28 • indenfor 60 dage hvis et væsentlig (pharmacovigilance eller risiko minimering) delmål er opnået. • ved foranledning fra EMEA.
28  When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities  Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached  At the request of the EMEA