SOCIAL QUESTIONS|health|pharmaceutical industry
- tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- regelmäßiger aktualisierter Unbedenklichkeitsbericht | PSUR | regelmäßig aktualisierter Sicherheitsbericht
- de
- PSUR | Periodic Safety Update Report
- en
- Definition update report on the worldwide safety experience of a medicinal product that must be submitted by the marketing authorisation holder to the competent authorities at defined time points after authorisation Reference COM-EN based on: European Medicines Agency. ICH Topic E 2 C (R1). Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs. Step 5. Note For Guidance On Clinical Safety Data Management: Periodic Safety Update Reports For Marketed Drugs. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002780.pdf [28.3.2012]
- Comment A single report may cover all products containing the same active substance(s) licensed by one MA holder. The report will usually include all dosage forms and formulations, as well as all indications, associated with such an active.For combinations of substances which are also registered individually, safety information for the fixed combination may be reported either in a separate PSUR or be included as a separate presentation in the report for one of the separate components, depending on the circumstances. Cross-referencing all relevant PSURs is essential.References:MHRA (Medicines and Healthcare products Regulatory Agency) > How we regulate > Medicines > Licensing of medicines > Information for licence holders > Periodic Safety Update Reports, http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/PeriodicSafetyUpdateReports/index.htm [23.4.2012]& 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 [23.4.2012]
- PSUR | rapport périodique actualisé de sécurité | rapport périodique actualisé relatif à la sécurité | rapport périodique actualisé de pharmacovigilance
- fr
- Definition document qui propose une évaluation des effets indésirables recensés par un laboratoire et qui doit être régulièrement soumis aux autorités sanitaires compétentes Reference Sénat français > Travaux parlementaires > Missions d'information > Mission commune d'information Mediator > Comptes rendus, comptes rendus de la mission commune d'information sur le Mediator, http://www.senat.fr/compte-rendu-commissions/20110523/mediator.html [8.10.2012]
- Comment L'enjeu n'est pas de savoir comment assurer le suivi en matière de pharmacovigilance, mais de faire connaître les événements indésirables qui se sont produits depuis le dernier rapport dans le cadre de l'utilisation d'un médicament.