CRO and Sponsor - Integrated Application Form
CRO and Sponsor - Integrated Application Form
CRO and Sponsor - Integrated Application Form
PROCEED
PROCEED
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 ______________________________