Registration for New Clients
- 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.
- After registration, you may apply for initial issuance of LTO through the Client Management Console.
STEP 1. Classify your product(s)
Products regulated by BFAD fall under any of the following product classes:
- medical devices
- diagnostic re-agents
- 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
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
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”.
Distributes or sells products to foreign buyers
The country where the buyer operates is referred to as “country of destination”
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.