7 Set up Reporting Rules

We recommend you retain the existing expedited reporting rules (#1, #2) for 15-day and periodic report types, and create the other new expedited reporting rules, below are the suggested reporting rules:

Country	License Type	Agency	Rule Name	Time Frame	Report Form	Condition
United States	Marketed Drug	FAERS	15-day	15	E2B	Serious (Event) = Yes and Listedness (Event) = No
United States	Marketed Drug	FAERS	Periodic	60	E2B	Case Serious = No or Case Serious = Yes Criteria using Advance conditions: Case Listedness = Yes Any other condition as per your company’s business process
United States	Marketed Drug	FAERS	5-day	5	E2B	Criteria using Advance conditions Remedial Action exists Case Classification = Combination Product Any other condition as per your company’s business process
United States	Marketed Drug	FAERS	30-day	30	E2B	Case Serious = No Criteria using Advance conditions Malfunction = Yes Case Classification = Combination Product Any other condition as per your company’s business process
World	Marketed Drug	FAERS	30-day	30	E2B	Case Serious = No Criteria using Advance conditions: Case Classification = Combination Product Malfunction = Yes Product type = Treatment/Other Drug not administered = Yes Similar Device = Yes