BFAD is the government agency that protect public health and ensure the safety, efficacy, purity and quality of all the products it regulates through the effective and efficient implementation of national policies consistent with international best practices.
BFAD services includes providing license to operate (LTO), Product Registration, and Laboratory Services, among others.
An establishment intending to engage in the importation, exportation, distribution, and manufacture and re-packing of products regulated by BFAD, must have a LICENSE TO OPERATE (LTO) prior to start of or for continued operations. The processing of applications for the initial issuance, renewal or amendment of the License to Operate of establishments is referred to as ESTABLISHMENT LICENSING.
BFAD establishes the identification and circumstances of the legal entity applying for the license and conducts site inspection to evaluate the capability of the establishment to engage in its stated activities, in compliance with BFAD standards and requirements
How to Apply for a License to Operate (LTO)
REGISTRATION FOR NEW CLIENTS
1. Is this the first time you will transact with BFAD? Register at the Client Management Console to get your account number and gain access to the web portal of BFAD. This is where you will regularly transact with BFAD after registration.
2. After registration, you may apply for initial issuance of LTO through the Client Management Console.
APPLICATION
STEP 1. Classify your product(s)
Products regulated by BFAD fall under any of the following PRODUCT CLASSES:
DRUGS
MEDICAL DEVICES
DIAGNOSTIC RE-AGENTS
FOOD
COSMETICS
HOUSEHOLD HAZARDOUS SUBSTANCES
STEP 2. Classify your establishment.
Based on activities the establishment is engaged in, the establishment can be classified under any of the following establishment categories:
ESTABLISHMENT CATEGORY ACTIVITIES
Manufacturer Purchases Raw Materials and Packaging Materials
Produces the product (in own plant or outsourced to a toll manufacturer)
Packs finished products
Maintains inventory of input materials, goods-in-process, and finished products
Distributes finished products
Distributor Purchases finished products
Distributes finished products
Retail Outlet (Drug Outlets only)
* Drugstores (private or government)
* Hospital Pharmacies (private or government)
* Retail Outlet of Non-prescription Drugs
Purchases finished products or compounds and dispenses prescription and/or non-prescription drugs
Your establishment can be further classified based on additional activities that make the establishment fall under any or all of the following establishment types.
ESTABLISHMENT TYPE ADDITIONAL ACTIVITIES
Importer
Purchases products from foreign suppliers (referred to as “sources”), whether:
* Raw materials and packaging materials of manufacturers or
* Finished products of distributors
The country where the source operates is referred to as “country of origin”.
Exporter
Distributes or sells products to foreign buyers
The country where the buyer operates is referred to as “country of destination”
Wholesaler
Purchases finished products from local suppliers and/or distributes or sells the products to local buyers
STEP 3. Determine the LTO Type required by your establishment.
LTO type is determined by the product class plus the establishment category and the establishment type.
For example, your establishment may need the LTO of a
Food distributor/importer
Food manufacturer/exporter
Drug manufacturer
Cosmetics Distributor/importer/wholesaler
STEP 4. After determining the LTO Type, determine the type of application you shall apply for:
TRANSACTION TYPE DEFINITION
Initial Issuance of LTO Issuance of License to Operate prior to opening of the establishment and start of operations
Renewal of LTO Extension of validity of the LTO after inspection and approval of BFAD
Amendment of LTO Re-issuance of LTO to reflect changes in circumstance of the establishment, after approval of BFAD
Change in ownership
Change in Establishment Name
Transfer of location of facilities
Addition or deletion of activities
Addition or deletion of products
Addition or deletion of sources
Change in name and address of sources
Replacement of lost LTO
STEP 5. Submit application online and pay processing fees
Now you are ready to access the applicable set of checklist of requirements, fees, and laws and regulations for the LTO type and transaction type you will apply for.
Prepare your application documents and apply online through the Client Management Console.
Pay through the payment option most convenient for you.
----
There website is found at http://www.bfad.gov.ph
Source: www.entrepreneur.com.ph
BFAD services includes providing license to operate (LTO), Product Registration, and Laboratory Services, among others.
An establishment intending to engage in the importation, exportation, distribution, and manufacture and re-packing of products regulated by BFAD, must have a LICENSE TO OPERATE (LTO) prior to start of or for continued operations. The processing of applications for the initial issuance, renewal or amendment of the License to Operate of establishments is referred to as ESTABLISHMENT LICENSING.
BFAD establishes the identification and circumstances of the legal entity applying for the license and conducts site inspection to evaluate the capability of the establishment to engage in its stated activities, in compliance with BFAD standards and requirements
How to Apply for a License to Operate (LTO)
REGISTRATION FOR NEW CLIENTS
1. Is this the first time you will transact with BFAD? Register at the Client Management Console to get your account number and gain access to the web portal of BFAD. This is where you will regularly transact with BFAD after registration.
2. After registration, you may apply for initial issuance of LTO through the Client Management Console.
APPLICATION
STEP 1. Classify your product(s)
Products regulated by BFAD fall under any of the following PRODUCT CLASSES:
DRUGS
MEDICAL DEVICES
DIAGNOSTIC RE-AGENTS
FOOD
COSMETICS
HOUSEHOLD HAZARDOUS SUBSTANCES
STEP 2. Classify your establishment.
Based on activities the establishment is engaged in, the establishment can be classified under any of the following establishment categories:
ESTABLISHMENT CATEGORY ACTIVITIES
Manufacturer Purchases Raw Materials and Packaging Materials
Produces the product (in own plant or outsourced to a toll manufacturer)
Packs finished products
Maintains inventory of input materials, goods-in-process, and finished products
Distributes finished products
Distributor Purchases finished products
Distributes finished products
Retail Outlet (Drug Outlets only)
* Drugstores (private or government)
* Hospital Pharmacies (private or government)
* Retail Outlet of Non-prescription Drugs
Purchases finished products or compounds and dispenses prescription and/or non-prescription drugs
Your establishment can be further classified based on additional activities that make the establishment fall under any or all of the following establishment types.
ESTABLISHMENT TYPE ADDITIONAL ACTIVITIES
Importer
Purchases products from foreign suppliers (referred to as “sources”), whether:
* Raw materials and packaging materials of manufacturers or
* Finished products of distributors
The country where the source operates is referred to as “country of origin”.
Exporter
Distributes or sells products to foreign buyers
The country where the buyer operates is referred to as “country of destination”
Wholesaler
Purchases finished products from local suppliers and/or distributes or sells the products to local buyers
STEP 3. Determine the LTO Type required by your establishment.
LTO type is determined by the product class plus the establishment category and the establishment type.
For example, your establishment may need the LTO of a
Food distributor/importer
Food manufacturer/exporter
Drug manufacturer
Cosmetics Distributor/importer/wholesaler
STEP 4. After determining the LTO Type, determine the type of application you shall apply for:
TRANSACTION TYPE DEFINITION
Initial Issuance of LTO Issuance of License to Operate prior to opening of the establishment and start of operations
Renewal of LTO Extension of validity of the LTO after inspection and approval of BFAD
Amendment of LTO Re-issuance of LTO to reflect changes in circumstance of the establishment, after approval of BFAD
Change in ownership
Change in Establishment Name
Transfer of location of facilities
Addition or deletion of activities
Addition or deletion of products
Addition or deletion of sources
Change in name and address of sources
Replacement of lost LTO
STEP 5. Submit application online and pay processing fees
Now you are ready to access the applicable set of checklist of requirements, fees, and laws and regulations for the LTO type and transaction type you will apply for.
Prepare your application documents and apply online through the Client Management Console.
Pay through the payment option most convenient for you.
----
There website is found at http://www.bfad.gov.ph
Source: www.entrepreneur.com.ph
Good day!
ReplyDeleteSir i would like to ask my concern. Is there a minimum volume of product required by BFAD to be able to apply a license? What if me i am planning to make perfumes actually home made only. Do i have to apply at BFAD even if im just starting in small volume and capital only? Thank you
Im backyard native pig grower and wamt to venture to small meat processing where will i apply to for LTO.
ReplyDeleteGumagawa po ako ng home made bagoong nais ko po itaning kailangannko po ba iparehistro uto dahil nais ko po inout sa market?
ReplyDeleteSame question po..paano po?
DeleteHow is the easy way to get bfad permit
ReplyDeleteSir/Madam, i am making perfumes at home and sell it in a retail. Is it do we need BFAD to continue my small businesss. I need your advice and how to apply. Thank you!
ReplyDeletegood morning , my concern is about how to secure a bfad permit/lto mini grocery/ convenience store . . please send me directly the requirements and fees for the permit. . Thank you
ReplyDeleteGood afternoon po...my sariling product po ako chicken Marinade Lequid po SYA paano ko po SYA iaaply ng BFAD..para makapag all out po ako sa marketing...pwede po ba mag pa assist sa into?
ReplyDeleteAsk lang po..Gumagawa po ako ng home made Dewormer for chickens and pre biotics, kailangan ko po ba iparehistro dahil gusto ko po ibebenta? Paano po magparehistro para mgkaroon permit?
ReplyDeleteGoodday po... Gumagawa po kami ng home made peanut butter...ano po ba first step na gawin namin para ma market po namin ang among product? Kasi we believed po na it has a potential po in the market... Baka po naman makatulong po kayo para makamit po namin ang among mithiin po na ma market po yung masarap naming homemade peanut butter... Salamat po sa inyo pong sagot
ReplyDeleteHello, pwede po ba magpa assist ng application? Peanut products po yung sa amin gusto ko po magka lto at bfad license para maka market kami kahit locally lang muna..thamx po.
ReplyDelete