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det er ikke nødvendigt, at indehaverne af markedsføringstilladelser systematisk inkluderer detaljerede fortegnelser over individuelle sager, herunder sagsbeskrivelserne, i den periodiske, opdaterede sikkerhedsindberetning.
marketing authorisation holders shall not be required to include systematically detailed listings of individual cases, including case narratives, in the periodic safety update report.
Last Update: 2014-11-21
Usage Frequency: 1
Quality:
de skal dog fremlægge sagsbeskrivelserne i det relevante risikovurderingsafsnit i den periodiske, opdaterede sikkerhedsindberetning, hvis de er væsentlige for den videnskabelige analyse af et signal eller en sikkerhedsbekymring i det relevante risikovurderingsafsnit.
however, they shall provide case narratives in the relevant risk evaluation section of the periodic safety update report where integral to the scientific analysis of a signal or safety concern in the relevant risk evaluation section.
Last Update: 2014-11-21
Usage Frequency: 1
Quality: