Desuden er de nødvendige ressourcer til en dybdegående vurdering af “ periodic safety update ” - rapporter i det omfang, der er defineret i volume 9a i bekendtgørelsen ’ Rules Governing Medicinal Product in the European Union ’, muligvis ikke tilstrækkelig under en pandemi til hurtigt at kunne identificere nye sikkerhedsproblemer.
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.