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Marketing authorization may be acquired using one of the following pathways (21 USC 387j): Substantial equivalence (SE) report for new TNCPs that have the same characteristics as another product with market approval or its exemption when applicable Premarket Tobacco Product Application (PMTA) The information to be included into SE reports is judged on a case-by-case basis, primarily depending on the changes proposed to the new product compared to a predicate product in a report

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