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Lot Distribution Report LDR

Lot Distribution Report LDR

In US under 21 CFR 600.81, marketing authorisation applicants must submit to the Center for Drug Evaluation and Research (CDER), LDRs containing certain specified information every 6 months about the quantity of the product distributed under their Therapeutic Biologic Applications (BLAs).

Biologic Lot Distribution Data must be submitted in SPL XML format within eCTD submissions.

FDA requires applicants to submit Biologic LDRs in an electronic format that the agency can process, review, and archive. This reporting requirement is effective as of June 10, 2015.

Every six months, applicants must submit to the appropriate center, LDRs containing certain specified information about the quantity of the product distributed under their BLAs (including to distributors).

The lot distribution file should be included in eCTD Module 3, section 3.2.R Regional Information. The lifecycle for this file should be updated as appropriate, in accordance with the current eCTD specification.