Philippines FDA requires e-Copies of LTO and CPR applications

Effective February 1, 2013, medical device and pharmaceutical manufacturers must now submit an electronic copy of the necessary forms in addition to a hard copy when applying for a License to Operate (LTO) and Certificate for Product Registration (CPR).

The requirements for the electronic copy are as follows:

  • Scanned copy in PDF searchable format at least 300dpi
  • On a DVD-R of the application
  • Submitted with a notarized affidavit stating the attached electronic company application/product dossier is the exact duplicate of the hard copy
  • The copy should be properly labeled  (LTO/CPR Application)