BFAD Requirements(Highlights)
(FDA Memorandum Circular no. 2013-001)
Initial application of LTO (License to Operate)General
Requirements1. Duly accomplished and notarized Integrated
Application Form (Refer to FDA Circular No. (2014-003)
2. Proof of Registration If Corporation or Partnership, valid
Registration with Securities and Exchange Commission (SEC) and
Articles of Incorporation or Partnership
3. Proof of Occupancy Manufacturing Facility /Office and/or
Warehouse/ Stock Room Valid notarized Contract of Lease /
Sub-Lease/ Certificate of Occupancy/WarehousingAgreement (for Third
Party Logistics) Transfer Certificate of Title (TCT) if owned and
notarized Certificate of Occupancy (if owned by one of the
incorporators) Clearance from the Condominium/ Building
Administration allowing the use of the unit for business purposes
as necessary
5. Location Plan/Site/Google Map (indicate size, location,
landmarks, immediate environment, type of building)
6. Floor Plan/Lay out with dimension (office and/or warehouse;
manufacturing plant)
7. List of food products to be manufactured/repacked/
distributed
8. Facsimile of Proposed Label (for local manufacturer) / sample
label of product to be imported/distributed
9. Secretarys certificate (Corp./ Partnership) or Special Power
of Attorney (others) if applicant is not the owner himself
authorizing the applicant for the purpose
Specific Requirements
DISTRIBUTOR WHOLESALERFor Locally Procured Raw Materials in Bulk
and Finished Products in original container1. Copy of valid License
to Operate (LTO) of Supplier/ Manufacturer2. Valid notarized
Distributor Agreement or Letter of Appointment with FDA
licensedSupplier/ Manufacturer to distribute their products within
the Philippines3. List of food products with registration numbers
and validities
Subcontracts to a Licensed Manufacturer/Repacker1. Copy of valid
License to Operate (LTO) of Manufacturer and/or Repacker (tolling/
repacking activity and specific product should be indicated in the
LTO)2. Valid notarized Toll Manufacturing and/or Repacking
Agreement with FDA licensed TollManufacturer and/or Repacker
Application for CPR ( Certificate of Product Registration)
Duly accomplished Product Information Sheet via online
containing pertinent information about the company and complete
information about the product.
a.) Notarized application letter with Affidavit of
Undertaking
b) Copy of valid License to Operate with list of products and
list of sources (it should be clear that the list of sources would
include the manufacturer and the list of products would mean same
process design if different flavors can be included in the database
so as not to crowd the LTO)c) Clear and complete loose labels of
all packaging labels
d) Picture of the products (all sides, all packaging sizes as
applicable)
e) Justification of label claims, as applicable Certificate of
Analysis Computation Certification to support declaration (i.e.
Halal, Organic, Kosher logos) Clinical/Scientific studies
(validated, peer-reviewed and published in scientific journal/s to
support claims) Safety studies/scientific data literature
FEES :
LTO :Initial(1 year validity)- P4000 Renewal(2 year
validity)-P8000
Pre-Site Inspection of Establishments- P500.00 +cost of
transportation & accommodation if outside M.Mla.
CPR: Initial (1 year validity) Category 1-P200 Category
2-P250Renewal(5 years validity)Category 1-P1000 Category
2-P1250
Product Classification (by ACB)- P500 per product
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