A description of medicines-related safety issues evaluated through a referral procedure at the EU level after 2012.
Andreea FarcasTeodora BalcescuLaura AnghelCamelia BucșaCristina MogoșanPublished in: Expert opinion on drug safety (2020)
PRAC recommended routine or additional RMMs for most referrals. Complete withdrawal of a drug or withdrawal of certain pharmaceutical forms or concentrations was advised only when the risk could not be managed by RMMs.