Prior Notice Service Terms
Client responsibilities, required information and cases in which Access FDA may refrain from transmitting a Prior Notice.
Draft pending legal review. This text is not yet the final, binding version.
What Prior Notice is
Prior Notice is the advance notice that must be submitted to the FDA before a shipment of imported food arrives in the United States, under applicable regulation (21 CFR Part 1, Subpart I). Access FDA may prepare and transmit the Prior Notice on the Client’s behalf when contracted.
Information the Client must provide
For each shipment, the Client delivers sufficiently in advance:
- the product (identity, presentation and quantities);
- shipment and transport details (mode, estimated dates and port of entry);
- the manufacturer and shipper, with their registration numbers when applicable;
- the importer, owner and consignee in the United States;
- the applicable documents (invoice, packing list and any others required).
[Pending: minimum lead time for the Client to send the information.]
Responsibility and refraining from transmission
The Client is responsible for the accuracy of the information provided. Access FDA may refrain from transmitting a Prior Notice when the documentation is incomplete, contradictory or insufficient, or when a prior regulatory requirement is pending. When appropriate, Access FDA may first recommend a Regulatory Assessment or another preparatory service.
Examples of a pending prior regulatory requirement are the lack of a current facility registration or product information that does not match its label.
Confirmation
When the Prior Notice is transmitted, Access FDA delivers the corresponding confirmation to the Client. That confirmation is not the admission of the shipment: the FDA and other authorities may review, inspect or hold the goods.
Limits
Access FDA does not promise border crossing or the release of shipments. Holds for reasons other than Prior Notice (for example, import alerts, labeling or sampling) can be handled through the detained shipment support service, quoted separately.
Payments
The General Terms of Service and the accepted proposal apply. [Pending: per-shipment or package pricing scheme.]