The document provides a structured workflow for processing adverse drug reaction (ADR) data:
: Clear identification of the substance or medicinal product involved. major_spz_x_dwie_belki_gwiazdka_konopie_prod_at...
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. The document provides a structured workflow for processing
: Specific details like gender or age must be present. which handles the collection
: Guidance on how the EMA monitors literature for certain active substances, reducing the duplicative workload for MAHs.
: Establishes strict rules for what qualifies as a valid ICSR.