Major_spz_x_dwie_belki_gwiazdka_konopie_prod_at... -

: Establishes strict rules for what qualifies as a valid ICSR.

: Guidance on how the EMA monitors literature for certain active substances, reducing the duplicative workload for MAHs.

This "detailed guide" is part of a broader set of that govern pharmacovigilance in the EU. It is specifically tied to Module VI , which handles the collection, management, and submission of reports for suspected adverse reactions. major_spz_x_dwie_belki_gwiazdka_konopie_prod_at...

: Instructions for performing "duplicate checks" to avoid redundant entries when the same case appears in multiple databases or journals.

: Specific details like gender or age must be present. : Establishes strict rules for what qualifies as

: Clear identification of the substance or medicinal product involved.

The document provides a structured workflow for processing adverse drug reaction (ADR) data: It is specifically tied to Module VI ,

This guide is designed for to ensure they correctly identify and report Individual Case Safety Reports (ICSRs) found in medical literature. Key Components of the Guidance