CRO and Sponsor - Integrated Application Form

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Department of Health

Food and Drug Administration

5 SOURCES & CLIENTS PROCEED


APPLICATION FORM 1 None
This is the application form. Without the
appropriate petition or declaration form, this
application may be rejected.
Document Tracking Number APPLICATION FORM STATUS
GENERAL INFORMATION: PROCEED
ESTABLISHMENT INFORMATION: PROCEED
Description (Optional): PRODUCT INFORMATION: PROCEED
SUPPORTING INFORMATION: PROCEED
1 GENERAL INFORMATION PROCEED SOURCES & CLIENTS: PROCEED
1.1 Product Center: Household and Urban Hazardous Substances
APPLICANT INFORMATION: PROCEED
ORDER OF PAYMENT
1.2 Authorization: Product Registration Amount Due: Php 1,010.00
Fee : Php 1,000.00
1.3 Type: Initial Legal Research Fee : Php 10.00
Surcharge : Php -
1.4 Primary Activity: Processor OR Number :
Date Paid:
Computation Valid Until: 00 January, 1900
This form was last edited on 18 May 2015, 5:50 PM.
1.5 Current License 4 SUPPORTING INFORMATION
253-671-125
Number: PROCEED
1.5.1 Expiry Date: 17-Nov-23 PROCEED
Your License will expire in 260 days.

PROCEED

PROCEED

2 ESTABLISHMENT INFORMATION PROCEED


2.1 Name of Establishment
J&S Products and Innovation, Inc.
2.2 Declared Capital (PhP): 250 K and below
2.3 Tax Identification Number: 127-812-996
2.4 Office Address 2.5.1 Region: NCR
Manila, Philippines 1008
2.5 Warehouse Address 2.6.1 Region: NCR
Manila, Philippines 1008
6 APPLICANT INFORMATION PROCEED
2.6 Plant Address 2.7.1 Region: NCR
The undersigned attest to have provided true and complete information in this form, and to provide complete
Manila, Philippines 1008
requirements at the time of submission. The undersigned agree to strict compliance with the rules and regulations of the
2.7.0 E-mail Address: [email protected] Food and Drug Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage Practice
2.7.1 Contact Detail 1 Mobile: 9173353820 (GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree to grant
2.7.2 Contact Detail 2 Mobile: 9327891209 authority to the FDA to verify the truthfulness of the information provided with this application.
2.7.3 Contact Detail 3 Mobile: 9271802987
6.1 APPROVING AUTHORITY
Signature 6.1.5 Mailing Address
Sigred Evangelista, Sta. Mesa,
3 PRODUCT INFORMATION PROCEED Manila, Philippines
Household
3.1 Product Category: Hazardous Substance 6.1.1.0 Family
Latest photo of applicant Evangelista
3.1.1 Valid Period Applied For (Years): 2 Name:
3.2 Product/Brand Name 6.1.1.1 First
Sigred
Forda Clean Name(s): 6.1.6.0 E-mail Address:
6.1.1.2 Middle [email protected]
Lambac
Name: 6.1.6.1 Contact Detail 1
6.1.2 Designation: Owner/ General Manager/ President Mobile: 9298147915
6.1.3 Tax ID Number: 531-342-124 6.1.6.2 Contact Detail 2
6.1.4.0 Type of Gov't ID: Philippine Passport Landline: (032) 272-0307
6.1.4.1 ID Number: P00000000A 6.1.6.3 Contact Detail 3
6.1.4.2 Date Expiry: 26-Jun-24 Mobile: 9156257381
6.2 APPLICANT Add
Signature 6.2.5 Mailing Address
Jon Allen Soriano, Caloocan City,
Philippines

Transparent container made with PET PROCEED 6.2.2.0 Family


3.4.0 Latest photo of applicant Soriano
Name:
Packaging: 6.2.2.1 First
Jon Allen
3.4.1 Presentation: Tall Name(s): 6.2.6.0 E-mail Address:
3.4.2 Storage Condition: Dry and well-ventilated are 6.2.2.2 Middle [email protected]
Lorenzo
3.4.3 Shelf-life: 2 years and 6 months Name: 6.2.6.1 Contact Detail 1
3.4.4 Sugg. Retail Price Php 80.00 6.2.2 Designation: Authorized Representative Mobile: 9163324589
6.2.3 Tax ID Number: 978-217-189 6.2.6.2 Contact Detail 2
6.2.4.0 Type of Gov't ID: Philippine Passport Mobile: 9279108756
6.2.4.1 ID Number: P00000000C 6.2.6.3 Contact Detail 3
6.2.4.2 Date Expiry: 21-Nov-25 Landline: (074) 304-4622

Page 1 CRO-and-Sponsor_Integrated-Application-Form 3/2/2023 9:13 AM


FALSE
Food
This is the declaration form for non-pharmaceutical product registration or notification by the Food and Drug Administration of the Philippines.

DECLARATION
We assume primary responsibility and/or stewardship over the product in case of liability, adverse events, or other public health & safety issues
arising from its use. We agree to have in good faith exerted due diligence in ensuring that third-party intellectual property rights are not infringed.
We further agree and bind ourselves that the label of the product shall at all times conform to the labeling regulations, and shall not be presented
including any advertisement of the product in a manner that is false, deceptive, misleading, or contrary to public policy. Non-observance of any of
the undertakings in this declaration is deemed a misrepresentation which is a ground for disapproval of this application or, if approved, the
suspension or cancellation of the product registration/ notification.
Enclosed are the documents stated in the Checklist of Requirements for Registration of our product:
Forda Clean;
We categorically declare that all data and information submitted in connection with this application as well as other submission in the future including
amendments, are true and correct and reflect the total information available.
We certify that we have examined the following statements and we attest to their accuracy and truthfulness:
1. The attached electronic copy of files/documents/information of this application are the exact duplicate of the hard copy and, any deficiency,
discrepancy, prejudicial contents or willful misrepresentation on any of the data therein shall be a ground for disapproval of application and/or the filing
of legal action against the undersigned and/or the company;
2. The market authorization holder has a risk management protocol including a standard operating procedure for handling adverse event reports of its
products, and if needed, a product recall.
3. All the documentation referred to or required in this application is available for review during an audit or an inspection.
4. Any change in formulation, labelling, technical specification, or any deviation on any information given in respect of this application will first have to be
known to, cleared, and/or approved by the Food and Drug Administration.
5. All ingredients, raw materials or additives used in the manufacture of the product (listed below) are listed in a codex, reference or registry recognized by
the Philippine Food and Drug Administration, including but not limited to the Codex Alimentarius, the European Commission Inventory of Cosmetic
Ingredients, or the United States' Food and Drug Administration Cosmetic Ingredient Listing.
Chemical and/or Microbiological
Raw Materials, Additives, and/or Ingredients Physical Description Specifications
Lot Code Interpretation
1) Raw Material, Additive or Ingredient;
2) Raw Material, Additive or Ingredient;
3) Raw Material, Additive or Ingredient;
4) Raw Material, Additive or Ingredient;
5) Raw Material, Additive or Ingredient;
Provide in this space a description of the
6) Raw Material, Additive or Ingredient;
Provide in this space a description of the product in terms of rheology, thermal, and
7) Raw Material, Additive or Ingredient; Use this space to explain how the lot code
product in terms of color, texture, geometry properties among others, as
8) Raw Material, Additive or Ingredient; used on the product label is correctly
functional properties, flavor, among others, applicable; Indicate if appropriate
9) Raw Material, Additive or Ingredient; interpreted
as applicable. microbiological cultures present in the
10) Raw Material, Additive or Ingredient;
product
11) Raw Material, Additive or Ingredient;
12) Raw Material, Additive or Ingredient;
13) Raw Material, Additive or Ingredient;
14) Raw Material, Additive or Ingredient;
15) Raw Material, Additive or Ingredient;

WAIVER
I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THROUGH BOTH GOVERNMENT AND PRIVATE
RESOURCES THE AUTHENTICITY OF ALL THE INFORMATION AND DOCUMENTS SUBMITTED .

ACKNOWLEDGEMENT
SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20 ________ at ______________________________

_______________________________________________________ , Philippines, personally appeared the following :


Name and Signature Identification Number Expiry Date of ID Place Issued

Philippine Passport:P00000000A 26-Jun-24


1) Sigred Lambac Evangelista ______________________________
Philippine Passport:P00000000C 21-Nov-25
2) Jon Allen Lorenzo Soriano ______________________________
Known to me and to me known to be the same persons who execute the application form and this declaration form, and they acknowledged to me that the same is
their free and voluntary act and deed. WITNESS MY HAND AND SEAL on the date and place first above written.

Doc. No. : _____________________________


Page No. : ____________________________
Book No. : ____________________________
Series of : _____________________________
1) Active Pharmaceutical Ingredient; 1) API Manufacturer, Address Address Address; 1) API Supplier, Address Address Address;
2) Active Pharmaceutical Ingredient; 2) API Manufacturer, Address Address Address; 2) API Supplier, Address Address Address;
3) Active Pharmaceutical Ingredient; 3) API Manufacturer, Address Address Address; 3) API Supplier, Address Address Address;
4) Active Pharmaceutical Ingredient; 4) API Manufacturer, Address Address Address; 4) API Supplier, Address Address Address;
5) Active Pharmaceutical Ingredient; 5) API Manufacturer, Address Address Address; 5) API Supplier, Address Address Address;
6) Active Pharmaceutical Ingredient; 6) API Manufacturer, Address Address Address; 6) API Supplier, Address Address Address;
7) Active Pharmaceutical Ingredient; 7) API Manufacturer, Address Address Address; 7) API Supplier, Address Address Address;
8) Active Pharmaceutical Ingredient; 8) API Manufacturer, Address Address Address; 8) API Supplier, Address Address Address;
9) Active Pharmaceutical Ingredient; 9) API Manufacturer, Address Address Address; 9) API Supplier, Address Address Address;
10) Active Pharmaceutical Ingredient; 10) API Manufacturer, Address Address Address; 10) API Supplier, Address Address Address;
11) Active Pharmaceutical Ingredient; 11) API Manufacturer, Address Address Address; 11) API Supplier, Address Address Address;
12) Active Pharmaceutical Ingredient; 12) API Manufacturer, Address Address Address; 12) API Supplier, Address Address Address;

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