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Amendment to FDA Memorandum Circular No. 2014-008 or "Guidelines on the Electronic Notification of Selected Household/Urban Hazardous Substances System

FDA amendment to guidelines on the electronic notification of selected household/urban hazardous substances system

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CHECKLIST of REQUIREMENTS
INITIAL APPLICATION FOR CERTIFICATE OF PRODUCT REGISTRATION (CPR)

HOUSEHOLD / URBAN PESTICIDES (HUP)
1. Documentary Requirements
1.1
Forms to be accomplished correctly and completely:
 Revised Assessment Slip (Ref: BC 20 s. 2005 Subject: Revised Assessment
Slips)
 Notarized Application Form and Declaration
 BFAD Worksheet: PART I ONLY
1.2
Attachments
 Copy of Valid License To Operate
 For Manufacturers – List of Trader/s and Product Lines must be reflected
 For Traders – List of Toll Manufacturer and List of Product Lines must be
reflected
 For Importer/Distributor – List of Product Source for Imported Products as
well as the Actual Manufacturer must be reflected
 For Wholesaler/Distributor – List of Product Source must be reflected
 Certificate of Agreement between Manufacturer/Importer/Trader/Distributor
regarding the product
 Duly Authenticated and Notarized by the Philippine Embassy shall be
submitted for Imported Products
 Certificate of Free Sale issued by a government authority
 Certificate of Good Manufacturing Practice
 Manufacturing License
2. Technical Requirements
2.1
Composition
 Qualitative and Quantitative composition of the finished product expressed in
percent
 Technical specification of raw materials used as a component of the product
2.2
Finished Product Description
 Finished Product Specifications
 Certificate of Analysis of the Finished Product
 Complete Test Methods used on the Finished Product
2.3
Substantiation to support special product claims
3. Unattached legible, comprehensible and indelible specimen of all labeling
materials per pack size (e.g. outer, immediate, package insert (if applicable)
(A.O. 311 s. 1977).
4. Specimen of the finished commercial product.
5. Additional Requirements






Material Safety Data Sheet
Bioefficacy Study
Toxicity Study
Stability Study
E-Copy (FDA Memorandum Circular Nos. 2013-001 and 2013-001-A)
 
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