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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