Website content concerning the obligations of MAHs in terms of pharmacovigilance has been updated
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content of the website concerning Pharmacovigilance obligations of MAHs has been reviewed in order to eliminate outdated information and introduce a clear and easy-to-follow structure.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
