Recently, content of the website concerning Pharmacovigilance obligations of MAHs has been reviewed in order to eliminate outdated information and introduce a clear and easy-to-follow structure. Main changes are summarised below:
- Adverse drug reaction reporting: Small updates with no change of content
- Direct healthcare professional communication (DHPC): Revised, with new content
- Additional risk minimisation measures: Unchanged content
- Periodic safety update reports (PSURs): Small updates with no change of content
- EU-QPPV and local pharmacovigilance contact: Revised, with new content
- Pharmacovigilance inspection: Unchanged content
