SEARCH
Philippine Government Forms All in One Location
Tweet
Share
Checklist of Requirements for the Initial, Renewal and Amendment Applications
FDA application requirements checklist for initial, renewal and amendment
Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: ANNEX A
CENTER FOR COSMETICS REGULATION AND RESEARCH
CHECKLIST OF REQUIREMENTS FOR THE ISSUANCE OF LICENSE TO
OPERATE FOR HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES (HUHS)
ESTABLISHMENTS
I.
INITIAL/OPENING APPLICATIONS
A. GENERAL REQUIREMENTS
Completely accomplished and notarized Integrated Application Form with ID picture of
both the Owner/Incorporator/General Manager and the Authorized Person (Refer to FDA
Circular No. 2014-003) (only for NCR and CHD IV-A)
Notarized Accomplished Petition Form with 2 x 2 ID picture of
Owner/Incorporator/Authorized Representative (see Annex A) (except for NCR and
CHD IV-A)
o Notarized Secretary’s Certificate/Special Power of Attorney (if the Authorized
Representative is not the owner in the DTI business registration or one of the
incorporators in the SEC)
Proof of Business Registration:
o valid certificate of business name registration with the Department of Trade and
Industry (DTI), (for single proprietorship)
o valid registration with the Securities and Exchange Commission (SEC) and
Articles of Incorporation or Partnership (for corporation or partnership)
If the business name is different from the corporate name, SEC
Certificate must reflect “Doing Business under the name and style of
(Name of Establishment)”
o certificate of Cooperative Development Authority (CDA), (for cooperatives),
Note: If the business address in the DTI business registration and SEC is different
from the declared office address, provide a valid Mayor’s Permit/Barangay
Clearance
Proof of Occupancy (Office, Manufacturing Plant and Warehouse):
o Transfer Certificate of Title (TCT) as proof of ownership.
o Notarized Certificate of Occupancy, if owned by one of the incorporators.
o Notarized valid contract of lease/sublease, if the space/building being occupied is
not owned,
o Valid Clearance from Homeowner’s Association (HOA) /
Condominium/Building Administration, if within a residential area/
condominium,
o Valid notarized warehousing agreement for third party logistics,
ANNEX A
CENTER FOR COSMETICS REGULATION AND RESEARCH
Other requirements
o Floor plan/lay-out in meters and proper identification of areas (office and
warehouse)
o Blueprint for manufacturing plant
o Vicinity/Location map with landmarks (i.e. google map, sketch of the area)
Pertinent Documents for Authorized Representative:
o Duties and responsibilities signed by the authorized representative and the
immediate supervisor
o Certificate of Attendance to “Qualified Person in Industry Regulatory
Affairs (QPIRA)-Household/Urban Hazardous Substances” under CCRR
or promissory letter to attend with proof of scheduled day of attendance
and payment
o Certificate of Attendance to“Training on the 13 ASEAN Cosmetic GMP
Modules” or promissory letter to attend with proof of scheduled day of
attendance and payment (only for traders and manufacturers)
B.
SPECIFIC REQUIREMENTS
1. FOR HUHS DISTRIBUTOR
List of products indicating the name and address of source/supplier/manufacturer,
country of origin (if imported) following the format below:
Source Name &
Manufacturer
Country of Origin Complete Product
Address
Name & Address
List*
S
p
*
*Specify the HUHS product type (Example: laundry detergent powder, liquid
laundry detergent, shoe polish, insect repellent spray, pencil, etc.)
FOR IMPORTER:
o
o
o
Valid Foreign Agency Agreement (FAA) or any form of authorization from each
source/supplier duly authenticated by the Territorial Philippine Consulate
If the source/supplier has appointed another logistic/invoicing company, any of
the following:
Valid Supply Agreement between the foreign source/supplier and
manufacturer
Valid Tripartite Agreement duly authenticated by the Territorial
Philippine Consulate
Proof of GMP Compliance of Manufacturer (any of the following):
Valid GMP Certificate of manufacturer issued by the government agency
or in the country of origin
ANNEX A
CENTER FOR COSMETICS REGULATION AND RESEARCH
Certificate of Free Sale issued by the government agency (National
Regulatory Authority or Chamber of Commerce) in the country of origin
ISO Certificate in compliance to GMP
Valid manufacturer’s license
FOR WHOLESALER
o Duly notarized valid distribution agreement with the FDA-licensed
supplier
FOR EXPORTER
o
o
Duly notarized valid distribution agreement with the local supplier reflecting the
country where the products are to be exported
List of products to be exported with their corresponding registration/notification
numbers and validities
2. FOR HUHS TRADER
Photocopy of the Financial statement notarized/received by the Bureau of Internal
Revenue (BIR) or notarized certification of initial capital invested
Duly notarized valid contract manufacturing agreement with the FDA-licensed Cosmetic
Manufacturer stipulating the following:
o That the trader owns the formulation
o That the trader and manufacturer are jointly responsible for the quality of the
product/s
o List of products to be manufactured by the toll manufacturer
FOR EXPORTER OF OWN FINISHED PRODUCTS:
o
Duly notarized valid distribution agreement with the supplier in the country
where the products are to be exported
o List of products to be exported with corresponding registration/notification
numbers and validities
3. FOR HUHS MANUFACTURER
Photocopy of the Financial statement notarized/received by the Bureau of Internal
Revenue (BIR) or notarized certification of initial capital invested
Site Master File (see Annex B)
List of products to be manufactured
List of manufacturing and quality control equipment and facilities
List of technical and non-technical personnel indicating their academic
qualifications and relevant experiences
Valid clearance from Department of Environment & Natural Resources (DENR)
ANNEX A
CENTER FOR COSMETICS REGULATION AND RESEARCH
FOR REPACKER:
o Duly notarized valid contract/agreement with the manufacturer of the
product/s to be repacked with stipulation that both the manufacturer and
repacker are jointly responsible for the quality of the product
o List of products to be repacked
o List of repacking and quality control equipment and facilities
FOR TOLL MANUFACTURER:
o Duly notarized valid contract manufacturing agreement with the FDAlicensed HUHS Distributor or Trader
o List of products to be manufactured by the toll manufacturer
FOR EXPORTER OF OWN FINISHED PRODUCTS/FINISHED BULK:
o Duly notarized valid distribution agreement with the supplier in the
country where the products are to be exported
o List of products to be exported with notification/registration numbers and
validity
C. FEES AND CHARGES (LTO valid for 1 year)
Proof of payment of fees as prescribed by the current FDA regulations
II.
RENEWAL APPLICATIONS(can be filed at least 3 months before LTO expiry date)
A. AUTOMATIC RENEWAL
Completely accomplished and notarized Integrated Application Form (Refer to
FDA Circular No. 2014-003) (for NCR and CHD IV-A)
Duly notarized Affidavit of Undertaking for Automatic Renewal (except for NCR
and CHD IV-A)
Photocopy of the Financial statement notarized/received by the Bureau of Internal
Revenue (BIR) or notarized certification of initial capital invested (for traders
and manufacturers only)
Original LTO (scanned copy only for NCR and CHD IV-A)
B. REGULAR RENEWAL
Completely accomplished and notarized Integrated Application Form (Refer to
FDA Circular No. 2014-003) (only for NCR and CHD IV-A)
Letter of request for the renewal of the LTO and the changes in the status of
business since the last issuance of LTO (except NCR and CHD IV-A)
ANNEX A
CENTER FOR COSMETICS REGULATION AND RESEARCH
Photocopy of the Financial statement notarized/received by the Bureau of Internal
Revenue (BIR) or notarized certification of initial capital invested (only for
traders and manufacturers)
Original LTO (scanned copy only for NCR and CHD IV-A)
C. SCHEDULE OF FEES (LTO valid for 2 years)
Proof of payment of fees as prescribed by the current FDA regulations
III.
AMENDMENT/CHANGE OF CIRCUMSTANCES
A. ADDITION OF ACTIVITY AND SOURCE (IMPORTER, EXPORTER, WHOLESALER,
TOLL MANUFACTURER, REPACKER)
Completely accomplished Integrated Application Form (Refer to FDA Circular No.
2014-003) ( only for NCR and CHD IV-A)
Letter of intent stating the change/amendment applied for
Original LTO (scanned copy only for NCR and CHD IV-A)
Required document stated in I B (Specific Requirements)
B. DELETION OF ACTIVITY AND SOURCE
Completely accomplished Integrated Application Form (Refer to FDA Circular No.
2014-003) (for NCR and CHD IV-A)
Letter of intent stating the change/amendment applied for
Original LTO (scanned copy only for NCR and CHD IV-A)
Proof of cancellation/deletion of supplier or notarized termination agreement
C. CHANGE IN BUSINESS NAME AND ADDRESS OF SOURCE AND/OR
MANUFACTURER:
Valid Foreign Agency Agreement (FAA) or any form of authorization from each
source/supplier duly authenticated by the Territorial Philippine Consulate reflecting the
new business name or address
If the source/supplier has appointed another logistic/invoicing company, any of the
following:
o Valid Supply Agreement between the foreign source/supplier and manufacturer
reflecting the new business name or address
o Valid Tripartite Agreement duly authenticated by the Territorial Philippine
Consulate reflecting the new name or address
Proof of GMP compliance of manufacturer under the new business name or address
ANNEX A
CENTER FOR COSMETICS REGULATION AND RESEARCH
D. ADDITION/DELETION OF PRODUCT
Completely accomplished Integrated Application Form (Refer to FDA Circular No.
2014-003) (for NCR and CHD IV-A)
Letter of request
Original LTO (scanned copy only for NCR and CHD IV-A)
If distributor/wholesaler, amendment in the distribution agreement with the FDA-licensed
supplier
If distributor/importer, amendment in the Foreign Agency Agreement (FAA) or any form
of authorization with the source/supplier duly authenticated by the Territorial Philippine
Consulate
If trader, amendment in the manufacturing agreement with the FDA-licensed
manufacturer
If manufacturer, letter of request for inspection
E. CHANGE OF BUSINESS NAME
Completely accomplished and notarized Integrated Application Form (Refer to FDA
Circular No. 2014-003) (only for NCR and CHD IV-A)
Letter of request
Original LTO (scanned copy only for NCR and CHD IV-A)
Notarized Accomplished Petition Form with 2 x 2 ID picture of
Owner/Incorporator/Authorized Representative (except for NCR and CHD IV-A)
Notarized Joint Affidavit of Undertaking with 2 x 2 ID picture of Authorized Person
(except for NCR and CHD IV-A)
Proof of Business Registration with amended business name
Amended agreement with each source/supplier reflecting the new business name
F. CHANGE OF OWNERSHIP/ MERGING/ BUY-OUT
Completely accomplished Integrated Application Form (Refer to FDA Circular
No. 2014-003) (for NCR and CHD IV-A)
Letter of request
Original LTO (scanned copy only for NCR and CHD IV-A)
Deed of Sale or Transfer of Rights
All the required documents applied for initial/opening application (for distributor
only)
G. TRANSFER OF OFFICE/WAREHOUSE ADDRESS (Distributor & Trader)
Completely accomplished Integrated Application Form (Refer to FDA Circular
No. 2014-003) (for NCR and CHD IV-A)
Letter of request
ANNEX A
CENTER FOR COSMETICS REGULATION AND RESEARCH
Original LTO (scanned copy only for NCR and CHD IV-A)
Proof of business registration (DTI or SEC) reflecting the new address
All required documents for proof of occupancy
H. TRANSFER OF MANUFACTURING SITE
Completely accomplished Integrated Application Form (Refer to FDA Circular
No. 2014-003) (for NCR and CHD IV-A)
Letter of request for inspection
Original LTO (scanned copy only for NCR and CHD IV-A)
All the required documents applied for initial/opening application
I. SCHEDULE OF FEES
Proof of payment of fees as prescribed by the current FDA regulations
IV.
OTHERS
A. RE-ISSUANCE OF LOST/DILAPIDATED LTO
Completely accomplished Integrated Application Form (Refer to FDA Circular
No. 2014-003) (only for NCR and CHD IV-A)
Letter of request
Original LTO (scanned copy only for NCR and CHD IV-A) (if lost, submit an
affidavit of loss)
Proof of payment of fees as prescribed by the current FDA regulations
B. CLOSURE OF BUSINESS ACTIVITY
Letter of request
Original LTO (if lost, submit an affidavit of loss)
Over the counter submission at PAIR Unit
NOTES:
1. If activity only deals with manufacturing, trading and distribution of raw materials except for
Household/Urban Pesticides, please refer to FDA Circular 2013-015 entitled “Deregulation of
Bulk Industrial Chemicals Used as Raw Materials in Cosmetic Products and Household Products
Considered as Urban Hazardous Substances”
2. For applicant establishments in NCR and CHD IV-A, all documentary requirements should be in
electronic copies stored in a USB flash drive and submitted in FDA Main Office in Alabang,
Muntinlupa City following the guidelines in FDA Circular 2014-003 (Link:
http://www.fda.gov.ph/issuances-2/others-laws-and-regulations-not-applicable-to-the-abovecategories/others-fda-circular/145645-fda-circular-no-2014-003)
ANNEX A
CENTER FOR COSMETICS REGULATION AND RESEARCH
3. For applicant establishments in other regions, all documentary requirements should be filed in an
orange folder with electronic copies saved in a DVD-R and submitted in respective FDA
Regional Offices or CHDs in each region.
