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How to Apply for a License to Operate (LTO)

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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.

259 Comments

  • noriel navarra says:

    Gud day atty. James, I just want to know if the homemade Rub and Oil pain reliever can register to FDA, and what are the requirements and how much the usual expenses… thanks and God bless…

  • hi sir,

    i am about to launch my own perfume line here in philippines and the products are made in europe. as of now, it is for customs clearance. i’d like to ask if you can have it registered in fda since some of marketplaces need it before they can start to display the products.

    P.S. please let me know how much it would be all in all and what requirement should i provide.

    thank you so much.

  • Fatima says:

    Good day atty. I’m applying for the LTO of my drugstore using the integrated application form. On the “order of payment” part, the COMPUTATION VALID UNTIL (or something like that) has a December 30,1899 date while others have January 00,1900. Am i on the right track attorney or should i contact FDA for verification? Your response is highly appreciated. God bless.

  • Maria Myla Cula says:

    Hello po. Mga how much po babayaran sa FDA para sa LTO? Salamat po.

  • jerome says:

    good am atty. can you send me your contact details and office add ? mag apply kmi FDA ng LTO para sa frozen products po namin.

  • Angel says:

    Hello Atty., what if my supplier is a local farmer without any licenses or trading name? I get his herbs and I have it tolled in capsule form.

  • Adrian Gan Lim says:

    Hi atty im launching a spanish style tuna product id like to ask for assistance for the lto and cpr thank you

  • Tin says:

    Hi! What category will baked goods and custom designed cakes fall? And do I need to register every single type of baked product that I will offer? Thanks in advance.

  • Ella says:

    Hello sir, in filling up the FDA Integrated application form as a new applicant for food manufacturer (bread production in particular), in the area where it is asked the current license number, may I know what license number is this referring to? I’m so sorry for my ignorant question. Hope to hear from you soon. Thank you in advance!

  • Mary says:

    Hi Atty

    We are launching a homemade pomade line and homemade eyelash grower locally. Do we need toregister to FDA? If so, what are the requirements and how much are the assocaiated expenses?

    Cheers!

  • Anthony Arellano III says:

    hello sir, I would like to ask, I have a homemade Herbal oil. How can I register and get a CPR? or how can I get a LTO? thank you atty for your reply.

  • JUNJUN says:

    Hello atty. paano po pag non food ung product namin pan0 po kumuha ng LTO? medical and hospital equipment po kasi product namin, at 1 year palang kmi. isa po kasi ito na requirements sa bidding. hopefully matulungan niyo po ko. thank u atty.

  • Rodolfo Del Prado, Jr. says:

    Hi Attorney,

    We need assistance for our FDA registration and certificates. We are putting up a meat processing company. How can we get in touch with you? Thank you and God bless.

  • Hello sir,
    I am planning to import slimming capsule Liquid Gel 100% pure herbal my slimming capsule are coming from Thailand and that slimming is already regesterd to ISO and GMP so i do need to comply BFAD FDA permit before i operate what should i do
    Hope to hear from you soon

  • Genevie says:

    Hi Atty.,

    I sent you a message via the contact form. We will wait for your reply. Thank you

  • Jett dela Pena says:

    Good Day Atty.

    Jett here. I am currently starting my own business of making mass production of Minced Garlic pacled and wanted it to be distributed to some certain supermarket or groceries.

    Called their offices and some are requiring me to have my product be BFAD approved first but apparently, I have no idea where to start and is curious about all the expenses and how-to’s since its just a simple little business.

    Just wanted to be in the market since it will target mostly shoppers and direct household.

    If its not too much to ask, just wanted to know on how and where should I start? and also, do we need a registered business first or do we have a bfad approval before anything else.

    Appreciate the help sir.

  • Shin says:

    Good day atty. James! I want to open homebased/online business in Philippines (food supplement) and the product is coming from Japan. Do i need to get LTO,CPR, and BIR? in order to begin engaging in importation of goods?

    Thank you so much!

  • Ian says:

    Hi atty! We are planning to have a cosmetic business wherein we would like to engrave our business name on the product and its packaging but somebody will manufactured it for us (manufacturing plant) philippines. What are the things that we need to comply in order to get the LTO (license to oprate) from FDA ? And what are thenevessary business permits that we need to produce? Thank you and we appreciate

    Best regards
    Ian

  • mae says:

    Good day Sir, tanong ko lang po yung mga requirements sa DRUG MANUFACTURER?and contact po sana kung meron

  • Paulo L. says:

    Hello and Good day Atty. James. I am planning to start my pharmacy business. however,we were advised to secure FDA’s license to operate (LTO) but I do not have any idea how to get started with securing the said permit and how much would it cost me,Atty.James? thank you and God bless you.

  • angelita p. says:

    Hi sir i just want to ask where do we apply to get Bfad certificate? Lipa batangas po. Is it true that we can apply only thru online? Thank you and more power.

  • MARY GRACE G D. says:

    hi sir can i ask how register to LTO and FDA

  • JOHN D. says:

    Good day atty.,

    I am planning to have a distribution business and I will get products from any supplier like cosmetics and food supplement and herbal beverages.My questions are;1.Do I need to get an FDA LTO before I will distribute the products? 2. What are the requirements for getting that FDA-LTO?3.How much is the charge?

    Thank you,

    JOHN

  • Nympha L. says:

    Hello Atty James. I have discovered a nutraceutical that helps the frequency and intensity of my epilepsy in 2012. Not just that, because I used to have 10 thousand pesos cost of medicines a month before. But now 600 pesos was the retention.recently I went out to the open and attended a trade fair sponsored by DTI any go Negosyo center in our city w/ the collaboration of the provincial tourism for it was held during the provincial anniversary.
    My question is how can I get an approval from the bfad? Thanks and more power.

  • Pamela says:

    Hi Atty. James! We are launching a homemade garlic chili sauce. Do we need toregister to FDA? If so, what are the requirements and how much are the expenses? Thank you!

  • Soren says:

    Hello,

    Are the information presented above still relevant today?

    Thanks

    • Atty. James Biron says:

      Hi Soren, the FDA changes its rules on a regular basis, please visit my office if you wish to learn the latest procedure

  • Jason R. says:

    Hi Atty. Biron. What’s your email? I have something important to ask. Please reply to me. Thank you.

  • porferio says:

    good day sir, what requirements do i prepared? for a homemade product like herbal capsule. and how to apply LTO? thank you.

  • Bert says:

    Gud day atty! We are planning to have a small business a home made herbal oil..somebody told me that i need a BFAD approve about it……do i have to get BFAD approve for small business? Ang how to apply for BFAD? and how much do i have to spend for it….tnx we appreciate.

  • Elsie B. says:

    Gd am Atty.

    Can I get a LTO for my bakeshop business and at the same time native delicacies in one registration only?

    Thanks for your reply.

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