: Guidance on how the EMA monitors literature for certain active substances, reducing the duplicative workload for MAHs.
: Instructions for performing "duplicate checks" to avoid redundant entries when the same case appears in multiple databases or journals. major_spz_x_dwie_belki_gwiazdka_konopie_prod_at...
: Formatting requirements for recording information in the EudraVigilance database, including author names and journal details in Vancouver style . Regulatory Context : Guidance on how the EMA monitors literature
: Clear identification of the substance or medicinal product involved. major_spz_x_dwie_belki_gwiazdka_konopie_prod_at...
detailed-guide-regarding-eudravigilance-data-management- ... - EMA