Securing License to Operate (LTO) with BFAD

[third]

Hello.  I am interested in entering into wholesale distribution of pharmaceutical goods and have been told that I must secure a license to operate with BFAD. 

Can someone please tell me more about the process?  I know that I will need to hire a licensed pharmacist, file some forms, and submit to warehouse inspection.  Does anyone know how long this will take?  Are there any complications or potential issues that I should know about?

Thank you.

Third

[chris lim]

call me 09208865651

[edwin_edwin30]

This is the site where you can get full details of your inquiry (bfad.gov.ph).
They are more competent to handle your inquiry.

edwin_edwin30@yahoo.com

[third]

Thank you for your responses.  Can anyone who has been through the process before shed some light on my questions.  Thanks.


Third

[GerelRoa]

Hello,

BFAD has recently computerized their operations, and so, you will not have to go to their office to fill up forms.   Their website claims that it will take only a few weeks to get the full LTO, but in the end, it will really depend on how fast they can send their representative to inspect your facility.   Typically, this will take anywhere between 2 weeks to 9 months.   You will need to constantly follow this up so that action can be made.

If you are not familiar with the BFAD requirements for pharma, you may need to hire someone to help you, specially in the planning stages so that you can minimize the necessary costly changes and help you with the documentary requirements for GMP, Traceability, etc.

Cheers!

Gerel

[third]

Thanks for your, response Gerel.  It's very helpful.  Would you have any idea about the going rate for a BFAD liaison who can assist with securing the LTO and managing the process of acquiring a CPR?

[GerelRoa]

Hello third,

It really depends on the situation and the deal that you will strike with the Liaison.  I am not sure with Pharma, but when we assist for food businesses, we usually get between PhP5,000 to PhP15,000 plus documentary expenses depending on the situation.   If your business do not have much of a problem, I suggest that you run the papers yourself.

Cheers!

Gerel

[agsb_marketing]

Thanks for your, response Gerel.  It's very helpful.  Would you have any idea about the going rate for a BFAD liaison who can assist with securing the LTO and managing the process of acquiring a CPR?

I guess it's good to have a liason ( pharmacist on a retainer basis) to assist you. Definitely, BFAD requires a pharmacist since your business is drug related ( i've heard it's a good business 'coz of good mark-up).. there are licensed pharmacist who accepts part-time (retainer)... simply means, she/he  will represents your company during registration/ processing of documents with BFAD.

[bhertlpz]

Gusto ko lang sana follow-up sa topic. What if I want to set-up a wholesale business (instant powder drink i.e. juice, ice tea, coffee with supplemental additives) and hindi ako ang mag-mamanufacture. Do I need to register my product/s with BFAD kung BFAD registered naman ang toll manufacturer ko?