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

  • noriel navarra

    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…

    • Atty. James Biron

      Good day Noriel, please check your email

      • Richie R.

        Hi atty good day, ano po approved flooring ng fda tiles po or pwede ung rubberize paint. Ty po

      • EDUARDO E.

        Hello Atty James. I and my Korean partners just recently established a company, *** BIOTECH INC, with business address using my place ***, Barangay Luta Sur, Malvar, Batangas. Our plan is to import human health and animal health products. For human health products it include MIRAPHARM 22 and CITRIC ACID both manufactured in the USA by HQ BIOTECH INC. For human health products it include vitamin supplement for fighting cocks, dogs, cats, horses. These animal health products are based on the formulation of MIRAPHARM 22. MIRAPHARM 22 is 100% natural substance. You can log on to *** . My mobile number is 09175201***. Please help me on this. God Bless.

      • Lei

        Hello i have skin care..how to apply for license to operate as distributor nh cosmetics..

  • 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

    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

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

  • jerome

    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

    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

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

  • Tin

    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

    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!

  • 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

    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

    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.

    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

    • Atty. James Biron

      Hello Cybelle, please check your email

      • Maricel T.

        hi atty.,
        We are previously franchising a drugstore and now the contract is ended and we no longer pay for the renewal, now we are trying to get a new LTO with new name and new owner, but sad to say that our application had been disapproved recently, can you help me where can i get assistance for new application and where can i get complete and updated check list of requirements for opening a new drugstore… Hope you can help us thank you…

    • Dennison D.R.

      Good afternnon atty. im planning on getting an lto for dog foods and i have zero idea on how to. May i ask for your help?

  • Genevie

    Hi Atty.,

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

  • Jett dela Pena

    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.

  • 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

    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

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

  • Paulo L.

    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.

    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.

    hi sir can i ask how register to LTO and FDA

  • 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.

    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

    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!

  • Hello,

    Are the information presented above still relevant today?

    Thanks

  • Jason R.

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

  • porferio

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

  • 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.

    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.

  • ABDEL

    HI Good afternoon Atty, I just want to ask how to apply LTO for Food and Beverages ? And what is the Requirements ? Thank you so much.

  • Ellimac v.

    Sa new policy ng fda to pass the requirements sa usb. Do we need to keep the files on the usb all throughout? And kanino yung usb sa botika or sa pharmacist?

  • Macario R.

    Hello Atty James. I was told that I need an LTO as Trader to br able to sell under my own brand. I have applied as “Distributor”. We dont manufacture our own products. They are all outsource. Do we have to reapply another LTO as Trader?

    Thank You.

  • teddy

    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…
    what is the first step and pls help po
    thanks and God bless…

  • Anthony A.

    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… anthony po from cebu…

  • alvin

    hello. I just want to ask if perfumes are also required to be registered at FDA? Thank you!

  • Jazy

    Atty. Biron

    I am Mr. Jazy Jongco of UNLAD International, we are engaged with the production of mushroom and also producing products out of it. Can I visit in your office to discuss about securing a BFAD permit in our food products?

    Thank you so much.

    • Atty. James Biron

      Jazy, please check your inbox. Thank you

    • Lando M.

      Hi atty, i have a small manufacturing business and nagsusuply po aq ng product ko na miswa sa isang Repacking company..hinihingian po nila aq ng fda and lto.. Paano po kaya aq makamakuha ng req. Pra don at how much po kya ang expenses.. Thanks!!!

  • Jen C.

    Hi Sir,

    Jen here, I just want to ask if the requirements above is still relevant since it was posted last 2013?

    Thank you.

    • Atty. James Biron

      Hi Jen, it is already outdated so I suggest you visit my office so we could discuss your concerns and we could help you with applying for LTO from FDA

  • Joshua U.

    Hello Atty,
    Im Joshua, and I thank you for this website of yours.
    Now I would like to ask, is there any government body or maybe somebody who can personally give assistance to us on the application for the FDA? as you said its quite tedious, and I think if somebody who can guide us will really be a big help for our situation. . .

  • LILIAN L.

    Good Am Atty.
    Pano po kumuha nang certificate from FDA. May Business po kami na Bakery.And its new po. Kailangan lang po namin para sa Permit namen,Thanks.

  • Mea

    good evening,i want to apply as repacker of beauty product.how can i apply thru online @ fda and how much will it cost?
    Thank you

  • kristine c.

    Hello Sir, we are having trouble in applying for fda. we cannot proceed though we are entering the right information.

  • harold c.

    hi. i would like to ask for assistance. how much it would cost me to get a permit. my business is ice candy. we are manufacturingand selling it to schools. thanks

  • Marlon A. S.

    Hi Atty!

    If I will re-brand a particular cosmetic product and sell it to public, do I need to accomplish the FDA requirements too?

    Or is it the manufacturer of said product should secure permits/licenses with DFA?

    Thank you.

  • Goodevening Atty. Pano po kaya kumuha ng LTO sa FDA para sa bedbug killer? Thankyou.

  • Agnes O.

    Gud am,ask ko lng po kung kailangan po bang kumuha ng fda ang homemade kakanin isang tindahan lng po ang dinadalan nmin kmi lng mag asawa ang gumagawa.

  • Josefino D.

    Good day attorney, I am planning to make a banana and camote chips (home made) I want to register to BFAD the products to get LTO or license to operate. Kindly advise for the process of legalisation to make it happen. Thankyou to email the requirements to jossdelacruz717@yahoo.com

    Looking forward to hearing from you soon.

    Kind Regards,
    Josefino delacruz

  • Mc E.

    Hi Atty. James, I am planning to put a wine shop. I will purchase from a local wine supplier. Am I required to apply for LTO? Thank you!

  • Lhen

    Hi Atty. I would like to secure from BFAD a license to operate for medical supplies and equipment.
    What are the requirements? can u please send me an email for the list of requirements. an also for the site where to upload the said requirements.

    Thank you.
    Lhen

  • Jerry

    Hello Atty how to get an Lto permit of drug distributors.. Thank you

  • Ester

    Hi sir, just want to ask what is good manufacturing practices certificate? Is it just a requirement by bfad to have trainings or seminars and then just get a certificate? Or do we need to have our product tested through bfad accredited laboraties? Our business is repacking coffee grounds and beans. Thank you.

  • Iana G.

    Hi Atty. I need help. Im planning to start a business and open in one of the big mall in cebu. I have Korean cosmetics and skincare. And one of the requirements before getting inside the mall, Is FDA . I need help in getting one. I waned to get inside the mall before December. Pls help atty. Please send me an email.

  • Joahn

    Hi Atty. Good day. It’s like this, we apply for our CPR for food and get denied. Our company is registered as Food Distributor/importer/wholesaler (FDA-LTO). We import our Rawmat and processed here in the Philippines. Reason of denial was ‘inconsistent declaration of company activity’ They told us that we should apply for another LTO as Food Trader since we are putting ‘Manufactured for’ in our label. When i ask them to differentiate Food Trader and our current LTO they cannot explain. Hope you could assist us. Thanks.

  • Cecilia S.C.

    Goodpm att. im lhia from pasig city.. i have a plan to have a business of selling snus from sweden here in phils. its a tobacco.. i dont know how to register to bfad the snus. pls advice me what i can do and to provide? thanks.. i hope i can have a reply from you its important to know.. God Bless.. here my email.. lhia22_cuenca@yahoo.com

  • Sandra

    Good day, Atty! May I ask if homemade or home cooked products can be approved by BFAD or can be issued with LTO? Thank you.

  • Jann

    Good day!

    Sir, I would like to ask kung pano po kapag medical devices ang i-aapply for LTO? Can you teach me the step by step procedures? Thank you.

  • Mae A.V.

    Hello Atty
    Im Planning to supply a hospital with one medical product only. Cautery pencil for surgery. in small quantity like 20 pc in a month. Do i need to register to FDA LTO?

  • Brandon

    Hi Atty. What are the requirements for food establishment in order for them to sell safe food?

  • Mae A.V.

    Hello Sir,
    I am planning to supply a local hospital nearby with CAUTERY Pencils (used for surgeries) and Suction Tubes. Only these two products. I’m importing these items from CHINA. And I will only supply one hospital. Do i still need FDA License to Operate?

    Thanks and More Power!

  • Adrian M.J.

    Hello Attorney,

    Im a Single Distributor of a food supplements from Thailand. Do I need to have a warehouse, stock room, etc. here in the Philippines since I am selling this product online? The Product is FDA Approved in Thailand. Planning to register this one here in the Philippines. Badly needed your advice please.

    Thanks!

  • Mary Jane

    Hello Attorney,
    I have received a letter fron BFAD telling us to submit a LTO within 90 days. We are just repackers, should we just present them the LTO of our suppliers and the authorization stating that they are allowing us to resell their products? Also, how long is the processing for that? Thanks:)

  • Silvano N.B.

    A Good Day to you Atty. James Biron.
    We are a Cat and Dog Food Manufacturer/Exporter from Malaysia. We have already appointed a distributor in Manila which will serve as importer of products from Malaysia. I only learned about LTO from our Broker recently. Since we are dealing with Animal and not human food, do we have to register with the FDA or the Bureau of Animal Industry? We are planning to ship products via container vans either 20 or 40Footer from Malaysia. In what category do our operation fall? Letter C Importer for finished product in Bulk, or E Importer of finished products?
    Thank you so much Atty. and hope to receive your reply regarding my inquiry. SILVANO N. BALAGTAS

  • Van

    Hi Atty,
    I would like to ask for assistance for the CPR application of medical devices to FDA. What is the process and requirements? How much is the fee for your assistance?

  • Lyn

    Good afternoon, Atty.

    Tanong ko lang. Are we entitled to get the CPR if we are only manufacturing and may distributor kami. Although, we are registered as “Food Manufacturer”.

    Please need your reply asap!
    Thank you very much!

  • Ayesha

    Good morning attorney, when applying for the LTO of a certain lab (cosmetics and food supplements), is it necessary to prepare the site master plan? or a simple production process manual is enough?

  • Michael A.

    Hi Atty. We are planning to introduce our own formulated natural toothpaste. We are yet to register our business with SEC, BIR and Local Gov’t but we already have an idea how the process flows. However, for FDA, do we need approval prior to start of business? Where can we access all the requirements for registration with FDA?

  • Rhodora

    hello atty. good day i just want to ask how to get lto from fda the medicine will be from korea po..tnx and more power

  • Sally C.

    Hi Atty,
    It is understood that we need a LTO in order to export to Philippine. Besides, FDA certificate is another requirement too.
    Ps advise on the followings;
    1) How to apply for LTO ( License To Operate )?
    2) Who should I send the sample for FDA analysis?
    3) Is there any agency in Singapore who handle all these LTO application.

    Thanks.

  • Joel P.

    Good Day Sir. Do I need to secure LTO if I am baking cakes at home and getting orders through social media?
    Thank you.
    Joel P.

  • Vicky P.

    Hi Atty.

    Kakaopen ko lang po ng Purified Water Refilling station in Candaba, Pampanga. Gusto ko po sang mag produce ng mga bottle waters na isusupply sa mga minimart like 7Eleven & Ministop. Possible po kata? Panu po ba ang process and what are the requirements.

    Thank you po.

  • Julie A.R.M.

    Atty. mag patulong po kmi sayo para po sa pag apply ng LTO sa FDA, may phamacist po ako hindi naman po sya marunong mag apply sa on line, taga bondok province po ksi sya, last year hindi po ako nakapag operate ng pharma destributor dahil wala po kmi ng LTO na galing sa FDA, sana po matulungan nyo po kmi mak pag negosyo ng drug distributor, salamat po.

  • Andrew

    Hello there,

    I would like to know if a sole proprietorship business can apply for LTO?. I have plan to sell online of different products which includes Multivitamins (will get directly from the distributor). My location and workplace is at our house, rented.

    PS. If I also sell Personal Care such as Shampoo, Body Wash and Soap do I need to secure for LTO? (Branded Products which I will get directly from the distributor)

    Would love to hear from you soon Atty.

    Thanks in Advance ?

  • Arlene

    Hi Sir,
    Atty. James Biron
    i am about to launch my own cosmetic perfume line here in Philippines and the products are made in Asian Countries like Pakistan,Thailand and U.A.E . as of now, it is for customs clearance. i’d like to ask if i can have to registered in FDA (LTO). Since some of marketplaces need it before they can start to display the products. And how much it Cast. to get Business Name and Certificate

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

    Thank you so much.

  • Richie R.

    Hi atty good day, regarding flooring for beverage buss ano po approved ng fda tiles po or pwede ung rubberize paint. Thank ypu

  • Len

    Dear Atty James,

    Greetings! We are planning to put up a distributorship business of local wine or tuba and imported gin. What are the requirements in applying for LTO and Product Certificate.

    Thanks and regards,

    Len

  • Cherilyn

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

    Thank you so much!

  • Hazel M.

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

  • Tif

    hi! what is a licensing seminar certificate? is it required to all lto applicants?

  • Helen R.

    Good day Atty! I need assistance re: LTO and CPR for my new outfit and line of products i.e. galenicals – tinctures, salves, essential oils, etc. I manufacture, market and distribute.

    I would appreciate a quote on this service. Thank you!

  • Jessica S.

    Hi Attorney.
    Magtatayo po kasi kami ng small restaurant, ask ko lang po ano need na mga requirements for LTO and how much po ang fee?
    Thank You!

  • Maria T.

    Good day po Atty. I’m planning to start a food manufacturing business, specifically longganisa, in Ilocos province. Do I need to apply for LTO before starting my business? Is provincial business covered by FDA or LGU? Please help me how to go about it. Thank you so much.

  • Lucky G.

    Where can you find the application form? Is it okay to email the link to me po? Thanks.

  • Good day Atty. James, i just want to know of the homemade Instant Turmeric Product, like Turmeric Tea and coffee can register to FDA, and whats are the requirements and how much the usual expenses to register Thank you.

  • I would like to aso for assistance, how much It woul cost me to get a LTO and BFAD permit

  • Sherly C.

    Hi po Atty. just want to ask po wat r the requirements for having LTO/CPR ? My business po is dental supply my main product is dental instruments (pambunot) ..Thanks po

  • Mariz

    Helu po atty. Nag expired n po ung lto ko nung june 2017 tpos pumunta aq fda sabi gawa aq e-portal kaya gumawa po ako at nagkaroon ng accnt tapos dun ko n po ginawa ung initial kc may branch po aq at renewal tpos binayaran ko po s land bank ang problema po ngaun ay ung initial lang ang may feedback wala po ung s renewal ko until now may 2018 panu po ang gagawin dun ma susurcharge po b ako? Please help po.

  • ivy

    good afternoon atty. we are planning to put up a bottled water business then we would like to make it a legit,what should we do?is there a requirement to be submitted in FDA office?if there’s a requirements it is necessary to submit in the national office?

  • ROGARD

    hi sir,

    i am about to launch my perfume products inspired by original perfume designers here in philippines and the products are made by me i only buy the raw materials from my supplier. 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.

  • Angelo

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

  • Mylene L. B.

    Good day Sir, I would just like to know if a seller of fruiting bags of mushroom is required to apply for lto? Also, the fruiting bags are being sold as home decor or for whatever purposes it may serve the consumer. Thank you!

  • Thadzmalene P.

    Good Day Atty. James.

    Ask ko lang po regarding sa LTO or License to Operate. Yung company po na pinagtatrabuhan ko is my LTO for food manufacturer po. Ngayon po they are planning po to import food products, are we still going to apply again for a LTO as Importer?

    Thank you in advance.

  • Lyan

    Hi sir. What are the requirements for herbal drinks that are made from leaves and how much are the fees to pay for the fda and consultancy? Thanks

  • Lanzz

    Good day sir!
    We applied already for an FDA Lto of a drugstore & naapprove naman po sya & napadala na samin ang copy but unfortunately nawala poh xa, wala po natira na kopya samin kahit photocopy, ano poh dapat namin gawin sir & ano po mga requirements na need namin e-comply sir?

    Thanks poh!

  • Kumar

    Hi Atty!

    We are going to start product registration through FDA philippines for food products (Capsules and tablets form). So please let us know the exact requirements for getting marketing approval. what is initial step ? is it required LTO for foreign manufacturers before filling of dossier for product registration? if required, what is LTO requirements for foreign manufactures?

    Please Advice for this … Thank u in advance.

  • Mary Jo L.

    Hi Atty. Biron,

    Good evening!

    I would like to inquire how much is the overall cost your office charges to secure LTO and FDA registration?

    Please advise.

    Thank you,
    Mary Jo

  • Robin T.

    Hi Sir James, I would like to ask for an assistance for our LTO registration. We are manufacturer of essential oil. And in the e-portal of fda there is no specific requirements given to our field. I hope you could give us some info. About which requirements do we need.

    Thanks po.

  • Earl M.B.

    Atty. Biron

    I am Mr. Balois, we are engaged with the importing of onions and other vegetables, Can we set an appointment to discuss about securing a LTO/BFAD permit in our food products?

    Thank you so much.

  • Cris D.

    Hi Atty James

    I order supplements and herbal from IHERB and shipped via DHL and now agent from DHL they informed me they not deliver my Items because Custom need FDA/LTO. It is really need to apply the LTO? Because I use it for my personal and my Maintenance only.

  • Catherine A.C.

    Dear Atty. I am a dentist and I bought some dental materials with very small quantities for personal use only from hongkong. The customs hold my materials when.it arrived in.the Philippines and they were requiring.me.to.submit LTO from FDA. I dont have the said document. Can you help me how.to apply? Thank you.

  • Joy

    Hi Sir,
    Ask ko lang po kung kailangan pa ba nang LTO if you are selling perfume from the comfort of own home. If yes po what are the necessary license i need to get para po legal yung pagooperate ko nang business. I’m planning din po to add skincare and bath products pls. Pa help naman po para makakuha po ako nang mga needed na license and permit. Thank you Sir.

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