12.06.2025
To the attention of marketing authorization holders and of interested persons
Please be informed that NAMMDR has published on its website general information regarding various types of pharmacovigilance activities, such as: Risk management plan (RMP), Periodic safety update reports (PSURs), Safety signals, Pharmacovigilance referrals, Post-authorisation safety studies (PASS).
Also, the section Educational materials has been updated in regards to ”Instructions for MAHs regarding submission for approval of educational materials”.
These documents contain important information to be considered by the MAHs in their pharmacovigilance activities.
Please consult the NAMMDR website, section Medicinal products for human use – Pharmacovigilance.