to distribute their products outside the Philippines

     iii.         List of food products with registration numbers and validities

b. Subcontracts to a Licensed Manufacturer/ Repacker – LTO of Manufacturer and/or Repacker (tolling/ repacking activity and specific product should be indicated in the LTO)

Are there any other requirements?

Yes, there are other requirements but these are still not final since the FDA’s draft revised rules and regulations governing the licensing of food establishments and registration of food products is still for comments and not yet final.

I will update the list once this is final. Subscribe to the mailing list to get updates.



Author: Atty. James Biron
Atty. James S. Biron is a corporate lawyer specializing in foreign investments, trade, mergers and acquisitions, planning and financing of projects and capital raising. Clients served include real estate, construction, energy, information technology, agriculture, education, medical and casino gaming companies.

357 Comments

  • ctj.

    Good day po atty.ask q lang po sana what are the requirements for applying LTO of FDA/bfad at magkano po lahat ang magagastos.gusto q po sanang mag karoon Ng pharmacy.ano po ang kailangan n dalhin s office po nila.thanks po in God bless po.

  • Alberto N.

    Good day, Atty!

    We are seeking your kind assistance on how to secure the BFAD for homemade Chicken Lumpia Product, we are processing the products from raw materials to finished goods. As of now our customers are asking for BFAD Permit but we can not provide to them because we have no knowledge getting such permit. If you don’t mind, what are the requirements and how much the usual expenses to register.

    Thank you and best regards,

    Alberto

  • Erwin L.

    Gud day atty. Ask lang gusto ko po kukuha ng LTO, ang bussness ko po ay mag diliver po ng food supplements sa mga pharmacy, tapos kukuha lang po ako sa mga manufacturer, anung uri ng LTO ang i apply ko po? At panu po kumuha? Anu din ang dapat kung ihanda na requirements? Salamat po

  • Jeya

    Hello Atty.

    I got a simple question, hope to hear from you soon.

    Are homemade snacks (small business) that will be sold online needed to be approved by FDA first? If yes, what to do. Again, it’s a small business while I work a different job for full time.

    Thanks for your article.

  • Joan M.

    Hi Atty. i just want to ask is it really needed to send a authenticated copy of foreign agency agreement for CPR ? thank you so much .

  • Norberto L.

    Hello Atty James Biron,
    I would like to distribute homemade fruit wines and and with other imported wines available in some supplier stores and to furtherly make my own kind of wine too in addition and other home made products like sardines, peanut butters and jams. What are the ways Atty. How to get LTO and other licenses?or should it be enough to get just the Dti and Mayors permit alone to operate?if not enough what are the other ways and how much it will cost me for this proper licensing process.
    Many Thanks and Godbless you more…

  • Gin

    Good pm, I’m planning to start a business of producing and selling pure organic oil. What permits do I need?

  • Audy F.D.

    I have already a LTO approved for my business, it will expires on the next three years, do I wait for the expiry date or every year will I go to dfa office for yearly monitoring and inspection, ?

  • Esperanza D.S.

    We started gathering requirement to register our product, but we are having a hard time, please, we need assistance to registration through FDA philippines for food supplement. Please let us know the exact requirements for get approval. what is initial step ? Can you help us through?

    We are looking forward for your assistance. Thank you in advance.

    Please Advice for this … Thank u in advance.

  • Joan I.

    Hello Atty. Biron!

    I am planning to have a whole saler distribution business and i will get product from any supplier like Medicines & Medical Supplies.What are the requirements for getting that FDA-LTO?
    How much is the cost?
    Atty. Biron your reply is highly appreciated.
    Thank you& Godbless.

  • Frances A.S.D.

    Hi atty. can you help me in how to applied LTO? We distribute a medicines in our barangay and they requesting us to provide a CPR. The pharmaceutical that we buy medicines ask for us LTO so that they provide us CPR. Can you help us through? Thank you..

  • Dennis R.

    Good morning Atty. I will engage in repacking and distribution of cooking oil and sugar products sourced from manufacturer and suppliers. What are the permits required that I have to secure and what are the requirements. Lastly, would you have an estimate how much it would cost me to secure these permits?

    Thanks,
    Dennis

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