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What are the pre-filing time limits for Prior Notice and when will they be enforced?

What are the pre-filing time limits for Prior Notice and when will they be enforced?

Prior Notice data must be electronically submitted and confirmation issued by the FDA before the clock starts.  The pre-filing times are dependent upon the mode of transportation for the goods. The minimum time limits are:

  • Truck/Pedestrian/Cart/Car: 2 hours before arrival
  • Air/Rail: 4 hours before arrival
  • Vessel: 8 hours before arrival

Merchandise arriving by ferry carries the same time frames as the mode of transportation placed on the ferry.

The earliest that PN data can be filled is 10 days prior to the arrival of the goods into the United States.  The law requires that trade must currently abide by these time limits.