Guideline on Specific Adverse Reaction Follow-up 4 questionnaires (Specific AR FUQ)

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  • providing general guidance on when and how to use Specific AR FUQs,
  • guidance for MAHs on developing Specific AR FUQs,
  • and considering discontinuation and removal of Specific AR FUQs

The content of a Specific AR FUQ should focus on collecting the missing data of main importance for assessing the safety concerns in question and should be prefilled with available information to avoid requesting the primary source to repeat information. A Specific AR FUQ should not be extensive and its completion by the reporter should be easy to minimize the burden on reporters and to avoid discouraging future spontaneous reporting.

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