: Clear identification of the substance or medicinal product involved.
: Guidance on how the EMA monitors literature for certain active substances, reducing the duplicative workload for MAHs. major_spz_x_dwie_belki_gwiazdka_konopie_prod_at...
The phrase appears to be a specific, internal file or code name associated with the European Medicines Agency (EMA) and its Good Pharmacovigilance Practices (GVP) . Specifically, this string is found in the metadata of the detailed guide regarding monitoring medical literature , which outlines the entry of relevant information into the EudraVigilance database. Purpose of the Guide : Clear identification of the substance or medicinal
: Establishes strict rules for what qualifies as a valid ICSR. Specifically, this string is found in the metadata
: Instructions for performing "duplicate checks" to avoid redundant entries when the same case appears in multiple databases or journals.
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