Workaround for the FDA Rejection for a Foreign Case- "Primary Source for Regulatory Purposes (C.2.r.5) = 1 and Reporter's Country Code (C.2.r.3) is empty" (Doc ID 3074927.1)

Last updated on MARCH 04, 2025

Applies to:

Goal

The purpose of this document is to provide a workaround for the FDA rejection for a foreign Case- "Primary Source for Regulatory Purposes (C.2.r.5) = 1 and Reporter's Country Code (C.2.r.3) is empty".

This error is encountered when a foreign Case is Transmitted with Protect Confidentiality enabled resulting in the C.2.r.3 data element to be populated as MSK.

FAERS regulations can be found using the below URL: https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions.

Solution

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