Posted on June 28th, 2009
Before applying for a License to Operate in BFAD, a registration to the Client Management should be made to acquire your account number which will enable you to access the web portal of BFAD. The web portal serves as a way of transacting to BFAD. Once the registration has been made, application for the initial LTO is now possible through the Client Management Console.
The following are the steps in the application:
1. Classification of Products- BFAD created a classification of product that they regulate. It is called Product Classes. The classes includes:
â€¢ Diagnostic reagents
â€¢ Medical devices
â€¢ Household hazardous substances
2. Classification of establishments- classification of establishments depends on the activities it is engaged with. BFAD has also categorized them according to the following:
Category of Establishment Activities
â€¢ Raw materials and packaging materials are purchased by the manufacturer
â€¢ It produces the product may it be in own plant or subcontracted to other manufacturer
â€¢ Packing finished products
â€¢ Keeps records of input materials, finished products and goods-process
â€¢ Finished product distribution
â€¢ Finished product purchasing
â€¢ Outlet of Retail for drug outlets only
o private and government drugstore
o private and government pharmacies
o non-prescription drugs retail outlet
â€¢ finished products or compounds purchasing and dispensing both prescription and non-prescription drugs
Establishments may fall under any or all of the following establishment types depending on the additional activities. Further classification is then made.
Additional Activities of Establishment Type
Importer- Both raw materials as well as packaging materials and finished products are purchased from suppliers outside the country.
Exporter- distributes or sells products to other countries called the country of destination or where the purchasing party operates.
Wholesaler- finished products acquired from suppliers within the country are distributed or sold to local buyers
3. Decision on what LTO Type is required on your establishment- depending on the product class, the establishment category and type of establishment, the LTO type required is determined. Your LTO may be food distributor/importer, food manufacture/exporter or others.
4. Decision on the type of application- the application type to be applied for is determined after determining on the LTO type. The different transaction types are:
â€¢ Initial issuance of LTO- the first LTO acquired prior to the commencement of operations.
â€¢ Renewal of LTO- this is done after the inspection and approval of BFAD to extend the legitimacy of the LTO.
â€¢ Amendment of LTO- a request to re-issue LTO indicating the changes in conditions upon the approval of BFAD.
â€¢ Change in ownership or the name of the establishment or the name and address of sources
â€¢ Transfer of facilitiesâ€™ location
â€¢ Addition or deletion of products, sources or activities
â€¢ Lost LTO replacement
5. Online submission of application and payment of processing fees- through the Client Management Console, application can be made online. With several payment options, payments can be done through the most convenient way to the applicants.