When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
Tootele loa andmisel hindavad liikmesriigid neid riske ja tagavad seejärel, et võetakse asjakohased meetmed või kehtestatakse eritingimused kindlakstehtud riskide vähendamiseks.