(FDA) License to Operate

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
Initial
Renewal
Add/Delete Source
Change Owner/Business Name
Add Activity/Reclassification
Change Address
Change/Add Warehouse
Change Name/Address of
Source
Fee (PhP)
4,040
8,080
60
510
510
510
510
310
SCHEDULE OF FEES
Manufacturer/Repacker/Trader
Circumstances
250K and below
Over 250K but below 500K
Initial
(1 Year)*
Renewal
(2 Years)*
500
750
1,000
1,500
500K but below 1M
1M but below 5M
1,000
2,000
2,000
4,000
5M but below 10M
10M but below 20M
3,000
5,000
6,000
10,000
20M but below 50M
50M and above
10,000
15,000
20,000
30,000
* Fee + LRF
SCHEDULE OF FEES
Manufacturer/Repacker/Trader
Circumstances
Add/Delete Source
Change Owner/Business Name
Add Activity/Reclassification
Change Address
Change/Add Warehouse
Change Name/Address of
Source
Fee (PhP)
60
510
510
510
510
310
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