SOCIAL QUESTIONS|health|pharmaceutical industry
- tuarascáil neamhspléach thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- stand-alone periodic safety update report | stand-alone PSUR | PSURs | reports
- en
- Definition independent periodic safety update report (PSUR) [ IATE:3535677 ] prepared for a combination of active substances authorised to one marketing authorisation holder for which separate single-substance PSURs [ IATE:3542065 ] have been provided Reference COM-EN, based on:European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VII – Periodic safety update report http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123207.pdf [11.4.2012] and on information provided by DG SANCO [30.3.2012]
- Comment Stand-alone PSURs should be cross-referenced to the related single-substance PSURs.