The Commission is empowered to adopt delegated acts in accordance with Article 87b, in order to supplement this Regulation by determining the situations in which post-authorisation efficacy studies may be required under point (cc) of Article 9(4) and point (b) of Article 10a(1).’;
Tugtar de chumhacht don Choimisiún gníomhartha tarmligthe a ghlacadh i gcomhréir le hAirteagal 87b, chun an Rialachán seo a fhorlíonadh trí na cásanna a chinneadh ina bhféadfadh gá a bheith le staidéir éifeachtúlachta iar-údaraithe faoi phointe (cc) d’Airteagal 9(4) agus pointe (b) d’Airteagal 10a(1).”;