Guideline Good Pharmacovigilance Practices GVP Module VI Collection Management AND Submission Reports Suspected Adverse Reactions Medicinal Products REV 2
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-and-submission-reports-suspected-adverse-reactions-medicinal-products-rev-2
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