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Getting a BFAD license

Procedures for a BFAD license.

May 12, 2012 10:00 am

BFAD (Bureau of Food and Drugs)

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”.

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