Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION
Alabang, Muntinlupa City
Tel. No. 857 1991

CHECKLIST OF REQUIREMENTS FOR AMENDMENTS
(FOOD ESTABLISHMENT)

CHANGE OF ADDRESS
1. Official letter regarding the change of business address
2. Copy of Business Name Registration
a. For single proprietorship registration from the Department of Trade & Industry (DTI)
b. For corporation / partnership, registration from Securities & Exchange Commission
(SEC)
and Articles of Incorporation
Note: If the registered address with DTI/SEC is different from the address of the
establishment
to licensed, submit a photocopy of Business/Mayors Permit
3. Proof of Occupancy
4. Location Plan/Site (indicate size, location, landmarks, immediate environment, type of
building)
5. Floor Plan/Lay out with dimension (office and/or warehouse)
6. Letter or Notification to the supplier/s and/or client/s regarding the change of address (for
Food Distributor)
7. Copy of License to Operate (LTO)
Note:
For Manufacturer / Repacker: All the general and specific requirements for initial
application

CHANGE OF BUSINESS NAME
1. Official letter regarding the change of business name
2. Copy of Business Name Registration
a. For single proprietorship registration from the Department of Trade & Industry (DTI)
b. For corporation / partnership, registration from Securities & Exchange Commission
(SEC)
and Articles of Incorporation
Note: If the registered address with DTI/SEC is different from the address of the
establishment
to licensed, submit a photocopy of Business/Mayors Permit

3.
Letter or Notification to the supplier/s and/or client/s regarding the change of business
name (for Food Distributor)
4. Copy of License to Operate (LTO)

CHANGE OF OWNERSHIP
1. Official letter regarding the change of ownership
2. Copy of Business Name Registration
a. For single proprietorship registration from the Department of Trade & Industry (DTI)
b. For corporation / partnership, registration from Securities & Exchange Commission
(SEC)
and Articles of Incorporation
Note:
If the registered address with DTI/SEC is different from the address of the establishment
to licensed, submit a photocopy of Business/Mayors Permit
3. Copy of Contract / Agreement with Manufacturer reflecting the new owner
4. Copy of Deed of Sale / Transfer of Rights
Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Alabang, Muntinlupa City
Tel. No. 857 1991

5. Copy of Dissolution Papers from SEC (for corporation/partnership)
6. Copy of Financial Statement duly notarized or received by Bureau of Internal Revenue
(BIR) (for Food Manufacturer/Repacker)
7. Copy of License to Operate (LTO)
Note:
For Distributor: All the general and specific requirements for opening












































Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Alabang, Muntinlupa City
Tel. No. 857 1991

CHECKLIST OF REQUIREMENTS FOR AMENDMENTS
(FOOD ESTABLISHMENT)

ADDITIONAL CLIENT/ TOLL MANUFACTURER/ REPACKER
1. Official letter request regarding the additional Client/Toll Manufacturer/Repacker
2. Copy of notarized Contract/Agreement indicating products to be manufactured
3. Copy of the valid License to Operate (LTO) of the Client/Manufacturer/Repacker
ADDITIONAL PRODUCT/S

1. Official letter request regarding the additional product(s)
2. Process flow and detailed description of manufacturing procedure
3. Finished product analysis
4. Copy of the Addendum to Contract/Agreement re: additional product(s) to be manufactured
(for Toll Manufacturer)

ADDITIONAL SOURCE AND/OR CHANGE OF NAME OF SOURCE
1. Official letter request regarding the additional source &/or change of name of source
2. List of products/raw materials
A. For Importer:
1) Any of the following from each supplier
Foreign Agency Agreement
Certificate of Distributorship
Appointment Letter
Proforma Invoice
Memorandum of Agreement
2) Any one of the following documents for the status of Manufacturer issued by the
Regulatory/ Health Authority from
the country of origin:
Certificate of Registration of Manufacturer and its conformity with GMP from
Regulatory/ Health Authority or its equivalent
Phytosanitary Certificate/Health Certificate
Certificate of Free Sale
ISO 22000 Certification
HACCP Certificate as applicable
Note: In the absence of a Regulatory/ Health Authority from the country of origin,
attestation by a recognized association from the country of origin or duly authenticated by
the Philippine Consulate.
Certificate of Analysis of the raw materials and/or finished product/s (for own use)
Any pertinent document/s from the supplier which serve/s as proof of change of name
B. For Wholesaler:
1) Copy of the valid License to Operate (LTO) & attachment of the
Manufacturer/Repacker/Supplier
2) Copy of valid notarized Distributorship/Toll Manufacturing and/or Repacking
Agreement or letter of Appointment with FDA licensed
Supplier/Manufacturer/Repacker

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION
Alabang, Muntinlupa City
Tel. No. 857 1991

ADDITIONAL ACTIVITY
Official letter request regarding the additional activity
A. For Importer of finished and/or finished bulk products and/or raw materials: See
requirements for Additional Source
B. For Distributor/Exporter of finished and/or finished bulk products:
1) Notarized Distributorship Agreement or Letter of Appointment with FDA
Licensed Supplier/Manufacturer to distribute their products outside the
Philippines
2) List of products with CPR and validity
3) Copy of valid LTO of Supplier/Manufacturer
C. For Distributor/Wholesaler:
1) Copy of notarized Contract Agreement with FDA licensed Toll Manufacturer/
Repacker/ Supplier
2) List of products with CPR and validity
D. For Repacker/ Toll Manufacturer:
1) Copy of notarized valid contract/agreement with manufacturer/source/supplier
2) Copy of License to Operate of the manufacturer/Source/supplier
E. For Exporter of their own products, submit official letter indicating list of registered
products for export
DELETION OF TOLL MANUFACTURER/REPACKER/SOURCE/PRODUCT
Official letter request regarding the deletion of toll
manufacturer/repacker/trader/source/product
Certification or acknowledgement letter re-termination of Contract/Agreement/Foreign
Agency Agreement
Photocopy of the valid License to Operate (LTO) & attachment of the
Manufacturer/Repacker/Trader

REISSUANCE OF LTO
Lost LTO
1. Copy of License to Operate (LTO)
2. Affidavit of Loss
3. Payment
Reconstruction of LTO
1. Copy of License to Operate (LTO)
2. Official letter requesting for reconstruction
3. Payment