Wednesday, June 9, 2010

How to get a BFAD license

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.

source: http://www.entrepreneur.com.ph

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