Begrundelsen for indbringelsen var, at der er forskelle mellem medlemsstaternes produktresuméer, herunder kvalitetsaspekter, for Lamictal og tilknyttede navne, som er godkendt i EU- medlemsstaterne, hvad angår indikationerne:
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Lamictal and associated names approved across EU Member States, with respect to the indication,