REPUBLIC OF THE PHILIPPINES

DEPARTMENT OF HEALTH
FOOD AND DRUG ADMINISTRATION

Securing FDA Authorizations

Philippine Exporters Confederation, Inc. (PHILEXPORT)

ITC Complex, Roxas Boulevard, Pasay City
28 April 2015
 FDA Authorizations:

License to Operate (LTO)

Certificate of Product Registration( CPR)

WHY DO WE NEED TO SECURE LTO?

 Assurance of Compliance
 Fair Trade Practices
 Assurance of Food Safety
 Opportunity for Business Growth
LEGAL BASIS

R.A. No. 10611 (Food Safety Act of 2013)

The Dept. of Health through the FDA is
mandated to ensure the safety of all food
processing and product packaging activities, to
develop and issue appropriate authorizations in
the form of a license and certificate or
registration that covers establishments, facilities
engaged in production and distribution of
products.
LEGAL BASIS
 A.O. 2014-0029 (Rules and Regulations on the
Licensing of Food Establishments and Registration of
Processed Food, and Other Food Products, and For
Other Purposes)
 Food establishments engaged in the manufacture and/or
distribution (i.e. import, export, wholesale) and trade
and/or repacking of processed food and food products.

 Signed on 05 September 2014

 Published on 15 September 2014
 LEGAL BASIS

R.A. 9711 (Food and Drug Administration Act of

2009)
The manufacturing, importation, exportation, sale,
offer for sale and distribution of the processed
food products (including food supplements) are
being licensed by FDA.
LEGAL BASIS
Administrative Order 37 s. 1979
 Registration of food and food products intended
for import/export

Bureau Order No. 163 s. 1997

 Specific requirements for the registration of
imported food and food products
 Basis for the product classification
(Category I or II)
Who needs to secure approval from FDA?

– Any establishment, whether a sole

proprietorship, a partnership, a
corporation, an institution, an association,
or an organization engaged in any of the
activities, as indicated in the following
categories, are being licensed by FDA:
 Distributor/ Importer/ Exporter

Any establishment that imports or exports

raw materials, ingredients and/or finished
products for its own use or for wholesale
distribution to other establishments or
outlets.
 Distributor/ Wholesaler

Any establishment that procures raw

materials, ingredients and/or finished
products from a local establishment for
local distribution on wholesale basis.
 Manufacturer
Engaged in any and all operations involved in
the production of health products including
preparation, processing, compounding,
formulating, filling, packing, repacking, altering,
ornamenting, finishing and labeling with the
end view of its storage, sale or distribution.
 Repacker
REPACKING
This activity falls under the production cycle
of a manufacturer, thus, any establishment
engaged in this activity has to be licensed and
shall be under the classification of
MANUFACTURER/REPACKER.
 TRADER
(A.O. 2014-0029)

A registered owner of food and food

products and/or procure the raw materials and
packing components, quality control standards
and procedures, but subcontracts the
manufacture to a licensed manufacturer. A
trader may also engage in the distribution
and/or marketing of its products.
LICENSING REQUIREMENTS
REQUIREMENTS FOR
INITIAL LTO ISSUANCE

i. General Requirements

ii. Specific Requirements

GENERAL REQUIREMENTS
GENERAL REQUIREMENTS
SPECIFIC REQUIREMENTS
SPECIFIC REQUIREMENTS
SPECIFIC REQUIREMENTS
SPECIFIC REQUIREMENTS
SPECIFIC REQUIREMENTS
SPECIFIC REQUIREMENTS
SPECIFIC REQUIREMENTS
SPECIFIC REQUIREMENTS
SPECIFIC REQUIREMENTS
LTO RENEWAL
SCHEDULE OF FEES

A. O. No. 50s.2001 (Revised 2001 Schedule of Fees and

Charges for the Corresponding
Services by the Bureau of Food and
Drugs)
SCHEDULE OF FEES
Distributor/ Importer/ Exporter/ Wholesaler
Circumstances Fee (PhP)
Initial 4,040
Renewal 8,080
Add/Delete Source 60
Change Owner/Business Name 510
Add Activity/Reclassification 510
Change Address 510
Change/Add Warehouse 510
Change Name/Address of 310
Source
SCHEDULE OF FEES
Manufacturer/Repacker/Trader
Circumstances Initial Renewal
(1 Year)* (2 Years)*
250K and below 500 1,000
Over 250K but below 500K 750 1,500
500K but below 1M 1,000 2,000
1M but below 5M 2,000 4,000
5M but below 10M 3,000 6,000
10M but below 20M 5,000 10,000
20M but below 50M 10,000 20,000
50M and above 15,000 30,000
* Fee + LRF
SCHEDULE OF FEES
Manufacturer/Repacker/Trader
Circumstances Fee (PhP)
Add/Delete Source 60
Change Owner/Business Name 510
Add Activity/Reclassification 510
Change Address 510
Change/Add Warehouse 510
Change Name/Address of 310
Source
 A.O. 2014-0029
ESTABLISHMENTS
Part C.
1. Any establishment applying for FDA LTO as Food
Distributor (Importer, Exporter, Wholesaler)
utilizing or sharing one office with another
establishment shall not the allowed regardless of
ownership.
2. For offices of distributors, all warehouses and
depots shall be declared. Sharing of offices by
different distributors shall not be allowed.
 A.O. 2014-0029

ESTABLISHMENTS
Part C.
4. An establishment with LTO as Food Distributor
(Importer, Exporter, Wholesaler) may engage in
manufacturing or repacking provided that a LTO as
Manufacturer (Repacker) shall be secured also from
the FDA.
 A.O. 2014-0029

LTO REQUIREMENTS
ANNEX C

A.9.f Specific Requirements for Food Trader:

• Valid and notarized toll manufacturing and/or repacking

agreement with an FDA-licensed toll manufacturer and/or
repacker.
 A.O. 2014-0029

LTO VALIDITY
Part E.
Unless revoked, the LTO shall have the following
validity period:
• Initial 2 years
• Renewal 5 years
HOW TO SECURE
CERTIFICATE OF PRODUCT REGISTRATION?
Queries on Integrated Application Form:

Public Assistance and Information & Receiving

(PAIR)

Contact : (02) 857-1975, -1939, -8386

pair@fda.gov.ph