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

  • teresa diawatan

    I would like to know if your office is processing FDA applications for new business enterprise ?

    • Atty. James Biron

      Hi Teresa, please check the email I sent to you. Thank you.

      • mafie

        hi atty. may i ask if what are the requirements if i will start to distribute the medicines in certain botikas, pharmacy, and the like? the main source is asking me for an LTO, how can i get this? thank you sir!

      • Jericho De Dios

        Good Day Sir James!

        I am interested in starting an importing/wholesaling company here in the Philippines and I intend to bring in imported packaged snacks such as cookies and chips. May you please tell me the exact requirements needed for the lto application as well as the exact procedure? I also heard that I need a Certificate of Product Registration in order to supply to supermarkets, can you enlighten me on this one as well? I badly need help and any input will surely be a tremendous boost for me and my business.

        Thank you Sir James and more power!

      • Shiery Ann

        Hi atty. plan po namin maging distributor ng vaccines for human, so pra po sa accreditation namin sa company one of the requirement is LTO from BFAD… Kung mag distributor lng naman po kme sa mga doctors need pa po ba ng license pharmacist ?? Pra po makakuha kme ng license to operate… Thank you

      • Roma Ramirez

        Atty. Biron, does your office assist in the process FDA LTO and Food registration?

  • we are a US based company and have an office here in the Philippines.

    we would like to ship out or send our products ( finished products – food supplement imported from USA and CHINA ) to other countries.

    How do we go about it?

    many thanks.

    • Atty. James Biron

      Camil,
      1. Upon receipt of a purchase order from a foreign buyer, immediately send him a proforma invoice for confirmation. An order is confirmed when the proforma invoice is signed and returned to you by the buyer.

      2. Payment for exports is normally made through the banks. The foreign buyer’s interest in the Philippines is represented by a local authorized agent bank, which is designated by the foreign buyer’s bank. The local Authorized Agent Bank (AAB) will assist you in negotiating the collection of the payment for your exports.

      3. The AAB will explain to you all the instructions concerning your shipment to ensure its acceptability for payment. Make sure that you understand all the instructions provided by the bank. If the instructions are written in a non-English language, ask the bank to give you an official translation in English or to officially recognize a translation of the instructions, if the translation was made by someone other than the bank.

      4. Exporters may be paid through banks by means letters of credit (L/C), documents against payment (D/P), documents against acceptance (D/A), open account (O/A), cash against documents (CAD), prepayment/export advance, inter-company open account, offset arrangement, consignment, or telegraphic transfer.

      5. You may or may not need outside financing to produce export products ordered by the buyer. Should you, however, find the need for outside financing. You can either tap the assistance of government or non-government financial institutions.

  • melvi

    Hi sir. Just want to ask where could i consult for our our layout plan. We are planning to put up a small juice factory

  • ellen

    Hello atty, good pm! Regarding the proof of business name registration, for chartered universities, can we use the charter as a supporting document? We cannot register under the DTI (for private sole proprietorship) and SEC (for private corporations) since we are not classified under those. Thank you very much.

    • Atty. James Biron

      Since your university is not registered with the SEC / DTI, you can ask FDA to accept the charter instead of a certificate of registration from the SEC / DTI

  • Mylene

    Good day Attorney. Saan po ba makakakuha ng application form para po sa LTO?

  • jem

    Hi atty. Mgstart p lang po ako ng product ko na bottled bagoong..pano ko po ba uumpisahan ang bfad reg. Ko, wala po ako office sa house ko lng po to niluluto ska 10klos. Lng po ung pinkamarami kong niluluto.

  • bea

    hello po good morning,ask ko lang po,ina accept po ba ng fda ang backyard/homemade manufacturing ng supplements. im planning po kasi gumawa ng mga food supplements and other food related products pero wala po kase akong office sa house ko lang po ito ginagawa. thank u po

  • jeff

    Hi Atty.,

    Ano po ang mga requirements for renewal ng LTO?
    Salamat!

    • Atty. James Biron

      Hi Jeff,

      STANDARD REQUIREMENTS:
      1. Renewal form
      2. Original LTO
      • Additional requirement for Manufacturer/Re-packer
      1. Financial Statement
      Fees : Php 8,080.00 for two years (for Importer/Wholesaler/)
      Note:
       For applications/submissions with 5 pages and above,
      • Notarized Electronic Copy (E-copy) of Affidavit
      • In addition to the hard copy of the abovementioned standard requirements, the client
      shall also submit an electronic/scanned copy (in PDF Searchable Format at least
      300dpi) on a DVD-R of the application.
      • The above stated requirements shall be properly labeled with table of contents
      indicating the number of pages, divider with ear-tags and place in a White Data
      Folder.

  • rose grasparil

    Atty, How will I apply for BFAD Licence for food Business/Restaurant here in Cavite. The Restaurant Building is still under construction, and estimated to be operational in December or January next year. We are already required to get BFAD permit to be able to Secure Business Permit.

    • Atty. James Biron

      Hi Rose, how are you? It is important for you to have the building before FDA will approve your LTO, so you have to wait until it is completed.

  • hi atty. tanung ko po sana, kung magdidistribute kami ng foods dito sa pilipinas galing taiwan..anu anu po bang requirements documents and kakailanaganin namin para maging legal.

    • Atty. James Biron

      Fernando, register your business first with SEC or DTI, then get a license to operate from FDA, register with the local government, and get import permit. All these steps will require different documents that are too many to mention here.

  • Jason

    Hi sir, just want to ask if juice concentrate is categirized as a finished product or raw material?

  • Cha B.

    Atty. ano po ba ang items na di na kailangan ng BFAD?

  • Alejandro Paez

    Hi Atty. James Biron,

    We just opened a new bakery and we would like to ask if we are going to proceeds with the general requirements for FDA LTO application?

    Please email me the details of requirements needed and the process / procedure to follow.

    Thank you.

  • Grace

    Hi Atty. Biron, our business is buy and sell and exports local products or finished products like pancit canton, canned goods, goods available in supermarkets and the like (not yet containerized, boxes only). It is a home-based business and we we don’t have an office or warehouse, we shipped out all the goods right away. The airlines is requiring us to provide BFAD Certificate. What category do we fall? What are the requirements? LTO issuance requires an office.

    I hope you can help us. Thank you.

  • Ann

    hi Atty.,

    I just want to ask if you know how long does it take for FDA to approve LTO for drugstores? I submitted all the requirements last first week of june but until now our LTO is not yet approved. I inquired about it numerous times through email but FDA did not reply. just like the rest, I hope you can help us on this.

    thank you!!

  • rhamsey

    Hi Atty Biron do you process lto and cpr for new a new business? Im planning to be a distributor of a finished food supplement from canada. I have an office already.. but ill be doing the selling via online.. i wonder what do i need.. please help me.

  • John Chua

    Hi Atty,
    I am opening my dessert cafe, I know I need to apply for an LTO at FDA, you mentioned it is time consuming especially for those who is first time to do this. Do you guys provide this service (applying for us)? If so what will be the cost? Thanks

  • gem

    good morning atty …we are planning to open a business engaging in a government medicine supply

    do i need to apply foe License to Operate in FDA OR AR THERE ANY OTHER PROCESS …

    MY BOSS I S AN OWNER /PHARMACIST

  • Good pm po atty. We are planning to put up our processing plant at the proposed 2nd floor of our house in san pedro laguna. The house is located inside the village. The business we plan to put up is powderizing leaves as food supplement. Do you think our application will be approved? thank you.

  • daix

    how to apply lto for export

  • Agnes Dimaculangan

    Good day Atty. Biron,

    Hope you can assist us in securing LTO, we are not really familiar on how it goes though we already read your article. Can we set an appointment with you and can we get your contact#.

    Hoping on your response, please send it on our email add.

    Many thanks,
    Agnes Dimaculangan

  • Ronald

    Sir, naglalakad po ba kayo ng L.T.O? ilang days po bago ko mareceive ang license? Shampoo and conditoner po products ma hinahawakan namin. Thanks and God bless you po.

  • how to apply the importation of food frozen meats like chicken or other meet..?
    what kind of application form to filled out?
    and what are those requirements and documents to comply pls answer those questions Atty. James Biron

    have a nice day…

  • how to apply the importation of food frozen meats like chicken or other meet..?
    what kind of application form to filled out?
    and what are those requirements and documents to comply pls answer those questions

    have a nice day…

  • Art Lou Dayao

    Hi Atty.,

    Good pm. Are restaurants covered by these requirements? If yes, can you send me a step by step guide how to apply lto for our restaurant/cafe’? Your prompt attention is highly appreciated. Thank you =)

    Ms.Art

  • jeson lim

    Good morning sir

    sir would like to ask,

    we changed our lto from distributor to manufacturing, but our CPR are still under distributor, iba pa ang nakalagay na manufacturer and 2015 and soe products ay 2016 pa ang validity, do we need to eapply this as new application or pwede ba kaming magletter nlng to ammend the CPR, na kami na ang manufacturer/

    hoping for your kind response.

    Best Regards
    Jeson

  • Jak

    Hi good day atty. What does GMP mean? And where should i secure first cpr or lto? Can you recomend any firm that can help me in acquiring this license. Ty

  • JAKE

    HI atty. may i ask for ur contact number please email me at jakehuberttan@yahoo.com.ph

  • Jonathan

    Hi po Atty. James,

    Ask ko lang po if June 2013 nagrenew ng LTO when po expiration nito? For clarification lang po.. Thanks

  • Jonathan

    Sales rep po ako kinukunan ko po kc ng requirements mga drugstore customer e.g LTO. Ask ko po sna if d pa expired LTO nila nag renew cla June 2013 nakalagay po sa OR nila 2013& 2014 sbi po nung customer ko July pa renew nila. Sa office nman po nmin feedback need daw latest O.R

  • Leticia Jumalon

    Hello Atty James Biron,

    I would like to start distribution of my own self made Vegetable Capsules. I understand that there are lots of papers to accomplish to be able to get an LTO and an FDA approval.

    Can you please advice me on these matters. I am just a starter with very limited capital who wanted to try my very very good vegetable capsules in the local market.

    Thank you and more power.

  • madz

    good day atty: tanong ko lang po kung hanggang kailan po ang validation ng lto ko sa drugstore. ang binayaran ko po is P 2020.00 ilang years po ba? start na po yun nung april 11, 2014, bale kailan po ba sya matatapos? salamat po

  • Margie

    Hello Atty.,

    I just want to ask lang po sana what are the requirements for applying LTO(initial) for trader and processor?

    Thank you po

  • Bhing

    Hi Atty., we live in an island province. I am starting to engage in food production like making cookies, pulvuron and hopia to sell. do I need to secure BFAD permit? we have already secured sanitary permit from health office.

  • Abby

    Hello Atty, is it required to hire a licensed pharmacist to apply for LTO? We’re having a hard time finding licensed pharmacist. Magkano po ba talaga ang standard salary ng licensed pharmacist? Pano naman po ang transaction at sweldo for part time licensed pharmacist?

  • Mariness

    hello Atty. mayproblema po kc ako regarding s LTO ung requirements po kc nahihirapan po aqng gumawa..di ko maintindihan, mag oopen po sana ako ng maliit n bakery lang, pls help po.

    • Atty. James Biron

      Hi Mariness, what are these requirements that are hard for you to comply with?

      • Mariness

        Hello po Atty. James yung sa may Specific Requirements po yung Manufacturer/Processor sana kasi di ko talaga alam kung paano umpisahan…yung may mga description po etc. tnx po ulit

  • Nesty V.

    hello atty. Me and my wife just started a micro home cannery producing canned-in-jar version of our traditional batangueno dishes. I already completed the general requirements for application of LTO as manufacturer/Processor, and finished 4 (#1, #2, #3 and #5) out of 5 of the specific requirement. We find specific requirement #4 “results of analysis of Finished Products” too costly for such a small enterprise like us, producing one single batch of what can be squeezed in our 41 qtz canner on a production day by ourselves from start to finish. Having 4 variants, I get quotations of twice the cost of our whole operation. Do we really need this for initial application, or is there an exemption we can apply as per financial capacity? Else, would the same “results of analysis of Finished Products” be used as requirement for the subsequent application for CPR. thank sir

  • Lyn

    Hello po atty. inquire ko lang po. We purchased Raw materials and finished goods from our supplier. may FDA na po sila. Kailangan pa rin po ba naming mag-apply?

  • faith

    Sir gud day po,gusto ko po sana mgbenta ng home made BBQ sauce sa mga supermarkets,ask nila ang FDA license,can u help me sir kung paano ang process nito, limited ng po ang capital ko sir at mga 20 bottles Lang ang max.na ginagawa ko sa bahay.Your help is very much appreciated sir.kindly give me your office number sir.Thanks,God Bless.

  • Randy

    Hello Attorney, DOST assisted po kami at gusto ko pong kumuha ng LTO para sa amin popcorn products. Tanong ko lang po kung naglalakad kayo at paki email yon office address nyo po para personal ko po kayong mapuntahan.

  • Rain

    Hello Atty Biron

    I am importing caramel blocks from the USA for sale in the Philippines. Under which category am I to follow ?

    B. Food Importer for Raw Materials

    C. Food Importer for Finished Products in Bulk

    Are you for hire to do this process for me ? What are your fees ?

  • Geraldine

    Hi Atty:

    I would like to clarify matters regarding the requirements for LTO.

    One of the requirements of opening an establishment as Medical Device Importer/ Wholesaler/ Exporter is a valid PTR of a Pharmacist. As we have researched, PTR is only used when a certain professional is self-employed. My question is do we still need PTR when the professional is employed in a company?

    Please see this link : http://www.fda.gov.ph/attachments/article/95818/CHECKLIST%20OF%20REQUIREMENTS%20FOR%20LTO%20IMPORTER_WHOLESALER_OPENING.pdf
    This link states that PTR is one of the Requirements.

    Thank you and God bless.

  • Edwin Reynoso

    Sir if we applied for our Herbal Tea and Food Supplement last 2004 and approved by DFA and we will only renew it now do you think we have a chance of having another license then.

    How much will be our penalties? thnks and more power.

  • Christopher Uy

    Hi Atty,

    Good Day! I am planning to bring in goods from Taiwan. My company is a license importer from the BIR/BOC. However I do understand we would be needing another set of LTO and CPR for a new product we plan to bring in to the country. Just like to ask if you are offering these services to us. Please advise.

    Thanks.

    Chris

  • Hello atty,

    May ask atty, kung pwede po kayo mag assist para sa Lto at product registration , kc po malayo pampanga pa po kmi and small scale lng since we are working on limited capital sa manufacturing of supplements , raw materials local at china sa online sir, halos parang backyard operation lng kc just to start lng po.
    I hope email nyo po ako regarding sa fee niyo po, nag inquire na po ako sa FDA pampanga at alabang, bka mas practical kung yung firm nyo na mag assist sa pag kuha ng mga permit n lic.

    Thanks in advance

  • janriz_02

    Hi po. ask ko lang po ano po mga requirements para makakuha ng LTO para sa medicine po. tnx and god bless

  • Lester gonzales

    Hi Atty,

    Ask ko lng po , ano requirements LTO for medical supplies. We dont sell any medications only medical consumables like glove,syringe etc.
    Kailangan prin ba namin ng pharmacist?

    Thank you,
    Lester

  • Maurice Quizon

    Hi! Is it possible to get a bfad permit for home made food products?

    • Atty. James Biron

      Hi Maurice, I sent you an email, please check.

      • Olivia A. Velando

        Hi Atty,

        I am starting a small herbal company, but with one very good product first. I already have suppliers for the raw materials and they can provide me with Certificate of Analysis.

        I will be making the supplements at home, do you think I have a chance to get an LTO? I have very limited resources but I really need all the help I can get to start. I read from the threads that your office can help with securing LTO, I just hope I can afford your fee. How can I get in touch with your office?

        Thank you very much.

        Olive

  • Cora

    Hi Atty. James

    Good day!

    I would like to ask a favor from you to provide me a sample letter of inviting the representative from Department of Health to visit my Lying Inn Clinic to check whether I completely complied with their standards for license to operate. Thank you and God bless.

  • Hello Atty Biron,
    We manufacture molecular supplements or nutraceuticals (not drugs or) in the US and we’d like to export them to the Philippines. Examples of these are Gout supplement, Collagen Silk for beauty, supplement for pregnant women, etc. Do we still need to have BFAD approval? If so, how long will it take? I was browsing through BFAD’s or Philippine FDA website and I can’t seem to find our category. Is this something that you can help us with?
    I look forward to your response.
    Soledad

  • JEROLD S. CHICO

    Good day Atty. Biron!
    Salamat po sa inyo at mayroong ganitong free counsel.

    I am a proprietor of an enterprise that repack household chemicals for cleaning purposes including oxalic acid. We supply them to groceries and supermarkets in Cavite area. Nais ko po sanang mag-apply ng mga kaukulang permits gaya ng FDA and LTO. Paano po ba yun?

    Thanks in advance. Blessings!

  • GENEFIL TOLOSA

    Good day Atty.
    i have concerned regarding po sa LTO..my daughter is a pharmacist. i’ve financed her to start a drugstore.while processing her BFAD requirements,she was told that she cannot start her business until LTO will be released.Upon hearing this, lots of questions and concerns bothers my mind.
    . We are renting the place for her drugstore.Because one of the requirements is a picture of a location with signage.Almost a month na po processing ng LTO.Bumabayad po kmi ng rent na walang kita.Ano po yung pwede kong gawin Atty?

  • Lei Solis

    Hello, i just want to ask about Foreign Agency Agreement(FAA).. Our company will apply as an importer. And i don’t know where to get Valid FAA duly authenticated by the Territorial Philippine Consulate. Where to get it? Can you provide sample? or just the contents of that FAA. I am lost.

  • Jorge Pioquinto

    Hi Atty. James, with the assistance of your office, how long and how much does it usually take to get an LTO and have a product registered? The FDA’s website is still not that ‘user-friendly’. I’m starting everything from scratch. Thank you.

  • Enrick Christian H. Bernardo

    hi atty james can you send me an email about the application for LTO as an importerthank you very much sir

  • Enrick Christian H. Bernardo

    sir can you send me guidelines as consignor of canned products/ ingredients thank you

  • Susan Escobidal

    Hi Atty. James, we’re planning to import dog and cat shampoo, do we need to apply LTO to BAI, or should we apply directly to FAD LTO?

  • Norman vega

    Hi atty, once you’ve submitted everything to FDA, how long does it take for the license to be released? Or is there another step that they will require? It’s been more than 2 months, and we still don’t have out LTO. We are checking thru their docs online status. Thanks

  • Al R

    hi i would love to know if a sole proprietorship business can apply for LTO, I have a online retail shop of cosmetics and medical device, my location and workplace is at our house, rented. some imported abroad and some of products are from here.. would love to hear from you soon Atty. thank you in advance.

  • Jer

    Hi Atty. James Biron,

    I am planning to put up a small home-based business such as making ice candy at home and sell it in a school nearby. Do I need to apply for LTO or is it a requirement for the application for a business permit for this kind of business?

    If so, where can I get the Application for Authorization Form and Proof of registration?

    Being a small home-based business, do I still need to provide the following?
    Proof of occupancy
    Notarized Fixed Asset & Operating Capital or Financial Statement
    Location Plan
    Floor Plan
    Proposed Label

    Your response will be very much appreciated.

  • lito

    gd pm po atty. ask ko lang ito. May an application for renewal of license to operate as food manufacturer, distributor be temporarily suspended pending an application forchange of business name? which one should be accomplished first. salamat

  • alex

    Good day atty.

    me and my friends are planning to put up a company that imports food products into the philippines.
    We would appreciate it if your could give us a general overview of the steps or process which will serve as our guide in realization of our plan.

    Thanks and regards

    alex

  • Jay Cancio

    Hi Atty, our company is engaged in the business of cosmetic products as wholesaler / trader. We have filed our LTO application but colleagues tell us it takes months before this is approved. Then we have to apply again for a CPR. Can you assist us in expediting the approval since we are in a tight timeline due to pending orders from major retailers and stores already. Thank you.

    • Atty. James Biron

      Hi Jay, it is not possible to expedite the approval for your LTO and CPR. They can issue a provisional license but FDA will soon remove that privilege.

  • Hi Atty, I would like to start a business of cosmetics distribution. products are manufactured by my Friend and I will be branding it and packaging it. CaN you assist on LTO process? also what would be the scope of our contract with the manufacturer in this case? Thank you!

  • jessica

    hi atty.. tanong ko lang po paano kami mkaka pag apply ng LTO para po mk pag pasok kami ng shipment dito s phil from international clients po.. brokerage po kami and need po kc namin ang bfad accreditation

  • ron lim

    Good day Atty. Biron

    We are in need of an FDA LTO for our food supplements business. How much do you charge for it …

    tnks Mr. Ron Lim

  • Aireen Borred

    Hi atty. Biron!

    I would like to seek an advise.. I am about to register my small manufacturing business.. I am struggling where to start and how to do it.. I hope your office can help me on this..
    Thank you.

  • Irene Pugong

    Hi sir James… How can i get LTO for Medical Supplies and Equipment? do we need to have Registered Pharmacist.

  • arnold ordonio

    good day sir. nag apply po ako sa philexport para po makapag export ng fresh manga
    isa po sa requirement nila yung FDA-LTO, kasi food daw yung product ko..
    nueva ecija po location ko. anu ano po dapat ko dalin para minsan nalang po ako lumuwas..
    saka ANO PO BA YUNG PRIMARY LICENSED BROKER.. wala po ako idea jan eh..
    thank you..

  • domingo chillag

    good morning attorney. may i ask if your good office is processing a requirements in securing fda certifications to register my very important food formula for health? please reply immediately if you read my post so that i know because i really need to register my very important food formulation to help many people in the world and in fact, there are so many orders but i can’t market my formula until it is registered to the fda or bfad here is my email add for your reference … thanks and more power…

  • john hernando

    good day sir, requesting for procedure on how to renew License To Operate. im having a hard time looking for downloadable forms at their website. many thank sir

  • heneliza

    good evening sir can i ask u for requirements for food supplement starting lng po kami?

  • Mildred Fernandez

    Good Day Atty,

    How can I get LTO for Medical Supplies and Equipment?

  • CHRISTIAN DELA CRUZ

    Hi Atty!

    Need help with my home based cookie business to have an LTO. Need your help Atty.

    Thanks!

  • Richard

    Hi Atty.

    Need assitance on how can I import food supplements from U.S. My counterpart have been in the business of retail/wholesale in US and wanting to market here the Philippines. I’ve sent you email last night. Thanks and hope to hear sir.

  • Concepcion Gacusana Isip

    Hi Sir, im planning to put up a business in phil for chicken satey marinated and frozen for BBQ and sharbat drinks to be packed in bottle with label. I will process the chicken satey marinated and drinks in our house. Is it ok to operate in the house since this is just a stary up process. My husband one helper and I will be doing the process. I have some distributor and we only do our part as supplier. Please help to advise on the requirements to apply permit to operate this business of mine. Thank u Sir.
    Best regards

  • Russell Fonte

    Hi Atty Brion,

    We are already DTI registered company and we would like to distribute chocolate product from a local supplier here in the Philippines. May I know what kind of LTO do we need to secure?

    Please do send us an email on whatever help you can offer.

    Thank you.

  • mazy Gonzales

    Hi Atty,

    Ask ko lng po , ano requirements LTO for medical supplies. We dont sell any medications only medical consumables like glove,syringe etc.
    Kailangan prin ba namin ng pharmacist?

    Thank you,

  • Erwin N

    Hi Atty Brion,

    I am sole proprietor and the business is DTI-registered. I am planning to secure a DFA License on a supplement I am importing. Please do send me an email on what services you can you can offer to secure the license.

    Thank you.

  • Klein

    Hi Atty,

    I need help in securing a FDA/LTO for reselling/distributing of skincare products made locally. What would be the requirements and how much would it cost. thank you!

  • Gheng

    Hi atty…Iam affiliated with an intl company who is interested to sell their products here in the Phils., (food and beverages)…We already talked to some supermarkets here and they are asking for more samples. Our office is based in Malaysia and Im based here. They sent me some samples as per request of the supermarkets…however the courier is asking for FDA-LTO requiremnts before they can send me the items…The thing is those items are just for sampling and not for sale yet..as we will still need to wait for the supermarkets’ feedback once I have sent them the samples…what do we need to do in order to progress the delivery…please advise..thank you

  • glecy lopez

    Hi atty.
    i am interested to put up a small company dealing with food products kindly email me. So we can discuss on how you and your firm may be able to consult and help us procure licenses.

    Thanka

  • wabi sabi

    Hi Atty. James, kailangan po ba physically present yung business owner (me) upon inspection of the premises by the FDA for LTO application? Salamat po.

  • wabi sabi

    Is there also personal interview involved at the FDA’s office for new LTO applications? Thanks in advance Atty. James.

  • Jackie C

    I would like to inquire on how to get fda permit and license to operate for an imported product.

  • Bong

    hello sir, I would like to ask how to fill up the Integrated Application Form of Philippine FDA, Please help me.

    Thanks!

  • Rsy

    Hi Atty! We would like to sell our own brand of cosmetic products and need to register for an LTO. We already have a manufacturer who will produce our products. What kind of LTO should we get? What is the difference between a cosmetic distributor and a cosmetic trader? Thanks!

  • Marlon Santiago

    Hi Atty. James,

    How long it would take for me to secure LTO and CPR?

    Thank you.

    • Atty. James Biron

      Marlon, that depends on a number of factors such as completeness of the files you submitted, compliance with the observations of the examiner etc

  • Rochelle

    Good day Atty.
    It’s take how long to have the LTO after submitting all the Requirement. I’m
    from Caraga,thanks po.

  • Mai

    Hi Atty!I submitted our lto application for a drugstore last feb 17 and it’s going to be 2 months already and no result yet.Usually how long is the process?I have been calling fda in all the nmbers in their website but no one answers.Thank you and hoping for your reply.

  • Danny

    Atty i would like to consult you personally regarding fda LTO.. may i know ur office address. Kindly msg me via email. Thanks

  • De Paolo Pangan

    Gud day sir,

    We are planning to offer our home made sherbet (sorbet) to groceries. We have talked to some groceries and one of their requirements is FDA approval. We just make our product in our house and have a limited capital. Can you email me your comments or suggestions regarding this matter? Thanks

  • Hello Atty, we’re planning on getting an LTO as food trader. Can you send me details on how your office can assist us? Thanks!

  • ma tereza f magno

    hi atty,

    I am so glad at nakita ko itong site na ito.. my mom is having a problem with her licence to operate she forgot to renew her license this year .. and i just discovered that her license to operate was already expired.. we need your help .. and I am so stressed out with her problem na rin she is already 75 yo and yung requirements ng FDA napaka dami we need someone who can help and apply it for her and if you can email me also your professional fee for this service.. thank you very much

  • Shei

    Hi Atty, do we need a FDA LTO for operating a snacks/drinks vending machine ?
    If yes, can you send me details on how your office can help us?
    Thanks!

  • Tony Chen

    hi Sir Atty
    Good afternoon.
    We are wholesaler of cosmetic and healthy food in Taiwan. we would to export our goods to Philippines Market.
    We would like to apply the related permit and document.
    Can I have detail on how we need to get and other things
    Salamat Po

  • Vincent Bernardez

    Atty. Is it possible if I will file LTO here in FDA Head Office while the principal office of the business is located in Cebu City. Thanks

  • Vincent Bernardez

    Atty. How much would be the estimated amount of filing fee for this application. Thank you.

  • irene Salih

    I would like to know if your office is processing FDA applications for new a single proprietor business ?

  • Glory Mae Logrono

    good day Atty., James,

    can i have details on how ur office could assist me to get our LTO,.. thanks

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