Regulatory Requirements for Applications with 'Awaiting Additional Documents' and 'Rejected' decisions

Notice to All Authorized Local Manufacturers and Importers,

This is to formally inform all authorized local Manufacturers and Importers of the following regulatory requirements regarding submissions for New, Renewal, and Re-registration applications with decisions of "Awaiting Additional Documents" or "Rejected."

  • For applications under "Awaiting Additional Documents," the required documents may be submitted within one (1) year from the date of the CEO's approval of the latest evaluation, along with the applicable data evaluation fee.
  • After one (1) year from the above decisions, the application will be considered a new application, and a new dossier with a sample license must be submitted.
  • No appeals will be accepted for such cases beyond the one-year period.