Guidelines on the Submission of LTO and CPR Application With Electronic Copy (E-Copy)

The following guidelines on the Submission of LTO and CPR Application With Electronic Copy (E-Copy) are based on FDA Memorandum Circular No. 2013-001 issued January 2, 2013. 




Requirement:
  1. Necessary requirements stated at Annex 2 & Annex 3 (Checklist of Requirements for LTO and CPR)  in hard copy and soft copy. The electronic or scanned copy (soft copy) must be in PDF Searchable Format at least 300 dpi and saved in DVD-R. Along with this is the Notarized Affidavit verifying that the Electronic Company Application/Product Dossier is the exact copy of the printed documents (hard copy).
  2. Standard requirements of Annex 2 & Annex 3 must be labelled accordingly whether LTO or CPR Application. It must have table of contents with the number of pages. Every documents must be divided with ear tags and place inside a Data Folder. Please take note of the following specification and color coding: 

LTO Data Folder (Size - 4" thick, A4 Size, 3-hole binder)
  • Dark Blue - Food
  • Green - Drug
  • Orange - Cosmetics
  • White - Medical Devices
  • Red - Household Urban/Hazardous Substances/Product Including Pest Control Providers
CPR Date Folder (Size - 4" thick, Legal Size, 3-hole Binder
  • Dark Blue - Food
  • Green - Drug
  • Orange - Cosmetics
  • White - Medical Devices
  • Red - Household Urban/Hazardous Substances/Product Including Pest Control Providers

For filing of application please see PROCESS FLOWCHART.
For copy of AFFIDAVIT, you can download it at FDA Website or you ask for copy at our CONTACT PAGE and we will email it to you. 


Disclaimer: 
The information and reference materials contained here are intended solely for the general information of the reader and NOT intended to replace the official advisory. We are only helping the FDA Philippines in disseminating these announcements.  The owner of this site disclaims any responsibility for the decisions you make based on this information. 

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